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Flagship tracker

Is it FDA-approved? The peptide status tracker

A living reference that separates three things the market constantly blurs: full FDA approval, eligibility for pharmacy compounding, and “research-use-only” sale. We track all three, per compound, and re-check them on a schedule.

Last reviewed · re-reviewed monthly

Editorial independence: peptidesmedia is a newsroom. We sell no peptides, take no affiliate commissions, and have no financial stake in any compound listed here.

The status tracker

CompoundClassFDA statusCompoundingEvidence gradeLast reviewed
SemaglutideGLP-1 agonistFDA-approved503B exclusion proposedStrongSep 2026
TirzepatideGIP/GLP-1 agonistFDA-approved503B exclusion proposedStrongSep 2026
TesamorelinGHRH analogFDA-approvedModerateJun 2026
LiraglutideGLP-1 agonistFDA-approved503B exclusion proposedStrongSep 2026
BPC-157Synthetic peptideUnapproved drugPCAC reviewed Jul 2026Preclinical onlySep 2026
TB-500Thymosin β4 fragmentUnapproved drugNoPreclinical onlyJun 2026
IpamorelinGH secretagogueUnapproved drugRemoved from listLimitedJun 2026
CJC-1295GHRH analogUnapproved drugNoLimitedJun 2026
Melanotan IIMelanocortin agonistUnapproved drugNoLimitedJun 2026
GHK-CuCopper tripeptideRestrictedCosmetic onlyLimitedJun 2026
Collagen peptidesHydrolysed collagenDietary supplementn/a — not a drugModerateJun 2026

“—” = not applicable; approved drugs do not rely on the compounding pathway. PCAC = FDA Pharmacy Compounding Advisory Committee. Sources: FDA Drugs@FDA database; FDA 503A/503B bulk substance lists; published peer-reviewed evidence (PubMed).

How to read this tracker

Six statuses get blurred together in marketing copy. They are not interchangeable, and the differences between them decide what has been tested and what a seller may legally claim.

FDA-approved

The FDA has reviewed safety and efficacy data and authorised the drug for a specific use. This is the highest bar — and the only one that means the agency has vetted it.

Unapproved drug

Not approved by the FDA for any human use. Availability through another pathway is not approval.

Research-only

Sold for laboratory use and labelled "not for human consumption". No approval, no manufacturing oversight for human use, no guarantee of identity or purity.

Restricted

Permitted in a narrow context only — for example cosmetic use — and not approved as a drug.

Dietary supplement

Regulated as a food supplement, not a drug. The FDA does not evaluate supplements for safety or efficacy before sale, and no supplement may legally claim to treat a disease. A different regime from every drug status above — not a weaker version of approval.

Withdrawn

Was once available through a pathway such as compounding, but has been pulled — usually after safety signals or insufficient evidence surfaced.

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