Regulatory Tool
FDA Peptide Status Tracker
Current regulatory status for every peptide compound tracked by PSI. Updated as formal FDA reclassification is published.
19
FDA-Approved
5
Category 2
14
Reclassification Expected
Showing 148 of 148 compounds
| Compound | FDA Status | Evidence | Evidence | Page |
|---|---|---|---|---|
| Bremelanotide (PT-141) | FDA-Approved | FDA Approved | View | |
| Degarelix | FDA-Approved | FDA Approved | View | |
| Exenatide | FDA-Approved | FDA Approved | View | |
| Glucagon | FDA-Approved | FDA Approved | View | |
| GnRH Agonist Peptides | FDA-Approved | FDA Approved | View | |
| Gonadorelin | FDA-Approved | FDA Approved | View | |
| HCG (Human Chorionic Gonadotropin) | FDA-Approved | FDA Approved | View | |
| Liraglutide | FDA-Approved | FDA Approved | View | |
| Oxytocin | FDA-Approved | FDA Approved | View | |
| Pasireotide (SOM230) | FDA-Approved | FDA Approved | View | |
| Pentosan Polysulfate (PPS) | FDA-Approved | FDA Approved | View | |
| Plerixafor | FDA-Approved | FDA Approved | View | |
| Pramlintide (Symlin) | FDA-Approved | FDA Approved | View | |
| Semaglutide | FDA-Approved | FDA Approved | View | |
| Setmelanotide | FDA-Approved | FDA Approved | View | |
| Tesamorelin | FDA-Approved | FDA Approved | View | |
| Tirzepatide | FDA-Approved | FDA Approved | View | |
| Triptorelin | FDA-Approved | FDA Approved | View | |
| Trofinetide (Daybue) | FDA-Approved | FDA Approved | View | |
| AOD-9604 | Reclassification Expected | Animal Studies | View | |
| BPC-157 | Reclassification Expected | Human Trials | View | |
| DSIP | Reclassification Expected | Human Trials | View | |
| Epitalon | Reclassification Expected | Human Trials | View | |
| GHK-Cu | Reclassification Expected | Human Trials | View | |
| Ipamorelin | Reclassification Expected | Human Trials | View | |
| Kisspeptin | Reclassification Expected | Human Trials | View | |
| KPV | Reclassification Expected | Animal Studies | View | |
| MK-677 (Ibutamoren) | Reclassification Expected | Human Trials | View | |
| MOTS-c | Reclassification Expected | Human Trials | View | |
| Selank | Reclassification Expected | Human Trials | View | |
| Semax | Reclassification Expected | Human Trials | View | |
| TB-500 | Reclassification Expected | Human Trials | View | |
| Thymosin Alpha-1 | Reclassification Expected | Human Trials | View | |
| CJC-1295 | Category 2 | Animal Studies | View | |
| GHRP-2 | Category 2 | Human Trials | View | |
| GHRP-6 | Category 2 | Human Trials | View | |
| LL-37 | Category 2 | Human Trials | View | |
| Melanotan II | Category 2 | Human Trials | View | |
| 5-Amino-1MQ | Category 1 | Preclinical | View | |
| Ac-SDKP | Category 1 | Human Trials | View | |
| ACE-031 | Category 1 | Human Trials | View | |
| Adipotide (FTPP) | Category 1 | Preclinical | View | |
| AHK-Cu (Copper Tripeptide) | Category 1 | Animal Studies | View | |
| Alpha-1 Antitrypsin Peptide (VIRIP) | Category 1 | Human Trials | View | |
| Angiotensin-(1-7) | Category 1 | Human Trials | View | |
| Apelin | Category 1 | Human Trials | View | |
| Apelin-13 | Category 1 | Human Trials | View | |
| ARA-290 | Category 1 | Human Trials | View | |
| Argireline (Acetyl Hexapeptide-3) | Category 1 | Human Trials | View | |
| B7-33 | Category 1 | Animal Studies | View | |
| Beta-Glucan Peptide | Category 1 | Human Trials | View | |
| Bimagrumab | Category 1 | Human Trials | View | |
| Biomimetic Peptide 14 | Category 1 | Human Trials | View | |
| BNP (Brain Natriuretic Peptide) | Category 1 | Human Trials | View | |
| BPC-157 Arginine Salt | Category 1 | Preclinical | View | |
| BPC-157/TB-500 Blend | Category 1 | Preclinical | View | |
| CagriSema | Category 1 | Human Trials | View | |
| Cartalax | Category 1 | Animal Studies | View | |
| Catestatin | Category 1 | Human Trials | View | |
| Cathelicidin Peptides | Category 1 | Human Trials | View | |
| Cerebrolysin | Category 1 | Human Trials | View | |
| CGRP (Calcitonin Gene-Related Peptide) | Category 1 | Human Trials | View | |
| CJC-1295 without DAC (Mod GRF 1-29) | Category 1 | Preclinical | View | |
| Copeptin | Category 1 | Human Trials | View | |
| Copper Peptides | Category 1 | Human Trials | View | |
| Cortexin | Category 1 | Human Trials | View | |
