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FDA-approved peptides: the status table

Of the 23 peptides covered here, 3 are in FDA-approved products sold today: tesamorelin (Egrifta), bremelanotide (Vyleesi) and elamipretide (Forzinity, sold online as SS-31). Sermorelin was approved as Geref but discontinued in 2008. The other 13 are not FDA-approved for any use (checked November 13, 2026).

Open Peptide Calculator editorial teamUpdated 51 sources

Status at a glance

U.S. regulatory status, sport status and human evidence (checked November 13, 2026)
PeptideFDA approvalCompounding (503A)WADA 2026Published human trials
BPC-157Not approved
No application found[3]		Category 2 from Sept 2023 to Apr 22, 2026[4]. Not on the 503A bulks list. Covered by a non-binding HHS enforcement-discretion policy since Oct 30, 2026[5]Prohibited, S0 (named)[2]Only small uncontrolled studies and meeting abstracts[6]
TB-500Not approved
No application found[3]		Category 2 from Sept 2023 to Apr 22, 2026[4]. Not on the 503A bulks list. In the HHS enforcement-discretion policy since Oct 30, 2026[5]Prohibited, S2.3 (named)[2]None found[7]
BPC-157 + TB-500 blendNot approved
None		Excluded from the HHS policy, which allows a single active ingredient only[5]Both components prohibited[2]None found
TesamorelinFDA-approved
Egrifta, approved Nov 10, 2010; Egrifta WR, Mar 25, 2025[8][9]		A biological product since Mar 23, 2020, so not eligible for compounding[10][11]Prohibited, S2.2.4 (named)[2]Yes: two phase 3 trials (n = 412 and 404)[12]
CJC-1295 / ipamorelinNot approved
No application found for either[3]		Advisory committee voted against both in 2024[13][14]. Ipamorelin is on the 503B Category 2 list[15]Both prohibited, S2.2.4 (named)[2]CJC-1295 with DAC: small studies in 63 adults. Ipamorelin: IV trials. Combination: none[16][17]
SermorelinDiscontinued
Geref approved 1990 and 1997; withdrawn at the company's request in 2009[18][19]		Not on the 503A category lists[20]. FDA's 503B list marks it as a component of an approved drug[15]Prohibited, S2.2.4 (named)[2]Yes: pediatric growth hormone deficiency (n = 110) and small adult studies[21]
GHK-CuNot approved
No application found[3]		Non-injectable: 503A Category 1. Injectable: formerly Category 2, nomination withdrawn[20][4]. On the February 2027 advisory committee agenda[22]Not named on the 2026 list[2]Topical only[23]
MOTS-cNot approved
No application found[3]		Category 2 from Sept 2023 to Apr 22, 2026[4]. In the HHS enforcement-discretion policy since Oct 30, 2026[5]Prohibited, S4.4.1 (named)[2]None for MOTS-c; one early trial of a different analog[24]
PT-141 (bremelanotide)FDA-approved
Vyleesi, approved June 21, 2019[25]		Not on the 503A category lists[20]Not named on the 2026 list[2]Yes: two phase 3 trials, 1,267 women[26]
SS-31 (elamipretide)FDA-approved
Forzinity, accelerated approval Sept 19, 2025[27]		Acetate API called ineligible for 503A by the FDA[28]Not named; approved drug[2]Yes: small Barth syndrome trial; larger myopathy trial negative[29][30]
AOD-9604Not approved
No application found[31]		Advisory committee voted 0–12 against (Dec 2024)[13]. Not in the HHS policy[5]Prohibited, S2.2.3 (named)[2]Six sponsor trials, IV and oral; the largest missed its goal[32]
KPVNot approved
No application found[31]		HHS policy covers topical and oral forms only (Oct 30, 2026)[5]Not named[2]None found[33]
EpitalonNot approved
No application found[31]		HHS policy covers injections in "intermittent courses" (Oct 30, 2026)[5]Not named[2]A few small Russian studies; no safety data[34]
SemaxNot approved
No U.S. application; registered in Russia per the FDA[35]		HHS policy covers intranasal use only (Oct 30, 2026)[5]Not named[2]Small, mostly Russian intranasal studies[35]
SelankNot approved
No application found[31]		Not in the HHS policy[5]Not named[2]Small Russian anxiety trials, doses not reported[36]
CagrilintideNot approved
CagriSema filed Dec 2025; no decision found[37]		Cannot be compounded under federal law, per the FDA[38]Not named[2]Yes: phase 2 alone, phase 3 with semaglutide[39][40]
MT2 (melanotan II)Not approved
Never approved[31]		Category 2 from Sept 2023; nomination withdrawn[4]. On the February 2027 advisory committee agenda[22]Not named[2]Three small studies, 1996–2000[41]
Thymosin alpha-1Approved in Italy
No U.S. approval; 4 orphan designations, none approved[42]. Approved in Italy as Zadaxin[43]		Advisory committee voted 4–17 against (Dec 2024)[13]. 503B Category 3[15]Not named[2]Yes: hepatitis and sepsis trials; the phase 3 sepsis trial (n = 1,106) was negative[44]
KisspeptinNot approved
No application found; FDA: no approved product in any country[45][46]		Kisspeptin-10: 503A Category 2; advisory committee voted 0–11 (Oct 2024)[20][14]Prohibited in males, S2.2.1 (named)[2]Physiology and IVF studies, mostly kisspeptin-54[47][46]
DSIP (emideltide)Not approved
Not registered in any country searched, per the FDA[48]		Category 2 from Sept 2023 to Apr 2026; FDA proposed against it in July 2026[4][48]Not named[2]Small IV studies, 209 subjects in total[48]
GHRP-6Not approved
No application found[45]		503B Category 2; 503A Category 3[15][20]Prohibited, S2.2.4 (named)[2]Single-dose GH studies; no treatment trial[49]
HexarelinNot approved
No application found[45]		On no FDA category list[20][15]Prohibited, S2.2.4 (named as examorelin)[2]GH-release studies; a 16-week study found a weaker response[50]
LL-37Not approved
No application found[45]		Category 2 from Sept 2023 to Apr 2026; on the February 2027 advisory committee agenda[4][22]Not named[2]Topical ulcer trials; the phase 2b trial (n = 148) missed its goal[51]

