BPC-157 vs TB-500: what the human studies and FDA records show
BPC-157 vs TB-500 has no proven winner for healing injuries in people. BPC-157 has small, mostly uncontrolled human reports. FDA’s May 2026 review found no human studies of the TB-500 fragment; full-length thymosin beta-4 trials concern a different molecule. No FDA-approved product was identified, and neither appears on the final 503A list checked October 14, 2026.
Sources checked October 14, 2026. FDA BPC-157 evaluation, FDA TB-500 evaluation, and final 503A list (displayed current through October 13, 2026).
That last point changes most comparisons you will read. Below, the human studies discussed here are sorted under the molecule they used or were reported to use. You can see what is real, what is borrowed from a different substance, and what to ask before paying for either one—or a blend.
Three facts that change the answer for some readers:
- A seller cites eye-drop, heart, or skin-gel trials for TB-500? Those studies used full-length thymosin beta-4, a different molecule. See Is TB-500 the same as thymosin beta-4?
- The offer is a premixed blend? The checked evidence does not establish that combining them improves recovery. See Does combining them work better?
- You are a drug-tested athlete? Both are prohibited at all times under World Anti-Doping Agency rules. See drug-tested athletes.
BPC-157 vs TB-500: the side-by-side comparison
BPC-157 and TB-500 are different molecules with different, and thin, evidence records. BPC-157 is a 15-amino-acid peptide based on a protein found in stomach juice. TB-500, as FDA evaluated it, is a lab-made, 7-amino-acid piece of thymosin beta-4. No FDA-approved finished product containing either was identified in the records checked.
| Question | BPC-157 | TB-500 |
|---|---|---|
| What it is | A 15-amino-acid peptide described as a fragment of a protein found in human gastric juice; also called Bepecin or PL 14736 (FDA BPC-157 evaluation, May 11, 2026) | A 7-amino-acid synthetic fragment of thymosin beta-4 (positions 17–23), with an acetyl cap: Ac-LKKTETQ (FDA TB-500 evaluation, May 15, 2026) |
| Forms FDA evaluated | Free base and acetate, treated as two different ingredients | Free base and acetate, treated as two different ingredients |
| Use FDA evaluated in 2026 | Ulcerative colitis—not tendons or muscles (FDA meeting page) | Wound healing (same page) |
| Human studies FDA identified in its May 2026 evaluations | Five small studies: two rectal-enema studies, knee-joint injections, bladder-wall injections, and an IV pilot (BPC-157 appendix, p. 54) | None identified, by any route (TB-500, p. 30) |
| Strongest human efficacy design | One randomized, placebo-controlled trial in ulcerative colitis, published only as a 2005 meeting abstract; FDA judged the data inadequate (p. 27) | — |
| FDA-approved product containing it | None identified (BPC-157 evaluation, p. 9) | None identified (TB-500 evaluation, p. 7) |
| On the final 503A bulks list | No (21 CFR 216.23, version displayed current through October 13, 2026; checked October 14) | No (same) |
| FDA staff recommendation, May 2026 | Do not add to the 503A list (BPC-157 evaluation) | Do not add to the 503A list (TB-500 evaluation) |
| Advisory committee, July 23, 2026 | News reports describe a narrow vote recommending it be added; the advice is non-binding | Same reported outcome and non-binding status |
| Sport rules (WADA, 2026) | Prohibited at all times, category S0, p. 4 | Prohibited at all times as a thymosin-β4 derivative, category S2.3, p. 8 |
| FDA's main safety concerns | Possible immune reactions for injected and nasal forms, unidentified impurities, unclear ingredient identity, clotting and liver signals in 28-day animal studies, no carcinogenicity studies identified | Possible immune reactions for injected forms, unidentified impurities, naming confusion, no animal toxicity studies or human safety studies identified |
FDA's 2026 documents are staff evaluations prepared for an advisory meeting, not final agency decisions. "None identified" describes what FDA reported finding in its search; it is not proof that nothing exists anywhere.
The table answers the most common question directly: if you want the peptide with more human data, that is BPC-157—narrowly. But "more" here means a handful of small reports, not proof of better healing. The sections below show what each report measured.
Is TB-500 the same as thymosin beta-4?
No. Thymosin beta-4 (often written TB4 or Tβ4) is a natural 43-amino-acid protein. TB-500, as FDA evaluated it, is a lab-made 7-amino-acid piece of that protein with a chemical cap added. Results from full-length thymosin beta-4 do not automatically apply to the fragment.
Think of thymosin beta-4 as a 43-bead necklace. TB-500 is 7 of those beads—positions 17 through 23—with a small cap on one end. The beads match, but it is a different necklace. It can behave differently in the body.
FDA says many websites use the two names as if they mean the same thing. Its 2026 review states plainly that thymosin beta-4 and TB-500 are not the same substance (FDA TB-500 evaluation). FDA also reports finding several salts and derivatives—including different active molecules—sold under the same "TB-500" name. That is a safety problem: a patient could receive a different ingredient than the clinician intended.
Why the cap matters. Adding an acetyl group (acetylation) changes a peptide's charge, size, and how it binds to other molecules. FDA says the results of the uncapped seven-bead peptide therefore cannot be directly carried over to TB-500 (FDA TB-500 evaluation, nonclinical section).
The acetyl cap is also different from an acetate salt. FDA evaluated both free-base and acetate forms of the capped TB-500 fragment.
The lab result most comparisons leave out. The only direct wound test of TB-500 that FDA identified did not find a statistically significant benefit. In a 2024 laboratory study (Rahaman and colleagues), TB-500 free base did not significantly speed the closing of scratch "wounds" in a dish of fibroblast cells compared with a blank solution. One of its breakdown products, a shorter piece called Ac-LKKTE, produced a small effect (FDA TB-500 evaluation, p. 27). One cell-dish study cannot settle what happens in a body. It does mean the popular claim that "TB-500 heals wounds" rests mainly on studies of other molecules.
Where TB-500 came from. FDA describes a veterinary preparation marketed around 2011 for racehorses and greyhounds, and anti-doping labs built tests to detect it. Its historical discussion also points to 2003, but the nonclinical section identifies that earlier research as the uncapped fragment—not the same capped TB-500 substance (FDA TB-500 evaluation, pp. 21 and 26).
| Feature | BPC-157 | TB-500 | Full-length thymosin beta-4 |
|---|---|---|---|
| Length | 15 amino acids | 7 amino acids (Ac-LKKTETQ) | 43 amino acids for natural thymosin beta-4; the recombinant NL005 study below used a 44-amino-acid preparation |
| Origin | Based on a gastric-juice protein | Synthetic fragment of thymosin beta-4 | Natural protein found in most human cells; made in labs for clinical trials |
| Human clinical trials | Small reports (see the register below) | None identified by FDA | Yes—eye drops, skin gel, and IV safety studies for specific conditions |
| Forms described in the reviewed sources | Injection vials, capsules, nasal sprays, blends | Injection vials, blends | Mainly studied in trials; some clinics advertise "thymosin beta-4" |
Sources: FDA BPC-157 evaluation; FDA TB-500 evaluation; trial records linked in Table 3C. Checked October 14, 2026.
