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Timeline of FDA-approved peptide drugs

All 40 FDA-approved peptide medicines, in the order they were approved — from glucagon in 1960 to SS-31 (Forzinity) in 2025. Every date is pulled straight from the FDA's own Drugs@FDA database and links back to the application record, so you can check any row yourself.

Compiled by the Peptide Almanac Editorial Team · Data last refreshed

Approvals by decade

Peptide medicine is not new — but it accelerated. 14 of the 40 approvals landed in the 2010s, driven by long-acting formulations, receptor-selective analogs, and the incretin (GLP-1) boom.

The full timeline

Dates are the first approval of each molecule. Many were later approved for additional conditions — those follow-on approvals aren't listed here; the linked guide covers them.

1960s — 1 approval

  1. Glucagon Glucagon (Lilly)

    Severe hypoglycemia (emergency rescue)

    Approved November 14, 1960 · FDA NDA012122

1970s — 2 approvals

  1. Desmopressin DDAVP

    Central diabetes insipidus, nocturnal enuresis, hemophilia A / von Willebrand disease

    Approved February 21, 1978 · FDA NDA017922

  2. Calcitonin Calcimar

    Osteoporosis, Paget's disease, hypercalcemia

    Calcimar (salmon calcitonin) — the first calcitonin approval in the Drugs@FDA record.

    Approved April 17, 1978 · FDA NDA017769

1980s — 6 approvals

  1. Oxytocin Syntocinon

    Labor induction; postpartum bleeding

    Synthetic oxytocin was in clinical use from the 1950s; Drugs@FDA's electronic record begins with this application, so the true first approval is earlier.

    Approved April 17, 1980 · FDA NDA018245

  2. Gonadorelin Factrel

    GH/gonadal-axis testing, pulsatile fertility therapy

    Factrel, a diagnostic GnRH product; now discontinued in the US.

    Approved September 30, 1982 · FDA NDA018123

  3. Insulin Humulin R

    Type 1 and type 2 diabetes

    Animal-derived insulin has been used since 1923, before the modern approval system; this is the first recombinant human insulin (Humulin R), and the earliest insulin application in Drugs@FDA.

    Approved October 28, 1982 · FDA BLA018780

  4. Leuprolide Lupron

    Prostate cancer, endometriosis, fibroids, precocious puberty

    Approved April 9, 1985 · FDA NDA019010

  5. Octreotide Sandostatin

    Acromegaly, carcinoid syndrome, VIPoma, variceal bleeding

    Approved October 21, 1988 · FDA NDA019667

  6. Goserelin Zoladex

    Prostate cancer, breast cancer, endometriosis

    Approved December 29, 1989 · FDA NDA019726

1990s — 3 approvals

  1. Nafarelin Synarel

    Endometriosis, central precocious puberty

    Approved February 13, 1990 · FDA NDA019886

  2. Histrelin Supprelin

    Central precocious puberty; prostate cancer

    Approved December 24, 1991 · FDA NDA019836

  3. Glatiramer Acetate Copaxone

    Relapsing-remitting multiple sclerosis

    Approved December 20, 1996 · FDA NDA020622

2000s — 9 approvals

  1. Triptorelin Trelstar

    Prostate cancer; (abroad) precocious puberty, endometriosis

    Approved June 15, 2000 · FDA NDA020715

  2. Cetrorelix Cetrotide

    Preventing premature ovulation in assisted reproduction

    Approved August 11, 2000 · FDA NDA021197

  3. Secretin ChiRhoStim (porcine secretin)

    Diagnostic pancreatic/gastrin testing

    Approved April 4, 2002 · FDA NDA021209

  4. Teriparatide Forteo

    Osteoporosis at high fracture risk

    Approved November 26, 2002 · FDA NDA021318

  5. Enfuvirtide Fuzeon

    HIV-1 infection (treatment-experienced)

    Approved March 13, 2003 · FDA NDA021481

  6. Pramlintide Symlin

    Type 1 & type 2 diabetes (adjunct to insulin)

    Approved March 16, 2005 · FDA NDA021332

  7. Exenatide Byetta

    Type 2 diabetes

    Approved April 28, 2005 · FDA NDA021773

  8. Lanreotide Somatuline Depot

    Acromegaly; gastroenteropancreatic neuroendocrine tumors

    Approved August 30, 2007 · FDA NDA022074

  9. Degarelix Firmagon

    Advanced prostate cancer

    Approved December 24, 2008 · FDA NDA022201

2010s — 14 approvals

  1. Liraglutide Victoza

    Type 2 diabetes; chronic weight management

    Approved January 25, 2010 · FDA NDA022341

  2. Tesamorelin Egrifta

    HIV-associated lipodystrophy (excess abdominal fat)

