FDA-Approved Peptides: The Verified List, and What Is Not on It

Yes, FDA has approved many peptide drugs. The ones most people mean are the GLP‑1 medicines: semaglutide (Ozempic, Wegovy, Rybelsus), tirzepatide (Mounjaro, Zepbound), liraglutide (Victoza, Saxenda), dulaglutide (Trulicity) and exenatide (Byetta). Others include tesamorelin (Egrifta WR), bremelanotide (Vyleesi), setmelanotide (Imcivree), teriparatide (Forteo) and octreotide (Sandostatin). None of the popular “wellness” peptides is on that list. BPC-157, TB-500, MOTS-c, Epitalon, Semax, KPV, ipamorelin, CJC-1295 and GHK-Cu have no FDA approval for any use.^[2] Under the HHS policy announced on October 28, 2026, HHS will not take enforcement action against pharmacies that compound six of them, under conditions. It approves none of them.^[1]

Approved GLP-1 and weight-loss peptides

Every GLP‑1 drug in this table is built on a peptide. Most are approved for type 2 diabetes rather than weight, which matters for insurance and for what a prescriber can say about them. Four carry a weight indication: Wegovy, Zepbound, Saxenda and Imcivree. Foundayo, the newer GLP‑1 pill for weight, is left out because it is not a peptide (see are GLP-1 drugs peptides?).

Two of these sit slightly apart. Dulaglutide is a GLP‑1 peptide fused to part of an antibody, a two-chain molecule the Trulicity label calls “a fusion protein,”^[10] so FDA licensed it as a biologic (BLA 125469) instead of approving it as an ordinary drug.^[11] Exenatide, the oldest GLP‑1 drug in the table, is a 39-amino-acid peptide first identified in the Gila monster, a lizard.^[12] Drugs@FDA now lists both Byetta strengths under its original application, NDA 021773, as discontinued,^[2] and the once-weekly version, Bydureon BCise, approved in 2017, as discontinued too.^[13]

Imcivree is the one most people have not heard of. It is an 8-amino-acid peptide that switches on the MC4 receptor,^[14] and it is approved only for rare forms of obesity. The label ties it to acquired hypothalamic obesity, Bardet-Biedl syndrome, or a POMC, PCSK1 or LEPR gene variant confirmed by testing.^[14] It is not a general weight-loss drug.

Other approved peptides people ask about

Peptide drugs are older than the GLP‑1 boom. Octreotide was approved in 1988 and teriparatide’s brand Forteo in 2002.^[2] The ones below come up next to the “wellness” peptides, usually because a seller borrows the approved drug’s name.

Tesamorelin is the odd one out on paper. At 44 amino acids it is above the 40-amino-acid line FDA uses to define a protein (explained in are GLP-1 drugs peptides?),^[15] so on March 23, 2020 its approval was converted to a biologics license, BLA 022505.^[16] Egrifta is still a prescription drug. What changed is whether a pharmacy may compound tesamorelin, which are peptides legal? explains. The seller-side picture is on the tesamorelin profile.

An approved peptide sold for an unapproved use

The most common stretch is real approval, wrong use. Two of the drugs above show it clearly.

PT-141 is the development code for bremelanotide, the drug in Vyleesi.^[18] So when a clinic says PT-141 is FDA-approved, the molecule is. The approval covers one use: premenopausal women with acquired, generalized low sexual desire that causes distress and has no other cause. The Vyleesi label adds that it “is not indicated for the treatment of HSDD in postmenopausal women or in men” and is not indicated to enhance sexual performance.^[17] PT-141 sold to men, often as a compounded or research-labeled vial, is outside that approval on both counts. The evidence for each group is on PT-141 (bremelanotide): what the evidence shows, and the sellers on the PT-141 profile.

Tesamorelin is sold online for fat loss. Its label limits it to abdominal fat in adults with HIV-associated lipodystrophy and states that it “is not indicated for weight loss management as it has a weight neutral effect.”^[15] The trial data behind that sentence are in tesamorelin for weight loss.

Compounded semaglutide and tirzepatide fall in the same gap from the other side. The molecule is approved, but a compounded version is a different product, and HHS restates the general rule in its October 2026 policy: “Compounded drugs are not FDA-approved, which means FDA does not review their safety, effectiveness, or quality before they are marketed.”^[1]

Approved once, no longer sold

A second stretch leans on an approval with no product behind it anymore. Each peptide below once had an approved brand that Drugs@FDA now lists as discontinued.

Sermorelin is the case clinics cite most. Geref’s discontinuation was not for safety, and FDA recorded that formally.^[22] Still, there is no approved sermorelin product to buy today, and a compounded one carries no approval of its own. The details are on the sermorelin profile. Gonadorelin has a stranger history. The name Factrel survives on DailyMed, but the current label belongs to a Zoetis product approved for animals and reads “For use in cattle only.”^[24]

Popular peptides with no FDA approval

Drugs@FDA, FDA’s database of approved drugs, has no approval on record for any of the peptides below.^[2] HHS says the same about its six in a different way: its policy applies only to peptide ingredients that are “not a component of an FDA-approved drug product.”^[1]

The routes in the third column are the only forms the policy covers for each peptide.^[1] For the five peptides marked “No,” where each stands on FDA’s own compounding lists is tracked in the status table of are peptides legal? Which of these compounds have any human trial at all is laid out in the peptide menu.

What the October 28, 2026 policy changed

On October 28, 2026, HHS said it “does not intend to take action” against a state-licensed pharmacy, a federal facility or a licensed physician compounding with BPC-157, TB-500, Epitalon, Semax, KPV or MOTS-c.^[1] That is enforcement discretion: a decision not to act, which lasts until FDA decides in a final rule whether each peptide goes on the 503A bulks list, and which HHS says it may revisit if a safety or quality problem appears.^[1] It is not an approval, and the difference is practical:

• No FDA review. An approved drug has been through FDA review of its safety, effectiveness and manufacturing. A compounded peptide under this policy has not, and HHS says so in the policy itself.^[1]
• Prescription, one patient at a time. The policy requires a patient-specific prescription and covers only 503A compounding by state-licensed pharmacies, federal facilities and licensed physicians.^[1]
• One peptide per product. Each compounded product may contain a single active ingredient, so a BPC-157 and TB-500 blend falls outside it.^[1]
• Research-use-only vials are not covered. HHS framed the policy as a way to move people away from “research-use-only peptides supplied by foreign manufacturers.”^[1]

The full list of conditions, including the certificate-of-analysis and adverse-event reporting rules, is in the HHS peptide compounding policy explained. For how a compounded prescription differs from a research vial in practice, see research-use-only vs. compounded peptides.

How to check whether a peptide is FDA-approved

1. Search the peptide’s name in Drugs@FDA (accessdata.fda.gov/scripts/cder/daf). An approved product shows a brand, an application number and a marketing status. “Discontinued” means no product is sold under that approval.^[2]
2. Open the brand’s label on DailyMed and read section 1, Indications and Usage. That is the approved use. Anything else is off-label.
3. Compare the product in front of you with the approved one. Same molecule is not enough: an approved drug comes from the approved manufacturer, in the approved form and strength.
4. If the seller says “FDA-registered” or “made in an FDA-registered facility,” treat it as a statement about the building. Registration is not approval.

If you are new to the category, what is peptide therapy? covers what clinics sell under that name. The compound-by-compound evidence lives on the peptides hub.