Status changesRegulatory status is a snapshot, checked on the date at the top of this page. Each peptide page links to the FDA, WADA and trial records it relies on, so you can check them yourself.

What the columns mean

Each column answers a different question: approval, pharmacy compounding, sport and human testing.

  • FDA approval means a company proved safety and effectiveness for a specific use and the FDA approved a specific product. Approval of one product, such as an injection for one condition, does not make other versions of the same molecule approved.
  • Compounding (503A) refers to the rules for state-licensed pharmacies that mix drugs for individual prescriptions. A pharmacy may only compound from a bulk substance that meets one of the conditions in section 503A of the federal Food, Drug, and Cosmetic Act. The FDA keeps lists of nominated substances, and its Category 2 holds those it says raise significant safety risks.[1]
  • WADA 2026 is the World Anti-Doping Agency's Prohibited List, which applies to athletes in sports that follow the World Anti-Doping Code.[2] The sport page quotes each listing.
  • Published human trials means controlled studies in people, found on PubMed or ClinicalTrials.gov. Animal and cell studies are not counted.

Peptide pages

Comparisons

Four of these peptides act on growth hormone release; they are compared directly on the HGH peptides page, and the sport rules for all of them are on the banned peptides page.

Why this table comes first

The calculator can turn any number into a syringe reading, but it cannot tell you whether the number makes sense or whether the product is what its label says. For an approved medicine, the label answers those questions. For the rest, the honest answer is often that nobody has published the data. The safety page explains what that means in practice.

Frequently asked questions

Which peptides are FDA-approved?

Of the peptides covered here, only tesamorelin (Egrifta SV and Egrifta WR), bremelanotide (Vyleesi) and elamipretide (Forzinity, SS-31) are in FDA-approved products sold today.[8][25][27] Sermorelin was approved as Geref and discontinued in 2008.[18]

What are Category 2 peptides?

Category 2 is the FDA's interim list of nominated compounding substances that it says raise significant safety risks.[1] BPC-157, TB-500 and MOTS-c were on it from September 2023 to April 22, 2026, and moved to a "nominated but withdrawn" table that keeps the FDA's safety wording.[4]

Is BPC-157 legal?

BPC-157 is not an FDA-approved drug, and it is not on the 503A bulks list. A draft HHS policy from October 30, 2026 says HHS will not act against licensed pharmacies compounding it under ten conditions.[5] It is banned in sport.[2] This site does not give legal advice.

