FDA-Approved Peptides: The Complete List
Every FDA-approved peptide medicine, grouped by use, with brand, generic, approved indication and first-approval year - each verified against Drugs@FDA this session.
The short version
More than forty FDA-approved medicines are peptides - short chains of amino acids. They treat weight and metabolic disease, fertility and hormone conditions, bone loss, heart and gut disorders, infections and several cancers. Others are imaging tests, a handful of rare-disease drugs, and sexual-health and skin drugs. Each went through FDA review with trial data behind its specific approved use. Unapproved "research" peptides have had no such review.
- Dozens of peptide drugs are FDA-approved, not just the GLP-1 medicines most people have heard of.
- Each approval covers a specific use, dose and patient population - not the compound in general.
- Some approved peptide brands have since been discontinued; a generic version often remains available.
- What makes a drug approved is FDA review of a specific product for a specific use, not being a peptide.
Peptide here means a drug whose active ingredient is a short chain of amino acids. It is short enough to be made by chemical or solid-phase synthesis rather than expressed as a folded protein. In practice that is roughly up to 40-50 amino acids.
Insulin (51 amino acids, made as two disulfide-linked chains) sits right at that edge. I treat it as a protein and leave it off this list, along with larger protein and glycoprotein hormones such as human growth hormone and hCG. I also leave off monoclonal antibodies and enzyme-replacement therapies, for the same reason.
I checked every drug below against Drugs@FDA this session for its application number, approval date and marketing status. The generic name in each row links to that record.
Foundayo (orforglipron), approved April 2026, is deliberately not on this list. It works on the same GLP-1 receptor as several drugs below, but it is a small molecule, not a peptide. That is the kind of case this definition exists to settle.
Metabolic and weight
| Brand | Generic | Approved for | First approved |
|---|---|---|---|
| Ozempic / Wegovy / Rybelsus | Semaglutide | Type 2 diabetes glycemic control and cardiovascular/kidney risk reduction (Ozempic); chronic weight management and cardiovascular risk reduction (Wegovy); oral type 2 diabetes (Rybelsus) | 2017 |
| Victoza / Saxenda | Liraglutide | Type 2 diabetes glycemic control (Victoza, 2010); chronic weight management (Saxenda, 2014) | 2010 |
| Mounjaro / Zepbound | Tirzepatide | Type 2 diabetes glycemic control (Mounjaro, 2022); chronic weight management and moderate-to-severe obstructive sleep apnea with obesity (Zepbound, 2023) | 2022 |
| Trulicity | Dulaglutide | Type 2 diabetes glycemic control and cardiovascular risk reduction | 2014 |
| Byetta / Bydureon (discontinued brands) | Exenatide | Type 2 diabetes glycemic control | 2005 |
| Symlin (discontinued) | Pramlintide | Adjunct to mealtime insulin in type 1 or type 2 diabetes | 2005 |
| Imcivree | Setmelanotide | Chronic weight management in obesity due to POMC, PCSK1 or LEPR deficiency, or Bardet-Biedl syndrome | 2020 |
| Baqsimi | Glucagon (nasal) | Severe hypoglycemia rescue | 2019 |
| Zegalogue (discontinued) | Dasiglucagon | Severe hypoglycemia rescue | 2021 |
Byetta and the extended-release Bydureon are both discontinued as branded products. A generic once-daily exenatide injection remains FDA-approved and marketed. I could not verify a generic on the market for Symlin or Zegalogue this session.
Hormonal and reproductive
| Brand | Generic | Approved for | First approved |
|---|---|---|---|
| Pitocin / generic | Oxytocin | Labor induction/augmentation and control of postpartum bleeding | 1980 |
| DDAVP | Desmopressin | Central diabetes insipidus, primary nocturnal enuresis, and bleeding control in hemophilia A and von Willebrand disease | 1984 |
| Lupron / Lupron Depot | Leuprolide | Advanced prostate cancer, endometriosis, central precocious puberty, and anemia before uterine fibroid surgery | 1985 |
| Zoladex | Goserelin | Advanced prostate cancer, breast cancer, and endometriosis | 1989 |
| Synarel | Nafarelin | Endometriosis and central precocious puberty | 1990 |
| Ganirelix Acetate | Ganirelix | Preventing a premature LH surge during controlled ovarian stimulation for IVF | 1999 |
| Cetrotide / generic | Cetrorelix | Preventing a premature LH surge during controlled ovarian stimulation for IVF | 2000 |
| Trelstar | Triptorelin | Advanced prostate cancer | 2000 |
| Vantas (discontinued) / Supprelin LA | Histrelin | Advanced prostate cancer (Vantas); central precocious puberty (Supprelin LA) | 2004 |
| Firmagon | Degarelix | Advanced prostate cancer | 2008 |
Factrel (gonadorelin, 1982) and Geref (sermorelin, 1990) were both diagnostic hormone tests, for pituitary gonadotropin and growth-hormone response. Both are discontinued, with no generic I could verify.
