FDA approved peptides list: verified products and uses

By Peptide Care Index · Updated October 2026

FDA-approved peptides include semaglutide, tirzepatide, liraglutide, and many medicines used outside weight care. This FDA approved peptides list maps 50 ingredients to named FDA-approved medicines, according to Peptide Care Index’s October 2026 review. Short and modified peptides, larger proteins, and historical products are kept separate. Each entry links to its record and label.

What are the key FDA peptide approval facts?

• 50 ingredient records: Peptide Care Index’s October 14, 2026 reference contains 46 short or modified peptide ingredients and 4 larger protein or fusion-protein examples. This is the size of this reference, not a count of every FDA-approved peptide. See the list and counting rules.Copy statistic, sources and link
• Three 2026 additions covered here: Hepcludex was approved May 22, Lipfendra July 15, and Mimrylo August 28, according to FDA’s 2026 novel drug approvals. See their products and uses.Copy statistic, sources and link
• BPC-157 and the TB-500 fragment are not components of FDA-approved drugs, according to FDA’s 2026 briefings for BPC-157 and TB-500. A compounding review does not change that fact by itself.Copy statistic, sources and link
• Two withdrawal cases that can mislead a current list: Geref’s sermorelin approvals were withdrawn effective June 18, 2009; Fuzeon’s enfuvirtide approval was withdrawn effective August 5, 2026. See historical records.Copy statistic, sources and link

Which peptide drugs have FDA-approved product records?

The 46 ingredients below have FDA-approved product examples with at least one prescription product entry in the checked FDA records. The list includes short, cyclic, and modified peptides, including selected peptide antibiotics and a PEG-linked peptide. Larger proteins appear in the next table.

Read the year as the original approval of the reference application. It is not necessarily the first approval of the ingredient, the current formulation, or every use shown. The use column gives selected labeled uses, not the full prescribing information. “Prescription” is a database status; it does not show what is in stock.

Source: Peptide Care Index’s compilation of the FDA application records and labels linked in each row. Checked October 14, 2026. The CSV includes exact dates, status notes, and additional product records.

For generic eptifibatide and daptomycin, the current generic record is linked separately from the discontinued reference brand. Their years refer to the original branded reference applications. For pegcetacoplan and cyclosporine, the row names more than one product; the download preserves each additional record and its date note.

Why do insulin, tesamorelin, and dulaglutide appear in a separate table?

FDA describes a protein as an amino-acid polymer longer than 40 amino acids; its regulatory-science explanation puts peptides on the other side of that boundary. Broad peptide lists often include larger medicines anyway. Keeping these 4 examples separate shows exactly what our count includes. FDA explanation

Source: FDA Purple Book, application histories, and prescribing information linked in each row. Checked October 14, 2026. These 4 rows are not part of the 46-row short/modified peptide table.

Tesamorelin is a good example of why the product name matters. Egrifta SV and Egrifta WR are labeled for excess abdominal fat in adults with HIV-associated lipodystrophy, not general weight-loss management. Their formulations are not substitutable. The original Egrifta presentation is listed as discontinued; SV and WR have prescription entries. FDA record · WR label

Which peptides are FDA approved for weight loss?

Semaglutide, tirzepatide, and liraglutide have named products labeled for weight reduction and long-term maintenance in qualifying patients. Other products containing the same ingredient have different uses. The selected crosswalk below covers 3 ingredients, 9 product/formulation rows, and 8 FDA applications.Copy statistic, sources and link

The weight-related products in this table are Wegovy injection, Wegovy tablets, Zepbound, and Saxenda. The full labels set the age, weight, medical-condition, and other limits. Setmelanotide is a separate option for specific rare forms of obesity; its Imcivree label does not make it a general obesity drug.

Source: the linked FDA labels and application records; checked October 14, 2026. Selected products only. Count each row once; Rybelsus tablets and Ozempic tablets share NDA 213051. Download: GLP-1 product crosswalk.

The distinction is easy to miss. Wegovy injection and Wegovy tablets both contain semaglutide. The checked label gives the injection an adult MASH indication and an adolescent weight indication that do not appear in the tablet indications. MASH is a form of liver disease with inflammation and scarring. Its injection indication has accelerated approval. FDA label, section 1

Likewise, Mounjaro and Zepbound both contain tirzepatide. Mounjaro’s August 2026 label covers type 2 diabetes and cardiovascular-event risk reduction in adults with type 2 diabetes at high risk. Zepbound’s label covers weight care and moderate-to-severe obstructive sleep apnea in adults with obesity. Approval of one product’s use does not transfer that use to every product containing the ingredient. Mounjaro label · Zepbound label

Which recent approvals should an updated peptide list include?