Sources

  1. Bulk drug substances used in compounding under section 503A of the FD&C Act · U.S. Food and Drug Administration, content current May 14, 2026
  2. World Anti-Doping Code: Prohibited List 2026 · World Anti-Doping Agency, in effect January 1, 2026
  3. openFDA Drugs@FDA searches for BPC-157, thymosin, CJC-1295, ipamorelin, MOTS-c and prezatide (no application found) · openFDA, searched November 13, 2026
  4. Certain bulk drug substances for use in compounding that may present significant safety risks · U.S. Food and Drug Administration, content current April 22, 2026
  5. Enforcement discretion policy regarding 503A compounding using certain peptide bulk drug substances (91 FR 68526) · U.S. Department of Health and Human Services, Federal Register, October 30, 2026
  6. FDA briefing document: BPC-157-related bulk drug substances · U.S. Food and Drug Administration, Pharmacy Compounding Advisory Committee, July 23, 2026
  7. FDA briefing document: TB-500-related bulk drug substances · U.S. Food and Drug Administration, Pharmacy Compounding Advisory Committee, July 23, 2026
  8. Drugs@FDA: Egrifta (tesamorelin), BLA 022505 · U.S. Food and Drug Administration, accessed November 13, 2026
  9. Approval letter, BLA 022505/S-020 (Egrifta WR) · U.S. Food and Drug Administration, March 25, 2025
  10. List of approved NDAs for biological products that were deemed to be BLAs on March 23, 2020 · U.S. Food and Drug Administration, 2020
  11. Notice to compounders: changes that affect compounding as of March 23, 2020 · U.S. Food and Drug Administration, March 5, 2020
  12. Egrifta SV (tesamorelin) prescribing information · FDA label via openFDA, effective July 29, 2026
  13. Pharmacy Compounding Advisory Committee, December 4, 2024: final summary minutes · U.S. Food and Drug Administration, approved February 21, 2025
  14. Pharmacy Compounding Advisory Committee, October 29, 2024: transcript (ipamorelin and kisspeptin-10) · U.S. Food and Drug Administration, October 29, 2024
  15. Bulk drug substances nominated for use in compounding under section 503B (category lists) · U.S. Food and Drug Administration, updated March 21, 2025
  16. FDA briefing document: CJC-1295-related bulk drug substances · U.S. Food and Drug Administration, Pharmacy Compounding Advisory Committee, December 4, 2024
  17. FDA briefing document: ipamorelin-related bulk drug substances · U.S. Food and Drug Administration, Pharmacy Compounding Advisory Committee, October 29, 2024
  18. Withdrawal of approval of 92 new drug applications, including Geref (74 FR 23407) · U.S. Food and Drug Administration, Federal Register, May 19, 2009
  19. Determination that Geref (sermorelin acetate) injection was not withdrawn from sale for reasons of safety or effectiveness (78 FR 14095) · U.S. Food and Drug Administration, Federal Register, March 4, 2013
  20. Bulk drug substances nominated for use in compounding under section 503A (category lists) · U.S. Food and Drug Administration, updated May 14, 2026
  21. Thorner M et al. Sermorelin in prepubertal children with growth hormone deficiency (JCEM 1996;81:1189–96) · Journal of Clinical Endocrinology & Metabolism (PubMed 8772599), 1996
  22. February 2027 meeting of the Pharmacy Compounding Advisory Committee (agenda: cathelicidin LL-37, GHK-Cu, dihexa acetate, melanotan II, pegylated mechano growth factor) · U.S. Food and Drug Administration, content current April 15, 2026
  23. Mulder GD et al. Topical GHK-Cu gel for diabetic neuropathic ulcers (Wound Repair Regen 1994;2:259–69) · Wound Repair and Regeneration, 1994
  24. FDA briefing document: MOTS-c-related bulk drug substances · U.S. Food and Drug Administration, Pharmacy Compounding Advisory Committee, July 23, 2026
  25. Drugs@FDA: Vyleesi (bremelanotide), NDA 210557 · openFDA, accessed November 13, 2026
