{ "version": "2026-10-14", "rows": [ { "record_id": "L01", "peptide": "Semaglutide", "formulation": "Ozempic injection", "evidence_class": "human_label", "human_numeric_value": true, "half_life_display": "About 1 week", "reported_point": 1, "reported_low": null, "reported_high": null, "reported_unit": "week", "uncertainty_type": "", "reported_sd": null, "hours_point": 168, "hours_low": null, "hours_high": null, "half_life_endpoint": "Elimination", "route": "Subcutaneous", "population": "Patients with type 2 diabetes", "source_id": "S01", "source_url": "https://www.novo-pi.com/ozempic.pdf", "additional_source_url": "", "source_section": "12.3 Pharmacokinetics — Elimination", "source_date": "Label revision: 05/2026 (cover).", "checked_date": "2026-10-14", "secondary_endpoint": "", "secondary_value": null, "secondary_sd": null, "secondary_unit": "", "qualification": "Approximately 1 week; label separately describes circulation presence about 5 weeks after last dose." }, { "record_id": "L02", "peptide": "Semaglutide", "formulation": "Rybelsus / Ozempic tablets", "evidence_class": "human_label", "human_numeric_value": true, "half_life_display": "About 1 week", "reported_point": 1, "reported_low": null, "reported_high": null, "reported_unit": "week", "uncertainty_type": "", "reported_sd": null, "hours_point": 168, "hours_low": null, "hours_high": null, "half_life_endpoint": "Elimination", "route": "Oral", "population": "Patients with type 2 diabetes", "source_id": "S02", "source_url": "https://www.novo-pi.com/rybelsus.pdf", "additional_source_url": "", "source_section": "12.3 Pharmacokinetics — Elimination", "source_date": "Label revision: 1/2026 (cover).", "checked_date": "2026-10-14", "secondary_endpoint": "", "secondary_value": null, "secondary_sd": null, "secondary_unit": "", "qualification": "Current file covers Rybelsus and Ozempic tablets; oral dosing does not imply a shorter systemic half-life." }, { "record_id": "L03", "peptide": "Tirzepatide", "formulation": "Mounjaro", "evidence_class": "human_label", "human_numeric_value": true, "half_life_display": "About 5 days", "reported_point": 5, "reported_low": null, "reported_high": null, "reported_unit": "day", "uncertainty_type": "", "reported_sd": null, "hours_point": 120, "hours_low": null, "hours_high": null, "half_life_endpoint": "Elimination", "route": "Subcutaneous", "population": "PK similar in healthy subjects and patients with type 2 diabetes", "source_id": "S03", "source_url": "https://pi.lilly.com/us/mounjaro-uspi.pdf", "additional_source_url": "", "source_section": "12.3 Pharmacokinetics — Elimination", "source_date": "Label revision: 08/2026 (cover).", "checked_date": "2026-10-14", "secondary_endpoint": "", "secondary_value": null, "secondary_sd": null, "secondary_unit": "", "qualification": "Approximate estimate." }, { "record_id": "L04", "peptide": "Liraglutide", "formulation": "Victoza", "evidence_class": "human_label", "human_numeric_value": true, "half_life_display": "About 13 hours", "reported_point": 13, "reported_low": null, "reported_high": null, "reported_unit": "hour", "uncertainty_type": "", "reported_sd": null, "hours_point": 13, "hours_low": null, "hours_high": null, "half_life_endpoint": "Elimination", "route": "Subcutaneous", "population": "Human single-dose PK; subgroup not specified for estimate sentence", "source_id": "S04", "source_url": "https://www.novo-pi.com/victoza.pdf", "additional_source_url": "", "source_section": "12.3 Pharmacokinetics — Elimination", "source_date": "Label revision: 10/2025 (cover).", "checked_date": "2026-10-14", "secondary_endpoint": "", "secondary_value": null, "secondary_sd": null, "secondary_unit": "", "qualification": "Approximate estimate." }, { "record_id": "L05", "peptide": "Dulaglutide", "formulation": "Trulicity", "evidence_class": "human_label", "human_numeric_value": true, "half_life_display": "About 5 days", "reported_point": 5, "reported_low": null, "reported_high": null, "reported_unit": "day", "uncertainty_type": "", "reported_sd": null, "hours_point": 120, "hours_low": null, "hours_high": null, "half_life_endpoint": "Elimination", "route": "Subcutaneous", "population": "PK similar in healthy subjects and patients with type 2 diabetes", "source_id": "S05", "source_url": "https://pi.lilly.com/us/trulicity-uspi.pdf", "additional_source_url": "", "source_section": "12.3 Pharmacokinetics — Elimination", "source_date": "Label revision: 03/2026 (cover).", "checked_date": "2026-10-14", "secondary_endpoint": "", "secondary_value": null, "secondary_sd": null, "secondary_unit": "", "qualification": "Approximate estimate. A GLP-1 analogue fused to modified human IgG4 Fc; larger biologic." }, { "record_id": "L06", "peptide": "Exenatide", "formulation": "Byetta immediate release", "evidence_class": "human_label", "human_numeric_value": true, "half_life_display": "2.4 hours", "reported_point": 2.4, "reported_low": null, "reported_high": null, "reported_unit": "hour", "uncertainty_type": "", "reported_sd": null, "hours_point": 2.4, "hours_low": null, "hours_high": null, "half_life_endpoint": "Mean terminal", "route": "Subcutaneous", "population": "Human PK; absorption section describes type 2 diabetes patients", "source_id": "S06", "source_url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=53d03c03-ebf7-418d-88a8-533eabd2ee4f", "additional_source_url": "", "source_section": "12.3 Pharmacokinetics — Metabolism and Elimination", "source_date": "Label revision September 2025; DailyMed effective date September 2, 2025.", "checked_date": "2026-10-14", "secondary_endpoint": "", "secondary_value": null, "secondary_sd": null, "secondary_unit": "", "qualification": "Label says independent of dose. Concentration measurability for about 10 hours is a separate observation." }, { "record_id": "L07", "peptide": "Exenatide", "formulation": "Bydureon BCise extended release", "evidence_class": "label_depot_profile", "human_numeric_value": false, "half_life_display": "No single depot value in cited