The FDA's Center for Drug Evaluation and Research approved two peptide drugs in 2024 through New Drug Application pathways: palopegteriparatide (Yorvipath) for hypoparathyroidism in adults and pegulicianine (Lumisight) for intraoperative fluorescence imaging during breast cancer lumpectomy. Two additional TIDES approvals that year were oligonucleotide products. They fall outside this registry PubMed, 2025.
The statutory phrase "approved peptide" carries a specific legal consequence. An unapproved peptide sold for human use without a valid investigational or compounding pathway violates the Federal Food, Drug, and Cosmetic Act.
More than 100 peptide drugs hold current FDA approval in the United States Forbes, 2026. Compounded peptides occupy a separate statutory category. BPC-157, TB-500, sermorelin, CJC-1295, and ipamorelin lack FDA approval. Where legally available, they exist as compounded preparations under physician prescription, governed by the 503A bulk drug substances list maintained by the FDA. The fda approved peptides list dictates whether a compound may be lawfully dispensed.
Figure 1: Distribution of FDA-approved peptide drugs by therapeutic indication.
Metabolic and Weight Management Peptides
Metabolic peptides represent the largest recent expansion in the approved registry. Semaglutide holds separate approvals for type 2 diabetes (Ozempic, 2017) and obesity (Wegovy, 2021). Tirzepatide holds approvals for type 2 diabetes (Mounjaro, 2022) and obesity (Zepbound, 2023). Liraglutide carries approvals for diabetes (Victoza, 2010) and obesity (Saxenda, 2014) Peptide Protocol Wiki, 2026. These glp 1 peptides operate through glucagon-like peptide-1 receptor agonism.
| Peptide | Brand Name(s) | Approved Indications | Approval Year | |---|---|---|---| | Semaglutide | Ozempic, Wegovy, Rybelsus | Type 2 diabetes; obesity | 2017–2021 | | Tirzepatide | Mounjaro, Zepbound | Type 2 diabetes; obesity | 2022–2023 | | Liraglutide | Victoza, Saxenda | Type 2 diabetes; obesity | 2010–2014 | | Dulaglutide | Trulicity | Type 2 diabetes | 2014 | | Exenatide | Byetta, Bydureon | Type 2 diabetes | 2005–2012 | | Lixisenatide | Adlyxin | Type 2 diabetes | 2016 | | Pramlintide | Symlin | Type 1 and type 2 diabetes adjunct | 2005 | | Tesamorelin | Egrifta | HIV-associated lipodystrophy | 2010 | | Setmelanotide | Imcivree | Genetic obesity disorders | 2020 |
Tesamorelin belongs in the metabolic category because its approved indication is reduction of excess abdominal fat in HIV-associated lipodystrophy Peptide Dossier, 2026. Setmelanotide addresses specific genetic obesity disorders through melanocortin-4 receptor agonism.
Oncology and Diagnostic Peptides
Oncology approvals include both therapeutic peptides and radiolabeled diagnostic agents. Degarelix (Firmagon, 2008) functions as a GnRH antagonist. Carfilzomib (Kyprolis, 2012) appears in some peptide registries but is a tetrapeptide epoxyketone proteasome inhibitor. It is classified as a proteasome inhibitor in published regulatory aggregators, not a conventional peptide therapeutic Peptide Stack, 2026.
| Peptide | Brand Name(s) | Approved Indications | Approval Year | |---|---|---|---| | Leuprolide | Lupron, Eligard | Prostate cancer, endometriosis, precocious puberty | 1985 | | Goserelin | Zoladex | Prostate cancer, breast cancer, endometriosis | 1989 | | Octreotide | Sandostatin | Acromegaly, carcinoid tumors | 1988 | | Lanreotide | Somatuline Depot | Acromegaly, GEP-NETs | 2007 | | Degarelix | Firmagon | Advanced prostate cancer | 2008 | | Lutetium Lu-177 dotatate | Lutathera | GEP-NETs | 2018 | | Gallium Ga-68 dotatate | Netspot | NET imaging | 2016 | | Pegulicianine | Lumisight | Breast cancer fluorescence imaging | 2024 | | Motixafortide | Aphexda | Stem cell mobilization in multiple myeloma | 2023 |
Systemic Peptides by Indication
Bone, cardiovascular, reproductive, and gastrointestinal peptides complete the registry. Palopegteriparatide (Yorvipath, 2024) targets hypoparathyroidism specifically. It is a PEGylated PTH prodrug Peptide Journal, 2024.
| Peptide | Brand Name(s) | Approved Indications | Approval Year | |---|---|---|---| | Calcitonin (salmon) | Miacalcin | Postmenopausal osteoporosis, Paget's disease | 1986 | | Teriparatide | Forteo | Osteoporosis | 2002 | | Abaloparatide | Tymlos | Osteoporosis | 2017 | | Palopegteriparatide | Yorvipath | Hypoparathyroidism | 2024 | | Vasopressin | Vasostrict | Vasodilatory shock | 2014 | | Desmopressin | DDAVP | Diabetes insipidus, bleeding disorders | 1978 | | Eptifibatide | Integrilin | Acute coronary syndrome | 1998 | | Bivalirudin | Angiomax | Anticoagulation in PCI | 2000 | | Linaclotide | Linzess | IBS-C, chronic constipation | 2012 | | Plecanatide | Trulance | Chronic constipation, IBS-C | 2017 | | Icatibant | Firazyr | Hereditary angioedema attacks | 2011 | | Enfuvirtide | Fuzeon | HIV-1 infection | 2003 | | Oxytocin | Pitocin | Labor induction, postpartum hemorrhage | 1980 | | Cetrorelix | Cetrotide | IVF premature LH surge prevention | 2000 | | Ganirelix | Ganirelix Acetate | IVF premature LH surge prevention | 2000 |
The reproductive category includes GnRH modulators approved for assisted reproduction. Cetrorelix and ganirelix prevent premature LH surges during IVF cycles The Peptide Guides, 2024.
Advisory Votes Versus Final Agency Decisions
The Pharmacy Compounding Advisory Committee reviewed BPC-157, TB-500, KPV, and MOTS-C on July 23 and 24, 2026. That vote has no binding effect. The 503A list remains unchanged AJMC, 2026.
FDA scientists unanimously recommended against adding BPC-157, TB-500, KPV, and MOTS-C to the compounding list. Animal studies produced by a single research group do not satisfy the statutory threshold for compounding access.
For supply chain and compliance teams, the operative question is whether a peptide holds a statutory approval tied to an indication. The fda approved peptides page separates that category from research chemicals. The question of are peptides legal turns on the same distinction. Different types of peptides face different regulatory pathways depending on their chemical structure and intended use.
A facility that treats a 503A candidate as an approved drug exposes itself to warning letters, recall liability, and supply contract rescission. A distributor importing unapproved peptide intermediates under the assumption of enforcement discretion faces pre-litigation notices when the agency alters its posture.
Pacific biotech manufacturers supplying active pharmaceutical ingredients to U.S. Each entry in this registry dictates whether a peptide active pharmaceutical ingredient enters lawful interstate commerce or remains restricted to research applications.
