Which peptides are FDA approved?

Of the 17 compounds on the Primara Labs Research Desk tracker, 5 are US FDA approved as branded medicines for named uses as of 23 September 2026: tirzepatide, semaglutide, tesamorelin, bremelanotide, elamipretide. Retatrutide is investigational, and 11 have no approved application at all.

Primara Labs sells some of the compounds covered here. Every figure on this page links to its source and the date it was checked.

Updated 23 September 2026

Approved in the United States, for a named use

Tirzepatide: Approved for glycemic control in type 2 diabetes mellitus (Mounjaro); weight reduction in obesity or overweight with a comorbidity and moderate to severe obstructive sleep apnea in adults with obesity (Zepbound).

Semaglutide: Approved for glycemic control in type 2 diabetes mellitus and related cardiovascular and kidney risk reduction (Ozempic, Rybelsus); chronic weight management and cardiovascular risk reduction in obesity or overweight (Wegovy).

Tesamorelin: Approved for reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy.

Bremelanotide: Approved for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.

Elamipretide: Approved under accelerated approval for Barth syndrome in patients weighing at least 30 kg.

Not approved

Retatrutide: investigational; its sponsor plans a US Biologics License Application submission in Q1 2027.

No approved application in Drugs@FDA: BPC-157, TB-500, NAD+, GHK-Cu, CJC-1295, Ipamorelin, MOTS-c, Semax, Selank, DSIP, KPV. FDA lists 10 of these on its page of bulk substances that may present significant safety risks in compounding.

What an approval covers

An approval applies to a named medicine, from a named maker, for a named indication. It never makes a vial of the same compound, sold for research use, an approved product. In the Philippines, registration is decided separately by FDA Philippines, and its verification portal could not be read for any of these compounds on the date checked.

Where to check each record

Each status on the tracker links the record it was read from: the Drugs@FDA application for US approvals, the EMA medicines report for Europe, and the sponsor's own statement for a planned filing. The same data downloads as JSON and CSV, dated, so the list here can be checked line by line.

This is general information, not legal advice.

Sources

Where every figure comes from

Primara Labs Research Desk, regulatory dataset · checked 23 September 2026
Drugs@FDA · checked 23 September 2026
FDA, bulk drug substances that may present significant safety risks in compounding · checked 23 September 2026

Last reviewed 23 September 2026