What to do with this: if a clinic or label says "TB-500 (thymosin beta-4)," ask which one. The answer decides which research, if any, applies to what you would receive.
Why are these peptides studied for repair at all?
Laboratory and animal findings gave researchers reasons to test both peptides. They do not show that a person will heal faster, or that two different mechanisms will work better together.
Here is one concrete example. A 2014 study cited in FDA's review exposed tendon cells from rats to BPC-157 and reported more growth-hormone receptors on those cells (Chang et al., 2014). That is a finding in a dish of animal cells. It is not a human injury trial, and it does not show that BPC-157 raises a person's growth hormone.
FDA's summary of the BPC-157 animal research describes rodent findings in the gut, liver, tendons, and nerves. It also notes that the doses tested did not show a clear dose-response pattern and that BPC-157's molecular targets and mechanisms "remain poorly understood" (FDA BPC-157 evaluation). For TB-500 itself, FDA identified no animal studies testing wound healing in a living animal.
The popular shorthand—"BPC-157 for local repair, TB-500 for whole-body repair"—comes from these mechanism ideas. No human study in the checked evidence establishes that local-versus-whole-body split.
What have human studies actually shown? The evidence register
Some human reports describe less pain, symptom relief, or short-term tolerability. The largest BPC-157 report in this register has paired outcome data for 101 people in an uncontrolled company study. FDA’s May 2026 review identified no human studies of the TB-500 fragment. Full-length thymosin beta-4 has real trials, but for eye, skin, and IV-safety questions—not injected sports injuries.
This register is a selected, decision-relevant set of original reports checked October 14, 2026. It is not a systematic review of every paper. Each row keeps the reported substance, route, population, and limit together, so the row stays accurate if you copy it.
Register A: BPC-157 human reports
| Report | People | Formulation and route | Design and follow-up | What was reported | What it cannot establish |
|---|---|---|---|---|---|
| Veljaca et al., 2002 and 2003 (meeting abstracts describing the same study, as summarized by FDA, p. 54) | 32 healthy volunteers randomized: 24 to BPC-157 and 8 to placebo | Rectal enema; a single administration, then a one-week washout and seven days of repeat administration | Randomized, placebo-controlled early safety study | Most common side effects were headache and gas; BPC-157 was mostly not detectable in blood | Abstracts only; safety monitoring unclear; not an injury study |
| Ruenzi et al., 2005, PL 14736 (meeting abstract, as summarized by FDA) | 53 adults with mild-to-moderate ulcerative colitis, randomized 1:1 to BPC-157 or placebo | 80 mg enema once daily for 2 weeks | The only randomized, placebo-controlled BPC-157 efficacy trial FDA found | Disease-activity score fell 3.2 points with BPC-157 and 1.6 with placebo; FDA reports the confidence interval for the difference crossed zero | Abstract only; the score was not clearly defined; FDA called the data inadequate to support efficacy or safety |
| Lee and Padgett, 2021 — BPC-157-only group | 12 followed patients with varied knee pain at a U.S. private clinic | Injection into the knee joint | Retrospective chart review; phone follow-up that varied in length | 11 of 12 reported improvement | No untreated or placebo group; self-reported pain; does not show repaired tissue; says nothing about capsules or under-the-skin shots |
| Same report — combination group | 4 followed patients | BPC-157 plus a substance the authors call "TB4," injected into the knee | Not randomized against the BPC-only group | 3 of 4 reported improvement | Does not identify "TB4" as the TB-500 fragment; cannot isolate the added substance's effect |
| Lee, Walker, and Ayadi, 2024 | 12 women with interstitial cystitis (a chronic bladder-pain condition) after other treatment failed | BPC-157 injected into the bladder wall during an endoscopic procedure | Uncontrolled pilot; follow-up mostly 4–6 months | 10 reported complete symptom relief; 2 reported about 80% improvement; no adverse events reported | No control or sham group; small, selected sample; not a gut or tendon study |
| Lee and Burgess, 2025 | 2 adults who had used BPC-157 before | IV infusions on two days | Uncontrolled safety pilot; observed through 24 hours after the second infusion | No adverse reactions reported | Two previously exposed people over three days cannot establish general or long-term safety; injury recovery not tested |
| OvationLab oral results summary, August 22, 2024 (company-associated results summary) | Paired data for 101 adults with chronic pain, mostly lasting over 6 months; initial enrollment and attrition not stated | Delayed-release oral BPC-157 capsule, swallowed; methods describe BPC-157 arginate with SNAC, while the cover depicts an acetate-associated structure | Uncontrolled, about 4 weeks; not established as a peer-reviewed journal article; not among the reports FDA listed | Average pain-intensity score on a standard scale (PROMIS T-score) fell from 65.0 to 58.7; pain-interference score fell from 62.8 to 57.8; pain-quality score fell from 53.7 to 47.2; no adverse events reported | No comparison group, so the change cannot be separated from time, expectation, or other care; scores are not a healing rate; the formulation conflict is unresolved, and product identity was not independently verified |
Also registered: an oral-tablet safety study of BPC-157 in healthy volunteers in Mexico (NCT02637284, 42 planned; sponsor PharmaCotherapia d.o.o., at Hospital Ángeles Tijuana). The last posted update is December 22, 2015; status is unknown, previously active but not recruiting. It shows no posted results, and FDA could not find a publication. The registry notes an unposted results submission and contains conflicting narrative and structured dates; neither establishes an outcome. Current injury-study records appear in Do new trial listings change the answer?
Our arithmetic: The participant totals in FDA's five-study summary add up to 32 + 53 + 17 + 12 + 2 = 116, including placebo recipients. (The knee report reviewed 17 patients and reached 16.) This is not 116 BPC-157 recipients: eight healthy volunteers and about half of the colitis group received placebo. Both enema studies had a comparison group; only the colitis trial tested clinical efficacy. This is a sum of reported study populations, not a pooled healing rate or a verified count of unique people across all research.