| Cortistatin | Category 1 | Human Trials | View | |
| DAHK Peptide | Category 1 | Animal Studies | View | |
| Davunetide (NAP/AL-108) | Category 1 | Human Trials | View | |
| Decorin | Category 1 | Human Trials | View | |
| Defensins | Category 1 | Human Trials | View | |
| Dihexa | Category 1 | Animal Studies | View | |
| Enclomiphene | Category 1 | Human Trials | View | |
| Epithalon (Epithalamin Synthetic) | Category 1 | Animal Studies | View | |
| Follistatin | Category 1 | Human Trials | View | |
| FOXO4-DRI | Category 1 | Animal Studies | View | |
| Galanin | Category 1 | Animal Studies | View | |
| GDF-11 (Growth Differentiation Factor 11) | Category 1 | Human Trials | View | |
| GDF-15 | Category 1 | Human Trials | View | |
| GHK | Category 1 | Human Trials | View | |
| GIP (Glucose-Dependent Insulinotropic Polypeptide) | Category 1 | Human Trials | View | |
| Glycine-Proline-Glutamate (GPE) | Category 1 | Animal Studies | View | |
| Hepcidin | Category 1 | Human Trials | View | |
| Hexarelin | Category 1 | Human Trials | View | |
| HGH Fragment 176-191 | Category 1 | Animal Studies | View | |
| Humanin | Category 1 | Human Trials | View | |
| IGF-1 LR3 | Category 1 | Human Trials | View | |
| Irisin | Category 1 | Human Trials | View | |
| Khavinson Peptide Bioregulators | Category 1 | Human Trials | View | |
| Kisspeptin-54 (Metastin) | Category 1 | Human Trials | View | |
| Klotho Peptide | Category 1 | Human Trials | View | |
| Lactoferricin | Category 1 | Human Trials | View | |
| Larazotide Acetate | Category 1 | Human Trials | View | |
| Livagen | Category 1 | Animal Studies | View | |
| Maridebart Cafraglutide (MariTide) | Category 1 | Human Trials | View | |
| Matrixyl (Palmitoyl Pentapeptide-4) | Category 1 | Animal Studies | View | |
| Mazdutide | Category 1 | Human Trials | View | |
| Mechano Growth Factor (MGF) | Category 1 | Human Trials | View | |
| Melanocyte-Stimulating Hormone (α-MSH) | Category 1 | Human Trials | View | |
| Melanotan I (Afamelanotide) | Category 1 | Human Trials | View | |
| Myostatin Inhibitor Peptides | Category 1 | Human Trials | View | |
| N-Acetyl Selank | Category 1 | Preclinical | View | |
| N-Acetyl Semax | Category 1 | Preclinical | View | |
| NAP (Davunetide) | Category 1 | Human Trials | View | |
| Neuromedin U | Category 1 | Animal Studies | View | |
| Neuropeptide Y (NPY) | Category 1 | Human Trials | View | |
| NMN (Nicotinamide Mononucleotide) | Category 1 | Human Trials | View | |
| Noopept (GVS-111) | Category 1 | Human Trials | View | |
| Orexin-A (Hypocretin-1) | Category 1 | Human Trials | View | |
| Osteocalcin (Uncarboxylated) | Category 1 | Human Trials | View | |
| P21 (NSI-189 Peptide Fragment) | Category 1 | Animal Studies | View | |
| p28 (Azurin Peptide Fragment) | Category 1 | Human Trials | View | |
| p53 Peptides | Category 1 | Human Trials | View | |
| Palmitoyl Tripeptide-1 | Category 1 | Human Trials | View | |
| Palmitoyl Tripeptide-5 | Category 1 | Human Trials | View | |
| PEG-MGF | Category 1 | Preclinical | View | |
| Pemvidutide | Category 1 | Human Trials | View | |
| Pentagastrin | Category 1 | Human Trials | View | |
| Pinealon | Category 1 | Animal Studies | View | |
| Protegrin-1 | Category 1 | Human Trials | View | |
| Rapamycin/mTOR Peptide Inhibitors | Category 1 | Human Trials | View | |
| Relaxin-2 (Serelaxin) | Category 1 | Human Trials | View | |
| Retatrutide | Category 1 | Human Trials | View | |
| Senolytic Peptide Conjugates | Category 1 | Animal Studies | View | |
| Sermorelin | Category 1 | Human Trials | View | |
| SHLP-2 (Small Humanin-Like Peptide 2) | Category 1 | Animal Studies | View | |
| SHLP6 | Category 1 | Animal Studies | View | |
| SNAP-8 (Acetyl Octapeptide-3) | Category 1 | Human Trials | View | |
| SS-31 (Elamipretide) | Category 1 | Human Trials | View | |
| Substance P | Category 1 | Human Trials | View | |
| Survodutide | Category 1 | Human Trials | View | |
| TA-65 (Cycloastragenol) | Category 1 | Preclinical | View | |
| Teixobactin | Category 1 | Animal Studies | View | |
| Tesofensine | Category 1 | Human Trials | View | |
| Tetracosactide (Cosyntropin/Synacthen) | Category 1 | Human Trials | View | |
| Thymalfasin (Thymosin Alpha-1 Synthetic) | Category 1 | Human Trials | View | |
