Quick answer: FDA approved peptides include about 50 active ingredients across more than a dozen drug classes, from insulin’s successors and GLP-1 drugs like semaglutide and tirzepatide to hormone analogs like leuprolide, octreotide, teriparatide, bremelanotide and tesamorelin. The newest on this list are elamipretide (September 19, 2025) and Wegovy tablets (December 22, 2025).[6][7] Popular wellness peptides such as BPC-157, TB-500 and ipamorelin are not FDA approved.
We checked each first-approval year below against Drugs@FDA.[1][2] For how approval differs from compounding, see FDA peptide ban 2026 and the history of peptide regulation. The FDA & Regulation hub has every related guide.
What counts as an “FDA approved peptide”
A peptide is a short chain of amino acids. For regulatory purposes, FDA treats chains of 40 amino acids or fewer as drugs and longer chains as proteins, which have been regulated as biologics since March 23, 2020.[5] We include both short peptides and a few longer peptide hormones that people commonly ask about, and we note when a product is a biologic. Reviews counted more than 80 peptide drugs on the market worldwide by 2021.[3][4]
Years are the first U.S. approval of that brand or ingredient. “Disc.” means Drugs@FDA lists the brand as discontinued; generics may still exist.
GLP-1, GIP and other diabetes and weight peptides
| Peptide (brand) | First approved | Main approved use |
|---|---|---|
| Exenatide (Byetta; Bydureon) | 2005; 2012 | Type 2 diabetes |
| Pramlintide (Symlin, disc.) | 2005 | Type 1 and 2 diabetes with mealtime insulin |
| Liraglutide (Victoza; Saxenda) | 2010; 2014 | Type 2 diabetes; chronic weight management |
| Dulaglutide (Trulicity) | 2014 | Type 2 diabetes (licensed as a biologic) |
| Lixisenatide (Adlyxin) | 2016 | Type 2 diabetes |
| Semaglutide (Ozempic; Rybelsus; Wegovy) | 2017; 2019; 2021 | Type 2 diabetes; oral type 2 diabetes; weight management |
| Semaglutide tablets (Wegovy) | 2025 | New oral form of Wegovy[7] |
| Tirzepatide (Mounjaro; Zepbound) | 2022; 2023 | Type 2 diabetes; weight management |
| Setmelanotide (Imcivree) | 2020 | Obesity from certain rare genetic deficiencies |
| Dasiglucagon (Zegalogue) | 2021 | Severe low blood sugar |
Orforglipron (Foundayo), approved April 1, 2026, is an oral GLP-1 drug but a small molecule, not a peptide.[8] See orforglipron.
Insulin analogs such as insulin lispro (Humalog, 1996) and insulin glargine (Lantus, 2000) are peptide hormones of about 51 amino acids. They are now regulated as biologics, so we mention them here but do not list each one.[5]
GnRH agonists and antagonists
| Peptide (brand) | First approved | Main approved use |
|---|---|---|
| Gonadorelin (Factrel, disc.) | 1982 | Diagnostic test of pituitary function |
| Leuprolide (Lupron) | 1985 | Advanced prostate cancer; later endometriosis, early puberty |
| Goserelin (Zoladex) | 1989 | Prostate and breast cancer, endometriosis |
| Nafarelin (Synarel) | 1990 | Endometriosis; central precocious puberty |
| Histrelin (Supprelin; Supprelin LA) | 1991; 2007 | Central precocious puberty |
| Ganirelix | 1999 | Preventing early ovulation during IVF |
| Cetrorelix (Cetrotide) | 2000 | Preventing early ovulation during IVF |
| Triptorelin (Trelstar) | 2000 | Advanced prostate cancer |
| Degarelix (Firmagon) | 2008 | Advanced prostate cancer |
Somatostatin analogs
| Peptide (brand) | First approved | Main approved use |
|---|---|---|
| Octreotide (Sandostatin; Mycapssa oral) | 1988; 2020 | Acromegaly; carcinoid tumor symptoms |
| Lanreotide (Somatuline Depot) | 2007 | Acromegaly; neuroendocrine tumors |
| Pasireotide (Signifor) | 2012 | Cushing’s disease |
| Lutetium Lu 177 dotatate (Lutathera) | 2018 | Neuroendocrine tumors (radioactive peptide) |
Oxytocin, vasopressin and related hormones
| Peptide (brand) | First approved | Main approved use |
|---|---|---|
| Cosyntropin (Cortrosyn) | 1970 | Diagnostic test of adrenal function |
| Desmopressin (DDAVP) | 1978 | Central diabetes insipidus; some bleeding disorders |
| Oxytocin (Pitocin) | 1980 (current NDA) | Inducing labor; postpartum bleeding |
| Vasopressin (Vasostrict) | 2014 | Low blood pressure in vasodilatory shock |
| Secretin (ChiRhoStim) | 2004 | Diagnostic test of pancreatic function |
Bone and parathyroid peptides
| Peptide (brand) | First approved | Main approved use |
|---|---|---|
| Calcitonin salmon (Miacalcin injection) | 1986 | Paget’s disease, high calcium, osteoporosis |
| Teriparatide (Forteo) | 2002 | Osteoporosis at high fracture risk |
| Abaloparatide (Tymlos) | 2017 | Osteoporosis at high fracture risk |
| Palopegteriparatide (Yorvipath) | 2024 | Hypoparathyroidism in adults |
Melanocortin and growth hormone axis peptides
| Peptide (brand) | First approved | Main approved use |
|---|---|---|
| Sermorelin (Geref, disc.) | 1990 | Growth hormone deficiency testing and treatment in children |
| Tesamorelin (Egrifta) | 2010 | Excess belly fat in HIV-associated lipodystrophy (now a biologic license) |
| Bremelanotide (Vyleesi) | 2019 | Low sexual desire in premenopausal women |
| Afamelanotide (Scenesse) | 2019 | Light-induced pain in erythropoietic protoporphyria |