This reference includes 3 selected peptide-related medicines first approved in 2026 and elamipretide’s 2025 approval. They treat different conditions. Their approvals are for the named products and labeled patients, not broad claims about cholesterol care, muscle building, or longevity.

Source: FDA 2025 and 2026 approval records and each product’s label. Checked October 14, 2026. This is not a complete list of new approvals.

Elamipretide is also known in research as SS-31. That makes “SS-31 is never FDA approved” too broad: Forzinity has an approved product record. It also makes “all SS-31 vials are FDA approved” wrong. The approval applies to Forzinity and its label. FDA integrated review · Forzinity label

Are BPC-157, TB-500, and other research peptides FDA approved?

BPC-157 and the TB-500 fragment have no approved-drug component in FDA’s 2026 assessments. Ipamorelin also lacks approved products in FDA’s cited assessment. Those findings belong beside the popular names, rather than being mixed into a list of approved medicines.

Source: FDA documents linked in each row; checked October 14, 2026. Where the wording is “no approval identified,” it describes the checked sources, not an exhaustive search of every possible alias or every jurisdiction.

FDA’s safety-risk page covers injectable GHK-Cu. A copper-peptide skin cosmetic is a different product context. FDA generally does not approve cosmetics before sale; a cosmetic listing does not establish approval of a peptide drug. FDA cosmetics explanation

For a fuller BPC-157 answer, see what FDA records say about BPC-157 approval. If you are checking an advertised offer, the BPC-157 access and provider-check guide explains which product and pharmacy details to request. The BPC-157 cost reference keeps advertised prices separate from approval evidence.

Which historical or discontinued peptide products need a separate label?

Two different things can happen: a product can stop being marketed, or FDA can withdraw its approval. Geref and Fuzeon have documented approval withdrawals. The other examples below have discontinued product entries; that status alone does not prove a formal approval withdrawal.

Source: FDA-authored Federal Register notices and Drugs@FDA records linked in the table. Checked October 14, 2026. These entries are excluded from the 50-ingredient main reference count.

Geref’s history is why a clinic’s “sermorelin was FDA approved” claim needs a second sentence. FDA withdrew both Geref approvals in 2009. In 2013, FDA determined that the products had not been withdrawn from sale for safety or effectiveness reasons. That finding did not approve a present compounded sermorelin product or an anti-aging use. FDA’s 2013 notice

The same care applies to brand discontinuation. Integrilin is discontinued, but a checked generic eptifibatide application has a prescription entry. Cubicin is discontinued, but a checked generic daptomycin application has a prescription entry. A brand’s status does not settle every product containing its ingredient. Eptifibatide generic record · Daptomycin generic record

Does a compounding decision mean a peptide is FDA approved?

No. FDA states that compounded drugs are not FDA approved and do not go through its premarket review for safety, effectiveness, and quality. A review of a bulk substance for compounding answers a different question from approval of a finished drug product. FDA compounding questions and answers

This matters for both research peptides and familiar medicines. Approval of a semaglutide product does not approve a compounded semaglutide product. FDA also distinguishes semaglutide sodium and acetate from the active ingredient in approved drugs. FDA GLP-1 concerns

For compounding-list placements, withdrawn nominations, and advisory review, use the separate FDA peptide compounding tracker. For human-study comparisons, use the peptide comparison chart. Neither a trial listing nor a human study is itself a product approval.

How can you check whether a peptide product is FDA approved?

Match the exact product, ingredient, route, and application. The names on a clinic page or vial are the start of the check, not the evidence that ends it. FDA registration or a National Drug Code does not establish product approval. FDA approval explanation · NDC definitions

1. Write down the product name, ingredient, salt form if named, and route. A brand, research alias, and compounded preparation may describe different things.
2. Search Drugs@FDA by the brand and ingredient. For biological products, also check the Purple Book.
3. Open the NDA, ANDA, or BLA record. These are the application types for new drugs, generics, and biological products. Look for an approval action and the specific product entry.
4. Read the current label’s “Indications and Usage.” Confirm the product’s route and patient limits. A record’s original approval date is not a date for every later use.
5. Check product status and any withdrawal notice. Keep “discontinued” distinct from “approval withdrawn.” If a search has no result, try known aliases and check the agency’s assessment; an empty search alone does not prove the full answer.