label", "reported_point": null, "reported_low": null, "reported_high": null, "reported_unit": null, "uncertainty_type": "", "reported_sd": null, "hours_point": null, "hours_low": null, "hours_high": null, "half_life_endpoint": "No single formulation half-life supplied", "route": "Subcutaneous depot", "population": "Adults with type 2 diabetes in PK description", "source_id": "S07", "source_url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2d18cfc4-e0de-4814-a712-c1b7c504bff5", "additional_source_url": "", "source_section": "12.3 Pharmacokinetics — Absorption / Elimination", "source_date": "Label revision: 5/2025; DailyMed update May 28, 2025.", "checked_date": "2026-10-14", "secondary_endpoint": "", "secondary_value": null, "secondary_sd": null, "secondary_unit": "", "qualification": "Do not import 2.4 h from Byetta. About 10 weeks after stopping, plasma concentrations generally below 20 pg/mL; this is not half-life. Current DailyMed record lists marketing end 2025-10-31; do not claim current availability." }, { "record_id": "L08", "peptide": "Lixisenatide", "formulation": "Adlyxin", "evidence_class": "human_label", "human_numeric_value": true, "half_life_display": "About 3 hours", "reported_point": 3, "reported_low": null, "reported_high": null, "reported_unit": "hour", "uncertainty_type": "", "reported_sd": null, "hours_point": 3, "hours_low": null, "hours_high": null, "half_life_endpoint": "Mean terminal", "route": "Subcutaneous", "population": "After multiple doses in patients with type 2 diabetes", "source_id": "S08", "source_url": "https://products.sanofi.us/adlyxin/adlyxin.pdf", "additional_source_url": "", "source_section": "12.3 Pharmacokinetics — Elimination", "source_date": "Label revision June 2022.", "checked_date": "2026-10-14", "secondary_endpoint": "", "secondary_value": null, "secondary_sd": null, "secondary_unit": "", "qualification": "Approximate estimate. Current manufacturer-hosted PDF checked; no current availability claim." }, { "record_id": "L09", "peptide": "Pramlintide", "formulation": "Symlin", "evidence_class": "human_label", "human_numeric_value": true, "half_life_display": "About 48 minutes", "reported_point": 48, "reported_low": null, "reported_high": null, "reported_unit": "minute", "uncertainty_type": "", "reported_sd": null, "hours_point": 0.8, "hours_low": null, "hours_high": null, "half_life_endpoint": "Label summary half-life", "route": "Subcutaneous", "population": "Healthy individuals", "source_id": "S09", "source_url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=4aea30ff-eb0d-45c1-b114-3127966328ff", "additional_source_url": "", "source_section": "12.3 Pharmacokinetics — Metabolism and Elimination / Table 5", "source_date": "Label revision: 12/2019 (highlights).", "checked_date": "2026-10-14", "secondary_endpoint": "", "secondary_value": null, "secondary_sd": null, "secondary_unit": "", "qualification": "Approximate summary estimate. Table 5 elimination values are 55,49,51,48 min for 30,60,90,120 mcg single SC doses respectively; not a confidence interval." }, { "record_id": "L10", "peptide": "Teriparatide", "formulation": "Forteo", "evidence_class": "human_label", "human_numeric_value": true, "half_life_display": "About 1 hour", "reported_point": 1, "reported_low": null, "reported_high": null, "reported_unit": "hour", "uncertainty_type": "", "reported_sd": null, "hours_point": 1, "hours_low": null, "hours_high": null, "half_life_endpoint": "Serum half-life", "route": "Subcutaneous", "population": "Human PK; 20 mcg dose context", "source_id": "S10", "source_url": "https://pi.lilly.com/us/forteo-pi.pdf", "additional_source_url": "", "source_section": "12.3 Pharmacokinetics — Elimination", "source_date": "Label revision: 08/2026 (cover).", "checked_date": "2026-10-14", "secondary_endpoint": "", "secondary_value": null, "secondary_sd": null, "secondary_unit": "", "qualification": "Approximate estimate. Severe renal impairment increased half-life in small subgroup." }, { "record_id": "L11", "peptide": "Abaloparatide", "formulation": "Tymlos", "evidence_class": "human_label", "human_numeric_value": true, "half_life_display": "About 1 hour", "reported_point": 1, "reported_low": null, "reported_high": null, "reported_unit": "hour", "uncertainty_type": "", "reported_sd": null, "hours_point": 1, "hours_low": null, "hours_high": null, "half_life_endpoint": "Mean label half-life", "route": "Subcutaneous", "population": "Human label PK; absorption bioavailability studied in healthy women at 80 mcg", "source_id": "S11", "source_url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=712143d9-e21e-4013-bb3b-3426a21060a8", "additional_source_url": "", "source_section": "12.3 Pharmacokinetics — Elimination / Excretion", "source_date": "Label revision: 8/2026 (highlights).", "checked_date": "2026-10-14", "secondary_endpoint": "", "secondary_value": null, "secondary_sd": null, "secondary_unit": "", "qualification": "Approximate estimate; label sentence says mean (SD), but no numeric SD is provided." }, { "record_id": "L12", "peptide": "Tesamorelin", "formulation": "Egrifta SV (2 mg/vial)", "evidence_class": "human_label", "human_numeric_value": true, "half_life_display": "8 minutes", "reported_point": 8, "reported_low": null, "reported_high": null, "reported_unit": "minute", "uncertainty_type": "", "reported_sd": null, "hours_point": 0.13333333333333333, "hours_low": null, "hours_high": null, "half_life_endpoint": "Mean elimination", "route": "Subcutaneous", "population": "Healthy subjects after single 1.4 mg dose", "source_id": "S12", "source_url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d783378-b02d-4f19-99dd-0fc91a042224", "additional_source_url": "", "source_section": "12.3 Pharmacokinetics — Elimination", "source_date": "Highlights revised February 2024; DailyMed updated July 29, 2026.", "checked_date": "2026-10-14", "secondary_endpoint": "", "secondary_value": null, "secondary_sd": null, "secondary_unit": "", "qualification": "Formulation specific; not generic 30 min; different from original Egrifta 1 mg/vial." }, { "record_id": "L13", "peptide": "Tesamorelin", "formulation": "Egrifta