    Approved November 10, 2010 · FDA BLA022505

  3. Icatibant Firazyr

    Acute hereditary angioedema (HAE) attacks

    Approved August 25, 2011 · FDA NDA022150

  4. Linaclotide Linzess

    IBS-C and chronic idiopathic constipation

    Approved August 30, 2012 · FDA NDA202811

  5. Pasireotide Signifor

    Cushing's disease; acromegaly

    Approved December 14, 2012 · FDA NDA200677

  6. Teduglutide Gattex

    Short bowel syndrome (dependence on IV nutrition)

    Approved December 21, 2012 · FDA NDA203441

  7. Vasopressin Vasostrict

    Vasodilatory / septic shock

    Vasopressin was marketed unapproved for decades; Vasostrict was the first FDA-approved vasopressin product.

    Approved April 17, 2014 · FDA NDA204485

  8. Dulaglutide Trulicity

    Type 2 diabetes (with CV risk reduction)

    Approved September 18, 2014 · FDA BLA125469

  9. Lixisenatide Adlyxin

    Type 2 diabetes

    Approved July 27, 2016 · FDA BLA208471

  10. Plecanatide Trulance

    Chronic idiopathic constipation; IBS-C

    Approved January 19, 2017 · FDA NDA208745

  11. Abaloparatide Tymlos

    Osteoporosis at high fracture risk

    Approved April 28, 2017 · FDA NDA208743

  12. Semaglutide Ozempic

    Type 2 diabetes; chronic weight management (injectable & oral); noncirrhotic MASH with fibrosis

    Approved December 5, 2017 · FDA NDA209637

  13. PT-141 Vyleesi

    HSDD in premenopausal women

    Approved June 21, 2019 · FDA NDA210557

  14. Afamelanotide Scenesse

    Erythropoietic protoporphyria (EPP)

    Approved October 8, 2019 · FDA NDA210797

2020s — 5 approvals

  1. Setmelanotide Imcivree

    Obesity from POMC, PCSK1, LEPR deficiency & Bardet-Biedl syndrome

    Approved November 25, 2020 · FDA NDA213793

  2. Tirzepatide Mounjaro

    Type 2 diabetes; chronic weight management; obstructive sleep apnea

    Approved May 13, 2022 · FDA NDA215866

  3. Terlipressin Terlivaz

    Hepatorenal syndrome; variceal bleeding

    Approved September 14, 2022 · FDA NDA022231

  4. Palopegteriparatide Yorvipath

    Hypoparathyroidism in adults

    Approved August 9, 2024 · FDA NDA216490

  5. SS-31 Forzinity

    Barth syndrome (FDA accelerated approval, 2025)

    Approved September 19, 2025 · FDA NDA215244

The same data as a table

Sortable by eye, easy to copy, and the version to cite.

