Regulatory Tool
FDA Status Tracker
FDA regulatory status for peptide compounds changes through Federal Register actions, Pharmacy Compounding Advisory Committee reviews, and category reassignments. PSI tracks each change against the federal primary source and updates this page when the regulatory record moves.
Why most peptides are not FDA approved
Most peptides are not FDA approved because the approval process costs between $500 million and $2 billion and typically requires a patent strong enough to fund the trial. Most peptides cannot be patented.
Read the full editorial →The table below tracks the current regulatory status of every peptide PSI covers: FDA-approved compounds, compounds allowed through pharmacy compounding, and compounds under active reclassification review. Status changes over time, sometimes quickly.
Showing 147 of 147 compounds
| Compound | Access | Details |
|---|---|---|
| 5-Amino-1MQ Compoundable(Under Review) | + | |
| Ac-SDKP Compoundable(Under Review) | + | |
| ACE-031 Compoundable(Under Review) | + | |
| Adipotide (FTPP) Compoundable(Under Review) | + | |
| AHK-Cu (Copper Tripeptide) Compoundable(Under Review) | + | |
| Alpha-1 Antitrypsin Peptide (VIRIP) Compoundable(Under Review) | + | |
| Angiotensin-(1-7) Compoundable(Under Review) | + | |
| AOD-9604 Not Compoundable(Voted Against) | + | |
| Apelin Compoundable(Under Review) | + | |
| Apelin-13 Compoundable(Under Review) | + | |
| ARA-290 Compoundable(Under Review) | + | |
| Argireline (Acetyl Hexapeptide-3) Compoundable(Under Review) | + | |
| B7-33 Compoundable(Under Review) | + | |
| Beta-Glucan Peptide Compoundable(Under Review) | + | |
| Bimagrumab Compoundable(Under Review) | + | |
| Biomimetic Peptide 14 Compoundable(Under Review) | + | |
| BNP (Brain Natriuretic Peptide) Compoundable(Under Review) | + | |
| BPC-157 Compoundable(Under Review) | + | |
| BPC-157 Arginine Salt Compoundable(Under Review) | + | |
| BPC-157/TB-500 Blend Compoundable(Under Review) | + | |
| CagriSema Compoundable(Under Review) | + | |
| Cartalax Compoundable(Under Review) | + | |
| Catestatin Compoundable(Under Review) | + | |
| Cathelicidin Peptides Compoundable(Under Review) | + | |
| Cerebrolysin Compoundable(Under Review) | + | |
| CGRP (Calcitonin Gene-Related Peptide) Compoundable(Under Review) | + | |
| CJC-1295 Not Compoundable(Voted Against) | + | |
| CJC-1295 without DAC (Mod GRF 1-29) Compoundable(Under Review) | + | |
| Copeptin Compoundable(Under Review) | + | |
| Copper Peptides Compoundable(Under Review) | + | |
| Cortexin Compoundable(Under Review) | + | |
| Cortistatin Compoundable(Under Review) | + | |
| DAHK Peptide Compoundable(Under Review) | + | |
| Davunetide (NAP/AL-108) Compoundable(Under Review) | + | |
| Decorin Compoundable(Under Review) | + | |
| Defensins Compoundable(Under Review) | + | |
| Degarelix FDA-Approved(Prescription) | + | |
| Dihexa Compoundable(Under Review) | + | |
| DSIP Compoundable(Under Review) | + | |
| Enclomiphene Compoundable(Under Review) | + | |
| Epitalon Compoundable(Under Review) | + | |
| Exenatide FDA-Approved(Prescription) | + | |
| Follistatin Compoundable(Under Review) | + | |
| FOXO4-DRI Compoundable(Under Review) | + | |
| Galanin Compoundable(Under Review) | + | |
| GDF-11 (Growth Differentiation Factor 11) Compoundable(Under Review) | + | |
| GDF-15 Compoundable(Under Review) | + | |
| GHK Compoundable(Under Review) | + | |