WR (11.6 mg/vial)", "evidence_class": "human_label", "human_numeric_value": true, "half_life_display": "11 minutes", "reported_point": 11, "reported_low": null, "reported_high": null, "reported_unit": "minute", "uncertainty_type": "", "reported_sd": null, "hours_point": 0.18333333333333332, "hours_low": null, "hours_high": null, "half_life_endpoint": "Mean elimination", "route": "Subcutaneous", "population": "Healthy subjects after single 1.28 mg dose", "source_id": "S13", "source_url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75", "additional_source_url": "", "source_section": "12.3 Pharmacokinetics — Elimination", "source_date": "Highlights revised March 2025; DailyMed updated July 29, 2026.", "checked_date": "2026-10-14", "secondary_endpoint": "", "secondary_value": null, "secondary_sd": null, "secondary_unit": "", "qualification": "WR and SV not substitutable. Weekly preparation does not mean weekly injection or week-long half-life." }, { "record_id": "L14", "peptide": "Bremelanotide", "formulation": "Vyleesi (PT-141)", "evidence_class": "human_label", "human_numeric_value": true, "half_life_display": "About 2.7 hours; range 1.9–4.0", "reported_point": 2.7, "reported_low": 1.9, "reported_high": 4.0, "reported_unit": "hour", "uncertainty_type": "reported range", "reported_sd": null, "hours_point": 2.7, "hours_low": 1.9, "hours_high": 4.0, "half_life_endpoint": "Mean terminal", "route": "Subcutaneous", "population": "Single SC administration; estimate sentence does not isolate subgroup", "source_id": "S14", "source_url": "https://vyleesi.com/docs/Vyleesi-Full-Prescribing-Information.pdf", "additional_source_url": "", "source_section": "12.3 Pharmacokinetics — Elimination", "source_date": "Label revision: 03/2024 (cover).", "checked_date": "2026-10-14", "secondary_endpoint": "", "secondary_value": null, "secondary_sd": null, "secondary_unit": "", "qualification": "Approximate mean with reported range. Not evidence for every nasal or research preparation." }, { "record_id": "L15", "peptide": "Octreotide", "formulation": "Sandostatin immediate-release injection", "evidence_class": "human_label", "human_numeric_value": true, "half_life_display": "1.7–1.9 hours", "reported_point": null, "reported_low": 1.7, "reported_high": 1.9, "reported_unit": "hour", "uncertainty_type": "reported range", "reported_sd": null, "hours_point": null, "hours_low": 1.7, "hours_high": 1.9, "half_life_endpoint": "Apparent plasma elimination", "route": "Subcutaneous / intravenous", "population": "Healthy volunteer / human label PK", "source_id": "S15", "source_url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=4e2c9856-1836-49f0-9472-4dbeeb408f39", "additional_source_url": "", "source_section": "12.3 Pharmacokinetics — Elimination", "source_date": "Highlights revised July 2024; DailyMed effective July 22, 2026; record-end revision July 2026.", "checked_date": "2026-10-14", "secondary_endpoint": "", "secondary_value": null, "secondary_sd": null, "secondary_unit": "", "qualification": "Preserve range. Up-to-12 h duration of action is distinct. Renal/hepatic impairment and age can alter half-life." }, { "record_id": "L16", "peptide": "Octreotide", "formulation": "Sandostatin LAR Depot", "evidence_class": "label_depot_profile", "human_numeric_value": false, "half_life_display": "No single depot value in cited label", "reported_point": null, "reported_low": null, "reported_high": null, "reported_unit": null, "uncertainty_type": "", "reported_sd": null, "hours_point": null, "hours_low": null, "hours_high": null, "half_life_endpoint": "No single depot half-life supplied", "route": "Intramuscular depot", "population": "Healthy volunteers / acromegaly patients", "source_id": "S16", "source_url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d0b7fe9e-7000-4b79-ba3b-291ce92c14f9", "additional_source_url": "", "source_section": "12.3 Pharmacokinetics — Sandostatin Injection / Sandostatin LAR Depot", "source_date": "Highlights revised July 2024; DailyMed effective December 22, 2025; record-end revision December 2025.", "checked_date": "2026-10-14", "secondary_endpoint": "", "secondary_value": null, "secondary_sd": null, "secondary_unit": "", "qualification": "Label 1.7 h comes from immediate-release data. LAR profile governed by microsphere release: plateau at 2–3 weeks, not a 2–3 week half-life." }, { "record_id": "L17", "peptide": "Lanreotide", "formulation": "Somatuline Depot", "evidence_class": "human_label", "human_numeric_value": true, "half_life_display": "23–30 days", "reported_point": null, "reported_low": 23, "reported_high": 30, "reported_unit": "day", "uncertainty_type": "reported range", "reported_sd": null, "hours_point": null, "hours_low": 552, "hours_high": 720, "half_life_endpoint": "Sustained-release formulation half-life", "route": "Deep subcutaneous depot", "population": "Healthy subjects after single 60,90,120 mg doses", "source_id": "S17", "source_url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=6e4a41fd-a753-4362-87ee-8cc56ed3660d", "additional_source_url": "", "source_section": "12.3 Pharmacokinetics — Pharmacokinetics", "source_date": "Highlights revised July 2024; DailyMed effective October 11, 2024; record-end revision October 2024.", "checked_date": "2026-10-14", "secondary_endpoint": "", "secondary_value": null, "secondary_sd": null, "secondary_unit": "", "qualification": "Preserve 23–30 day range. Not applicable to immediate-release or different lanreotide formulations." }, { "record_id": "H01", "peptide": "CJC-1295 with DAC", "formulation": "DAC form; salt unspecified", "evidence_class": "human_study", "human_numeric_value": true, "half_life_display": "Estimated 5.8–8.1 days", "reported_point": null, "reported_low": 5.8, "reported_high": 8.1, "reported_unit": "days", "reported_sd": null, "uncertainty_type": "reported estimate range", "hours_point": null, "hours_low": 139.2, "hours_high": 194.39999999999998, "half_life_endpoint": "Estimated half-life", "route": "subcutaneous", "population": "Healthy adults age 