Register B: the TB-500 fragment
| Evidence type | Finding |
|---|---|
| Human clinical studies, any route | None identified |
| Human blood-level (pharmacokinetic) studies | None identified |
| FDA adverse-event database (FAERS), through March 26, 2025 | 0 reports |
| FDA food and supplement complaint system (January 1, 2004–March 10, 2025) | 2 reports about "blended TB-500 and BPC-157," with no safety assessments |
| Animal toxicity studies (single-dose, repeat-dose, genetic, reproductive, cancer) | None identified |
| Animal studies testing TB-500 for wound healing | None identified; a horse study measured blood levels only |
| Cell-dish wound test | TB-500 free base did not significantly speed scratch-wound closure (Rahaman, 2024; FDA, p. 27) |
| Pharmacies found marketing it in FDA's review | None identified; FDA also reported no outsourcing-facility submissions in the data it accessed February 15, 2024 |
| Approved products in the countries checked by FDA | None identified in that review (including Canada, Australia, U.K., and the EU) |
Source: FDA TB-500 evaluation, May 15, 2026, checked October 14, 2026. FAERS reports do not prove cause, and FDA notes that adverse events involving compounded and research products can go unreported.
Register C: full-length thymosin beta-4 — not TB-500
These are listed so you can recognize evidence that is often borrowed for TB-500. They are real human trials of full-length or recombinant thymosin beta-4 preparations, not the TB-500 fragment, and involve different routes and conditions.
| Trial or product | People | Route | What it showed | Why it does not apply to TB-500 |
|---|---|---|---|---|
| RGN-259 0.1% eye drops for dry eye (Sosne and Ousler, 2015) | 72 randomized, 69 completed; 28 days | Eye drops | Neither main (co-primary) result beat placebo (P = 0.26 and 0.22); some secondary and after-the-fact analyses favored the drug | Full protein, eye surface, dry eye |
| RGN-259 eye drops for neurotrophic keratopathy, a non-healing cornea condition (Sosne et al., 2023 issue) | 10 on drug, 8 on placebo analyzed | Eye drops | 6 of 10 vs 1 of 8 healed at 4 weeks; main comparison not statistically significant (P = 0.0656) | Full protein, eye surface, rare condition |
| RGN-352 IV, Phase 1 (Ruff et al., 2010; sponsor summary) | The paper's abstract describes four cohorts of 10 healthy volunteers, with single-dose and 14-day repeat-dose phases; the sponsor reports 40 per phase, not a verified total of 80 different people | IV | The abstract reports infrequent mild or moderate adverse events and no serious adverse events or dose-limiting toxicities; the sponsor reported none judged drug-related | Safety only, healthy people, full protein; abstract and sponsor summary, not a full-text audit |
| Recombinant thymosin beta-4 (NL005), Phase 1, China (2021 report) | 54 single-dose and 30 multi-dose healthy adults, including placebo groups | IV | Studied safety, blood levels, and antibodies against the drug; adverse events were mild or moderate, with no serious adverse events or dose-limiting toxicities reported | Safety only; a 44-amino-acid recombinant preparation, not the 7-amino-acid TB-500 fragment |
| RGN-137 skin gel: pressure ulcers (NCT00382174, RegeneRx) | 72 enrolled: 54 active, 18 placebo | Gel applied to the skin; up to 84 days | Posted results: complete wound healing in 8 of 54 active-group participants and 3 of 18 placebo participants; record completed, last update posted February 1, 2010 | Skin-surface gel, full protein, pressure ulcers; pooled active concentrations do not establish superiority |
| RGN-137 skin gel: venous leg ulcers (NCT00832091, RegeneRx/Sigma-Tau) | 72 enrolled: 55 active, 17 placebo in posted results | Gel applied to the skin; up to 84 days | Posted results: wound closure without drainage in 12 of 55 active-group participants and 4 of 17 placebo participants; completed, last updated March 30, 2010. The sponsor separately reported meeting its safety goal and a faster-healing signal at a middle concentration | Skin-surface gel, full protein, venous ulcers; a sponsor-reported concentration-specific signal is not an overall proven healing benefit |
| RGN-137 skin gel: epidermolysis bullosa (NCT00311766, RegeneRx) | 30 enrolled: 22 active, 8 placebo in posted results | Gel applied to the skin; up to 56 days | Posted results: wound closure without drainage in 8 of 22 active-group participants and 5 of 8 placebo participants; the comparison was not statistically significant. Terminated for lack of patient availability and study-drug expiration; last update posted May 12, 2014 | Skin-surface gel, full protein, a specific blistering disorder; early termination and small groups limit interpretation |
Checked October 14, 2026. Sponsor summaries are labeled as such; they are not independent analyses.
The bottom line of the register: the full-length thymosin beta-4 trials above are not human evidence for the TB-500 fragment. FDA's 2026 review found no human study of the TB-500 fragment by any route. BPC-157 has real human reports—including positive findings—but none of the completed reports in this register is a controlled trial of injury healing.
Why pain relief is not a healing rate
Feeling better matters. But less pain does not, by itself, show that damaged tissue repaired. A healing claim needs an outcome that measures healing, plus a comparison group that can help explain why the change happened.
Here is a hypothetical. Someone with an aching knee starts a peptide, rests more, and does physical therapy. Six weeks later, the pain is lower. The improvement is real as an experience. But the cause—peptide, rest, therapy, or time—and the state of the tissue are separate questions. A study with a placebo group, a measure of function, and imaging where appropriate can answer them. A report without those cannot.
That is why "11 of 12 improved" in the knee report is worth reading, but is not a success rate you can apply to yourself. The same goes for the oral pain-score drop. Both describe what people reported, not what a peptide repaired.
How much weight should each report carry?
A randomized trial, an uncontrolled report, a company summary, and a registry listing are different kinds of evidence. Read the design and the measured result before accepting the conclusion printed above it.
- A randomized, controlled trial assigns people by chance to the treatment or a comparison. It can show whether the treatment caused a difference.
- An uncontrolled report follows treated people only. It can raise a question, but it cannot rule out natural recovery, expectations, or other care.
- A company-run results summary may contain useful observations, but it has not necessarily passed independent peer review.
- A registry listing describes a plan or submitted record and can also contain posted results. Registration alone is not a result or proof a study is enrolling.
- An animal or cell study tests a model. It is a reason to study something in people, not proof it works in people.
For more on oral BPC-157 products and their records, see our guide to BPC-157 capsules and oral evidence.
You can now separate a recovery claim from what a study actually measured. If you are weighing a specific offer, the next question is different: what supports supplying that exact product, from which pharmacy, and at what full cost. Peptide Care Index's Find My Peptide Path tool lays out the dated U.S. access summaries for both BPC-157 and TB-500 and helps you prepare those questions before you pay. It is free to use and needs no account or email. It does not recommend a peptide or match you with a provider.