Several GnRH agonists in this table (leuprolide, goserelin, triptorelin, histrelin) are also approved cancer treatments. I list each once, under its reproductive-endocrinology mechanism.
Bone
| Brand | Generic | Approved for | First approved |
|---|---|---|---|
| Forteo | Teriparatide | Osteoporosis with high fracture risk, in postmenopausal women, in men, and glucocorticoid-induced | 2002 |
| Tymlos | Abaloparatide | Osteoporosis with high fracture risk | 2017 |
| Miacalcin / generic | Calcitonin-salmon | Postmenopausal osteoporosis (more than 5 years past menopause), Paget’s disease of bone, and hypercalcemia | 1986 |
Cardiovascular
| Brand | Generic | Approved for | First approved |
|---|---|---|---|
| Angiomax | Bivalirudin | Anticoagulation during percutaneous coronary intervention | 2000 |
| Integrilin (brand discontinued) / generic | Eptifibatide | Acute coronary syndrome and PCI, to reduce clot-related events | 1998 |
| Giapreza | Angiotensin II | Raising blood pressure in septic or other distributive shock | 2017 |
| Natrecor (discontinued) | Nesiritide | Acutely decompensated congestive heart failure | 2001 |
| Vasostrict / generic | Vasopressin | Raising blood pressure in adults with vasodilatory shock | 2014 |
I could not verify a generic of Natrecor as currently marketed. Integrilin is discontinued as a brand, but a generic eptifibatide injection remains FDA-approved and marketed.
Gastrointestinal
| Brand | Generic | Approved for | First approved |
|---|---|---|---|
| Linzess | Linaclotide | Irritable bowel syndrome with constipation, and chronic idiopathic constipation | 2012 |
| Gattex | Teduglutide | Short bowel syndrome, to reduce dependence on parenteral nutrition | 2012 |
| Trulance | Plecanatide | Chronic idiopathic constipation and irritable bowel syndrome with constipation | 2017 |
| ChiRhoStim | Secretin | Diagnostic aid for pancreatic function and gastrinoma | 2004 |
Antimicrobial
| Brand | Generic | Approved for | First approved |
|---|---|---|---|
| Vancocin / generic | Vancomycin | Serious Gram-positive infections; oral form for C. difficile colitis | pre-1982* |
| Coly-Mycin M (discontinued) / generic | Colistimethate | Serious infections from susceptible Gram-negative bacteria | 1970 |
| Generic (multiple ANDAs) | Polymyxin B | Serious infections from susceptible Gram-negative bacteria | 1964 |
| Cubicin (brand discontinued) / generic | Daptomycin | Complicated skin infections and Staph aureus bloodstream infection/endocarditis | 2003 |
| Vibativ | Telavancin | Complicated skin infections; hospital-acquired bacterial pneumonia | 2009 |
| Dalvance | Dalbavancin | Acute bacterial skin and skin-structure infections | 2014 |
| Orbactiv | Oritavancin | Acute bacterial skin and skin-structure infections | 2014 |
| Fuzeon (discontinued) | Enfuvirtide | HIV-1 infection, as part of combination antiretroviral therapy | 2003 |
* Vancomycin’s earliest record in Drugs@FDA’s electronic system this session dates to 1983. The drug has been in US use since the 1950s, before FDA kept electronic approval records, so I give the earliest verifiable date rather than an unverified older one.
Vancomycin, telavancin, dalbavancin and oritavancin are glycopeptide antibiotics. They are chemically related to, but a distinct subclass from, the cyclic lipopeptides in this table (colistimethate, polymyxin B, daptomycin).
Oncology and imaging
| Brand | Generic | Approved for | First approved |
|---|---|---|---|
| Sandostatin / Sandostatin LAR | Octreotide | Acromegaly; symptom control in carcinoid syndrome and VIPoma | 1988 |
| Somatuline Depot | Lanreotide | Acromegaly; gastroenteropancreatic neuroendocrine tumors | 2007 |
| Netspot | Gallium Ga 68 dotatate | PET imaging of somatostatin receptor-positive neuroendocrine tumors | 2016 |
| Lutathera | Lutetium Lu 177 dotatate | Treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors | 2018 |
| Detectnet | Copper Cu 64 dotatate | PET imaging of somatostatin receptor-positive neuroendocrine tumors | 2020 |
Octreotide and lanreotide are octapeptide analogs of somatostatin. The three imaging and therapy agents below them use the same eight-amino-acid scaffold carrying a radioisotope, so I group all five together rather than splitting imaging from treatment.
