Peptide Intelligence

Peptide FDA Status Tracker

Real-time classification data on every peptide therapy. Know what's approved, what's compoundable, and what's restricted before you source or prescribe.

10

FDA Approved

6

Approved Intl.

2

Category 1

8

Category 2

PeptideClassFDA StatusCompoundingUpdated
SemaglutideGLP-1 Receptor AgonistFDA ApprovedNo2026-03-18
TirzepatideDual GIP/GLP-1 Receptor AgonistFDA ApprovedNo2026-03-18
SermorelinGHRH AnalogFDA Approved (Diagnostic)Yes2026-03-18
TesamorelinGHRH AnalogFDA ApprovedYes2026-03-18
BPC-157Tissue Repair & RegenerationCategory 2 (Restricted)No2026-03-18
TB-500Tissue Repair & RegenerationCategory 2 (Restricted)No2026-03-18
CJC-1295GH SecretagogueCategory 2 (Restricted)No2026-03-18
IpamorelinGH SecretagogueCategory 2 (Restricted)No2026-03-18
Thymosin Alpha-1Immune ModulatorApproved InternationallyNo2026-03-18
GHK-CuTissue Repair / Anti-AgingCategory 1 (Topical Only)Yes2026-03-18
AOD 9604GH Fragment / Weight ManagementCategory 2 (Restricted)No2026-03-18
PT-141Sexual HealthFDA ApprovedYes2026-03-18
EpitalonAnti-AgingCategory 2 (Restricted)No2026-03-18
Melanotan IITanning / Sexual HealthCategory 2 (Restricted)No2026-03-18
MOTS-cMetabolic / Exercise MimeticCategory 2 (Restricted)No2026-03-18
LiraglutideGLP-1 Receptor AgonistFDA ApprovedNo2026-03-18
ExenatideGLP-1 Receptor AgonistFDA ApprovedNo2026-03-18
MK-677GH Secretagogue (Ghrelin Mimetic)InvestigationalNo2026-03-18
HexarelinGH Secretagogue (GHRP)InvestigationalNo2026-03-18
GHRP-6GH Secretagogue (GHRP)InvestigationalNo2026-03-18
GHRP-2GH Secretagogue (GHRP)InvestigationalNo2026-03-18
Kisspeptin-10Hormone Modulator (GnRH Stimulant)InvestigationalNo2026-03-18
SelankNootropic / Anxiolytic PeptideApproved InternationallyNo2026-03-18
SemaxNootropic / Neuroprotective PeptideApproved InternationallyNo2026-03-18
DihexaNootropic / Cognitive EnhancerInvestigationalNo2026-03-18
LL-37Antimicrobial PeptideInvestigationalNo2026-03-18
KPVAnti-Inflammatory PeptideInvestigationalNo2026-03-18
Pentosan PolysulfateTissue Repair / GlycosaminoglycanFDA ApprovedYes2026-03-18
NAD+Metabolic CofactorUnclassifiedYes2026-03-18
SS-31Mitochondrial-Targeted PeptideInvestigationalNo2026-03-18
VIPImmune / Neuro ModulatorInvestigationalYes2026-03-18
CerebrolysinNeuroprotective Peptide ComplexApproved InternationallyNo2026-03-18
DSIPSleep / Recovery PeptideInvestigationalNo2026-03-18
Follistatin 344Myostatin Inhibitor / Muscle GrowthInvestigationalNo2026-03-18
BremelanotideMelanocortin Receptor Agonist (Sexual Health)FDA ApprovedNo2026-03-18
OxytocinNeuropeptide HormoneFDA ApprovedYes2026-03-18
ThymalinImmune Modulator (Thymic Peptide)Approved InternationallyNo2026-03-18
PE-22-28Nootropic / Antidepressant PeptideInvestigationalNo2026-03-18
5-Amino-1MQMetabolic / Weight Management (Small Molecule)InvestigationalNo2026-03-18
RetatrutideTriple Incretin Receptor Agonist (GLP-1/GIP/Glucagon)InvestigationalNo2026-03-18
CJC-1295 + IpamorelinGH Secretagogue CombinationCategory 1 (Compoundable)Yes2026-03-18
AHK-CuHair & Skin PeptideUnclassifiedYes2026-03-18
Snap-8Cosmetic / Anti-Wrinkle PeptideUnclassifiedNo2026-03-18
Palmitoyl Pentapeptide-4Skin / Collagen-Stimulating PeptideUnclassifiedNo2026-03-18
FOXO4-DRISenolytic PeptideInvestigationalNo2026-03-20
GlutathioneEndogenous Tripeptide AntioxidantUnclassifiedYes2026-03-20
HumaninMitochondrial-Derived PeptideInvestigationalNo2026-03-20
CagriSemaAmylin Analog + GLP-1 Receptor Agonist (Combination)InvestigationalNo2026-03-20
SurvodutideDual GLP-1/Glucagon Receptor AgonistInvestigationalNo2026-03-20
ArgirelineCosmeceutical PeptideUnclassifiedNo2026-03-20
PinealonBioregulator PeptideApproved InternationallyNo2026-03-20

Status Legend

FDA Approved

Fully FDA-approved for specific indications under NDA or BLA.

Approved Internationally

Approved in other countries but not FDA-approved in the US.

Category 1 (Compoundable)

On FDA interim 503A bulks list. May be compounded under specific conditions.

Category 2 (Restricted)

FDA-identified safety concerns. Cannot be compounded for human use.

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Data Source: FDA bulk drug substance lists under Sections 503A and 503B, FDA guidance documents, and PCAC meeting outcomes. Status data is manually verified and updated. Last full review: March 2026.

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