21–61", "source_id": "R01", "source_url": "https://academic.oup.com/jcem/article-abstract/91/3/799/2843281", "additional_source_url": "https://www.fda.gov/media/183819/download", "source_section": "2006; JCEM 91:799–805; original abstract Results.", "source_date": "2006; JCEM 91:799–805; original abstract Results.", "checked_date": "2026-10-14", "secondary_endpoint": "", "secondary_value": null, "secondary_sd": null, "secondary_unit": "", "qualification": "DAC-GRF form confirmed by FDA 2024 review; salt unspecified. Not transferable to no-DAC." }, { "record_id": "H02", "peptide": "Ipamorelin", "formulation": "Study compound", "evidence_class": "human_study", "human_numeric_value": true, "half_life_display": "Terminal half-life 2 hours", "reported_point": 2, "reported_low": null, "reported_high": null, "reported_unit": "hours", "reported_sd": null, "uncertainty_type": "", "hours_point": 2, "hours_low": null, "hours_high": null, "half_life_endpoint": "Terminal", "route": "intravenous 15-minute infusion", "population": "8 healthy male subjects at each of 5 escalating dose levels", "source_id": "R02", "source_url": "https://link.springer.com/article/10.1023/A:1018955126402", "additional_source_url": "", "source_section": "1999; Pharmaceutical Research 16:1412–1416; original abstract Methods and Results.", "source_date": "1999; Pharmaceutical Research 16:1412–1416; original abstract Methods and Results.", "checked_date": "2026-10-14", "secondary_endpoint": "", "secondary_value": null, "secondary_sd": null, "secondary_unit": "", "qualification": "Terminal drug half-life; GH peak at 0.67h is separate PD. Does not establish SC blend PK." }, { "record_id": "H03", "peptide": "GHRP-2 (pralmorelin)", "formulation": "Study compound", "evidence_class": "human_study", "human_numeric_value": true, "half_life_display": "0.55 ± 0.14 hours (about 33 minutes)", "reported_point": 0.55, "reported_low": null, "reported_high": null, "reported_unit": "hours", "reported_sd": 0.14, "uncertainty_type": "mean ± SD", "hours_point": 0.55, "hours_low": null, "hours_high": null, "half_life_endpoint": "Terminal beta", "route": "Intravenous injection", "population": "10 prepubertal short-stature children; mean age 7.7 ± 2.4 years", "source_id": "R03", "source_url": "https://academic.oup.com/jcem/article-abstract/83/4/1168/2865268", "additional_source_url": "", "source_section": "1998; JCEM 83:1168–1172; original abstract, terminal beta half-life.", "source_date": "1998; JCEM 83:1168–1172; original abstract, terminal beta half-life.", "checked_date": "2026-10-14", "secondary_endpoint": "", "secondary_value": null, "secondary_sd": null, "secondary_unit": "", "qualification": "Mean ± SD; children, not an adult SC estimate. Study used a single 1 microgram/kg IV dose over 1 minute. Drug half-life is distinct from growth-hormone half-life." }, { "record_id": "H04", "peptide": "GHRP-6", "formulation": "Study compound", "evidence_class": "human_study", "human_numeric_value": true, "half_life_display": "2.5 ± 1.1 hours (elimination)", "reported_point": 2.5, "reported_low": null, "reported_high": null, "reported_unit": "hours", "reported_sd": 1.1, "uncertainty_type": "± as reported; averaged across three dose levels", "hours_point": 2.5, "hours_low": null, "hours_high": null, "half_life_endpoint": "Terminal elimination", "route": "Intravenous bolus", "population": "9 healthy men; averaged across 100,200,400 μg/kg dose levels", "source_id": "R04", "source_url": "https://pubmed.ncbi.nlm.nih.gov/23099431/", "additional_source_url": "https://www.sciencedirect.com/science/article/pii/S0928098712003880", "source_section": "2013 issue; online 2012; original abstract, distribution and elimination parameters.", "source_date": "2013 issue; online 2012; original abstract, distribution and elimination parameters.", "checked_date": "2026-10-14", "secondary_endpoint": "Distribution", "secondary_value": 7.6, "secondary_sd": 1.9, "secondary_unit": "minutes", "qualification": "Plus/minus figures as reported, averaged across 100, 200 and 400 microgram/kg IV dose levels in nine healthy men; unusually high study exposures. The full paper uses a standard-deviation convention, but this aggregate is not a pooled individual-patient range. Separate distribution half-life: 7.6 ± 1.9 minutes. Not a SC estimate." }, { "record_id": "H05", "peptide": "Sermorelin (GEREF 50)", "formulation": "GEREF 50 archived diagnostic product", "evidence_class": "archived_official_human", "human_numeric_value": true, "half_life_display": "Plasma half-life 6–7 minutes", "reported_point": null, "reported_low": 6, "reported_high": 7, "reported_unit": "minutes", "reported_sd": null, "uncertainty_type": "reported estimate range", "hours_point": null, "hours_low": 0.1, "hours_high": 0.11666666666666667, "half_life_endpoint": "Plasma", "route": "intravenous", "population": "Historical diagnostic product; population not detailed in SmPC PK section", "source_id": "R05", "source_url": "https://assets.hpra.ie/products/Human/16600/LicenseSPC_PA0285-006-001_13072006155719.pdf", "additional_source_url": "", "source_section": "Text revised May 2004, printed July 13, 2006; section 5.2.", "source_date": "Text revised May 2004, printed July 13, 2006; section 5.2.", "checked_date": "2026-10-14", "secondary_endpoint": "", "secondary_value": null, "secondary_sd": null, "secondary_unit": "", "qualification": "Archived official Irish Medicines Board SmPC; 11–12min vendor claim not selected. GH peak/effect duration differs." }, { "record_id": "H06", "peptide": "Recombinant thymosin beta-4 NL005", "formulation": "44-amino-acid recombinant investigational product", "evidence_class": "human_study", "human_numeric_value": true, "half_life_display": "0.5–2.084 hours across single-dose cohorts", "reported_point": null, "reported_low": 0.5, "reported_high": 2.084, "reported_unit": "hours", "reported_sd": null, "uncertainty_type": "range across dose-cohort estimates, not individuals", "hours_point": null, "hours_low": 0.5, "hours_high": 2.084, "half_life_endpoint": "Plasma