Peptides / Regulatory tracker
Peptide regulatory tracker
Where every peptide in the VALREXA library stands with U.S. regulators, from FDA-approved medicines to research compounds, alongside its human evidence grade.
Read this first: "Compounding allowed" means the FDA said in October 2026 it will use enforcement discretion for licensed 503A compounding pharmacies. It is not FDA approval, and it does not apply to products sold online as "research chemicals." Status can change quickly; confirm with the FDA before relying on it.
| Compound | U.S. status | Detail | Human evidence | 2026 compounding decision |
|---|---|---|---|---|
| Abaloparatide Endocrine & Growth | FDA-approved | FDA-approved (Tymlos) | Approved use | — |
| Albiglutide Metabolic Research | Discontinued in U.S. | Formerly approved; withdrawn worldwide 2017–2018 | Controlled trials | — |
| Amylin Metabolic Research | Natural molecule / not a drug | Natural hormone; analogues studied | Early human | — |
| Angiotensin II Approved Peptide Medicines | FDA-approved | FDA-approved (Giapreza) | Approved use | — |
| AOD-9604 Metabolic Research | Not FDA-approved | Not FDA-approved | Controlled trials | — |
| Aprotinin Approved Peptide Medicines | Discontinued in U.S. | Formerly approved in the U.S.; withdrawn 2008, restricted use in EU/Canada | Controlled trials | — |
| ARA-290 / Cibinetide Repair & Tissue Biology | Investigational | Investigational; not FDA-approved | Controlled trials | — |
| Bivalirudin Approved Peptide Medicines | FDA-approved | FDA-approved (Angiomax and generics) | Approved use | — |
| BPC-157 Repair & Tissue Biology | Compounding allowed | Not FDA-approved | Preclinical | Allowed for 503A pharmacies under FDA enforcement discretion (Oct 2026) |
| Bremelanotide Neuroscience | FDA-approved | FDA-approved (Vyleesi) | Approved use | — |
| Bulevirtide Approved Peptide Medicines | FDA-approved | FDA accelerated approval May 2026 (Hepcludex); approved in EU 2020 | Approved use | — |
| Cagrilintide Metabolic Research | Investigational | Investigational; CagriSema under FDA review | Controlled trials | — |
| Calcitonin Endocrine & Growth | FDA-approved | FDA-approved (Miacalcin and others) | Approved use | — |
| Carfilzomib Approved Peptide Medicines | FDA-approved | FDA-approved (Kyprolis) | Approved use | — |
| Cetrorelix Endocrine & Growth | FDA-approved | FDA-approved (Cetrotide) | Approved use | — |
| CJC-1295 Endocrine & Growth | Not FDA-approved | Not FDA-approved | Early human | — |
| Colistimethate sodium Approved Peptide Medicines | FDA-approved | FDA-approved (Coly-Mycin M and generics) | Approved use | — |
| Corticotropin Endocrine & Growth | FDA-approved | FDA-approved (H.P. Acthar Gel) | Approved use | — |
| Cosyntropin Endocrine & Growth | FDA-approved | FDA-approved (Cortrosyn and generics) | Approved use | — |
| Dalbavancin Approved Peptide Medicines | FDA-approved | FDA-approved (Dalvance) | Approved use | — |
| Daptomycin Approved Peptide Medicines | FDA-approved | FDA-approved (Cubicin and generics) | Approved use | — |
| Degarelix Approved Peptide Medicines | FDA-approved | FDA-approved (Firmagon) | Approved use | — |
| Desirudin Approved Peptide Medicines | Discontinued in U.S. | Formerly approved; product discontinued | Controlled trials | — |
| Desmopressin Approved Peptide Medicines | FDA-approved | FDA-approved | Approved use | — |
| DSIP Neuroscience | Not FDA-approved | Not FDA-approved | Early human | FDA advisory committee voted against (Jul 2026) |
