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FDA Status of 24 Peptides, Compound by Compound

Which peptides are FDA-approved, where each stands in US compounding review, and whether WADA bans it. One table, 24 compounds, a source for every row.

Updated October 22, 2026 · 1,920 words

Of the 24 compounds below, four are active ingredients in FDA-approved drugs available today (tesamorelin, bremelanotide, semaglutide and tirzepatide), one was approved and later discontinued by its maker (sermorelin), and the other 19 have no FDA approval for any use. The July 2026 advisory committee vote recommended six peptides for the compounding bulks list, but no peptide has been added to it, and a recommendation is not an approval.

Status questions about peptides usually mix up three separate systems. This page keeps them in separate columns.

How to read the table

FDA approval means a specific product passed a drug review and carries a reviewed label. Approval belongs to that product, not to the molecule name: material sold under the same name by a research supplier is not the approved drug. Our explainer on whether peptides are FDA-approved covers why.

Compounding status concerns what state-licensed pharmacies may prepare for individual patients with prescriptions under section 503A. A bulk substance qualifies if it has a USP monograph, is a component of an approved drug, or appears on the 503A bulks list. While nominations are pending, the FDA sorts substances into Category 1 (under evaluation, compounding generally tolerated), Category 2 (may present significant safety risks) and Category 3 (nominated without adequate support). The Pharmacy Compounding Advisory Committee (PCAC) votes on nominations, but its votes are advisory. Our 503A, 503B and research use only explainer sets out the lanes.

WADA status is the World Anti-Doping Agency's 2026 Prohibited List, which is in force through December 31, 2026. "Named" means the substance appears by name. Section S0 also covers, without naming them, substances with no current approval from any government health authority for human use, so an unnamed compound is not automatically permitted.

The table

Status as of October 22, 2026. Category lists are the FDA's 503A lists as updated May 14, 2026.

Compound FDA approval Compounding status WADA 2026 Key source
BPC-157 None Removed from Category 2 in April 2026 after nomination withdrawn; PCAC recommended 8 to 6 (1 abstention), July 23, 2026; no rule Prohibited, named (S0) FDA briefing
TB-500 None Removed from Category 2 in April 2026; PCAC recommended 8 to 6 (1 abstention), July 23, 2026; no rule Prohibited, named (S2.3) FDA briefing
CJC-1295 None PCAC voted against every form, December 4, 2024; listed by FDA among withdrawn Category 2 substances Prohibited, named (S2.2.4) PCAC minutes
Ipamorelin None PCAC voted 0 to 12 (1 abstention) against, October 29, 2024; in 503B Category 2 since September 29, 2023 Prohibited, named (S2.2.4) PCAC minutes
Sermorelin Approved as Geref (1990, 1997); discontinued by maker 2008; FDA found it was not withdrawn for safety or effectiveness Not on the FDA's 503A category lists Prohibited, named (S2.2.4) Federal Register
Tesamorelin Approved as Egrifta (November 10, 2010) for excess abdominal fat in adults with HIV and lipodystrophy Component of an approved drug; not on the category lists Prohibited, named (S2.2.4) Drugs@FDA
AOD-9604 None PCAC voted 0 to 12 against, December 4, 2024; listed among withdrawn Category 2 substances Prohibited, named (S2.2.3) PCAC minutes
PT-141 (bremelanotide) Approved as Vyleesi (June 21, 2019) for acquired, generalized HSDD in premenopausal women Component of an approved drug; not on the category lists Not named Approval letter
Melanotan II None Listed among withdrawn Category 2 substances; expected at the next PCAC meeting Not named FDA safety list
GHK-Cu None as a drug Category 1 except for injectable routes (restored May 14, 2026); injectable form listed among withdrawn Category 2 substances; expected at the next PCAC meeting Not named FDA category list
KPV None PCAC recommended 8 to 6 (1 abstention), July 23, 2026; no rule Not named FDA briefing
MOTS-c None PCAC recommended 7 to 5 (2 abstentions), July 23, 2026; no rule Prohibited, named (S4.4.1) FDA briefing
Epitalon None PCAC recommended 7 to 4 (1 abstention), July 24, 2026; no rule Not named FDA briefing
Semax None in the US (registered in Russia) PCAC recommended 8 to 5 (1 abstention), July 24, 2026; no rule Not named FDA briefing
Selank None Nomination withdrawn; listed among withdrawn Category 2 substances; not on the July agenda Not named FDA safety list
DSIP (emideltide) None PCAC voted 6 to 7 (1 abstention) against, July 24, 2026 Not named FDA briefing
IGF-1 LR3 None (mecasermin, sold as Increlex, is a different, approved IGF-1 product) Not on the FDA's 503A category lists Prohibited (S2.3, IGF-1 and its analogues) Drugs@FDA, Increlex
Kisspeptin-10 None 503A Category 2 since September 29, 2023 Prohibited in males (S2.2.1, kisspeptin and its agonist analogues) FDA safety list
Thymosin alpha-1 None in the US PCAC voted 4 to 17 against, December 4, 2024; listed among withdrawn Category 2 substances Not named PCAC minutes
NAD+ None as a drug 503A Category 1 Not named; intravenous infusions above a set volume are a prohibited method (M2.2) whatever the substance FDA category list
5-amino-1MQ None Not on the FDA's 503A category lists Not named FDA category list
Semaglutide Approved (Ozempic 2017, Rybelsus 2019, Wegovy 2021) Component of approved drugs; FDA declared the shortage resolved February 21, 2025, ending shortage-era compounding Not named FDA statement
Tirzepatide Approved (Mounjaro, May 13, 2022; Zepbound, November 8, 2023) Component of approved drugs; FDA declared the shortage resolved in December 2024 Not named FDA statement
Retatrutide None; investigational, with Eli Lilly planning to file in early 2027 FDA says it cannot be used in compounding under federal law Not named; S0 covers drugs in clinical development FDA GLP-1 page

