Last updated: June 3, 2026
How a peptide gets FDA approval
The standard FDA pathway for a new peptide drug:
- Preclinical: In vitro and animal toxicology, pharmacokinetics
- Phase 1: Healthy volunteers, dose escalation, PK/PD
- Phase 2: Patient populations, proof of efficacy, dose-finding
- Phase 3: Large randomized trials demonstrating efficacy + safety
- NDA submission: New Drug Application, FDA review
- Approval: Drug enters Orange Book, becomes prescription-available
GLP-1 Receptor Agonists
- Exenatide (Byetta, Bydureon) — T2D — 2005
- Liraglutide (Victoza, Saxenda) — T2D, obesity — 2010, 2014
- Lixisenatide (Adlyxin) — T2D — 2016
- Dulaglutide (Trulicity) — T2D — 2014
- Semaglutide (Ozempic, Wegovy, Rybelsus) — T2D, obesity, MACE reduction — 2017, 2021, 2019
- Tirzepatide (Mounjaro, Zepbound) — T2D, obesity, OSA — 2022, 2023
GH/GHRH Analogs
- Sermorelin — Adult GH deficiency — 1990 (discontinued for marketing reasons but still legally available)
- Tesamorelin (Egrifta) — HIV-associated lipodystrophy — 2010
- Mecasermin (Increlex) — Severe IGF-1 deficiency — 2005
Somatostatin Analogs
- Octreotide (Sandostatin) — Acromegaly, carcinoid syndrome — 1988
- Lanreotide (Somatuline) — Acromegaly, neuroendocrine tumors — 2007
- Pasireotide (Signifor) — Cushing’s disease, acromegaly — 2012
GnRH Agonists / Antagonists
- Leuprolide (Lupron) — Prostate cancer, endometriosis — 1985
- Goserelin (Zoladex) — Prostate cancer, breast cancer — 1989
- Triptorelin (Trelstar) — Prostate cancer — 2000
- Histrelin (Vantas, Supprelin LA) — Central precocious puberty — 2004
- Degarelix (Firmagon) — GnRH antagonist, prostate cancer — 2008
- Cetrorelix (Cetrotide) — IVF — 2000
- Ganirelix (Antagon) — IVF — 1999
- Relugolix (Orgovyx) — Prostate cancer (oral GnRH antagonist) — 2020
Oxytocin and Analogs
- Oxytocin (Pitocin, Syntocinon) — Labor induction, post-partum hemorrhage — 1960s
- Carbetocin — Post-partum hemorrhage prevention — limited US availability
Calcitonin and PTH Analogs
- Salmon calcitonin (Miacalcin) — Osteoporosis — 1986
- Teriparatide (Forteo) — Recombinant PTH (1-34), osteoporosis — 2002
- Abaloparatide (Tymlos) — PTHrP analog, osteoporosis — 2017
Insulin and Analogs
- Regular insulin (Humulin R, Novolin R) — Diabetes — 1982 (recombinant)
- Insulin glargine (Lantus, Basaglar) — Diabetes — 2000
- Insulin lispro (Humalog) — Diabetes — 1996
- Insulin aspart (NovoLog) — Diabetes — 2000
- Insulin detemir (Levemir) — Diabetes — 2005
- Insulin degludec (Tresiba) — Diabetes — 2015
- Insulin glargine U-300 (Toujeo) — Diabetes — 2015
Antimicrobial Peptides
- Vancomycin — Gram-positive bacterial infections — 1958
- Polymyxin B and Polymyxin E (Colistin) — Gram-negative infections — pre-1960s
- Daptomycin (Cubicin) — MRSA, complicated skin infections — 2003
- Bacitracin — Topical antibiotic — pre-1960s
Anti-coagulants
- Bivalirudin (Angiomax) — Direct thrombin inhibitor, PCI — 2000
- Desirudin (Iprivask) — DVT prophylaxis — 2003
- Lepirudin (Refludan) — HIT — 1998 (discontinued)
Other Notable Approvals
- Afamelanotide (Scenesse) — Melanotan I, erythropoietic protoporphyria — 2019
- Plecanatide (Trulance) — Chronic idiopathic constipation — 2017
- Linaclotide (Linzess) — IBS-C, chronic constipation — 2012
- Eptifibatide (Integrilin) — Acute coronary syndrome — 1998
- Carfilzomib (Kyprolis) — Multiple myeloma — 2012
- Pasireotide (Signifor) — Cushing’s disease — 2012
Most-Recent Approvals (2024-2026)
- Tirzepatide for OSA (Zepbound expanded indication) — 2024
- Semaglutide for cardiovascular outcomes (Wegovy MACE reduction label) — 2024
- Tirzepatide for HFpEF (under FDA review)
Peptide drugs in late-stage trials
- Retatrutide (Eli Lilly) — GLP-1/GIP/glucagon triple agonist, Phase 3 obesity/T2D
- Orforglipron (Eli Lilly) — Oral non-peptide GLP-1, Phase 3
- Survodutide (Boehringer/Zealand) — GLP-1/glucagon dual, Phase 3
- Mazdutide (Innovent Biologics) — GLP-1/glucagon dual, Phase 3
How many peptide drugs has the FDA approved?<br />
Over 80 peptide-based drugs have received FDA approval across hormone replacement, oncology, antimicrobial, metabolic, and rare disease categories.
What’s the most recently approved peptide?<br />
As of 2024-2026, the major recent approvals are tirzepatide expanded indications (obesity, OSA, sleep apnea) and semaglutide cardiovascular outcomes label.
Are there any oral peptides approved?<br />
Yes — Rybelsus (oral semaglutide) was the first oral GLP-1, approved 2019, using SNAC absorption enhancer technology. Linaclotide and plecanatide are oral peptides for GI indications.
What’s coming next?<br />
Retatrutide (triple agonist), orforglipron (oral GLP-1), and several dual-agonist peptides are in late-stage trials, with multiple approvals expected 2026-2027.
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