Every FDA-approved peptide drug with its first approval date, brand name, and use
YearPeptideFirst brandApproved forFDA application
1960GlucagonGlucagon (Lilly)Severe hypoglycemia (emergency rescue)NDA012122
1978DesmopressinDDAVPCentral diabetes insipidus, nocturnal enuresis, hemophilia A / von Willebrand diseaseNDA017922
1978CalcitoninCalcimarOsteoporosis, Paget's disease, hypercalcemiaNDA017769
1980OxytocinSyntocinonLabor induction; postpartum bleedingNDA018245
1982GonadorelinFactrelGH/gonadal-axis testing, pulsatile fertility therapyNDA018123
1982InsulinHumulin RType 1 and type 2 diabetesBLA018780
1985LeuprolideLupronProstate cancer, endometriosis, fibroids, precocious pubertyNDA019010
1988OctreotideSandostatinAcromegaly, carcinoid syndrome, VIPoma, variceal bleedingNDA019667
1989GoserelinZoladexProstate cancer, breast cancer, endometriosisNDA019726
1990NafarelinSynarelEndometriosis, central precocious pubertyNDA019886
1991HistrelinSupprelinCentral precocious puberty; prostate cancerNDA019836
1996Glatiramer AcetateCopaxoneRelapsing-remitting multiple sclerosisNDA020622
2000TriptorelinTrelstarProstate cancer; (abroad) precocious puberty, endometriosisNDA020715
2000CetrorelixCetrotidePreventing premature ovulation in assisted reproductionNDA021197
2002SecretinChiRhoStim (porcine secretin)Diagnostic pancreatic/gastrin testingNDA021209
2002TeriparatideForteoOsteoporosis at high fracture riskNDA021318
2003EnfuvirtideFuzeonHIV-1 infection (treatment-experienced)NDA021481
2005PramlintideSymlinType 1 & type 2 diabetes (adjunct to insulin)NDA021332
2005ExenatideByettaType 2 diabetesNDA021773
2007LanreotideSomatuline DepotAcromegaly; gastroenteropancreatic neuroendocrine tumorsNDA022074
2008DegarelixFirmagonAdvanced prostate cancerNDA022201
2010LiraglutideVictozaType 2 diabetes; chronic weight managementNDA022341
2010TesamorelinEgriftaHIV-associated lipodystrophy (excess abdominal fat)BLA022505
2011IcatibantFirazyrAcute hereditary angioedema (HAE) attacksNDA022150
2012LinaclotideLinzessIBS-C and chronic idiopathic constipationNDA202811
2012PasireotideSigniforCushing's disease; acromegalyNDA200677
2012TeduglutideGattexShort bowel syndrome (dependence on IV nutrition)NDA203441
2014VasopressinVasostrictVasodilatory / septic shockNDA204485
2014DulaglutideTrulicityType 2 diabetes (with CV risk reduction)BLA125469
2016LixisenatideAdlyxinType 2 diabetesBLA208471
2017PlecanatideTrulanceChronic idiopathic constipation; IBS-CNDA208745
2017AbaloparatideTymlosOsteoporosis at high fracture riskNDA208743
2017SemaglutideOzempicType 2 diabetes; chronic weight management (injectable & oral); noncirrhotic MASH with fibrosisNDA209637
2019PT-141VyleesiHSDD in premenopausal womenNDA210557
2019AfamelanotideScenesseErythropoietic protoporphyria (EPP)NDA210797
2020SetmelanotideImcivreeObesity from POMC, PCSK1, LEPR deficiency & Bardet-Biedl syndromeNDA213793
2022TirzepatideMounjaroType 2 diabetes; chronic weight management; obstructive sleep apneaNDA215866
2022TerlipressinTerlivazHepatorenal syndrome; variceal bleedingNDA022231
2024PalopegteriparatideYorvipathHypoparathyroidism in adultsNDA216490
2025SS-31ForzinityBarth syndrome (FDA accelerated approval, 2025)NDA215244

Cite or reuse this timeline

These are public facts and we'd rather they were used than hoarded. Reproduce the table or chart anywhere you like — please credit The Peptide Almanac and link back so readers can check the source data.

Suggested citation: The Peptide Almanac. Timeline of FDA-Approved Peptide Drugs (1960–2025). https://thepeptidealmanac.com/peptide-timeline.html

Underlying approval data is US government public-domain information from the FDA's Drugs@FDA database; the compilation, indications, and guides are ours.

Methodology & limitations

Related: the FDA-approved peptide drugs list groups these same medicines by what they treat, and the A–Z list of peptides covers all 108 peptides — approved and research alike.

Frequently asked questions

How many peptide drugs has the FDA approved?

40 of the peptides in this encyclopedia are FDA-approved medicines, approved between 1960 and 2025. That is a small fraction of the 108 peptides covered here — most remain investigational or are sold as unapproved "research chemicals". See the grouped list of FDA-approved peptide drugs.

What was the first FDA-approved peptide drug?

The earliest approval in the FDA's own Drugs@FDA record is glucagon in 1960. Insulin is older still — animal-derived insulin entered use in 1923, before the modern approval system existed — so the first recombinant human insulin (Humulin R, 1982) is what appears in the database.

Which decade had the most peptide drug approvals?

The 2010s, with 14 approvals — more than the 21 approved in all the preceding decades combined. Peptide drug development accelerated sharply once long-acting formulations and receptor-selective analogs became routine.

Where does this timeline's data come from?

Every date is pulled programmatically from the FDA's public Drugs@FDA API — we take the earliest original approved application for each molecule and link to its record. Nothing on this page is a remembered or estimated date.

Which peptide drugs are expected next?

Several are in late-stage development or under review, including CagriSema, retatrutide, petrelintide, eloralintide, and maridebart cafraglutide — all in the obesity and metabolic space. None is approved; this page updates when that changes.

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