FDA-approved peptide therapeutics
The following 26 peptide-based drugs have received FDA approval for one or more clinical indications. For research-only and investigational peptides, see the main peptide index, or read FDA-approved vs research-only peptides for how the categories differ.
New in 2026 (5)
Latest FDA approvals. FDA Novel Drug Approvals 2026 ↗
›Indication, dosing & mechanism
Indication: Chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis. Granted accelerated approval based on reduction in HDV RNA and ALT normalization (Phase 3 MYR301, Week 48); clinical-outcome benefit not yet established and continued approval may depend on confirmatory trial.
Mechanism: 47-amino-acid myristoylated pre-S1-derived lipopeptide that binds and inactivates the sodium taurocholate co-transporting polypeptide (NTCP) on hepatocytes, blocking viral entry. Administered by subcutaneous injection.
›Indication, dosing & mechanism
Indication: Obesity or overweight with at least one weight-related comorbidity in adults; combined with reduced-calorie diet and increased physical activity
Mechanism: 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.
›Indication, dosing & mechanism
Indication: Moderate-to-severe plaque psoriasis in patients 12 years and older weighing at least 40 kg who are candidates for systemic therapy or phototherapy
Mechanism: 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.
›Indication, dosing & mechanism
Indication: Increase linear growth in pediatric patients 2 years and older with achondroplasia with open epiphyses
Mechanism: PEGylated CNP analog activates NPR-B receptor signaling to promote endochondral bone growth at growth plates. SC injection.
›Indication, dosing & mechanism
Indication: Hyperarginemia in adults and pediatric patients 2 years and older with Arginase 1 Deficiency, in conjunction with dietary protein restriction
Mechanism: PEGylated recombinant human arginase 1 degrades L-arginine to prevent toxic accumulation in Arginase 1 Deficiency. IV infusion.
›Indication, dosing & mechanism
Indication: Chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis. Granted accelerated approval based on reduction in HDV RNA and ALT normalization (Phase 3 MYR301, Week 48); clinical-outcome benefit not yet established and continued approval may depend on confirmatory trial.
Mechanism: 47-amino-acid myristoylated pre-S1-derived lipopeptide that binds and inactivates the sodium taurocholate co-transporting polypeptide (NTCP) on hepatocytes, blocking viral entry. Administered by subcutaneous injection.
›Indication, dosing & mechanism
Indication: Obesity or overweight with at least one weight-related comorbidity in adults; combined with reduced-calorie diet and increased physical activity
Mechanism: 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.
›Indication, dosing & mechanism
Indication: Moderate-to-severe plaque psoriasis in patients 12 years and older weighing at least 40 kg who are candidates for systemic therapy or phototherapy
Mechanism: 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.
›Indication, dosing & mechanism
Indication: Increase linear growth in pediatric patients 2 years and older with achondroplasia with open epiphyses
Mechanism: PEGylated CNP analog activates NPR-B receptor signaling to promote endochondral bone growth at growth plates. SC injection.
›Indication, dosing & mechanism
Indication: Hyperarginemia in adults and pediatric patients 2 years and older with Arginase 1 Deficiency, in conjunction with dietary protein restriction
Mechanism: PEGylated recombinant human arginase 1 degrades L-arginine to prevent toxic accumulation in Arginase 1 Deficiency. IV infusion.
›Indication, dosing & mechanism
Indication: Type 2 diabetes (Mounjaro), Chronic weight management (Zepbound)
Typical dosing: 2.5-15 mg (weekly)
›Indication, dosing & mechanism
Indication: Acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women
Typical dosing: 1.75 mg (As needed, at least 45 minutes before anticipated sexual activity (maximum one dose per 24 hours, no more than 8 doses per month))
Mechanism: Cyclic 7-amino-acid melanocortin receptor agonist (non-selective, with activity at the melanocortin-4 receptor, MC4R) thought to act on neural pathways regulating sexual response. Also known as PT-141. Administered by subcutaneous injection.