Which is better for tendons, muscles, joints, or gut symptoms?
The checked human evidence does not establish a better choice for any of these goals. No controlled comparison of BPC-157 with the TB-500 fragment was identified, and none of the completed human reports checked establishes that either heals a tendon, muscle, or ligament. A plausible mechanism, or a positive report for one condition, is not enough to pick a peptide for a different problem.
| Question | Answer | Basis |
|---|---|---|
| Which has more human data? | BPC-157, narrowly | A few small reports vs none for the TB-500 fragment (Tables 3A–3B) |
| Which is proven to heal injuries better? | Neither | No completed controlled human injury-healing result identified for either |
| Which has the larger animal record? | BPC-157 | FDA summarizes many rodent studies of BPC-157; it found no living-animal wound studies of TB-500 itself |
| Which has more human safety data? | BPC-157 has more reported human safety observations, but not enough to rank marketed products as safer | FDA identified small BPC-157 human studies but no human safety studies of the TB-500 fragment; full-length thymosin beta-4 studies concern different preparations |
| Is one proven better for the gut? | No | One 53-person colitis enema trial, published only as an abstract |
This is an editorial reading of the cited sources, not a clinical recommendation for any condition.
Name the result you want first
Before comparing peptides, decide what "better" means for you. Less pain? Better function? Documented healing on a scan? A faster return to sport? Then ask whether the study a seller cites measured that result, with the same substance, by the same route.
This is a way to test a claim. It is not a questionnaire that picks a treatment.
Tendon and joint problems
The knee report is relevant if your question is about reported knee-pain improvement after knee-joint injections. It does not establish a winner for tendon healing, ligament repair, or any particular joint diagnosis.
A clinic proposing either peptide for a tendon should be able to explain what human result it expects, what the evidence for that result is, and how it compares with established care such as a graded rehabilitation plan. A link to a rat study is not that explanation.
Muscle strains and recovery after surgery
New study listings are not recovery results. The BPC-157 injury studies registered now—a U.S. rotator-cuff surgery study and a hamstring-strain study in China—have no posted results (details below). The TB-500 record examined below concerns cardiovascular biomarkers, not muscle recovery, and describes itself as a fictional example; we exclude it.
If you are recovering from surgery, the decision belongs with your surgical team and your existing recovery plan. A peptide offer is not an automatic replacement for either.
Gut symptoms and oral products
A bladder study is not a gut study, and a chronic-pain capsule report does not establish treatment of a digestive condition. The gut-treatment efficacy trial FDA evaluated was the 2005 colitis enema abstract, which it judged inadequate. Oral BPC-157 has human records, but they do not prove a "gut-healing" role. FDA identified no human gut-treatment data for the TB-500 fragment.
A worked example (hypothetical)
Sam has elbow tendinopathy and two offers: BPC-157 injections under the skin, or a BPC-157/TB-500 blend. The knee report used injections into the knee joint and cannot predict an elbow result from under-the-skin shots. No controlled result in this register tests Sam's exact blend, route, and elbow condition. The register gives Sam no evidence reason to pay more for two peptides instead of one. Sam's most useful next move is to ask both clinics the same questions about product, pharmacy, supply, and cost—and to compare both offers with a standard rehab plan.
Which molecule does the evidence actually belong to?
Many common BPC-157 vs TB-500 claims borrow evidence from a different molecule, route, or species. This table matches popular claims to the evidence underneath them. The finding labels describe each specific claim, not the peptide overall.
| Claim you may see | Evidence actually behind it | Finding |
|---|---|---|
| "TB-500 has a Phase 2 human trial" | Eye-drop trials of full-length thymosin beta-4 (RGN-259) | Not applicable to the TB-500 fragment |
| "TB-500 has a clean safety record in many patients" | Trials of full-length thymosin beta-4 given IV, as a gel, or as eye drops | Not applicable; FDA found no human TB-500 data |
| "TB-500 speeds wound healing" | An uncapped version of the 7-bead peptide on mouse skin (2003); TB-500 free base showed no significant benefit in a cell-dish wound test (2024) | Unresolved—no human or living-animal TB-500 wound data |
| "TB-500 repairs heart tissue" | Full-length thymosin beta-4 in rodent heart-attack models | Not applicable to TB-500 in people |
| "BPC-157 heals tendons in people" | Rodent tendon studies; one uncontrolled knee-pain report | Unresolved |
| "BPC-157 is proven for gut problems" | One 53-person colitis enema trial, abstract only | Unresolved; FDA judged the data inadequate |
| "FDA approved BPC-157 and TB-500 in July 2026" | A non-binding advisory recommendation about a compounding list | Contradicted |
| "Both are on the 503A list now" | 21 CFR 216.23, current through October 13 and checked October 14, 2026 | Contradicted |
| "The stack is clinically proven" | Four uncontrolled BPC-157 + TB4 knee cases, with the TB4 not identified as the TB-500 fragment; no controlled result establishing blend benefit | Unresolved—those observations do not establish the claim |
| "A 99%-pure certificate proves it is safe" | Purity tests on a sample; FDA found typical certificates for these peptides did not test endotoxins, aggregates, or specific impurities | Not applicable to safety or effectiveness |
Sources: Tables 3A–3C; FDA BPC-157 evaluation; FDA TB-500 evaluation; 21 CFR 216.23. Checked October 14, 2026. Labels follow our methodology: Supported, Contradicted, Unresolved, Conflicting, Not applicable.
Does combining BPC-157 and TB-500 work better?
No controlled human study identified here establishes whether the combination works better than either peptide alone. The "Wolverine stack" is a marketing name for the pair, not a tested clinical protocol. The human records discussed here include four knee patients given BPC-157 plus the authors' “TB4,” and adverse-event reports tied to products labeled as blends. These are not all evidence about the same verified ingredients.
Why the small combination group cannot pick a winner
In the knee report, 3 of 4 combination patients and 11 of 12 BPC-only patients reported improvement. Those groups were not assigned by chance, and there was no TB4-only group. So the different counts cannot show that adding TB4 helped—or that BPC-157 alone is better. The report also does not say the "TB4" was the TB-500 fragment.
What the blended-product safety reports show
FDA's BPC-157 review describes one adverse-event report worth knowing about. A 40-year-old woman used an under-the-skin product containing BPC-157 and TB-500, labeled "for research purposes only," twice daily for "joint healing and wound healing support." After about a week she developed widespread skin darkening and darkening of the gums. When she started the product again two weeks later, the same reaction returned. No further reactions were reported after she quit all peptides; the account does not establish that the discoloration resolved (FDA BPC-157 evaluation, p. 41).