| GHK-Cu Compoundable(Under Review) | + | |
| GHRP-2 Not Compoundable(Insufficient Data) | + | |
| GHRP-6 Not Compoundable(Insufficient Data) | + | |
| GIP (Glucose-Dependent Insulinotropic Polypeptide) Compoundable(Under Review) | + | |
| Glucagon FDA-Approved(Prescription) | + | |
| Glycine-Proline-Glutamate (GPE) Compoundable(Under Review) | + | |
| GnRH Agonist Peptides FDA-Approved(Prescription) | + | |
| Gonadorelin FDA-Approved(Prescription) | + | |
| HCG (Human Chorionic Gonadotropin) FDA-Approved(Prescription) | + | |
| Hepcidin Compoundable(Under Review) | + | |
| Hexarelin Compoundable(Under Review) | + | |
| HGH Fragment 176-191 Compoundable(Under Review) | + | |
| Humanin Compoundable(Under Review) | + | |
| IGF-1 DES Compoundable(Under Review) | + | |
| IGF-1 LR3 Compoundable(Under Review) | + | |
| Ipamorelin Not Compoundable(Voted Against) | + | |
| Irisin Compoundable(Under Review) | + | |
| Khavinson Peptide Bioregulators Compoundable(Under Review) | + | |
| Kisspeptin Not Compoundable(Voted Against) | + | |
| Kisspeptin-54 (Metastin) Compoundable(Under Review) | + | |
| Klotho Peptide Compoundable(Under Review) | + | |
| KPV Compoundable(Under Review) | + | |
| Lactoferricin Compoundable(Under Review) | + | |
| Larazotide Acetate Compoundable(Under Review) | + | |
| Liraglutide FDA-Approved(Prescription) | + | |
| Livagen Compoundable(Under Review) | + | |
| LL-37 Compoundable(Under Review) | + | |
| Maridebart Cafraglutide (MariTide) Compoundable(Under Review) | + | |
| Matrixyl (Palmitoyl Pentapeptide-4) Compoundable(Under Review) | + | |
| Mazdutide Compoundable(Under Review) | + | |
| Mechano Growth Factor (MGF) Compoundable(Under Review) | + | |
| Melanocyte-Stimulating Hormone (α-MSH) Compoundable(Under Review) | + | |
| Melanotan I (Afamelanotide) Compoundable(Under Review) | + | |
| Melanotan II Compoundable(Under Review) | + | |
| MK-677 (Ibutamoren) Not Compoundable(Voted Against) | + | |
| MOTS-c Compoundable(Under Review) | + | |
| Myostatin Inhibitor Peptides Compoundable(Under Review) | + | |
| N-Acetyl Selank Compoundable(Under Review) | + | |
| N-Acetyl Semax Compoundable(Under Review) | + | |
| Neuromedin U Compoundable(Under Review) | + | |
| Neuropeptide Y (NPY) Compoundable(Under Review) | + | |
| NMN (Nicotinamide Mononucleotide) Compoundable(Under Review) | + | |
| Noopept (GVS-111) Compoundable(Under Review) | + | |
| Orexin-A (Hypocretin-1) Compoundable(Under Review) | + | |
| Osteocalcin (Uncarboxylated) Compoundable(Under Review) | + | |
| Oxytocin FDA-Approved(Prescription) | + | |
| P21 (NSI-189 Peptide Fragment) Compoundable(Under Review) | + | |
| p28 (Azurin Peptide Fragment) Compoundable(Under Review) | + | |
| p53 Peptides Compoundable(Under Review) | + | |
| Palmitoyl Tripeptide-1 Compoundable(Under Review) | + | |
| Palmitoyl Tripeptide-5 Compoundable(Under Review) | + | |
| Pasireotide (SOM230) FDA-Approved(Prescription) | + | |
| PEG-MGF Compoundable(Under Review) | + | |
| Pemvidutide Compoundable(Under Review) | + | |
| Pentagastrin Compoundable(Under Review) | + | |
| Pentosan Polysulfate (PPS) FDA-Approved(Prescription) | + | |
| Pinealon Compoundable(Under Review) | + | |
| Plerixafor FDA-Approved(Prescription) | + | |
| Pramlintide (Symlin) FDA-Approved(Prescription) | + | |
| Protegrin-1 Compoundable(Under Review) | + | |
| PT-141 (Bremelanotide) FDA-Approved(Prescription) | + | |