›Indication, dosing & mechanism
Indication: Postmenopausal osteoporosis
Typical dosing: 80 mcg (daily)
›Indication, dosing & mechanism
Indication: Type 2 diabetes (Ozempic), Chronic weight management (Wegovy)
Typical dosing: 0.25-2.4 mg (weekly)
›Indication, dosing & mechanism
Indication: Type 2 diabetes
Typical dosing: 0.75-4.5 mg (weekly)
›Indication, dosing & mechanism
Indication: Leptin deficiency in generalized lipodystrophy
Typical dosing: 2.5-10 mg (Daily subQ)
›Indication, dosing & mechanism
Indication: Cushing's disease
Typical dosing: 0.3-0.9 mg (twice daily)
›Indication, dosing & mechanism
Indication: Type 2 diabetes (Victoza), Weight management (Saxenda)
Typical dosing: 0.6-3.0 mg (daily)
›Indication, dosing & mechanism
Indication: HIV-associated lipodystrophy
Typical dosing: 2 mg (daily)
›Indication, dosing & mechanism
Indication: Acromegaly, neuroendocrine tumors
Typical dosing: 60-120 mg (monthly)
›Indication, dosing & mechanism
Indication: Type 2 diabetes
Typical dosing: 5-10 mcg or 2 mg (twice-daily or weekly)
›Indication, dosing & mechanism
Indication: Diabetes (adjunct to insulin)
Typical dosing: 60-120 mcg (with meals)
›Indication, dosing & mechanism
Indication: Osteoporosis
Typical dosing: 20 mcg (daily)
›Indication, dosing & mechanism
Indication: Anticoagulation during cardiac procedures
Typical dosing: IV administration (procedural)
›Indication, dosing & mechanism
Indication: Growth hormone deficiency in children
Typical dosing: 200-500 mcg (daily)
›Indication, dosing & mechanism
Indication: Acromegaly, carcinoid syndrome
Typical dosing: 50-500 mcg (multiple times daily)
›Indication, dosing & mechanism
Indication: Osteoporosis, Paget's disease
Typical dosing: 100-200 IU (daily)
›Indication, dosing & mechanism
Indication: Diabetes management
Typical dosing: Individualized (varies)
›Indication, dosing & mechanism
Indication: Hypogonadotropic hypogonadism
Typical dosing: 100 mcg (as prescribed)
›Indication, dosing & mechanism
Indication: Labor induction, postpartum bleeding
Typical dosing: IV administration (as prescribed)
›Indication, dosing & mechanism
Indication: Diabetes insipidus, hemophilia A
Typical dosing: 0.1-0.4 mg (varies)
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 | |
|---|---|---|---|---|---|---|
| Bulevirtide | Hepcludex | 2026-05-22 | HBV/HDV entry inhibitor (lipopeptide) | Chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis. Granted accelerated approval based on reduction in HDV RNA and ALT normalization (Phase 3 MYR301, Week 48); clinical-outcome benefit not yet established and continued approval may depend on confirmatory trial. | — | FDA Approved |
| 47-amino-acid myristoylated pre-S1-derived lipopeptide that binds and inactivates the sodium taurocholate co-transporting polypeptide (NTCP) on hepatocytes, blocking viral entry. Administered by subcutaneous injection. | ||||||
| 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 | |
|---|---|---|---|---|---|---|
| Bulevirtide | Hepcludex | 2026-05-22 | HBV/HDV entry inhibitor (lipopeptide) | Chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis. Granted accelerated approval based on reduction in HDV RNA and ALT normalization (Phase 3 MYR301, Week 48); clinical-outcome benefit not yet established and continued approval may depend on confirmatory trial. | — | FDA Approved |
| 47-amino-acid myristoylated pre-S1-derived lipopeptide that binds and inactivates the sodium taurocholate co-transporting polypeptide (NTCP) on hepatocytes, blocking viral entry. Administered by subcutaneous injection. | ||||||
| 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. | ||||||
| Bremelanotide | Vyleesi | 2019-06-21 | Melanocortin receptor agonist | Acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women | 1.75 mg (As needed, at least 45 minutes before anticipated sexual activity (maximum one dose per 24 hours, no more than 8 doses per month)) | FDA Approved |
| Cyclic 7-amino-acid melanocortin receptor agonist (non-selective, with activity at the melanocortin-4 receptor, MC4R) thought to act on neural pathways regulating sexual response. Also known as PT-141. Administered by subcutaneous injection. | ||||||
| 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 |