FDA-approved vs research-only peptides

“Peptides” are discussed online as if they were a single category, but regulators treat them very differently. Some — like semaglutide and tirzepatide — are FDA-approved drugs with prescribing labels. Many of the most-searched research peptides, such as BPC-157 and TB-500, are not FDA-approved. This page separates them.

The four regulatory categories

FDA-approved(25 in catalog)

Approved by the U.S. FDA for one or more labeled indications, with an official prescribing label. Approval is specific to those indications, populations, and dosing — not a blanket endorsement of the molecule.

Investigational (in clinical trials)(1 in catalog)

Under active clinical investigation but not yet approved for marketing. Promising trial data is not the same as approval, and a trial compound can still fail.

Removed from Category 2 (not approved)(15 in catalog)

Not FDA-approved. On 22 April 2026 FDA removed these from Category 2 of its Section 503A bulk drug substance categories after the nominators withdrew their nominations. Removal is not permission to compound: it did not, by itself, place them on the 503A Bulks List or in Category 1, the only category FDA’s interim compounding policy covers. It does not establish safety or efficacy.

Research-only / not approved(58 in catalog)

Studied in laboratory, preclinical, or early-clinical settings and typically sold labeled “for research use only.” Not approved for human therapeutic use, and evidence quality varies widely.

At a glance: is it FDA-approved?

The most-discussed compounds and their U.S. regulatory status. Follow any name for its full profile, evidence grade, and citations.

See also the full FDA-approved drug table and the research-stage index.

Frequently asked questions

Are any peptides FDA-approved?

Yes. 25 peptides in this catalog are FDA-approved (and 47 peptide-based drugs are indexed in the full approved-drug table), including semaglutide and tirzepatide. However, many widely discussed research peptides — such as BPC-157 and TB-500 — are not FDA-approved.

What is the difference between an FDA-approved peptide and a research-only peptide?

An FDA-approved peptide has passed FDA review for a specific labeled use and has an official prescribing label covering its indications, dosing, and safety. A research-only peptide has not been approved for human therapeutic use; it is studied in laboratory or early-clinical settings and sold for research use only, with evidence quality that varies widely.

What does it mean when a peptide is “compounded”?

Compounding means a licensed pharmacy prepares the substance for a specific patient with a valid prescription. It is not FDA approval: a compounded peptide has not been reviewed by the FDA for safety or efficacy.

Is Semaglutide FDA-approved?

Semaglutide is approved by the U.S. Food and Drug Administration for one or more labeled indications. Approval covers only the labeled indication, population and dosing.

Is Tirzepatide FDA-approved?

Tirzepatide is approved by the U.S. Food and Drug Administration for one or more labeled indications. Approval covers only the labeled indication, population and dosing.

Is BPC-157 FDA-approved?

BPC-157 is not FDA-approved for any indication. On 22 April 2026 FDA removed it from Category 2 of its Section 503A bulk drug substance categories after the nominations were withdrawn. Removal did not, by itself, add it to the 503A Bulks List or to Category 1, the only category FDA's interim compounding policy covers, so it is not permission to compound it.

Is TB-500 FDA-approved?

TB-500 is not FDA-approved for any indication. On 22 April 2026 FDA removed it from Category 2 of its Section 503A bulk drug substance categories after the nominations were withdrawn. Removal did not, by itself, add it to the 503A Bulks List or to Category 1, the only category FDA's interim compounding policy covers, so it is not permission to compound it.

Is Retatrutide FDA-approved?

Retatrutide is not currently FDA-approved for any indication and is generally classified as a research compound.

Is Ipamorelin FDA-approved?

Ipamorelin is not currently FDA-approved for any indication and is generally classified as a research compound.

Regulatory status is recorded from the best information currently catalogued and can change. It describes how a compound is regulated — not whether it is safe or effective. Nothing here is medical advice; consult a licensed healthcare professional.