half-life (noncompartmental analysis)", "route": "Intravenous injection", "population": "Healthy Chinese adults; single-dose cohorts from Table 4", "source_id": "R06", "source_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC8419156/", "additional_source_url": "https://onlinelibrary.wiley.com/doi/10.1111/jcmm.16693", "source_section": "Introduction (44-aa identity), Methods 2.3/2.4, Table 4 and Discussion", "source_date": "2021", "checked_date": "2026-10-14", "secondary_endpoint": "", "secondary_value": null, "secondary_sd": null, "secondary_unit": "", "qualification": "This range spans Table 4 dose-cohort estimates, not the range across individual patients. NL005 is recombinant 44-aa product, distinct from natural 43-aa thymosin beta-4 and the 7-aa TB-500 fragment. No SC half-life is established by this study. Half-life values vary by dose without monotonically increasing across every single-dose cohort. Not interchangeable with arbitrary research products." }, { "record_id": "G01", "peptide": "BPC-157", "formulation": "Identity/route-specific evidence record", "evidence_class": "human_value_not_verified", "human_numeric_value": false, "half_life_display": "Human elimination half-life not established by reviewed records", "reported_point": null, "reported_low": null, "reported_high": null, "reported_unit": null, "reported_sd": null, "uncertainty_type": "", "hours_point": null, "hours_low": null, "hours_high": null, "half_life_endpoint": "No route-specific human value selected", "route": "Human elimination value unresolved; reviewed animal IV/IM", "population": "Rat/beagle PK is not human PK", "source_id": "R08", "source_url": "https://www.fda.gov/media/193343/download", "additional_source_url": "https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2022.1026182/full", "source_section": "Staff evaluation May 11, 2026; Human Safety, Pharmacokinetic Data (PDF page 40).", "source_date": "Staff evaluation May 11, 2026; Human Safety, Pharmacokinetic Data (PDF page 40).", "checked_date": "2026-10-14", "secondary_endpoint": "", "secondary_value": null, "secondary_sd": null, "secondary_unit": "", "qualification": "The cited FDA review reports human rectal-enema plasma measurements mostly below quantification and no human PK for oral, SC, nasal or transdermal administration. The 2022 animal half-lives do not establish a human elimination value." }, { "record_id": "G02", "peptide": "TB-500 (Ac-LKKTETQ fragment)", "formulation": "Identity/route-specific evidence record", "evidence_class": "human_value_not_verified", "human_numeric_value": false, "half_life_display": "Human half-life not identified for this fragment", "reported_point": null, "reported_low": null, "reported_high": null, "reported_unit": null, "reported_sd": null, "uncertainty_type": "", "hours_point": null, "hours_low": null, "hours_high": null, "half_life_endpoint": "No route-specific human value selected", "route": "No qualifying human administration PK selected", "population": "Analytical identification and equine data are not human PK", "source_id": "R09", "source_url": "https://www.fda.gov/media/193349/download", "additional_source_url": "https://pubmed.ncbi.nlm.nih.gov/22962027/", "source_section": "July 2026 advisory-meeting briefing; chemical identity and Human Safety, Pharmacokinetic Data.", "source_date": "July 2026 advisory-meeting briefing; chemical identity and Human Safety, Pharmacokinetic Data.", "checked_date": "2026-10-14", "secondary_endpoint": "", "secondary_value": null, "secondary_sd": null, "secondary_unit": "", "qualification": "FDA reviewed the seven-amino-acid Ac-LKKTETQ fragment, not full-length thymosin beta-4. The cited FDA review did not identify human PK/PD studies for free base or acetate via any route." }, { "record_id": "G03", "peptide": "MOTS-c", "formulation": "Identity/route-specific evidence record", "evidence_class": "official_human_pk_gap", "human_numeric_value": false, "half_life_display": "Human PK half-life not identified in reviewed sources", "reported_point": null, "reported_low": null, "reported_high": null, "reported_unit": null, "reported_sd": null, "uncertainty_type": "", "hours_point": null, "hours_low": null, "hours_high": null, "half_life_endpoint": "No route-specific human value selected", "route": "No qualifying route-specific human half-life selected", "population": "Human serum degradation is in vitro", "source_id": "R10", "source_url": "https://www.fda.gov/media/193347/download", "additional_source_url": "", "source_section": "July 2026 advisory-meeting briefing; Human Safety, Pharmacokinetic Data.", "source_date": "July 2026 advisory-meeting briefing; Human Safety, Pharmacokinetic Data.", "checked_date": "2026-10-14", "secondary_endpoint": "", "secondary_value": null, "secondary_sd": null, "secondary_unit": "", "qualification": "FDA did not identify clinical studies providing PK for MOTS-c-related BDSs. CB4211 is a distinct analog; endogenous biomarker changes not administered peptide clearance." }, { "record_id": "G04", "peptide": "KPV", "formulation": "Identity/route-specific evidence record", "evidence_class": "official_human_pk_gap", "human_numeric_value": false, "half_life_display": "Human PK half-life not identified", "reported_point": null, "reported_low": null, "reported_high": null, "reported_unit": null, "reported_sd": null, "uncertainty_type": "", "hours_point": null, "hours_low": null, "hours_high": null, "half_life_endpoint": "No route-specific human value selected", "route": "Any route in cited FDA review", "population": "No human administration PK identified by FDA", "source_id": "R11", "source_url": "https://www.fda.gov/media/193346/download", "additional_source_url": "", "source_section": "Staff evaluation May 12, 2026; Human Safety, Pharmacokinetic Data.", "source_date": "Staff evaluation May 12, 2026; Human Safety, Pharmacokinetic Data.", "checked_date": "2026-10-14", "secondary_endpoint": "", "secondary_value": null, "secondary_sd": null, "secondary_unit": "", "qualification": "FDA brief dated May 12 2026, July PCAC: no clinical human PK/PD via any route. Do not infer a number from size." }, { "record_id": "G05", "peptide": "AOD-9604", "formulation": "Identity/route-specific evidence record", "evidence_class": "official_human_pk_gap", "human_numeric_value": false, "half_life_display": "Human PK half-life not identified", "reported_point": null, "reported_low": null, "reported_high": null, "reported_unit": null, "reported_sd": null, "uncertainty_type": "", "hours_point": null, "hours_low": null, "hours_high": null, "half_life_endpoint": "No route-specific human value selected", "route": "Any route in cited FDA review", "population": "Animal/in-vitro results not human PK", "source_id": "R12", "source_url": "https://www.fda.gov/media/183584/download", "additional_source_url": "", "source_section": "Staff evaluation November 5, 2024; Human Safety, Pharmacokinetic Data.", "source_date": "Staff evaluation November 5, 2024; Human Safety, Pharmacokinetic Data.", "checked_date": "2026-10-14", "secondary_endpoint": "", "secondary_value": null, "secondary_sd": null, "secondary_unit": "", "qualification": "Brief dated Nov 5 2024; FDA found no clinical human PK/PD any route. ~3min IV pigs, ~4min rat blood in vitro are not human. Human trial participation is not PK measurement." }, { "record_id": "G06", "peptide": "Epitalon", "formulation": "Identity/route-specific evidence record", "evidence_class": "official_human_pk_gap", "human_numeric_value": false, "half_life_display": "Human PK half-life not identified", "reported_point": null, "reported_low": null, "reported_high": null, "reported_unit": null, "reported_sd": null, "uncertainty_type": "", "hours_point": null, "hours_low": null, "hours_high": null, "half_life_endpoint": "No route-specific human value selected", "route": "No qualifying route-specific human PK selected", "population": "Free base and acetate evaluated", "source_id": "R13", "source_url": "https://www.fda.gov/media/193345/download", "additional_source_url": "", "source_section": "July 2026 advisory-meeting briefing; Human Safety, Pharmacokinetic Data.", "source_date": "July 2026 advisory-meeting briefing; Human Safety, Pharmacokinetic Data.", "checked_date": "2026-10-14", "secondary_endpoint": "", "secondary_value": null, "secondary_sd": null, "secondary_unit": "", "qualification": "FDA found no PK data for free base or acetate. Epitalon and Epithalamin are distinct." }, { "record_id": "G07", "peptide": "GHK-Cu", "formulation": "Identity/route-specific evidence record", "evidence_class": "search_scoped_gap", "human_numeric_value": false, "half_life_display": "No route-specific human elimination half-life verified in this audit", "reported_point": null, "reported_low": null, "reported_high": null, "reported_unit": null, "reported_sd": null, "uncertainty_type": "", "hours_point": null, "hours_low": null, "hours_high": null, "half_life_endpoint": "No route-specific human value selected", "route": "Topical and systemic must be kept separate", "population": "No qualifying primary human PK half-life retrieved in targeted searches", "source_id": "R14", "source_url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks", "additional_source_url": "", "source_section": "Injectable GHK-Cu entry; safety context only, not a pharmacokinetic measurement.", "source_date": "Injectable GHK-Cu entry; safety context only, not a pharmacokinetic measurement.", "checked_date": "2026-10-14", "secondary_endpoint": "", "secondary_value": null, "secondary_sd": null, "secondary_unit": "", "qualification": "No route-specific human elimination half-life verified in our targeted primary-source search. FDA link supplies safety context only and does not prove absence of PK studies. Topical GHK-Cu, injectable GHK-Cu, free GHK and endogenous measurements are not interchangeable." }, { "record_id": "G08", "peptide": "Modified GRF(1–29) / CJC-1295 no DAC", "formulation": "Identity/route-specific evidence record", "evidence_class": "official_form_scoped_gap", "human_numeric_value": false, "half_life_display": "Human half-life not verified for the specified no-DAC compound", "reported_point": null, "reported_low": null, "reported_high": null, "reported_unit": null, "reported_sd": null, "uncertainty_type": "", "hours_point": null, "hours_low": null, "hours_high": null, "half_life_endpoint": "No route-specific human value selected", "route": "No qualifying human no-DAC PK selected", "population": "Human CJC numerical evidence reviewed was DAC form", "source_id": "R15", "source_url": "https://www.fda.gov/media/183819/download", "additional_source_url": "", "source_section": "December 2024 advisory-meeting briefing; chemical identities and human clinical-data sections.", "source_date": "December 2024 advisory-meeting briefing; chemical identities and human clinical-data sections.", "checked_date": "2026-10-14", "secondary_endpoint": "", "secondary_value": null, "secondary_sd": null, "secondary_unit": "", "qualification": "FDA separates no-DAC free base/acetate from DAC moiety. 30min not verified in human source reviewed. 5.8–8.1d belongs to DAC form." }, { "record_id": "G09", "peptide": "DSIP (emideltide)", "formulation": "Identity/route-specific evidence record", "evidence_class": "unresolved_source", "human_numeric_value": false, "half_life_display": "Route-specific in vivo human estimate not verified in this audit", "reported_point": null, "reported_low": null, "reported_high": null, "reported_unit": null, "reported_sd": null, "uncertainty_type": "", "hours_point": null, "hours_low": null, "hours_high": null, "half_life_endpoint": "No route-specific human value selected", "route": "No verified SC PK; IV source attribution unresolved", "population": "Animal IV and human serum in vitro data identified", "source_id": "R16", "source_url": "https://www.fda.gov/media/193344/download", "additional_source_url": "https://www.cambridge.org/core/services/aop-cambridge-core/content/view/04EA29FACB57F0D24E6FCD4B7E54AA00/S0265021501000898a.pdf/delta-sleep-inducing-peptide.pdf", "source_section": "Staff evaluation