| Dulaglutide Metabolic Research | FDA-approved | FDA-approved (Trulicity) | Approved use | — |
| Ecallantide Approved Peptide Medicines | FDA-approved | FDA-approved (Kalbitor) | Approved use | — |
| Enfuvirtide Approved Peptide Medicines | Not FDA-approved | U.S. marketing ended February 2025 (Fuzeon) | Controlled trials | — |
| Epitalon Mitochondrial & Longevity | Compounding allowed | Not FDA-approved; compounding allowed | Preclinical | Allowed for 503A pharmacies under FDA enforcement discretion (Oct 2026) |
| Eptifibatide Approved Peptide Medicines | FDA-approved | FDA-approved (generics; Integrilin brand discontinued) | Approved use | — |
| Exenatide Metabolic Research | FDA-approved | FDA-approved (type 2 diabetes) | Approved use | — |
| Ganirelix Endocrine & Growth | FDA-approved | FDA-approved (Antagon) | Approved use | — |
| GHK-Cu Repair & Tissue Biology | Cosmetic use only | Cosmetic use; not an approved drug | Early human | — |
| GHRP-2 Endocrine & Growth | Not FDA-approved | Not FDA-approved | Early human | — |
| GHRP-6 Endocrine & Growth | Not FDA-approved | Not FDA-approved | Early human | — |
| Glucagon Metabolic Research | FDA-approved | FDA-approved (severe hypoglycemia) | Approved use | — |
| Gonadorelin Endocrine & Growth | Discontinued in U.S. | Formerly approved; discontinued in U.S. | Controlled trials | — |
| Goserelin Endocrine & Growth | FDA-approved | FDA-approved (Zoladex) | Approved use | — |
| Hexarelin Endocrine & Growth | Not FDA-approved | Not FDA-approved | Early human | — |
| Histrelin Endocrine & Growth | FDA-approved | FDA-approved (Supprelin LA; Vantas discontinued 2021) | Approved use | — |
| Humanin Mitochondrial & Longevity | Not FDA-approved | Not FDA-approved | Preclinical | — |
| Icatibant Approved Peptide Medicines | FDA-approved | FDA-approved (Firazyr) | Approved use | — |
| Insulin (human) Metabolic Research | FDA-approved | FDA-approved (many brands and follow-on products) | Approved use | — |
| Insulin aspart Metabolic Research | FDA-approved | FDA-approved (NovoLog/Fiasp and follow-on products) | Approved use | — |
| Insulin degludec Metabolic Research | FDA-approved | FDA-approved (Tresiba, Ryzodeg, Xultophy) | Approved use | — |
| Insulin detemir Metabolic Research | FDA-approved | FDA-approved; Levemir brand ended U.S. sales in 2024 | Approved use | — |
| Insulin glargine Metabolic Research | FDA-approved | FDA-approved (Lantus, Basaglar, Semglee and others) | Approved use | — |
| Insulin glulisine Metabolic Research | FDA-approved | FDA-approved (Apidra) | Approved use | — |
| Insulin lispro Metabolic Research | FDA-approved | FDA-approved (Humalog and follow-on products) | Approved use | — |
| Ipamorelin Endocrine & Growth | Not FDA-approved | Not FDA-approved | Early human | — |
| Kisspeptin-10 Endocrine & Growth | Not FDA-approved | Not FDA-approved | Early human | — |
| KPV Repair & Tissue Biology | Compounding allowed | Not FDA-approved | Preclinical | Allowed for 503A pharmacies under FDA enforcement discretion (Oct 2026) |
| Lanreotide Approved Peptide Medicines | FDA-approved | FDA-approved (Somatuline Depot and others) | Approved use | — |
| Leuprolide Approved Peptide Medicines | FDA-approved | FDA-approved (Lupron and others) | Approved use | — |
| Linaclotide Metabolic Research | FDA-approved | FDA-approved (Linzess) | Approved use | — |
| Liraglutide Metabolic Research | FDA-approved | FDA-approved (Victoza, Saxenda) | Approved use | — |
| Lixisenatide Metabolic Research | FDA-approved | FDA-approved only within Soliqua; stand-alone Adlyxin discontinued (2023) | Approved use | — |