Rare disease
| Brand | Generic | Approved for | First approved |
|---|---|---|---|
| Firazyr | Icatibant | Acute attacks of hereditary angioedema | 2011 |
| Voxzogo | Vosoritide | Achondroplasia in children with open growth plates | 2021 |
Dermatology and sexual health
| Brand | Generic | Approved for | First approved |
|---|---|---|---|
| Vyleesi | Bremelanotide | Acquired, generalized hypoactive sexual desire disorder in premenopausal women | 2019 |
| Scenesse | Afamelanotide | Increasing pain-free light exposure in erythropoietic protoporphyria | 2019 |
| Korsuva | Difelikefalin | Moderate-to-severe pruritus in hemodialysis patients with chronic kidney disease | 2021 |
Bremelanotide is the FDA-approved form of the compound sold in research circles as PT-141. See my PT-141 page for how the two relate.
Afamelanotide is the peptide sold online as Melanotan 1. See Melanotan 1.
Approved medicine versus research-labelled peptide
Every compound in the tables above went through FDA review for a specific product, dose and use, and has a public label to show for it. Being a peptide had nothing to do with earning that review. Plenty of unapproved compounds are peptides too, and this site covers dozens of them on its own safety pages.
The line that matters is regulatory status, not chemical class. An FDA-approved drug has been through trials FDA has seen and signed off on for that exact use. A compound sold “for research use only” has not, however similar its amino acid sequence is to something in the tables above.
My GLP-1 peptides guide and my research peptides and US law page cover that distinction and what it means for buying either kind of product. Read those next if you are trying to work out which side of the line something you have seen falls on.
Related
- Best GLP-1 for weight loss: the approved options compared
- Research peptides and US law: what the label means
- Semaglutide (Ozempic, Wegovy, Rybelsus)
- Tirzepatide (Mounjaro, Zepbound)
- Tesamorelin (Egrifta)
- PT-141 (bremelanotide/Vyleesi)
- Oxytocin
- Sermorelin
- hCG
- Are peptides safe?
Common questions
How many peptide drugs has the FDA approved?
More than forty distinct peptide active ingredients have current or historical FDA approval. They are sold under dozens of brand names. The categories are weight and metabolic disease, hormonal and reproductive conditions, bone loss, cardiovascular and gastrointestinal disorders, infections, oncology and imaging, rare diseases, and dermatology and sexual health. New ones are still being approved most years.
What counts as a peptide versus a protein drug like insulin?
This page counts single (or small multi-chain) peptides of roughly up to 40-50 amino acids, verified against Drugs@FDA. Insulin (51 amino acids, produced as two linked chains) sits right at that edge. Human growth hormone and human chorionic gonadotropin are larger still. I treat all three as proteins and leave them off this list for consistency.
Is semaglutide (Ozempic, Wegovy) FDA-approved?
Yes. Semaglutide is approved as Ozempic (2017, type 2 diabetes and cardiovascular/kidney risk reduction), Rybelsus (2019, oral, type 2 diabetes) and Wegovy (2021, chronic weight management and cardiovascular risk reduction). Each brand has its own label and approved use.
Are "research peptides" like BPC-157 on this list?
No. Nothing sold as a research or research-use-only peptide is FDA-approved for human use, so none of them appear here. This page lists only compounds with a current or historical FDA approval, verified on Drugs@FDA.
Does a discontinued brand mean the drug is unsafe?
Not necessarily. FDA marks a brand or package "Discontinued" for business reasons as often as for safety. Several of the discontinued brands on this list have a generic version of the same approved drug. I mark discontinued products and note when a generic remains on the market.
Why are drugs like leuprolide and octreotide listed under one category when they treat several conditions?
Several peptide drugs have more than one approved indication across categories. Leuprolide, for example, treats prostate cancer, endometriosis and central precocious puberty. I list each drug once, under its primary or best-known approved use.
References (50 sources)
Bibliographic detail is fetched from PubMed, not written by me - so a citation here cannot drift from the paper it names. Study design comes from PubMed's own tags rather than my judgement.