  26. Vyleesi (bremelanotide) prescribing information · FDA label via openFDA, effective November 5, 2026
  27. Drugs@FDA: Forzinity (elamipretide), NDA 215244 · U.S. Food and Drug Administration, approved September 19, 2025
  28. Warning letter: Darmerica, LLC (API distributor) · U.S. Food and Drug Administration, December 8, 2025
  29. Thompson WR et al. Elamipretide in Barth syndrome: TAZPOWER randomized crossover trial (Genet Med 2021;23:471–478) · Genetics in Medicine, 2021
  30. Karaa A et al. Elamipretide in primary mitochondrial myopathy: MMPOWER-3 (Neurology 2023;101:e238–e252) · Neurology, 2023
  31. openFDA Drugs@FDA searches for AOD-9604, KPV, epitalon, semax, selank, cagrilintide, melanotan and NAD (no application found) · openFDA, searched November 13, 2026
  32. FDA briefing document: AOD-9604-related bulk drug substances · U.S. Food and Drug Administration, Pharmacy Compounding Advisory Committee, December 4, 2024
  33. FDA briefing document: KPV-related bulk drug substances · U.S. Food and Drug Administration, Pharmacy Compounding Advisory Committee, July 23, 2026
  34. FDA briefing document: epitalon-related bulk drug substances · U.S. Food and Drug Administration, Pharmacy Compounding Advisory Committee, July 24, 2026
  35. FDA briefing document: semax-related bulk drug substances · U.S. Food and Drug Administration, Pharmacy Compounding Advisory Committee, July 24, 2026
  36. Zozulia AA et al. Selank vs medazepam in anxiety disorders (Zh Nevrol Psikhiatr 2008;108:38–48) · PubMed 18454096, 2008
  37. Novo Nordisk files for FDA approval of CagriSema · Novo Nordisk company announcement, December 18, 2025
  38. FDA's concerns with unapproved GLP-1 drugs used for weight loss · U.S. Food and Drug Administration, content current October 1, 2026
  39. Lau DCW et al. Once-weekly cagrilintide for weight management: phase 2 dose-finding trial (Lancet 2021;398:2160–2172) · The Lancet, 2021
  40. Garvey WT et al. Cagrilintide–semaglutide in adults with overweight or obesity (REDEFINE 1) (NEJM 2025;393:635–647) · New England Journal of Medicine, 2025
  41. Dorr RT et al. Melanotan-II pilot phase 1 study in healthy men (Life Sci 1996;58:1777–84) · Life Sciences, 1996
  42. Search orphan drug designations and approvals (thymalfasin: 4 designations; kisspeptin, hexarelin, emideltide, cathelicidin: none) · U.S. Food and Drug Administration, Office of Orphan Products Development, searched November 13, 2026
  43. ZADAXIN 1.6 mg/ml (timosina alfa 1): Riassunto delle Caratteristiche del Prodotto (Italian label) · AIFA, Agenzia Italiana del Farmaco, made available February 26, 2026
  44. Wu J et al. Thymosin alpha 1 in sepsis (TESTS): multicentre, double-blind, placebo-controlled phase 3 trial (BMJ 2025;388:e082583) · The BMJ, 2025
  45. openFDA Drugs@FDA searches for thymalfasin, thymosin, kisspeptin, emideltide, hexarelin, examorelin, GHRP, cathelicidin and Zadaxin (no match) · openFDA, searched November 13, 2026
  46. FDA briefing document: kisspeptin-10 · U.S. Food and Drug Administration, Pharmacy Compounding Advisory Committee, October 29, 2024
  47. Jayasena CN et al. Kisspeptin-54 triggers egg maturation in women undergoing IVF (J Clin Invest 2014;124:3667–3677) · Journal of Clinical Investigation, 2014
  48. FDA briefing document: emideltide (DSIP)-related bulk drug substances · U.S. Food and Drug Administration, Pharmacy Compounding Advisory Committee, July 24, 2026
  49. Bowers CY et al. GHRP-6 and GHRH: synergistic GH release in normal men (J Clin Endocrinol Metab 1990;70:975–982) · JCEM, 1990
  50. Rahim A et al. Partial, reversible attenuation of GH response after 16 weeks of hexarelin (J Clin Endocrinol Metab 1998;83:1644–1649) · JCEM, 1998
  51. Mahlapuu M et al. HEAL LL-37: phase 2b RCT of topical LL-37 in venous leg ulcers (Wound Repair Regen 2021;29:938–950) · Wound Repair and Regeneration, 2021