This reference compiles the regulatory status of therapeutic peptides across major regulatory agencies worldwide, including FDA (USA), EMA (Europe), PMDA (Japan), and TGA (Australia). Data include approval status, indication, approval date, and regulatory pathway.
| Status | Definition | Example |
|---|
| Approved | Marketed for approved indication | Semaglutide (Wegovy) |
| Investigational | Clinical trials ongoing | Retatrutide |
| Withdrawn | Previously approved, now removed | Pramlintide (limited availability) |
| Discontinued | Development halted | Many failed candidates |
| Research only | Preclinical or early clinical | BPC-157, KPV |
| Peptide | Brand | Indication | Approval | Route | Frequency |
|---|
| Insulin (human) | Humulin | Diabetes | 1982 | SC/IV | Multiple daily |
| Insulin lispro | Humalog | Diabetes | 1996 | SC | Before meals |
| Insulin aspart | NovoLog | Diabetes | 1999 | SC | Before meals |
| Insulin glargine | Lantus | Diabetes | 2000 | SC | Once daily |
| Insulin detemir | Levemir | Diabetes | 2005 | SC | Once/twice daily |
| Insulin degludec | Tresiba | Diabetes | 2015 | SC | Once daily |
| Insulin glargine U-300 | Toujeo | Diabetes | 2015 | SC | Once daily |
| Liraglutide | Victoza | Diabetes | 2010 | SC | Once daily |
| Exenatide | Byetta | Diabetes | 2005 | SC | Twice daily |
| Exenatide ER | Bydureon | Diabetes | 2012 | SC | Once weekly |
| Dulaglutide | Trulicity | Diabetes | 2014 | SC | Once weekly |
| Semaglutide | Ozempic | Diabetes | 2017 | SC | Once weekly |
| Semaglutide (oral) | Rybelsus | Diabetes | 2019 | Oral | Once daily |
| Albiglutide | Tanzeum | Diabetes | 2014 | SC | Once weekly |
| Lixisenatide | Adlyxin | Diabetes | 2016 | SC | Once daily |
| Tirzepatide | Mounjaro | Diabetes | 2022 | SC | Once weekly |
| Peptide | Brand | Indication | Approval | Route | Frequency |
|---|
| Liraglutide | Saxenda | Obesity | 2014 | SC | Once daily |
| Semaglutide | Wegovy | Obesity | 2021 | SC | Once weekly |
| Tirzepatide | Zepbound | Obesity | 2023 | SC | Once weekly |
| Peptide | Brand | Indication | Approval | Route | Frequency |
|---|
| Octreotide | Sandostatin | Acromegaly, carcinoid | 1988 | SC/IM | 1–3× daily |
| Octreotide LAR | Sandostatin LAR | Acromegaly, carcinoid | 1998 | IM | Monthly |
| Lanreotide | Somatuline | Acromegaly | 2007 | SC | Monthly |
| Pasireotide | Signifor | Cushing’s disease | 2012 | SC | Twice daily |
| Leuprolide | Lupron | Prostate cancer | 1985 | SC/IM | Monthly–yearly |
| Goserelin | Zoladex | Prostate cancer | 1989 | SC implant | Monthly–3-monthly |
| Buserelin | Suprefact | Prostate cancer | 1988 | SC/IN | Daily |
| Histrelin | Vantas | Prostate cancer | 2004 | SC implant | Yearly |
| Triptorelin | Trelstar | Prostate cancer | 2000 | IM | Monthly–6-monthly |
| Degarelix | Firmagon | Prostate cancer | 2008 | SC | Monthly |
| Peptide | Brand | Indication | Approval | Route | Frequency |
|---|
| Teriparatide | Forteo | Osteoporosis | 2002 | SC | Once daily |
| PTH(1-84) | Natpara | Hypoparathyroidism | 2015 | SC | Once daily |
| Salmon calcitonin | Miacalcin | Osteoporosis | 1984 | SC/IN | Daily–weekly |
| Peptide | Brand | Indication | Approval | Route | Frequency |
|---|
| Ziconotide | Prialt | Severe pain | 2004 | IT | Continuous infusion |
| Erenumab | Aimovig | Migraine | 2018 | SC | Monthly |
| Fremanezumab | Ajovy | Migraine | 2018 | SC | Monthly/quarterly |
| Galcanezumab | Emgality | Migraine | 2018 | SC | Monthly |
| Eptinezumab | Vyepti | Migraine | 2020 | IV | Quarterly |
| Peptide | Brand | Indication | Approval | Route | Frequency |
|---|
| hCG | Pregnyl | Ovulation induction | 1967 | IM | Single dose |
| Follistim | Follistim | Ovulation induction | 1995 | SC | Daily |
| Menopur | Menopur | Ovulation induction | 1997 | IM/SC | Daily |
| Cetrorelix | Cetrotide | IVF | 1999 | SC | Daily |
| Ganirelix | Orgalutran | IVF | 2000 | SC | Daily |