- 1.Drugs@FDA - the FDA database of approved drug products, application numbers and approval history, used to verify every entry on this page.- US Food and Drug Administrationdatabase
- 2.Semaglutide: approval record- US Food and Drug Administration (Drugs@FDA)database
- 3.Liraglutide: approval record- US Food and Drug Administration (Drugs@FDA)database
- 4.Tirzepatide: approval record- US Food and Drug Administration (Drugs@FDA)database
- 5.Dulaglutide: approval record- US Food and Drug Administration (Drugs@FDA)database
- 6.Exenatide: approval record- US Food and Drug Administration (Drugs@FDA)database
- 7.Pramlintide: approval record- US Food and Drug Administration (Drugs@FDA)database
- 8.Setmelanotide: approval record- US Food and Drug Administration (Drugs@FDA)database
- 9.Glucagon (nasal): approval record- US Food and Drug Administration (Drugs@FDA)database
- 10.Dasiglucagon: approval record- US Food and Drug Administration (Drugs@FDA)database
- 11.Oxytocin: approval record- US Food and Drug Administration (Drugs@FDA)database
- 12.Desmopressin: approval record- US Food and Drug Administration (Drugs@FDA)database
- 13.Leuprolide: approval record- US Food and Drug Administration (Drugs@FDA)database
- 14.Goserelin: approval record- US Food and Drug Administration (Drugs@FDA)database
- 15.Nafarelin: approval record- US Food and Drug Administration (Drugs@FDA)database
- 16.Ganirelix: approval record- US Food and Drug Administration (Drugs@FDA)database
- 17.Cetrorelix: approval record- US Food and Drug Administration (Drugs@FDA)database
- 18.Triptorelin: approval record- US Food and Drug Administration (Drugs@FDA)database
- 19.Histrelin: approval record- US Food and Drug Administration (Drugs@FDA)database
- 20.Degarelix: approval record- US Food and Drug Administration (Drugs@FDA)database
- 21.Teriparatide: approval record- US Food and Drug Administration (Drugs@FDA)database
- 22.Abaloparatide: approval record- US Food and Drug Administration (Drugs@FDA)database
- 23.Calcitonin-salmon: approval record- US Food and Drug Administration (Drugs@FDA)database
- 24.Bivalirudin: approval record- US Food and Drug Administration (Drugs@FDA)database
- 25.Eptifibatide: approval record- US Food and Drug Administration (Drugs@FDA)database
- 26.Angiotensin II: approval record- US Food and Drug Administration (Drugs@FDA)database
- 27.Nesiritide: approval record- US Food and Drug Administration (Drugs@FDA)database
- 28.Vasopressin: approval record- US Food and Drug Administration (Drugs@FDA)database
- 29.Linaclotide: approval record- US Food and Drug Administration (Drugs@FDA)database
- 30.Teduglutide: approval record- US Food and Drug Administration (Drugs@FDA)database
- 31.Plecanatide: approval record- US Food and Drug Administration (Drugs@FDA)database
- 32.Secretin: approval record- US Food and Drug Administration (Drugs@FDA)database
- 33.Vancomycin: approval record- US Food and Drug Administration (Drugs@FDA)database
- 34.Colistimethate: approval record- US Food and Drug Administration (Drugs@FDA)database
- 35.Polymyxin B: approval record- US Food and Drug Administration (Drugs@FDA)database
- 36.Daptomycin: approval record- US Food and Drug Administration (Drugs@FDA)database
- 37.Telavancin: approval record- US Food and Drug Administration (Drugs@FDA)database
- 38.Dalbavancin: approval record- US Food and Drug Administration (Drugs@FDA)database
- 39.Oritavancin: approval record- US Food and Drug Administration (Drugs@FDA)database
- 40.Enfuvirtide: approval record- US Food and Drug Administration (Drugs@FDA)database
- 41.Octreotide: approval record- US Food and Drug Administration (Drugs@FDA)database
- 42.Lanreotide: approval record- US Food and Drug Administration (Drugs@FDA)database
- 43.Gallium Ga 68 dotatate: approval record- US Food and Drug Administration (Drugs@FDA)database
- 44.Lutetium Lu 177 dotatate: approval record- US Food and Drug Administration (Drugs@FDA)database
- 45.Copper Cu 64 dotatate: approval record- US Food and Drug Administration (Drugs@FDA)database
- 46.Icatibant: approval record- US Food and Drug Administration (Drugs@FDA)database
- 47.Vosoritide: approval record- US Food and Drug Administration (Drugs@FDA)database
- 48.Bremelanotide: approval record- US Food and Drug Administration (Drugs@FDA)database
- 49.Afamelanotide: approval record- US Food and Drug Administration (Drugs@FDA)database
- 50.Difelikefalin: approval record- US Food and Drug Administration (Drugs@FDA)database