FDA Status Tracker

Where every peptide stands with the FDA right now. 9 approved, 34 available via compounding pharmacies or research-only.

✓ FDA-approved

Prescribed for specific indications with full FDA clinical-trial review. Covered by most insurance plans within approved indications.

Semaglutide

A+

FDA-approved for weight management and type 2 diabetes

Tirzepatide

A+

FDA-approved for weight management and type 2 diabetes

PT-141

FDA-approved for hypoactive sexual desire disorder (HSDD) in women

Tesamorelin

FDA-approved for HIV-associated lipodystrophy

Sermorelin

B+

FDA-approved (1990) for pediatric growth hormone deficiency; off-label adult use via compounding pharmacies

Liraglutide

A+

FDA-approved for weight management (Saxenda) and type 2 diabetes (Victoza)

Afamelanotide

FDA-approved (2019) for erythropoietic protoporphyria (EPP)

Gonadorelin

FDA-approved (Factrel) historically for diagnostic GnRH stimulation; off-label use in TRT to preserve testicular function

GHRH (1–44)

FDA-approved (Geref) historically as diagnostic GH stimulant; current US availability limited

⚠ Not FDA-approved

Not approved for any indication by the FDA. May be available via compounding pharmacies, prescription off-label use, or research-only channels. Always consult a licensed medical professional.

BPC-157

B+

Not FDA-approved — Category 2 (reclassification to Cat 1 expected 2026)

TB-500

Not FDA-approved — Category 2 (reclassification to Cat 1 expected 2026)

GHK-Cu

B+

Not FDA-approved — available as cosmetic ingredient and research compound

CJC-1295 (no DAC)

Not FDA-approved — Category 1 (compounding allowed)

Ipamorelin

Not FDA-approved — Category 1 (compounding allowed)

Semax

Not FDA-approved in US — approved in Russia for stroke and cognitive disorders

Selank

Not FDA-approved in US — approved in Russia as anxiolytic

AOD-9604

C+

Not FDA-approved — Category 1 (compounding allowed)

MK-677

B+

Not FDA-approved — investigational (orally active GH secretagogue)

GHRP-2

Not FDA-approved — research compound; previously studied as growth hormone deficiency diagnostic

GHRP-6

Not FDA-approved — research compound

Hexarelin

Not FDA-approved — research compound (cardioprotective signals investigated)

Retatrutide

Not FDA-approved — Phase 3 trials (TRIUMPH program) for obesity

Cagrilintide

Not FDA-approved — combined with semaglutide as CagriSema; Phase 3 in progress

Thymosin Alpha-1

Approved in 35+ countries for hepatitis B/C, immune support; not FDA-approved in US (orphan-drug designations)

Epitalon

C+

Not FDA-approved — Russian-origin research peptide

DSIP

Not FDA-approved — research compound

MOTS-c

Not FDA-approved — research peptide; multiple early-phase clinical trials

SS-31

B+

Not FDA-approved — Phase 3 trials for primary mitochondrial myopathy

5-Amino-1MQ

C+

Not FDA-approved — small-molecule research compound (NNMT inhibitor)

KPV

C+

Not FDA-approved — research peptide

Melanotan II

C+

Not FDA-approved — sold illegally as cosmetic; FDA warning letters issued

Kisspeptin-10

Not FDA-approved — used in clinical research as a kisspeptin/GnRH stimulus test

ARA-290

Not FDA-approved — Phase 2/3 trials for sarcoidosis-associated small fiber neuropathy

Larazotide

B+

Not FDA-approved — Phase 3 completed for celiac disease (results mixed)

Cerebrolysin

Not FDA-approved in US — approved in 50+ countries for stroke, traumatic brain injury, and dementia

Dihexa

Not FDA-approved — research compound (HGF/c-Met-mimetic)

LL-37

Not FDA-approved — endogenous antimicrobial peptide; clinical trials for infected wounds

Pinealon

Not FDA-approved — Russian-origin research peptide

VIP

Not FDA-approved — investigational; ongoing trials for sarcoidosis

PDA

C+

Not FDA-approved — newer compounded analog of BPC-157

Survodutide

Not FDA-approved — Phase 3 trials for obesity and MASH

Humanin

Not FDA-approved — mitochondrial-derived peptide research compound

Glutathione (GSH)

Not FDA-approved as therapeutic — sold as supplement; intravenous use compounded

Educational use only

FDA status is current as of our last review but regulatory designations change frequently. This page is for educational purposes only and does not constitute medical advice. Consult a licensed medical professional before using any peptide therapy.