FDA-approved peptide therapeutics
Peptide drugs approved by the U.S. Food and Drug Administration. This list excludes investigational, research-only, and compounded peptides.
The following 24 peptide-based drugs have received FDA approval for one or more clinical indications. For research-only and investigational peptides, see the main peptide index.
2026 approvals
New FDA approvals in 2026. Source: FDA Novel Drug Approvals 2026.
| Generic name | Brand name(s) | Approval date | Drug class | Indication | Typical dosing | |
|---|---|---|---|---|---|---|
| Orforglipron | Foundayo | 2026-04-01 | GLP-1 Receptor Agonist (oral small molecule) | Obesity or overweight with at least one weight-related comorbidity in adults; combined with reduced-calorie diet and increased physical activity | — | FDA Approved |
| Non-peptide small molecule that activates GLP-1 receptors orally, reducing appetite and improving glycemic signaling. First oral GLP-1 RA approved for weight management. | ||||||
| Icotrokinra | Icotyde | 2026-03-17 | IL-23 Receptor Antagonist (oral macrocyclic peptide) | Moderate-to-severe plaque psoriasis in patients 12 years and older weighing at least 40 kg who are candidates for systemic therapy or phototherapy | — | FDA Approved |
| Oral macrocyclic peptide that selectively blocks the IL-23 receptor, inhibiting the IL-23/Th17 inflammatory pathway. First-in-class oral peptide for autoimmune disease. | ||||||
| Navepegritide | Yuviwel | 2026-02-27 | CNP Analog (PEGylated C-type Natriuretic Peptide) | Increase linear growth in pediatric patients 2 years and older with achondroplasia with open epiphyses | — | FDA Approved |
| PEGylated CNP analog activates NPR-B receptor signaling to promote endochondral bone growth at growth plates. SC injection. | ||||||
| Pegzilarginase-nbln | Loargys | 2026-02-23 | PEGylated Recombinant Enzyme (arginase 1) | Hyperarginemia in adults and pediatric patients 2 years and older with Arginase 1 Deficiency, in conjunction with dietary protein restriction | — | FDA Approved |
| PEGylated recombinant human arginase 1 degrades L-arginine to prevent toxic accumulation in Arginase 1 Deficiency. IV infusion. | ||||||
All approved therapeutics
| Generic name | Brand name(s) | Year | Drug class | Indication | Typical dosing | |
|---|---|---|---|---|---|---|
| Orforglipron | Foundayo | 2026-04-01 | GLP-1 Receptor Agonist (oral small molecule) | Obesity or overweight with at least one weight-related comorbidity in adults; combined with reduced-calorie diet and increased physical activity | — | FDA Approved |
| Non-peptide small molecule that activates GLP-1 receptors orally, reducing appetite and improving glycemic signaling. First oral GLP-1 RA approved for weight management. | ||||||
| Icotrokinra | Icotyde | 2026-03-17 | IL-23 Receptor Antagonist (oral macrocyclic peptide) | Moderate-to-severe plaque psoriasis in patients 12 years and older weighing at least 40 kg who are candidates for systemic therapy or phototherapy | — | FDA Approved |
| Oral macrocyclic peptide that selectively blocks the IL-23 receptor, inhibiting the IL-23/Th17 inflammatory pathway. First-in-class oral peptide for autoimmune disease. | ||||||
| Navepegritide | Yuviwel | 2026-02-27 | CNP Analog (PEGylated C-type Natriuretic Peptide) | Increase linear growth in pediatric patients 2 years and older with achondroplasia with open epiphyses | — | FDA Approved |
| PEGylated CNP analog activates NPR-B receptor signaling to promote endochondral bone growth at growth plates. SC injection. | ||||||
| Pegzilarginase-nbln | Loargys | 2026-02-23 | PEGylated Recombinant Enzyme (arginase 1) | Hyperarginemia in adults and pediatric patients 2 years and older with Arginase 1 Deficiency, in conjunction with dietary protein restriction | — | FDA Approved |
| PEGylated recombinant human arginase 1 degrades L-arginine to prevent toxic accumulation in Arginase 1 Deficiency. IV infusion. | ||||||
| Abaloparatide | Tymlos | 2017 | — | Postmenopausal osteoporosis | 80 mcg (daily) | FDA Approved |
| Bivalirudin | Angiomax | 2000 | — | Anticoagulation during cardiac procedures | IV administration (procedural) | FDA Approved |
| Calcitonin | Miacalcin, Fortical | 1984 | — | Osteoporosis, Paget's disease | 100-200 IU (daily) | FDA Approved |
| Desmopressin | DDAVP, Stimate | 1978 | — | Diabetes insipidus, hemophilia A | 0.1-0.4 mg (varies) | FDA Approved |
| Dulaglutide | Trulicity | 2014 | — | Type 2 diabetes | 0.75-4.5 mg (weekly) | FDA Approved |
| Exenatide | Byetta, Bydureon | 2005 | — | Type 2 diabetes | 5-10 mcg or 2 mg (twice-daily or weekly) | FDA Approved |
| Gonadorelin | Factrel | 1980 | — | Hypogonadotropic hypogonadism | 100 mcg (as prescribed) | FDA Approved |
| Insulin | Humalog, Novolog, Lantus, many others | 1982 | — | Diabetes management | Individualized (varies) | FDA Approved |
| Lanreotide | Somatuline | 2007 | — | Acromegaly, neuroendocrine tumors | 60-120 mg (monthly) | FDA Approved |
| Liraglutide | Victoza, Saxenda | 2010 | — | Type 2 diabetes (Victoza), Weight management (Saxenda) | 0.6-3.0 mg (daily) | FDA Approved |
| Metreleptin | Myalept | 2014 | — | Leptin deficiency in generalized lipodystrophy | 2.5-10 mg (Daily subQ) | FDA Approved |
| Octreotide | Sandostatin | 1988 | — | Acromegaly, carcinoid syndrome | 50-500 mcg (multiple times daily) | FDA Approved |
| Oxytocin | Pitocin | 1980 | — | Labor induction, postpartum bleeding | IV administration (as prescribed) | FDA Approved |
| Pasireotide | Signifor | 2012 | — | Cushing's disease | 0.3-0.9 mg (twice daily) | FDA Approved |
| Pramlintide | Symlin | 2005 | — | Diabetes (adjunct to insulin) | 60-120 mcg (with meals) | FDA Approved |
| Semaglutide | Ozempic, Wegovy, Rybelsus | 2017 | — | Type 2 diabetes (Ozempic), Chronic weight management (Wegovy) | 0.25-2.4 mg (weekly) | FDA Approved |
| Sermorelin | Sermorelin Acetate | 1997 | — | Growth hormone deficiency in children | 200-500 mcg (daily) | FDA Approved |
| Teriparatide | Forteo | 2002 | — | Osteoporosis | 20 mcg (daily) | FDA Approved |
| Tesamorelin | Egrifta | 2010 | — | HIV-associated lipodystrophy | 2 mg (daily) | FDA Approved |
| Tirzepatide | Mounjaro, Zepbound | 2022 | — | Type 2 diabetes (Mounjaro), Chronic weight management (Zepbound) | 2.5-15 mg (weekly) | FDA Approved |