FDA judged the reaction likely due to the product, because it came back on restarting. But it could not tell which peptide caused it. Separately, FDA found two complaint reports about "blended TB-500 and BPC-157" products that lacked safety assessments (FDA TB-500 evaluation). One case does not give a rate of harm. It does show that blends add unknowns rather than removing them.
Does a premixed blend solve the uncertainty?
No. Putting two ingredients in one vial does not show they work better together. FDA's BPC-157 review found blends sold as injections, nasal sprays, and capsules, some labeled for research use only (FDA BPC-157 evaluation). Each ingredient still needs its own identity, form, and supply basis.
Blends with three or four peptides—such as products combining GHK-Cu, BPC-157, TB-500, and KPV—add more unanswered questions. FDA has separate safety entries for injectable GHK-Cu and for KPV (FDA safety-risk page). Our peptide comparison chart summarizes the human record for each.
We do not give blending ratios, doses, or cycles. The checked evidence does not establish a particular combination plan for recovery.
Do capsules, injections, and other forms change the comparison?
Yes. Evidence from one route does not automatically establish the same result by another. BPC-157's human reports used enemas, knee-joint injections, bladder-wall injections, IV infusions, and one branded capsule—not a controlled outcome study of under-the-skin BPC-157 for injury healing. FDA identified no human studies of the TB-500 fragment by any route, so the checked evidence supports neither a claim that oral TB-500 works nor a claim that it cannot work.
| Route | BPC-157 human evidence | TB-500 human evidence |
|---|---|---|
| Under the skin (subcutaneous) | No controlled injury-healing results identified; the two injury studies below have no posted results. Spontaneous adverse-event reports are discussed separately | None identified by FDA |
| Into a joint | Knee report (uncontrolled) | None |
| Into a vein (IV) | 2-person safety pilot | None |
| Rectal enema | 32-person safety study, including 24 active recipients; 53-person colitis trial (abstracts) | None identified by FDA |
| Into the bladder wall | 12-person pilot | None |
| Swallowed capsule or tablet | One company-run uncontrolled pain report for one product; a Mexico tablet study with no posted results | None |
| Under the tongue (sublingual) | None found | None |
| Nasal spray | None found | None |
Sources: Tables 3A–3B and the trial records below. “None” means no relevant human study identified in FDA's May 2026 evaluation or the selected records checked October 14, 2026—not a complete search of all unpublished research.
Swallowed capsules and under-the-tongue products
A swallowed capsule and a strip held under the tongue are different products. Evidence for one is not proof of the other's absorption or benefit. FDA notes that BPC-157 resisted breakdown by stomach juice in a lab test, but found no human data on how much is absorbed by mouth (FDA BPC-157 evaluation). The oral pain report describes one branded delayed-release capsule, not every capsule.
Injection routes and eye drops
"Injected" is not a complete evidence match. An IV infusion, a knee-joint injection, and an under-the-skin shot reach the body differently and answer different research questions. The full-length thymosin beta-4 eye-drop trials are another route entirely. Matching the route is how you spot a borrowed claim. It is not advice about which route to choose.
Which works faster, and what dose is established?
The records checked do not establish which works faster or a standard dose for either peptide for recovery. A study's follow-up period is not the time it took to work, and a planned return-to-sport date in a registry is not an achieved result. A study regimen or a forum post is not a personal treatment plan.
What would change this answer: a well-described human study of the exact preparation that reports the relevant outcome, its timing, and its side effects. No such controlled injury-recovery result was identified in the records checked.
Is one safer than the other?
There is not enough human safety data to rank one as safer. FDA's main concerns for both are possible immune reactions to injected peptides, poorly controlled impurities, and uncertainty about what is actually in the vial. BPC-157 also showed clotting and liver-related signals in 28-day animal studies; FDA identified no animal toxicity studies of the TB-500 fragment.
| Safety question | BPC-157 | TB-500 |
|---|---|---|
| Human adverse-event reports in FAERS | 3 through December 4, 2025: redness and swelling at the injection site (person also using another thymosin product); shortness of breath leading to an emergency visit (no further details); skin and gum darkening with a BPC-157/TB-500 blend that returned on restarting | 0 through March 26, 2025 |
| Animal toxicity studies | 28-day injections into muscle in rats and dogs: changes in a clotting test (aPTT) and higher liver-related blood values; no increase in fetal malformations in a rat study; not mutagenic in standard tests | None of any kind identified |
| Studies designed to test cancer-causing potential (carcinogenicity) | None identified by FDA | None identified by FDA |
| Immune-reaction concern | Significant for injected and nasal routes; lower but not zero for oral | Significant for injected routes |
| Impurities and clumping (aggregation) | Typical certificates showed purity only, without identified impurities, endotoxin, or aggregate testing | Typical certificates skipped endotoxin and aggregate testing |
| Controlled human studies establishing long-term safety | None identified in the checked records | None identified in the checked records |
Sources: FDA BPC-157 evaluation, nonclinical and human-safety sections; FDA TB-500 evaluation. Checked October 14, 2026. FAERS reports do not prove a product caused an event.
The two FAERS searches used different terms and cutoff dates. Their counts cannot be compared as side-effect rates or used to rank one peptide as safer.
Immunogenicity means the ability to trigger an immune response. FDA says such responses can range from harmless antibodies to severe reactions, and that peptides injected under the skin carry more of this risk than those swallowed (FDA BPC-157 evaluation). That is a concern, not a measured rate.
What about cancer? Questions about blood-vessel growth and cell movement do not establish a cancer risk in people. FDA identified no carcinogenicity studies of either substance—studies designed to test whether an exposure can cause cancer. That gap does not mean there is no cancer-related laboratory research; it means these records cannot establish the cancer risk of using either product. Do not accept a confident "it causes cancer" or "it is cancer-safe" claim from anyone.
What a certificate of analysis does and does not prove
A lab certificate answers only the questions it tested. A purity number does not, by itself, establish sterility, the absence of bacterial toxins, the right molecule, clinical benefit, or permission to supply it for patient care.
When you see one, check:
- Sample match. Does the lot or batch number match the product you would receive?
- Lab and date. Who tested it, and when?
- Identity. Was the exact molecule confirmed (for TB-500: the fragment or full-length protein; for BPC-157: its stated form, such as free base, acetate, or arginate)?
- Amount. Was the actual quantity measured, not just purity?
- Impurities. Were specific impurities identified, or only a total percentage?
- Sterility and endotoxin. For anything injected, were these tested, and did they pass?