May 11, 2026; nonclinical PK (PDF page 45) and human PK summary (PDF page 50).", "source_date": "Staff evaluation May 11, 2026; nonclinical PK (PDF page 45) and human PK summary (PDF page 50).", "checked_date": "2026-10-14", "secondary_endpoint": "", "secondary_value": null, "secondary_sd": null, "secondary_unit": "", "qualification": "FDA summarizes an 8-minute plasma half-life on PDF page 50, but the referenced nonclinical section on page 45 describes animals and human serum in vitro. We could not verify the underlying route-specific in vivo human measurement. FDA also reports no SC PK information. This is an unresolved source trail, not a finding that FDA is wrong." } ], "sources": [ { "id": "S01", "title": "Ozempic injection prescribing information", "url": "https://www.novo-pi.com/ozempic.pdf", "section": "12.3 Pharmacokinetics", "source_date_note": "Label revision: 05/2026 (cover).", "checked_date": "2026-10-14", "source_refs": [ "turn2view0", "turn5view0" ], "number": 1 }, { "id": "S02", "title": "Rybelsus and Ozempic oral-tablet prescribing information", "url": "https://www.novo-pi.com/rybelsus.pdf", "section": "12.3 Pharmacokinetics", "source_date_note": "Label revision: 1/2026 (cover).", "checked_date": "2026-10-14", "source_refs": [ "turn2view1", "turn5view1", "turn30view3" ], "number": 2 }, { "id": "S03", "title": "Mounjaro prescribing information", "url": "https://pi.lilly.com/us/mounjaro-uspi.pdf", "section": "12.3 Pharmacokinetics", "source_date_note": "Label revision: 08/2026 (cover).", "checked_date": "2026-10-14", "source_refs": [ "turn2view2", "turn5view2", "turn25view4" ], "number": 3 }, { "id": "S04", "title": "Victoza prescribing information", "url": "https://www.novo-pi.com/victoza.pdf", "section": "12.3 Pharmacokinetics", "source_date_note": "Label revision: 10/2025 (cover).", "checked_date": "2026-10-14", "source_refs": [ "turn8view0", "turn11view0" ], "number": 4 }, { "id": "S05", "title": "Trulicity prescribing information", "url": "https://pi.lilly.com/us/trulicity-uspi.pdf", "section": "12.3 Pharmacokinetics", "source_date_note": "Label revision: 03/2026 (cover).", "checked_date": "2026-10-14", "source_refs": [ "turn2view3", "turn5view3", "turn25view5", "turn30view2" ], "number": 5 }, { "id": "S06", "title": "Byetta label", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=53d03c03-ebf7-418d-88a8-533eabd2ee4f", "section": "12.3 Pharmacokinetics", "source_date_note": "Label revision September 2025; DailyMed effective date September 2, 2025.", "checked_date": "2026-10-14", "source_refs": [ "turn13view0", "turn28view4" ], "number": 6 }, { "id": "S07", "title": "Bydureon BCise label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2d18cfc4-e0de-4814-a712-c1b7c504bff5", "section": "12.3 Pharmacokinetics", "source_date_note": "Label revision: 5/2025; DailyMed update May 28, 2025.", "checked_date": "2026-10-14", "source_refs": [ "turn19view1", "turn30view4" ], "number": 7 }, { "id": "S08", "title": "Adlyxin prescribing information", "url": "https://products.sanofi.us/adlyxin/adlyxin.pdf", "section": "12.3 Pharmacokinetics", "source_date_note": "Label revision June 2022.", "checked_date": "2026-10-14", "source_refs": [ "turn8view3", "turn11view1", "turn25view6" ], "number": 8 }, { "id": "S09", "title": "Symlin label", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=4aea30ff-eb0d-45c1-b114-3127966328ff", "section": "12.3 Pharmacokinetics", "source_date_note": "Label revision: 12/2019 (highlights).", "checked_date": "2026-10-14", "source_refs": [ "turn19view2", "turn22view1" ], "number": 9 }, { "id": "S10", "title": "Forteo prescribing information", "url": "https://pi.lilly.com/us/forteo-pi.pdf", "section": "12.3 Pharmacokinetics", "source_date_note": "Label revision: 08/2026 (cover).", "checked_date": "2026-10-14", "source_refs": [ "turn19view3", "turn22view2", "turn25view8" ], "number": 10 }, { "id": "S11", "title": "Tymlos label", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=712143d9-e21e-4013-bb3b-3426a21060a8", "section": "12.3 Pharmacokinetics", "source_date_note": "Label revision: 8/2026 (highlights).", "checked_date": "2026-10-14", "source_refs": [ "turn13view2", "turn22view3" ], "number": 11 }, { "id": "S12", "title": "Egrifta SV label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d783378-b02d-4f19-99dd-0fc91a042224", "section": "12.3 Pharmacokinetics", "source_date_note": "Highlights revised February 2024; DailyMed updated July 29, 2026.", "checked_date": "2026-10-14", "source_refs": [ "turn19view0", "turn22view0", "turn28view6", "turn30view5" ], "number": 12 }, { "id": "S13", "title": "Egrifta WR label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75", "section": "12.3 Pharmacokinetics", "source_date_note": "Highlights revised March 2025; DailyMed updated July 29, 2026.", "checked_date": "2026-10-14", "source_refs": [ "turn13view1", "turn28view5", "turn30view6" ], "number": 13 }, { "id": "S14", "title": "Vyleesi prescribing information", "url": "https://vyleesi.com/docs/Vyleesi-Full-Prescribing-Information.pdf", "section": "12.3 Pharmacokinetics", "source_date_note": "Label revision: 03/2024 (cover).", "checked_date": "2026-10-14", "source_refs": [ "turn13view3", "turn25view7" ], "number": 14 }, { "id": "S15", "title": "Sandostatin immediate-release injection label", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=4e2c9856-1836-49f0-9472-4dbeeb408f39", "section": "12.3 Pharmacokinetics", "source_date_note": "Highlights revised July 2024; DailyMed effective July 22, 2026; record-end revision July 2026.", "checked_date": "2026-10-14", "source_refs": [ "turn25view0", "turn28view8", "turn30view1" ], "number": 15 }, { "id": "S16", "title": "Sandostatin LAR Depot label", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d0b7fe9e-7000-4b79-ba3b-291ce92c14f9", "section": "12.3 Pharmacokinetics", "source_date_note": "Highlights revised July 2024; DailyMed effective December 22, 2025; record-end revision December 2025.", "checked_date": "2026-10-14", "source_refs": [ "turn25view2", "turn28view10", "turn30view0" ], "number": 