Gut, heart, blood and other peptides
| Peptide (brand) | First approved | Main approved use |
|---|---|---|
| Eptifibatide (Integrilin) | 1998 | Acute coronary syndrome, heart stenting |
| Bivalirudin (Angiomax) | 2000 | Blood thinner during heart procedures |
| Nesiritide (Natrecor, disc.) | 2001 | Acute heart failure |
| Enfuvirtide (Fuzeon, disc.) | 2003 | HIV-1 infection |
| Ziconotide (Prialt) | 2004 | Severe chronic pain (spinal infusion) |
| Icatibant (Firazyr) | 2011 | Hereditary angioedema attacks |
| Linaclotide (Linzess) | 2012 | IBS with constipation; chronic constipation |
| Teduglutide (Gattex) | 2012 | Short bowel syndrome |
| Plecanatide (Trulance) | 2017 | Chronic constipation; IBS with constipation |
| Pegcetacoplan (Empaveli) | 2021 | Paroxysmal nocturnal hemoglobinuria |
| Difelikefalin (Korsuva) | 2021 | Itch in dialysis patients |
| Vosoritide (Voxzogo) | 2021 | Achondroplasia in children |
| Zilucoplan (Zilbrysq) | 2023 | Generalized myasthenia gravis |
| Elamipretide (Forzinity) | 2025 | Barth syndrome (accelerated approval)[6] |
Patterns in the list
A few trends stand out when you look at FDA approved peptides together.
Most are copies or tweaks of the body’s own hormones. GLP-1 drugs mimic a gut hormone, leuprolide and its relatives mimic gonadotropin-releasing hormone, octreotide mimics somatostatin, and teriparatide is a fragment of parathyroid hormone. Starting from a natural signal gives developers a known target and a known biology.[3]
Chemistry has mostly been about making peptides last longer. Natural peptides break down in minutes. Developers have added fatty acid chains (as in liraglutide and semaglutide), attached polyethylene glycol (as in pegcetacoplan and palopegteriparatide), fused peptides to larger proteins (as in dulaglutide), or used slow-release depots (as in leuprolide and octreotide formulations). These changes are why some products are injected weekly or monthly rather than several times a day.[4]
Oral peptides are still rare. Most peptides are digested in the gut. Rybelsus and Wegovy tablets use an absorption enhancer, linaclotide and plecanatide act inside the gut, and Mycapssa uses a special capsule. Most others are injected, infused or sprayed into the nose.[4]
Approvals are speeding up. About half of the peptide ingredients above were first approved in 2010 or later, led by metabolic and rare-disease drugs.[3]
Notes on biologics and discontinued brands
Two labels in the tables can be confusing. First, a few peptide products, including dulaglutide, tesamorelin and every insulin, carry a biologics license (BLA) rather than a new drug application (NDA). For insulin and tesamorelin, this happened on March 23, 2020, when products with chains longer than 40 amino acids were “deemed to be” biologics licenses.[5] The products themselves did not change, and they remain FDA approved.
Second, “discontinued” in Drugs@FDA usually means the company stopped selling that brand, often for business reasons. It does not by itself mean FDA withdrew the drug for safety. Pramlintide, sermorelin, nesiritide and enfuvirtide are listed as discontinued brands, and some may still be available as other versions. Ask a pharmacist what is currently stocked.[1]
Why most “wellness” peptides are not approved
Since 1962, a drug must be shown to be effective, not just safe, before FDA approves it. That normally means large, controlled human trials for a specific condition. Peptides like BPC-157, TB-500 and epitalon have mostly been studied in animals or in small studies, and no company has completed the trials FDA would need.
Their legal route to patients has instead been compounding, which skips FDA approval. In 2023 FDA placed many of them in Category 2, its list of nominated compounding ingredients with significant safety risks, and in 2026 it removed 12 after their nominations were withdrawn.[9] Neither step says anything about whether they work. See FDA peptide ban 2026 for the details.
Approved vs compounded vs “research” peptides
| Type | FDA review before sale? | Example |
|---|---|---|
| FDA-approved peptide drug | Yes: safety, effectiveness and manufacturing | Semaglutide (Wegovy) |
| Compounded peptide | No; pharmacy follows 503A or 503B rules | Patient-specific mixture from a licensed pharmacy |
| “Research use only” peptide | No; FDA treats many as unapproved new drugs | Vials sold online with a “not for human use” label |
How to check a peptide’s FDA approval yourself
- Search the ingredient or brand name in Drugs@FDA. An approved product shows an NDA, ANDA or BLA number and approval history.[1]
- For products over 40 amino acids, also check FDA’s Purple Book of licensed biologics.
- Read the approved label. The “Indications and Usage” section lists the only uses FDA has approved. Anything else is off-label.
- A product with no application number is not FDA approved, whatever its website says.
For more, see are peptides legal and research use only peptides.
This is general information, not legal or medical advice. Ask a clinician whether an approved peptide fits your situation.