This checklist helps you read a document. It does not make a research-use product suitable for treating yourself. For a worked example of reading one BPC-157 lab report, see our guide to how to get BPC-157.
Long-term effects and complex health histories
Small, short reports cannot settle long-term effects or questions for every health history. An unknown risk is not proof of harm, but it is also not evidence that the risk is absent.
If you have an ongoing condition or take other medicines, bring the exact product name and your medicine list to your treating clinician. Ask what is known for your situation, what is unknown, and what would change the plan. For new skin or gum darkening, a rash, or a red, hot injection site, contact a clinician promptly. Trouble breathing, swelling of the lips or throat, or fainting after using a product needs emergency help: call 911 (MedlinePlus: anaphylaxis). Bring the product label when you can do so without delaying care.
What changes for a drug-tested athlete?
Switching from one peptide to the other is not a way around anti-doping rules. Under the World Anti-Doping Agency's 2026 list, BPC-157 is prohibited at all times under S0 (non-approved substances), and thymosin beta-4 and its derivatives such as TB-500 are prohibited under S2.3, which covers growth factors and growth-factor modulators (WADA Prohibited List; 2026 list, S0 on p. 4, S2.3 on p. 8).
A prescription or a compounding decision does not change sport rules. Check the rules that govern your sport with its anti-doping organization.
Are BPC-157 and TB-500 FDA-approved or legal to compound in 2026?
No FDA-approved product containing either one was identified in the records checked, and neither appears on FDA's final 503A compounding list checked October 14, 2026. News reports describe a narrow advisory recommendation to add both on July 23, but that advice does not bind FDA. Adding either to the codified list requires FDA rulemaking; a proposal alone does not change the list.
FDA approval, eligibility for compounding, and a particular pharmacy's ability to supply your product are three separate questions. A clinic advertisement or an advisory vote does not answer all three.
| Requirement | Evidence and check | Finding | Next question; what would change it |
|---|---|---|---|
| The evaluated forms are ingredients in an FDA-approved drug | Read the approval statements in the BPC-157 evaluation, p. 9 and TB-500 evaluation, p. 7 | Contradicted for both | Ask for an exact approved-product record; a new FDA approval would change it |
| An applicable USP or NF drug-substance monograph existed at FDA's May 2026 evaluation | Read the monograph statements on the same pages: BPC-157 p. 9, TB-500 p. 7 | Contradicted for both at that review date | Has a relevant monograph been published since then? A newly published applicable monograph would change this finding only |
| Either appears on the final 503A bulks list | Searched 21 CFR 216.23, version displayed current through October 13, 2026; checked October 14 | Contradicted for both | Has an effective final amendment added either substance? That addition would change this list finding |
| The July 2026 advisory vote itself authorizes compounding or treatment | Read the meeting page: advisory committees make non-binding recommendations | Not applicable as an access basis | What final FDA action followed? An applicable final action—not the vote itself—would change the access evidence |
| FDA's interim policy covers compounding either one | FDA lists both among withdrawn nominations previously in Category 2 (safety-risk page); how the interim policy applies after withdrawal needs regulatory review we have not obtained (503A framework) | Unresolved | Qualified regulatory review, or an FDA statement addressing these substances |
| A particular advertised preparation can be supplied to you | No product-specific dispensing route, pharmacy license, state coverage, or supply basis was verified for this page | Unresolved | Which pharmacy would supply this exact product, and under what applicable basis? Product-, route-, and state-specific evidence could resolve the question |
| Date | Record | What it means | What it does not mean |
|---|---|---|---|
| Before May 2026 | The original nominations for both were withdrawn; FDA chose to evaluate both on its own initiative (BPC-157, TB-500) | The review went ahead anyway | Not approval; not a list addition |
| Current FDA page | Both listed among withdrawn nominations previously in Category 2 (safety-risk page) | Where FDA now files them | Does not by itself say a pharmacy may compound them |
| May 11 and May 15, 2026 | FDA staff evaluations of BPC-157 and TB-500 | Staff recommended not adding either to the 503A list | Not a final decision |
| July 23, 2026 | Pharmacy Compounding Advisory Committee meeting | News reports, including ABC News and Pharmaceutical Executive, describe a narrow vote recommending both be added, against the staff recommendation | Non-binding; FDA had not posted minutes on the meeting page when we checked |
| Checked October 14, 2026; displayed current through October 13 | 21 CFR 216.23 | Neither appears on the final list | This list check is not a complete determination of every possible access route |
| Before end of February 2027 | Next committee meeting announced | Its five listed substances do not include BPC-157 or TB-500 (FDA's meeting announcement; our hearing tracker) | Not a deadline for a BPC-157 or TB-500 decision |
| Future rulemaking, if pursued | Proposed rule, public comment, then any effective final rule | A proposal or comment period is not a list addition; an effective final amendment would change the codified list | Even then, list placement is not FDA drug approval (21 CFR 216.23(d)) |
How 503A works, in plain terms. For a bulk ingredient, FDA describes a sequence: comply with an applicable USP or NF monograph if one exists; if none exists, the ingredient must be a component of an FDA-approved drug; if neither applies, it must appear on the final 503A bulks list. Other requirements also apply (FDA 503A framework). FDA's May evaluations reported no applicable monograph or approved-drug component for either evaluated substance, and neither appears on the final list checked here. FDA also describes a separate interim policy for some nominated substances; how it applies here is unresolved.
So if one page tells you a pharmacy "can fill it today" and another says it is not on the list, ask which current record supports the first claim. A licensed pharmacy, a prescription, or a lab certificate does not answer that by itself. For BPC-157 depth, see Is BPC-157 FDA approved? and our FDA peptide compounding list cross-check.
Do new trial listings change the answer?
A trial record shows what researchers plan or submitted and can include results. Registration alone is not a treatment result or a confirmed spot in a study. None of the records below supplies a result that picks a winner between these peptides.
| Record and sponsor | Substance, population, location | Status and dates | What matters for this comparison |
|---|---|---|---|
| NCT07803250, University of Arkansas | Under-the-skin BPC-157 after rotator-cuff surgery; UAMS Medical Center, Little Rock, Arkansas | Not yet recruiting; estimated start January 1, 2027; last update September 3, 2026; no results | Conflicting: the summary says 20 participants, the enrollment field says 30 (estimated); control descriptions differ between saline injections and no injections |
| NCT07437547, Hudson Biotech | Under-the-skin BPC-157 for acute hamstring strain; one site in Shenzhen, China | Listed as recruiting; 120 estimated; last update February 27, 2026; no results | Not a U.S. study; arm coding differs from the placebo-comparison description; recruitment not independently confirmed |
| NCT07752381, Parlay Wellness; collaborator Citruslabs | Branded BPC-157 gummies; physically active adults; Citruslabs, Las Vegas, Nevada | Completed, 40 actual participants; completion November 1, 2025; first posted and last updated August 7, 2026; no posted results | No outcome to compare; not open. Registration was posted after completion, and the sponsor's supplement classification is not a regulatory determination |
| NCT07487363, Hudson Biotech | Labeled as a TB-500 fragment study; Shenzhen, China | Status field says recruiting; 80 estimated participants; last update March 23, 2026; no posted results | Its own summary calls it a fictional example; we exclude it from evidence and do not count the estimated participants as people treated |
These are four selected full records, not a complete registry search. Only the study team can confirm whether a study is enrolling and who qualifies. More BPC-157 registry details are in our access guide.