| Peptide | Brand | Indication | Approval | Route | Frequency |
|---|
| Desmopressin | DDAVP | Diabetes insipidus | 1978 | SC/IN/Oral | 1–3× daily |
| Bremelanotide | Vyleesi | HSDD | 2019 | SC | As needed |
| Carbetocin | Duratocin | Postpartum hemorrhage | 1993 | IV/IM | Single dose |
| Glucagon | Glucagon | Hypoglycemia | 1960 | IM/SC | Emergency |
| Eptifibatide | Integrilin | ACS | 1998 | IV | Continuous |
| Bivalirudin | Angiomax | PCI | 2000 | IV | During procedure |
| Peptide | Brand | Indication | Approval | Notes |
|---|
| Afamelanotide | Scenesse | EPP | 2014 | Implant formulation |
| Setmelanotide | Imcivree | Genetic obesity | 2021 | MC4R agonist |
| Lixisenatide | Lyxumia | Diabetes | 2013 | SC injection |
| Oral semaglutide | Rybelsus | Diabetes | 2020 | Oral formulation |
| Tirzepatide | Mounjaro | Diabetes | 2022 | Dual GIP/GLP-1 |
| Retatrutide | Investigational | Obesity | Phase III | Triple agonist |
| Peptide | Brand | Indication | Approval | Notes |
|---|
| insulin tregopil | Oncglide | Diabetes | 2019 | Oral insulin |
| Liraglutide | Victoza | Diabetes | 2010 | SC injection |
| Semaglutide | Ozempic | Diabetes | 2018 | SC injection |
| Tirzepatide | Mounjaro | Diabetes | 2022 | Dual agonist |
| Peptide | Class | Indication | Phase | Expected Approval |
|---|
| Retatrutide | GLP-1/GIP/Glucagon triple agonist | Obesity | Phase III | 2025–2026 |
| Survodutide | GLP-1/Glucagon dual agonist | Obesity/NASH | Phase III | 2025–2026 |
| Orforglipron | Oral GLP-1 RA | Obesity | Phase III | 2025–2026 |
| Danuglipron | Oral GLP-1 RA | Obesity | Phase III | 2025–2026 |
| Cagrilintide | Amylin analog | Obesity (combination) | Phase III | 2025 |
| Amycretin | GLP-1/Amylin dual agonist | Obesity | Phase III | 2026 |
| Pemvidutide | GLP-1/Glucagon dual agonist | Obesity/NASH | Phase III | 2025 |
| Mazdutide | GLP-1/Glucagon dual agonist | Obesity | Phase III | 2025 |
| Pathway | Agency | Purpose | Timeline |
|---|
| NDA (505(b)(2)) | FDA | New drug (modified existing) | 8–12 months |
| NDA (505(b)(1)) | FDA | New drug (new entity) | 10–16 months |
| ANDA (505(j)) | FDA | Generic (bioequivalent) | 8–12 months |
| BLA | FDA | Biologic (peptide) | 10–16 months |
| MAA | EMA | Marketing authorization | 12–18 months |
| JNDA | PMDA | New drug application | 12–18 months |
| Requirement | Standard | Timeline |
|---|
| Reference product | FDA-approved | Must be approved |
| Analytical similarity | >90% similarity | 2–3 years |
| Animal studies | Pharmacology, toxicology | 1–2 years |
| Clinical PK/PD | Bioequivalence | 6–12 months |
| Immunogenicity | Comparative ADA | 6–12 months |
| Total timeline | — | 4–6 years |
| Region | Obesity | Diabetes | Status |
|---|
| USA (FDA) | Approved (2021) | Approved (2017) | Marketed |
| Europe (EMA) | Approved (2022) | Approved (2018) | Marketed |
| Japan (PMDA) | Approved (2022) | Approved (2018) | Marketed |
| Australia (TGA) | Approved (2022) | Approved (2019) | Marketed |
| UK (MHRA) | Approved (2022) | Approved (2019) | Marketed |
| Canada (Health Canada) | Approved (2022) | Approved (2018) | Marketed |
| Region | Obesity | Diabetes | Status |
|---|
| USA (FDA) | Approved (2023) | Approved (2022) | Marketed |
| Europe (EMA) | Under review | Approved (2023) | Marketed |
| Japan (PMDA) | Under review | Approved (2022) | Marketed |
| Australia (TGA) | Under review | Approved (2023) | Marketed |
- FDA. “Peptide drug products: chemistry, manufacturing, and controls.” Guidance for Industry 2021.
- EMA. “Guideline on the quality, non-clinical, and clinical aspects of peptide-based medicinal products.” EMA/CHMP/CVMP/QWP/BWP 2022.
- PMDA. “Peptide-based therapeutics: regulatory guidance.” PMDA Notification 2022.
- Bhatt NR, et al. “Regulatory landscape of peptide therapeutics.” Regul Toxicol Pharmacol 2023;139:105357.
- Koch G, et al. “Global regulatory requirements for peptide drugs.” BioDrugs 2024;38:1-15.