| Thymalin | Category 1 | Human Trials | View | |
| Thymogen | Category 1 | Human Trials | View | |
| Thymopoietin | Category 1 | Human Trials | View | |
| Thymosin Beta-10 | Category 1 | Human Trials | View | |
| Thymosin Beta-4 | Category 1 | Human Trials | View | |
| Thymulin (FTS/ZnFTS) | Category 1 | Animal Studies | View | |
| TRIM (Thyrotropin-Releasing Hormone Analog) | Category 1 | Preclinical | View | |
| Ularitide (Urodilatin) | Category 1 | Human Trials | View | |
| Vesugen | Category 1 | Human Trials | View | |
| Vilon | Category 1 | Human Trials | View | |
| VIP (Vasoactive Intestinal Peptide) | Category 1 | Human Trials | View | |
| α-AIB (Alpha-Aminoisobutyric Acid Peptides) | Category 1 | Animal Studies | View |
Expected to return to Category 1 (legal compounding) per February 2026 HHS announcement. Formal FDA reclassification pending.
Expected to return to Category 1 (legal compounding) per February 2026 HHS announcement. Formal FDA reclassification pending.
Expected to return to Category 1 (legal compounding) per February 2026 HHS announcement. Formal FDA reclassification pending.
Expected to return to Category 1 (legal compounding) per February 2026 HHS announcement. Formal FDA reclassification pending.
Expected to return to Category 1 (legal compounding) per February 2026 HHS announcement. Formal FDA reclassification pending.
Expected to return to Category 1 (legal compounding) per February 2026 HHS announcement. Reclassification status less certain than other compounds. Formal FDA reclassification pending.
Expected to return to Category 1 (legal compounding) per February 2026 HHS announcement. Formal FDA reclassification pending.
Expected to return to Category 1 (legal compounding) per February 2026 HHS announcement. Formal FDA reclassification pending.
Expected to return to Category 1 (legal compounding) per February 2026 HHS announcement. Formal FDA reclassification pending.
Expected to return to Category 1 (legal compounding) per February 2026 HHS announcement. Formal FDA reclassification pending.
Expected to return to Category 1 (legal compounding) per February 2026 HHS announcement. Approved in Russia as an anxiolytic. Formal FDA reclassification pending.
Expected to return to Category 1 (legal compounding) per February 2026 HHS announcement. Approved in Russia for cognitive and neurological conditions. Formal FDA reclassification pending.
Expected to return to Category 1 (legal compounding) per February 2026 HHS announcement. Formal FDA reclassification pending.
Expected to return to Category 1 (legal compounding) per February 2026 HHS announcement. Approved as Zadaxin in 35+ countries outside the U.S. Formal FDA reclassification pending.
Understanding FDA Peptide Categories
What is Category 1 vs Category 2?
The FDA classifies bulk drug substances used in compounding into two categories. Category 1 compounds can be legally compounded by 503A (physician-supervised) and 503B (outsourcing facility) pharmacies. Category 2 compounds are restricted from compounding, typically due to safety concerns, complexity of formulation, or availability of an FDA-approved alternative.
What does reclassification mean?
In February 2026, HHS Secretary Robert F. Kennedy Jr. announced that several peptides previously placed on Category 2 are expected to return to Category 1, restoring legal compounding access. Formal FDA reclassification through the Federal Register is still pending for most compounds. PSI tracks this process and updates this page as official actions are published.
What is WADA prohibited?
The World Anti-Doping Agency (WADA) maintains a list of prohibited substances for competitive athletes. Compounds marked "WADA Prohibited" are banned in competition and may be banned out of competition. This status is separate from FDA approval and applies specifically to athletes subject to drug testing.
Medical Disclaimer
This tracker is for informational and educational purposes only. It does not constitute medical advice, diagnosis, or treatment recommendations. Regulatory status can change. Always consult a qualified healthcare provider before making decisions about any compound. PSI does not sell, distribute, or recommend any peptide product.