Which is cheaper when all charges are included?
We cannot say which costs less, because there is no verified TB-500 price for a comparable offer and published prices usually cover different things. A vial price, a capsule pack, a consultation fee, and a full care plan are different purchase units. A vial is not a month.
Here is what a fair comparison needs: the same exact product type, the stated quantity and strength, and every required charge. One advertised BPC-157 order we documented totals $134 in disclosed charges—a $39 medical review, an $80 vial containing 15 mg, and $15 shipping (Rx Peps Direct's published offer). Our calculation: $39 + $80 + $15 = $134. The vial's stated 3 mg/mL × 5 mL equals 15 mg; that identifies the purchase quantity, not a dose. That is one review, one vial, and one shipment, not a monthly cost, and it is the provider's published price, not a quote for you (our BPC-157 access guide; BPC-157 cost and published fees). We did not verify a comparable TB-500 offer, so we do not place a TB-500 number beside it.
The provider says it collects the $39 review fee; the pharmacy separately charges for the product and shipping. Its terms describe optional automatic refills, with a new review fee for each order. Its refund policy says the review fee is nonrefundable once review begins, including when no prescription is issued; pharmacy refunds are a separate question. These are published terms, not a completed checkout or a verified supply route. Any additional required charges would make a personal total incomplete.
Monthly price ranges you may see on comparison pages often lack a stated quantity, a product type, or a source, and some come from research-use listings. Those are not the same purchase as prescription care. When a required charge is missing, the total is incomplete—not zero.
Before comparing totals, ask each seller for:
- consultation fee and whether it is credited toward treatment;
- exact product, strength, and quantity the price covers;
- required labs and who bills them;
- membership or program fees;
- shipping, including cold shipping;
- what is charged today and what renews automatically;
- what you owe if nothing is prescribed or the pharmacy cannot fill it.
Our peptide price list records dated published prices with their package sizes and fees.
What should you check before paying for either?
Make sure the evidence, the product, the service, and the bill all describe the same offer. A lower price does not tell you whether the offer matches any research or what you will owe in total.
BPC-157 vs TB-500 before-you-pay checklist
- The promised result. What exact outcome is being offered, and which human study measured it with this substance and route?
- The exact ingredients. For BPC-157: what form—for example, free base, acetate, or arginate? For TB-500: the 7-amino-acid fragment or full-length thymosin beta-4? For a blend: every active ingredient.
- The product description. What route, labeled strength, and quantity does the offer cover? These identify the product; they are not instructions for use.
- The responsible people. Who evaluates you, and which named pharmacy would dispense it? Can both serve your state?
- The access basis. Which current rule or policy supports supplying this exact preparation by this route?
- The lab report. Does it match the batch, and did it test identity, amount, impurities, sterility, and endotoxin?
- The complete bill. What do you pay now, to whom, and later? Itemize consultation, product, labs, membership, shipping, follow-up, and any prepaid commitment.
- No prescription or no fill. Which charges are kept or refunded, by whom, and how fast? How do renewals and cancellation work?
- The care decision. What alternatives and uncertainties should you discuss? Who answers clinical, pharmacy, and billing questions afterward?
A message you can copy to a clinic:
Before I pay, please confirm the exact peptide or peptides you would consider. If BPC-157, what form is it—for example, free base, acetate, or arginate? If TB-500, is it the 7-amino-acid fragment (Ac-LKKTETQ) or full-length thymosin beta-4? Please list every active ingredient in any blend, plus the route, labeled strength, and quantity.
Which clinician and which pharmacy would be involved, can both serve my state, and what current source supports supplying this exact preparation?
Please itemize what I would pay now and later—consultation, product, required labs, membership, shipping, follow-up, and any renewals. What would I owe if no prescription is written or the pharmacy cannot fill it? Which human study supports the result you expect, for this substance and route?
You can now tell whether an offer is complete. Find My Peptide Path brings the BPC-157 and TB-500 access summaries, the provider checks, and the fee questions into one place, so you can take a single clear list back to a clinic—including one you already use. It is an information tool, not a medical evaluation, a prescription service, or a provider match.
How we checked this comparison
We matched original human reports, FDA's summaries of older abstracts, and current official records to the exact question each can answer. Our conclusions are source-based editorial judgments, not a clinical evaluation of either peptide for any person.
Peptide Care Index is the independent decision and access index for peptide care—helping you understand the route, the cost, the evidence, and the next step before you pay.
What we actually checked
Checked October 14, 2026: the relevant identity, approval, efficacy, safety, and appendix sections of FDA's BPC-157 and TB-500 staff evaluations (dated May 11 and May 15, 2026), including the decisive tables and figures; FDA's July advisory meeting page, follow-up meeting announcement, safety-risk page, and 503A framework; 21 CFR 216.23, displayed current through October 13; the original knee, bladder, IV, and oral-results documents; the cited full-text dry-eye, neurotrophic-cornea, recombinant thymosin beta-4, and rat tendon-cell papers; eight full ClinicalTrials.gov records, including their posted results where present; and the 2026 WADA list. We also read the current Path resource, relevant site pages, and the price example's provider offer and published terms.
Source limits, labeled where used: the early enema studies remain meeting abstracts summarized by FDA, not full clinical reports independently obtained here. The Ruff IV study was checked through its original abstract and the sponsor's summary, not the full paper. The oral pain result comes from the recovered original company-associated summary, not confirmed peer review. The July vote remains attributed to news reports: no minutes were found on the meeting page, and the official webcast could not be inspected. Sponsor statements are not independent analyses, and the price example remains provider-published—not a completed checkout.
Not done: contacting providers, pharmacies, or study teams; buying or testing products; checking licenses; confirming state coverage or enrollment; a systematic review; clinical, pharmacy, or regulatory specialist review.