16 }, { "id": "S17", "title": "Somatuline Depot label", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=6e4a41fd-a753-4362-87ee-8cc56ed3660d", "section": "12.3 Pharmacokinetics", "source_date_note": "Highlights revised July 2024; DailyMed effective October 11, 2024; record-end revision October 2024.", "checked_date": "2026-10-14", "source_refs": [ "turn25view1", "turn28view9" ], "number": 17 }, { "id": "R01", "title": "CJC-1295 with DAC — Teichman et al.", "url": "https://academic.oup.com/jcem/article-abstract/91/3/799/2843281", "section": "2006; JCEM 91:799–805; original abstract Results.", "source_date_note": "2006; JCEM 91:799–805; original abstract Results.", "checked_date": "2026-10-14", "number": 18 }, { "id": "R02", "title": "Ipamorelin — Gobburu et al.", "url": "https://link.springer.com/article/10.1023/A:1018955126402", "section": "1999; Pharmaceutical Research 16:1412–1416; original abstract Methods and Results.", "source_date_note": "1999; Pharmaceutical Research 16:1412–1416; original abstract Methods and Results.", "checked_date": "2026-10-14", "number": 19 }, { "id": "R03", "title": "GHRP-2 — Pihoker et al.", "url": "https://academic.oup.com/jcem/article-abstract/83/4/1168/2865268", "section": "1998; JCEM 83:1168–1172; original abstract, terminal beta half-life.", "source_date_note": "1998; JCEM 83:1168–1172; original abstract, terminal beta half-life.", "checked_date": "2026-10-14", "number": 20 }, { "id": "R04", "title": "GHRP-6 — Cabrales et al.", "url": "https://pubmed.ncbi.nlm.nih.gov/23099431/", "section": "2013 issue; online 2012; original abstract, distribution and elimination parameters.", "source_date_note": "2013 issue; online 2012; original abstract, distribution and elimination parameters.", "checked_date": "2026-10-14", "number": 21 }, { "id": "R05", "title": "GEREF 50 archived official product information", "url": "https://assets.hpra.ie/products/Human/16600/LicenseSPC_PA0285-006-001_13072006155719.pdf", "section": "Text revised May 2004, printed July 13, 2006; section 5.2.", "source_date_note": "Text revised May 2004, printed July 13, 2006; section 5.2.", "checked_date": "2026-10-14", "number": 22 }, { "id": "R06", "title": "Recombinant thymosin beta-4 NL005 — Wang et al.", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC8419156/", "section": "2021; J Cell Mol Med; introduction, methods and Table 4; DOI 10.1111/jcmm.16693.", "source_date_note": "2021; J Cell Mol Med; introduction, methods and Table 4; DOI 10.1111/jcmm.16693.", "checked_date": "2026-10-14", "number": 23 }, { "id": "R07", "title": "BPC-157 animal pharmacokinetics — He et al.", "url": "https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2022.1026182/full", "section": "2022; Results and Tables 1–6; rats and beagle dogs.", "source_date_note": "2022; Results and Tables 1–6; rats and beagle dogs.", "checked_date": "2026-10-14", "number": 24 }, { "id": "R08", "title": "FDA BPC-157 briefing", "url": "https://www.fda.gov/media/193343/download", "section": "Staff evaluation May 11, 2026; Human Safety, Pharmacokinetic Data (PDF page 40).", "source_date_note": "Staff evaluation May 11, 2026; Human Safety, Pharmacokinetic Data (PDF page 40).", "checked_date": "2026-10-14", "number": 25 }, { "id": "R09", "title": "FDA TB-500 briefing", "url": "https://www.fda.gov/media/193349/download", "section": "July 2026 advisory-meeting briefing; chemical identity and Human Safety, Pharmacokinetic Data.", "source_date_note": "July 2026 advisory-meeting briefing; chemical identity and Human Safety, Pharmacokinetic Data.", "checked_date": "2026-10-14", "number": 26 }, { "id": "R10", "title": "FDA MOTS-c briefing", "url": "https://www.fda.gov/media/193347/download", "section": "July 2026 advisory-meeting briefing; Human Safety, Pharmacokinetic Data.", "source_date_note": "July 2026 advisory-meeting briefing; Human Safety, Pharmacokinetic Data.", "checked_date": "2026-10-14", "number": 27 }, { "id": "R11", "title": "FDA KPV briefing", "url": "https://www.fda.gov/media/193346/download", "section": "Staff evaluation May 12, 2026; Human Safety, Pharmacokinetic Data.", "source_date_note": "Staff evaluation May 12, 2026; Human Safety, Pharmacokinetic Data.", "checked_date": "2026-10-14", "number": 28 }, { "id": "R12", "title": "FDA AOD-9604 briefing", "url": "https://www.fda.gov/media/183584/download", "section": "Staff evaluation November 5, 2024; Human Safety, Pharmacokinetic Data.", "source_date_note": "Staff evaluation November 5, 2024; Human Safety, Pharmacokinetic Data.", "checked_date": "2026-10-14", "number": 29 }, { "id": "R13", "title": "FDA epitalon briefing", "url": "https://www.fda.gov/media/193345/download", "section": "July 2026 advisory-meeting briefing; Human Safety, Pharmacokinetic Data.", "source_date_note": "July 2026 advisory-meeting briefing; Human Safety, Pharmacokinetic Data.", "checked_date": "2026-10-14", "number": 30 }, { "id": "R14", "title": "FDA compounding safety-risk page", "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks", "section": "Injectable GHK-Cu entry; safety context only, not a pharmacokinetic measurement.", "source_date_note": "Injectable GHK-Cu entry; safety context only, not a pharmacokinetic measurement.", "checked_date": "2026-10-14", "number": 31 }, { "id": "R15", "title": "FDA CJC-1295 briefing", "url": "https://www.fda.gov/media/183819/download", "section": "December 2024 advisory-meeting briefing; chemical identities and human clinical-data sections.", "source_date_note": "December 2024 advisory-meeting briefing; chemical identities and human clinical-data sections.", "checked_date": "2026-10-14", "number": 32 }, { "id": "R16", "title": "FDA emideltide (DSIP) briefing", "url": "https://www.fda.gov/media/193344/download", "section": "Staff evaluation May 11, 2026; nonclinical PK (PDF page 45) and human PK summary (PDF page 50).", "source_date_note": "Staff evaluation May 11, 2026; nonclinical PK (PDF page 45) and human PK summary (PDF page 50).", "checked_date": "2026-10-14", "number": 33 } ] }