If you are checking a clinic’s claims before paying, Find My Peptide Path provides a free checklist of product, pharmacy, access, and fee questions. It does not recommend a treatment.

How was this FDA approved peptides list built?

Peptide Care Index assembled and checked this reference on October 14, 2026. Its unit is a distinct normalized ingredient with a named approved product example. The dataset contains 50 ingredient rows; the separate brand/formulation crosswalk contains 9 rows.

We read FDA application histories, product entries, linked labels, Purple Book records, and FDA-authored withdrawal notices. The 2025 and 2026 novel-approval lists helped identify recent additions. FDA compounding assessments supplied product-status distinctions for popular research names.

The method follows these rules:

• Count ingredients once. Different brands, strengths, and routes do not each add an ingredient. Salt and familiar research names are recorded as aliases or explained beside the source; approval still belongs to the exact record.
• Keep the groups visible. The main table covers short and modified peptide drugs, including selected cyclic peptides, peptide antibiotics, and PEG-linked peptides. Four larger protein or fusion-protein examples are separate. This is an editorial reference selection, not a census under a single molecular definition.
• Use the application’s original date. Read it from the approval history. Do not replace it with the label’s “Initial U.S. Approval” year, which can describe a different history. The Humulin R example makes that distinction explicit in the download.
• Summarize the named product’s label. The indication column is a selected-use summary. It does not reproduce all warnings, populations, eligibility rules, or uses. Some FDA records link older prescribing information where a later supplement has no available label; the CSV retains that limitation where applicable.
• Check status separately. A prescription or Rx entry supports the database-status statement. It does not prove current stock, distribution, or availability. Current generic records are checked separately when a reference brand is discontinued.
• Keep historical rows out of the main count. A withdrawal needs a withdrawal notice. A discontinued entry alone is reported only as discontinued.
• Do not turn a missing name into an absolute conclusion. Negative-status wording follows the source: an explicit FDA finding where one exists, and a narrower “no approval identified” statement otherwise.

To reproduce the counts, open the ingredient CSV, count unique row_id values, and group by inclusion_group. The result is 46 + 4 = 50. In the GLP-1 crosswalk, count unique row_id values for 9 rows, unique ingredient values for 3 ingredients, and unique application values for 8 applications. The latter count is smaller because two tablet brand rows share NDA 213051.

The data dictionary defines every field. Our methodology and editorial standards explain the publication’s wider source and correction rules.

What does this list establish—and what does it leave out?

It establishes the linked approval and label evidence for the named product examples on the check date. It does not establish a complete total of FDA-approved peptides. It also does not show whether a product is suitable for a person or available from a particular pharmacy.

This edition does not attempt to collect every peptide antibiotic, diagnostic agent, radiolabeled peptide, insulin analog, antibody conjugate, protein hormone, generic manufacturer, or formulation. Absence from this selected list does not mean absence of FDA approval. Readers checking a missing name can use the verification steps above.

The page gives no dose, treatment ranking, purchase recommendation, or judgment about whether an off-label prescription is appropriate. FDA-approved drugs can still have serious risks. Read the full product label and discuss medical decisions with a qualified clinician.

How can you cite this reference?

Publication: Peptide Care Index
Title: FDA approved peptides list: verified products and uses
URL: https://peptidecareindex.com/research/fda-approved-peptides-list/
Data checked: October 14, 2026
Edition: 2026-10-14

Copy this citation:

Peptide Care Index. “FDA approved peptides list: verified products and uses.” October 2026 edition; data checked October 14, 2026. https://peptidecareindex.com/research/fda-approved-peptides-list/

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For a count, use the scope in the sentence: “Peptide Care Index’s October 2026 reference maps 46 short or modified peptide ingredients and four larger protein examples to FDA product records.” For a product’s approved indication, cite the FDA label linked in its row as well.

You may reuse our original table organization and summaries with Peptide Care Index named as the source; preserve the FDA source references and any underlying source terms. This permission does not cover third-party material in FDA labels.