| LL-37 Immunology | Not FDA-approved | Not FDA-approved | Controlled trials | — |
| Mecasermin Endocrine & Growth | FDA-approved | FDA-approved (Increlex) | Approved use | — |
| Melanotan II Neuroscience | Not FDA-approved | Not approved; regulators have issued warnings | Early human | — |
| Metreleptin Endocrine & Growth | FDA-approved | FDA-approved (Myalept) | Approved use | — |
| MOTS-c Mitochondrial & Longevity | Compounding allowed | No approved product | Preclinical | Allowed for 503A pharmacies under FDA enforcement discretion (Oct 2026) |
| NAD+ Related Molecules | Natural molecule / not a drug | Not an approved anti-aging treatment | Early human | — |
| Nafarelin Endocrine & Growth | FDA-approved | FDA-approved (Synarel) | Approved use | — |
| Nesiritide Approved Peptide Medicines | Discontinued in U.S. | Formerly approved; product discontinued | Controlled trials | — |
| Neuropeptide Y Neuroscience | Natural molecule / not a drug | Natural neuropeptide; not a drug | Preclinical | — |
| Octreotide Approved Peptide Medicines | FDA-approved | FDA-approved (Sandostatin and others) | Approved use | — |
| Oritavancin Approved Peptide Medicines | FDA-approved | FDA-approved (Orbactiv) | Approved use | — |
| Oxytocin Neuroscience | FDA-approved | FDA-approved (obstetrics) | Approved use | — |
| PACAP-38 Neuroscience | Natural molecule / not a drug | Natural neuropeptide; not a drug | Early human | — |
| Palifermin Approved Peptide Medicines | FDA-approved | FDA-approved (Kepivance) | Approved use | — |
| Parathyroid hormone (PTH) Endocrine & Growth | FDA-approved | Approved forms; check availability | Approved use | — |
| Pasireotide Endocrine & Growth | FDA-approved | FDA-approved (Signfora/Somactul) | Approved use | — |
| Plecanatide Metabolic Research | FDA-approved | FDA-approved (Trulance) | Approved use | — |
| Polymyxin B Approved Peptide Medicines | FDA-approved | FDA-approved (polymyxin B sulfate injection) | Approved use | — |
| Pramlintide Metabolic Research | FDA-approved | FDA-approved (Symlin) | Approved use | — |
| Retatrutide Metabolic Research | Investigational | Investigational (Phase 3) | Controlled trials | — |
| Romidepsin Approved Peptide Medicines | FDA-approved | FDA-approved (Istodax and generics; one indication withdrawn) | Approved use | — |
| Romiplostim Endocrine & Growth | FDA-approved | FDA-approved (Nplate) | Approved use | — |
| Secretin Metabolic Research | FDA-approved | FDA-approved (ChiRhoStim, diagnostic use) | Approved use | — |
| Selank Neuroscience | Not FDA-approved | Not FDA-approved | Early human | — |
| Semaglutide Metabolic Research | FDA-approved | FDA-approved (Ozempic, Rybelsus, Wegovy) | Approved use | — |
| Semax Neuroscience | Compounding allowed | Not FDA-approved | Early human | Allowed for 503A pharmacies under FDA enforcement discretion (Oct 2026) |
| Sermorelin Endocrine & Growth | Discontinued in U.S. | Formerly approved; discontinued | Controlled trials | — |
| Setmelanotide Endocrine & Growth | FDA-approved | FDA-approved (Imcivree) | Approved use | — |
| SHLP2 Mitochondrial & Longevity | Not FDA-approved | Not FDA-approved | Preclinical | — |
| Somatropin Endocrine & Growth | FDA-approved | FDA-approved (Genotropin, Norditropin, Humatrope and others) | Approved use | — |
| SS-31 (Elamipretide) Mitochondrial & Longevity | FDA-approved | FDA accelerated approval for Barth syndrome (2025) | Approved use | — |
| Substance P Neuroscience | Natural molecule / not a drug | Natural neuropeptide; not a drug | Early human | — |
