FDA-Approved Peptides: The 2026 List of Peptide Drugs

These are new active ingredients, taken from FDA's novel drug approval lists for 2024, 2025, and 2026.

2026 is already the busiest year for peptide approvals in some time. FDA approved one new peptide in 2025 and two in 2024. Two of this year's six are taken by mouth, which used to be rare for a peptide.

Approvals of new forms or uses of an existing peptide are left out of the table. The largest of those was the Wegovy pill, oral semaglutide 25 mg for chronic weight management, approved in December 2025. A second weekly insulin, insulin efsitora alfa (Onswik), was approved in September 2026; it joins insulin to an antibody fragment, which makes it a protein by FDA's definition.

Every FDA-approved peptide drug by therapeutic area

Some of these products have been discontinued or replaced over the years, and new generics arrive often. Before you prescribe, confirm the product is still marketed in Drugs@FDA, or in the Purple Book for insulin and other peptides regulated as biologics.

Which peptides are FDA-approved for weight loss?

Four peptide drugs carry a chronic weight management indication: semaglutide as Wegovy, tirzepatide as Zepbound, liraglutide as Saxenda, and setmelanotide as Imcivree. Setmelanotide is limited to obesity caused by specific genetic deficiencies or Bardet-Biedl syndrome. Orforglipron (Foundayo), approved in April 2026, acts on the same GLP-1 receptor but is a small molecule, so it belongs on a list of obesity drugs and stays off a list of peptides.

The approval covers the branded product. Compounded semaglutide and tirzepatide use the same active ingredient, but no compounded version has been through FDA review, and once FDA declared the shortages of both drugs over, in late 2024 for tirzepatide and February 2025 for semaglutide, the legal room for routine compounded copies narrowed sharply. Our guide to 503A and 503B pharmacies explains the copies rule.

Are any peptides FDA-approved for muscle growth?

No. FDA has approved no peptide to build muscle, raise growth hormone, or improve body composition in healthy adults. Two approvals come close and are narrower than they look. Tesamorelin is approved only to reduce excess abdominal fat in adults with HIV-associated lipodystrophy. Elamipretide is approved only to improve muscle strength in Barth syndrome, a rare mitochondrial disease, and its approval is conditional on a confirmatory trial.

Prescribing an approved peptide outside its label is legal and common, and our off-label prescribing guide covers how to document the rationale. The approved product is what makes that prescription defensible.

Popular peptides that are not FDA-approved

BPC-157, TB-500, ipamorelin, CJC-1295, GHK-Cu, MOTS-c, epitalon, KPV, semax, selank, and AOD-9604 have no FDA approval for any indication. No GHK-Cu injection has been approved for hair loss or anything else. Copper histidinate (Zycubo), approved in January 2026 for Menkes disease, is a different copper compound.

Three cases cause most of the confusion:

• PT-141 is bremelanotide, approved as Vyleesi in 2019 for low sexual desire in premenopausal women. Only Vyleesi, given by autoinjector, is the approved product; compounded nasal sprays and injections sold as PT-141 are unapproved.
• Sermorelin was approved as Geref for growth hormone deficiency in children and was discontinued by its maker in 2008. FDA later found the withdrawal was unrelated to safety or effectiveness, but no approved sermorelin product is sold in the United States today.
• The six peptides in the October 2026 HHS policy (BPC-157, TB-500, epitalon, MOTS-c, KPV, and semax) remain unapproved. HHS said it will not take enforcement action against qualifying 503A compounding of them under ten conditions, which is a statement about enforcement and grants no approval. Our peptide regulation tracker follows that policy month by month.

A vial labeled "research use only" is unapproved whatever peptide it holds, and it is illegal to sell for human use. Our guide to research use only peptides covers why.

What FDA approval means when you prescribe

Approval attaches to a specific product from a specific manufacturer: its active ingredient, dose, route, formulation, and label. A clinician can prescribe that product for its labeled use or off label. The same molecule made by a compounding pharmacy, sold online, or mixed into a blend is a different product, and the approval does not transfer to it.

For compounded peptides, the question shifts from approval to compounding law: whether the substance is a component of an approved drug, on the 503A Bulks List, or in one of FDA's interim categories. Our guide to the compounding categories walks through how to check, and the US legality guide covers the state rules that sit on top. Record which of these bases you relied on in the chart, along with the product, pharmacy, and lot.

To check a peptide's status yourself, search the active ingredient in Drugs@FDA, which lists every approved drug product and its labels, and in the Purple Book for products regulated as biologics. FDA's novel drug approvals page shows each year's new active ingredients as they are approved.

Knowing which peptides are approved, which can be compounded, and which have neither status is the starting point for prescribing them safely. Peptavo's accredited course teaches the regulatory pathways, sourcing, consent, and monitoring for each class, with Dr. Jesse Morse, MD, as instructor.

Frequently asked questions

What peptides are FDA-approved?

About 100 peptide drugs are FDA-approved, including insulin, the GLP-1 agonists semaglutide, liraglutide, and tirzepatide, the bone drugs teriparatide and abaloparatide, the GnRH analogs such as leuprolide, octreotide, oxytocin, tesamorelin, and bremelanotide. The tables above list them by therapeutic area.

Which peptides did FDA approve in 2026?

Through early November 2026, six: navepegritide (Yuviwel) in February, icotrokinra (Icotyde) and insulin icodec (Awiqli) in March, bulevirtide (Hepcludex) in May, enlicitide decanoate (Lipfendra) in July, and rusfertide (Mimrylo) in August.

How many FDA-approved peptide drugs are there in 2026?

Roughly 100 to 120, depending on whether insulin, diagnostic agents, and radioligands are counted. Peer-reviewed counts put the total at around 100 approved since insulin and around 120 on the market, before the six approvals of 2026.

Is BPC-157 FDA-approved?

No. BPC-157 has never been approved for any use. The October 2026 HHS enforcement discretion policy covers compounding of it under set conditions, and that policy approves nothing.

Is compounded semaglutide FDA-approved?

No. Only the branded products, Ozempic, Rybelsus, and Wegovy, are FDA-approved. A compounded version contains the same active ingredient but has never been reviewed by FDA, and FDA's semaglutide shortage ended in February 2025.

Is sermorelin FDA-approved?

Sermorelin was approved as Geref, but the product was discontinued in 2008, and no approved sermorelin product is marketed in the United States today.

Are peptides FDA-approved for muscle growth?

No peptide is approved for muscle growth or body composition in healthy adults. Tesamorelin is approved for abdominal fat in HIV-associated lipodystrophy, and elamipretide for muscle strength in Barth syndrome.

Can I prescribe an FDA-approved peptide off label?

Yes. Off-label prescribing of an approved product is legal and is part of ordinary practice. The prescription rests on the approved product, so a compounded or research-grade version of the same peptide does not carry the same footing.