Free data downloads

• Ingredient reference: CSV
• Ingredient reference: JSON
• GLP-1 product and formulation crosswalk: CSV
• Historical and discontinued product records: CSV
• Popular peptide approval checks: CSV
• Data dictionary

All files are free to read without an account or email address. Dates in the data refer to the record or label identified, not a blanket approval of a peptide class.

Frequently asked questions

How many peptides are FDA approved?

The number depends on what is counted: ingredients, brands, formulations, short peptides, larger proteins, or historical approvals. This reference contains 50 selected ingredients: 46 in the short/modified group and 4 larger protein examples. It does not claim that 50 is the total number FDA has approved.

Is BPC-157 FDA approved?

No. FDA’s 2026 assessment states that neither BPC-157 free base nor its acetate form is a component of an FDA-approved drug. A compounding nomination or advisory review is a different process. FDA briefing

Is TB-500 FDA approved?

No for the fragment FDA evaluated. FDA states that neither the free base nor acetate form is a component of an approved drug. The evaluated fragment, LKKTETQ, must not be treated as the same molecule as full-length thymosin beta-4. FDA briefing

Is sermorelin FDA approved?

Sermorelin has historical FDA approvals through Geref, but FDA withdrew those approvals effective June 18, 2009. The later finding that the products were not withdrawn from sale for safety or effectiveness reasons did not approve today’s compounded sermorelin preparations. FDA notice

Is tesamorelin FDA approved?

Egrifta SV and Egrifta WR are FDA-licensed tesamorelin products. Their labels cover excess abdominal fat in adults with HIV-associated lipodystrophy, not general weight loss. This reference keeps tesamorelin in the larger-protein section because it has 44 amino acids. FDA record · Label

Is SS-31 FDA approved?

Elamipretide, known in research as SS-31, has an FDA-approved product: Forzinity. Its 2025 accelerated approval is for improving muscle strength in adults and children with Barth syndrome weighing at least 30 kg. That approval does not cover every vial sold under the research name. FDA record · FDA label

Are FDA-approved peptide medicines all injections?

No. This list includes oral medicines such as linaclotide, plecanatide, voclosporin, cyclosporine, and enlicitide. It also includes semaglutide tablets, nasal glucagon, afamelanotide implants, and other routes. The route belongs to the particular product, so check its label.

Does FDA approval mean a peptide has no serious risks?

No. Approval applies to a product used under its labeling and does not mean it is risk-free. The tables summarize selected uses; they do not replace the warnings and other information in the full prescribing information. FDA approval explanation

Sources and check dates

Every product row links to its application record and FDA label. The download retains the exact source URL and October 14, 2026 check date. The sources below explain the scope, recent actions, and regulatory distinctions.

1. Drugs@FDA product records and application histories — checked October 14, 2026.
2. Purple Book biological product records — checked October 14, 2026.
3. FDA peptide/protein boundary explanation — checked October 14, 2026.
4. FDA draft peptide clinical-pharmacology guidance (December 2023; draft/nonbinding) — checked October 14, 2026.
5. FDA novel drug approvals, 2026 — checked October 14, 2026.
6. FDA novel drug approvals, 2025 — checked October 14, 2026.
7. FDA BPC-157 2026 compounding assessment — checked October 14, 2026.
8. FDA TB-500 2026 compounding assessment — checked October 14, 2026.
9. FDA ipamorelin compounding assessment — checked October 14, 2026.
10. FDA compounding safety-risk page — checked October 14, 2026.
11. FDA unapproved GLP-1 concerns — checked October 14, 2026.
12. FDA compounding questions and answers — checked October 14, 2026.
13. FDA Geref withdrawal-history notice, March 4, 2013 — checked October 14, 2026.
14. FDA Fuzeon withdrawal notice, July 6, 2026 — checked October 14, 2026.
15. FDA explanation of approval, registration, and listing — checked October 14, 2026.
16. FDA NDC product-file definitions — checked October 14, 2026.
17. FDA cosmetics approval explanation — checked October 14, 2026.
18. FDA human-insulin structure explanation — checked October 14, 2026.

What changed: October 14, 2026 — first edition assembled; recent product approvals, the 2026 Fuzeon withdrawal, and historical Geref approvals are separated from the main reference.

Peptide Care Index Research is the research and reference section of peptidecareindex.com.