| TB-500 Repair & Tissue Biology | Compounding allowed | Not FDA-approved | Preclinical | Allowed for 503A pharmacies under FDA enforcement discretion (Oct 2026) |
| Teduglutide Metabolic Research | FDA-approved | FDA-approved (Gattex/Revestive) | Approved use | — |
| Telavancin Approved Peptide Medicines | FDA-approved | FDA-approved (Vibativ; 250 mg strength discontinued 2025) | Approved use | — |
| Teriparatide Endocrine & Growth | FDA-approved | FDA-approved (Forteo and others) | Approved use | — |
| Terlipressin Approved Peptide Medicines | FDA-approved | FDA-approved (Terlivaz) | Approved use | — |
| Tesamorelin Endocrine & Growth | FDA-approved | FDA-approved for one indication | Approved use | — |
| Thymosin alpha-1 Immunology | Approved outside U.S. | Approved outside the U.S. | Controlled trials | — |
| Thymosin beta-4 Repair & Tissue Biology | Not FDA-approved | Not FDA-approved | Controlled trials | — |
| Tirzepatide Metabolic Research | FDA-approved | FDA-approved (Mounjaro, Zepbound) | Approved use | — |
| Triptorelin Endocrine & Growth | FDA-approved | FDA-approved (Trelstar and generics) | Approved use | — |
| Vancomycin Approved Peptide Medicines | FDA-approved | FDA-approved (Vancocin and generics) | Approved use | — |
| Vasopressin Neuroscience | FDA-approved | FDA-approved (vasodilatory shock) | Approved use | — |
| VIP Neuroscience | Not FDA-approved | Not FDA-approved | Controlled trials | — |
| Ziconotide Approved Peptide Medicines | FDA-approved | FDA-approved (Prialt) | Approved use | — |
| CBL-514 Related Molecules · small molecule, not a peptide | Investigational | Localized abdominal fat-reduction program; separate tirzepatide combination study. Caliway · Trial record | Controlled trials | Not assessed in this profile |
| P11-4 Repair & Tissue Biology · dental peptide | Not individually FDA-approved | U.S. Curodont Repair Fluoride Plus is listed as an OTC Monograph Drug: sodium fluoride is active; oligopeptide-104 is inactive. Professional office use only. Monograph marketing is not individual FDA approval of P11-4. Product label · FDA framework | Controlled trials; formulation-specific limits | Not assessed in this profile |
| CT20p Oncology Research | Investigational | Preclinical research; the cited papers do not establish patient benefit or current trial/approval status. (Bassiouni et al., 2016) (Cox et al., 2022) | Preclinical | Not assessed in this profile |
Change log
Every regulatory change we track, newest first. Sources are on the News page.
- 50 approved peptide medicines added to the library (insulins, incretin mimetics, GnRH analogues, antibiotics, and more), each with three reading levels and verified against PubChem, UniProt, FDA records and ClinicalTrials.gov.
- Regulatory tracker launched, covering all 103 compounds in the library.
- FDA announces enforcement discretion for 503A compounding of BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500. None is FDA-approved. Read the summary
- FDA Pharmacy Compounding Advisory Committee votes to recommend the six peptides above for the 503A bulks list and votes against DSIP (emideltide). Read the summary
- Elamipretide (SS-31) receives FDA accelerated approval for Barth syndrome. See the profile
- FDA places BPC-157 in Category 2 for compounding over safety concerns. See the profile
Spotted a status that has changed? Tell us and we will verify it. See our corrections policy.
Educational reference only. Nothing here is medical advice, a treatment recommendation, or dosing or sourcing guidance.