Regulatory Verification Engine
FDA Approval Status & Compounding Checker
Search any research peptide to verify whether it holds an active FDA approved drug label, is under Phase 3 investigational new drug (IND) evaluation, or is restricted from 503A pharmacy compounding under FDA Category 2 safety rules.
| Peptide / Brand | FDA Status | Clinical Indication / Scope | 503A Compounding Law | WADA Status |
|---|---|---|---|---|
Ozempic, Wegovy, Rybelsus GLP-1 Receptor Agonist | FDA Approved | T2D Glycemic Control, Chronic Weight Management, MACE CVD Risk Reduction | Prescription only; restricted compounding post-shortage resolution | Not Prohibited |
Mounjaro, Zepbound Dual GIP / GLP-1 Agonist | FDA Approved | T2D Glycemic Control, Chronic Weight Management | Prescription only; subject to ongoing patent litigation | Not Prohibited |
Victoza, Saxenda GLP-1 Receptor Agonist | FDA Approved | T2D Glycemic Control, Chronic Weight Management | Prescription only; generic versions under review | Not Prohibited |
LY3437943 (Investigational) Triple Agonist (GLP-1/GIP/Glucagon) | Phase 3 (IND) | Investigational: Severe Obesity, T2D, MASH | Illegal to compound outside authorized clinical trials | Prohibited (S0 Non-Approved) |
PL 14736, Bepecin Gastric Pentadecapeptide | 503A Category 2 | Preclinical: Tissue & Gut Repair (No FDA Approved Indication) | Banned from 503A pharmacy compounding due to safety risks | Prohibited (S0 Non-Approved) |
Thymosin Beta-4 Fragment Actin-Sequestering Peptide | 503A Category 2 | Preclinical: Tissue Regeneration, Wound Repair | Banned from 503A pharmacy compounding | Prohibited (S2 Growth Factors) |
Mod GRF 1-29, DAC:GRF GHRH Analog | 503A Category 2 | Investigational: Growth Hormone Secretagogue | Banned from 503A pharmacy compounding | Prohibited (S2 Peptide Hormones) |
NNC 26-0161 GHRP Secretagogue | 503A Category 2 | Investigational: Postoperative Bowel Function (Discontinued) | Banned from 503A pharmacy compounding | Prohibited (S2 Growth Factors) |
Egrifta, Egrifta SV Stabilized GHRH Analog | FDA Approved | HIV-Associated Lipodystrophy (Visceral Adiposity) | Available via commercial prescription (Rx only) | Prohibited in Competition (S2) |
Sermorelin Geref (Historical) GHRH (1-29) | FDA Approved | Diagnostic Evaluation of Pituitary GH Function | Permitted under valid 503A patient-specific prescription | Prohibited (S2 Peptide Hormones) |
Vyleesi MC4R Agonist | FDA Approved | Hypoactive Sexual Desire Disorder (HSDD) in Premenopausal Women | Prescription only (auto-injector format) | Not Prohibited |
MT-2 Non-Selective Melanocortin Agonist | Banned / Unlawful | None (Associated with Severe Toxicities & Melanoma Risk) | Completely illegal for human compounding or sales | Prohibited (S0 Non-Approved) |
Copper Tripeptide-1 Copper Chelate Tripeptide | Cosmetic Only | Cosmetic: Topical Skin Remodeling (Unapproved as Injectable) | Topical compounding permissible; unapproved as injectable | Not Prohibited |
Mitochondrial 12S rRNA-c Mitochondrial-Derived Peptide | 503A Category 2 | Preclinical: Metabolic Signaling & AMPK Activation | Banned from 503A compounding | Prohibited (S2 Metabolic Modulators) |
SS-31 (Elamipretide) Bendavia (Investigational) Mitochondrial Cardiolipin Stabilizer | Phase 3 (IND) | Investigational: Barth Syndrome, Mitochondrial Myopathy | Illegal outside authorized clinical trials | Prohibited (S0 Non-Approved) |
Epitalon Epithalamin Synthetic Synthetic Pineal Tetrapeptide | 503A Category 2 | Preclinical: Telomerase Induction (No Human Phase 3 Data) | Restricted from 503A compounding | Prohibited (S0 Non-Approved) |
Official Regulatory Data Sources:Classifications are cross-referenced with the U.S. FDA Orange Book: Approved Drug Products, FDA 503A Category 1/2 Bulk Drug Substances Lists, and the World Anti-Doping Agency (WADA) 2026 Prohibited List. Consult our Medical Review Policy for auditing timelines.