| Rapamycin/mTOR Peptide Inhibitors Compoundable(Under Review) | + | |
| Relaxin-2 (Serelaxin) Compoundable(Under Review) | + | |
| Retatrutide Compoundable(Under Review) | + | |
| Selank Compoundable(Under Review) | + | |
| Semaglutide FDA-Approved(Prescription) | + | |
| Semax Compoundable(Under Review) | + | |
| Senolytic Peptide Conjugates Compoundable(Under Review) | + | |
| Sermorelin Compoundable(Under Review) | + | |
| Setmelanotide FDA-Approved(Prescription) | + | |
| SHLP2 (Small Humanin-Like Peptide 2) Compoundable(Under Review) | + | |
| SHLP6 Compoundable(Under Review) | + | |
| SNAP-8 (Acetyl Octapeptide-3) Compoundable(Under Review) | + | |
| SS-31 (Elamipretide) Compoundable(Under Review) | + | |
| Substance P Compoundable(Under Review) | + | |
| Survodutide Compoundable(Under Review) | + | |
| TA-65 (Cycloastragenol) Compoundable(Under Review) | + | |
| TB-500 Compoundable(Under Review) | + | |
| Teixobactin Compoundable(Under Review) | + | |
| Tesamorelin FDA-Approved(Prescription) | + | |
| Tesofensine Compoundable(Under Review) | + | |
| Tetracosactide (Cosyntropin/Synacthen) Compoundable(Under Review) | + | |
| Thymalfasin (Thymosin Alpha-1 Synthetic) Compoundable(Under Review) | + | |
| Thymalin Compoundable(Under Review) | + | |
| Thymogen Compoundable(Under Review) | + | |
| Thymopoietin Compoundable(Under Review) | + | |
| Thymosin Alpha-1 Not Compoundable(Voted Against) | + | |
| Thymosin Beta-10 Compoundable(Under Review) | + | |
| Thymosin Beta-4 Compoundable(Under Review) | + | |
| Thymulin (FTS/ZnFTS) Compoundable(Under Review) | + | |
| Tirzepatide FDA-Approved(Prescription) | + | |
| TRIM (Thyrotropin-Releasing Hormone Analog) Compoundable(Under Review) | + | |
| Triptorelin FDA-Approved(Prescription) | + | |
| Trofinetide (Daybue) FDA-Approved(Prescription) | + | |
| Ularitide (Urodilatin) Compoundable(Under Review) | + | |
| Vesugen Compoundable(Under Review) | + | |
| Vilon Compoundable(Under Review) | + | |
| VIP (Vasoactive Intestinal Peptide) Compoundable(Under Review) | + | |
| α-AIB (Alpha-Aminoisobutyric Acid Peptides) Compoundable(Under Review) | + |
Access state definitions
FDA Approved. Prescription medicines that completed the full FDA regulatory process.
Compoundable. A physician can currently have the compound prepared through a licensed specialty pharmacy under the FDA's 503A framework. Under Review: evaluated for formal 503A inclusion. On 503A Bulks List: evaluation complete and the compound has been formally authorized for compounding.
Not Compoundable. The 503A pathway is currently closed. Safety Risk: the FDA evaluated the compound and identified safety concerns that preclude compounding. Insufficient Data: the compound was nominated for evaluation but the nomination did not include sufficient information for the FDA to act. Voted Against: the Pharmacy Compounding Advisory Committee reviewed the compound and voted against recommending it for compounding.
Sources: PubMed, Federal Register, FDA advisory committee records. Full methodology at Editorial Standards.
Medical Disclaimer
This content is for educational and informational purposes only and does not constitute medical advice. The information presented reflects published research as indexed by PSI and should not be used to make treatment decisions. Always consult a qualified healthcare provider before starting, stopping, or modifying any treatment.