FDA tracker

Peptide regulation, in one place.

Name: The Peptide Examiner — FDA peptide status tracker
Creator: The Peptide Examiner
License: https://thepeptideexaminer.com/terms

Compounding cutoffs, Category 2 status, warning letters, and HHS reclassifications — sourced from FDA.gov and federal-register filings. Last reviewed April 23, 2026.

Peptide	Status	FDA detail
SemaglutideOzempic	FDA approved	FDA approved 2017 (T2D), 2021 (obesity)
TirzepatideMounjaro	FDA approved	FDA approved 2022 (T2D), 2023 (obesity)
RetatrutideLY-3437943	Investigational	Phase 3 (Eli Lilly, 2025–)
CagrilintideAM833	Investigational	Phase 3 (Novo Nordisk) paired with semaglutide
OrforglipronLY-3502970	Investigational	Oral GLP-1; Phase 3 (2026)
BPC-157Body Protection Compound	Research use only	Category 2 (Feb 2026 HHS proposed removal)
TB-500Thymosin Beta-4 fragment	Research use only	Category 2 (Feb 2026 HHS proposed removal)
KPVLys-Pro-Val	Research use only	—
CJC-1295Modified GRF (1-29)	Research use only	—
Ipamorelin	Research use only	—
SermorelinGHRH 1-29	FDA approved	Historical FDA approval; now compounded
TesamorelinEgrifta	FDA approved	FDA approved 2010 (HIV-lipodystrophy)
MK-677Ibutamoren	Research use only	—
GHK-CuCopper peptide	Supplement	Cosmetic approval; injectable Category 2
EpitalonEpithalon	Research use only	—
MOTS-cMitochondrial-derived peptide	Research use only	—
Thymosin Alpha-1Zadaxin	Investigational	Approved in 30+ countries; US investigational
Semax	Research use only	—
Selank	Research use only	—
PT-141Bremelanotide	FDA approved	FDA approved 2019 (HSDD, women)