What the table shows

Approval is rare in this list, and narrow where it exists. Tesamorelin is approved for one population, adults with HIV and lipodystrophy. Bremelanotide is approved for one condition in premenopausal women. Neither approval extends to material sold under the same name as research chemicals, and in August 2026 the FDA cited products labeled PT-141 and tesamorelin, sold online, as unapproved new drugs in warning letters. Our coverage of those letters has the detail.

Compounding status moved more in 2026 than in any recent year, and most of the movement was procedural. In April the FDA removed 12 peptides from Category 2 after their nominations were withdrawn, without moving them to Category 1. In July the committee recommended six peptides and rejected one. The recommendations are not binding, and we found no proposed or final rule adding any peptide to the 503A bulks list. On October 14 an FDA "Interim Access Policy for Compounding Using Certain Peptides" went to the White House regulatory office for review. Its text and its list of covered substances are not public. Our coverage of that filing tracks what is confirmed.

A compounding listing would not be an approval. Even a final rule would let licensed pharmacies prepare a substance for individual prescribed patients. It would not establish that the compound works, and it would not change the status of material sold outside pharmacy channels.

Sport is stricter than drug law. Ten of the 24 are prohibited by name or by class (kisspeptin in males only), and several of the others may fall within S0's general definition. WADA published its 2027 list on October 6, 2026; it takes effect January 1, 2027, and keeps the current status of GLP-1 receptor agonists pending further data.

Caveats

Status changes. The interim access policy, a second advisory meeting that law firm Holland & Knight expects before the end of February 2027 (covering GHK-Cu, LL-37, dihexa, Melanotan II and PEG-MGF), and any proposed rule could each change rows above. Where this table says a compound is not on the category lists, that describes the FDA document dated May 14, 2026, not a judgment that compounding with it is permitted. None of this is legal advice, and state law can differ. For a specific legal question, ask a lawyer.

Frequently asked questions

Which peptides are FDA-approved?

Of the compounds on this list, tesamorelin, bremelanotide, semaglutide and tirzepatide are active ingredients in currently approved drugs. Sermorelin was approved and later discontinued. Many other peptide drugs exist outside this list, including insulin, leuprolide and octreotide.

Did the FDA approve BPC-157 in 2026?

No. An advisory committee recommended it for the compounding bulks list in July 2026, against FDA staff advice. That is not an approval, and no rule has followed.

Is retatrutide FDA-approved?

No. It is an investigational drug in Eli Lilly's TRIUMPH program, and the FDA says it cannot be used in compounding. Our retatrutide explainer has the detail.

Which peptides are banned by WADA?

On this list, BPC-157, TB-500, CJC-1295, ipamorelin, sermorelin, tesamorelin, AOD-9604, MOTS-c and IGF-1 analogues are prohibited at all times, and kisspeptin and its agonist analogues are prohibited in males. Unnamed substances with no government approval can fall under S0.


Sources:

Nothing here is legal or medical advice, and nothing above is dosing guidance or a treatment claim. Research use only.

For research use only · Not for human or veterinary use · No research compound discussed here is FDA-approved for any indication

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