Accountability: This work used AI assistance. No clinician, pharmacist, or regulatory specialist reviewed this page. Source dates belong to each record; our check date is not a publication date.
We use the Peptide Care Access Check: for each requirement, we name the applicable evidence, what we checked, the finding, the next question, and what would change it. Supported, Contradicted, Unresolved, Conflicting, and Not applicable describe a specific requirement—never an overall safety or quality rating. Read our methodology, editorial standards, and how we make money. To report an error, use contact and corrections.
Questions readers still ask
Does a label that says "TB4" mean TB-500?
Not necessarily. "TB4" usually refers to full-length thymosin beta-4, but sellers use it loosely. Ask for the exact molecule and its chemical name. The knee report's "TB4" was not identified as the TB-500 fragment.
Didn't FDA take these off Category 2 in 2026?
FDA's current page lists both among withdrawn nominations previously in Category 2. That is a filing change in a compounding-review process. It is not approval, a move onto the final 503A list, or proof that a pharmacy may compound them (FDA safety-risk page).
Can a doctor prescribe TB-500?
A prescription does not, by itself, settle whether a pharmacy has a basis to prepare the exact ingredient. FDA's May 2026 evaluation found no pharmacies marketing TB-500 in its search and no outsourcing-facility submissions in data accessed February 15, 2024 (FDA TB-500 evaluation, p. 21). That is a dated search finding, not proof that no pharmacy supplies it today. Ask for the named pharmacy and its supply basis before paying.
Is "research use only" TB-500 or BPC-157 an option for treatment?
A research-use label is not authorization for patient treatment, whatever other claims the seller makes. It is not evidence of suitability for human use, and the one reproducible skin reaction FDA described involved a research-labeled blend. We do not cover or recommend research-use sellers.
What is the most useful next step?
First resolve the missing fact that changes your decision. That might be the exact molecule, whether a cited study matches the result you want, or the full terms of an offer—not which peptide has the stronger sales pitch.
If an offer does not name the molecule, ask for it. If the product is named, compare the cited evidence and the complete bill. If you already have a clinician or a product, start with that relationship; you do not need a new provider to ask better questions. Nothing on this page is a reason to start, stop, or change a treatment on your own.
Find My Peptide Path keeps the dated access summaries for BPC-157 and TB-500 next to the provider and fee questions, so you can take them to the clinic you are considering. Free, with no account or email, and no promise of a prescription.
Sources
Sources reviewed October 14, 2026, at the depths described above. Source dates are their own; our check date does not replace them.
- U.S. Food and Drug Administration. BPC-157-related bulk drug substances: FDA evaluation for the July 23–24, 2026 Pharmacy Compounding Advisory Committee. Staff evaluation dated May 11, 2026. Approval and monograph statement, p. 9; colitis effectiveness, p. 27; animal safety, pp. 34–40; adverse-event reports, p. 41; clinical-study summary, p. 42; study appendix, p. 54.
- U.S. Food and Drug Administration. TB-500-related bulk drug substances: FDA evaluation for the July 23–24, 2026 Pharmacy Compounding Advisory Committee. Dated May 15, 2026. Approval statement, p. 7; historical/marketing discussion and footnote 35, p. 21; fragment figure, p. 25; uncapped-fragment distinction, p. 26; scratch assay, p. 27; toxicity, pp. 28–29; human studies/FAERS, p. 30; complaint-system reports, p. 31.
- U.S. Food and Drug Administration. July 23–24, 2026 Pharmacy Compounding Advisory Committee meeting. Agenda, uses evaluated, advisory role, materials list.
- U.S. Food and Drug Administration. Certain bulk drug substances for use in compounding that may present significant safety risks. Withdrawn-nomination entries for BPC-157 and the TB-500 fragment.
- U.S. Food and Drug Administration. Bulk drug substances used in compounding under section 503A. Three ingredient conditions and interim policy.
- Electronic Code of Federal Regulations. 21 CFR 216.23. Final 503A bulks list, version displayed current through October 13, 2026; checked October 14.
- Lee E, Padgett B. Intra-articular injection of BPC 157 for multiple types of knee pain. Altern Ther Health Med, 2021.
- Lee E, Walker C, Ayadi B. Effect of BPC-157 on symptoms in patients with interstitial cystitis: a pilot study. Altern Ther Health Med, 2024;30(10):12–17.
- Lee E, Burgess K. Safety of intravenous infusion of BPC157 in humans: a pilot study. Altern Ther Health Med, 2025.
- D'Adamo C, Wehage S, Piedrahita G. Human study of BPC-157 in a delayed capsule: summary of results, August 22, 2024. Original company-associated summary; cover, p. 1; methods, p. 4; outcome scores, p. 5. Peer-reviewed publication and the exact product identity were not independently established. Numerical findings come from this original report.
- Sosne G, Ousler GW. Thymosin beta 4 ophthalmic solution for dry eye: a randomized, placebo-controlled, Phase II clinical trial. Clin Ophthalmol, 2015.
- Sosne G, et al. RGN-259 in neurotrophic keratopathy. Int J Mol Sci, 24(1):554; published December 29, 2022, in the 2023 issue. Primary outcome and denominators: Table 2.
- Ruff D, et al. Randomized, placebo-controlled, single and multiple dose study of intravenous thymosin beta4 in healthy volunteers. Ann N Y Acad Sci, 2010;1194:223–229. Sponsor results summary.
- First-in-human Phase I study of recombinant human thymosin β4 in healthy Chinese volunteers. J Cell Mol Med, 2021.
- ClinicalTrials.gov: NCT00382174, NCT00832091, NCT00311766 (RGN-137 gel); sponsor venous-ulcer summary.
- ClinicalTrials.gov: NCT07803250, NCT07437547, NCT07752381, NCT07487363, NCT02637284.
- World Anti-Doping Agency. Prohibited List; 2026 list, S0, p. 4; S2.3, p. 8. In force January 1, 2026; both categories apply at all times.
- News reports of the July 23, 2026 advisory vote: ABC News; Pharmaceutical Executive.
- Chang CH, et al. Pentadecapeptide BPC 157 enhances the growth hormone receptor expression in tendon fibroblasts. Molecules, 2014. Original rat Achilles-tendon-cell experiment.
- FDA. Announced Pharmacy Compounding Advisory Committee meeting before the end of February 2027. The five-substance agenda does not include BPC-157 or TB-500.
- Rx Peps Direct. BPC-157 offer, terms, and refund policy. Published price and payment terms only; not evidence of lawful supply or treatment benefit.
- MedlinePlus. Anaphylaxis. Emergency-response guidance.