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FDA-Approved Peptide Drug List (Complete, Updated)

The FDA has approved roughly 100 peptide-based drugs since insulin first reached patients in 1922. That number continues to grow: peptides accounted for about 10% of all new FDA drug approvals between 2020 and 2024, and the peptide therapeutics market is projected to exceed $49 billion by 2026.

The FDA has approved roughly 100 peptide-based drugs since insulin first reached patients in 1922. That number continues to grow: peptides accounted for about 10% of all new FDA drug approvals between 2020 and 2024, and the peptide therapeutics market is projected to exceed $49 billion by 2026.

This page catalogs every major FDA-approved peptide medication, organized by therapeutic category. Each entry includes the generic name, brand name(s), approval year, indication, and manufacturer. We update this list as new approvals occur.

For a broader look at peptide regulation, see our guide on which peptides are FDA-approved.


Table of Contents


How We Define "Peptide Drug"

For this list, we include drugs where the active ingredient is a peptide (typically 2--100 amino acids) or a close peptide analog. We include peptide-drug conjugates and PEGylated peptides. We exclude monoclonal antibodies (which are full-length proteins), recombinant proteins larger than ~200 amino acids (like erythropoietin or interferon), and non-peptide small molecules that target peptide receptors (like orforglipron). Insulin and its analogs are included as the foundational peptide drugs, though they sit at the boundary between peptide and small protein.


Diabetes and Metabolic Disorders

GLP-1 receptor agonists have transformed diabetes and obesity treatment. This category also includes insulin, amylin analogs, and the dual/triple agonists that represent the newest generation.

Generic NameBrand Name(s)Approval YearIndicationManufacturer
Insulin (human, recombinant)Humulin, Novolin1982Type 1 and Type 2 diabetesEli Lilly / Novo Nordisk
Insulin lisproHumalog1996Diabetes (rapid-acting)Eli Lilly
Insulin aspartNovoLog, Fiasp2000, 2017Diabetes (rapid-acting)Novo Nordisk
Insulin glargineLantus, Toujeo, Basaglar2000Diabetes (long-acting basal)Sanofi / Eli Lilly
Insulin detemirLevemir2005Diabetes (long-acting basal)Novo Nordisk
Insulin degludecTresiba2015Diabetes (ultra-long-acting basal)Novo Nordisk
Insulin glulisineApidra2004Diabetes (rapid-acting)Sanofi
PramlintideSymlin2005Type 1 and Type 2 diabetes (adjunct to insulin)AstraZeneca (originally Amylin Pharmaceuticals)
ExenatideByetta, Bydureon2005, 2012Type 2 diabetesAstraZeneca
LiraglutideVictoza, Saxenda2010, 2014Type 2 diabetes; chronic weight managementNovo Nordisk
LixisenatideAdlyxin2016Type 2 diabetesSanofi
DulaglutideTrulicity2014Type 2 diabetesEli Lilly
SemaglutideOzempic, Rybelsus, Wegovy2017, 2019, 2021Type 2 diabetes; chronic weight managementNovo Nordisk
TirzepatideMounjaro, Zepbound2022, 2023Type 2 diabetes; chronic weight managementEli Lilly
TesamorelinEgrifta2010HIV-associated lipodystrophy (excess abdominal fat)Theratechnologies

Semaglutide and tirzepatide are the two fastest-growing prescription drugs in history by revenue. In 2025, the FDA expanded semaglutide's indication to include cardiovascular risk reduction and slowing kidney disease progression in type 2 diabetes patients. An oral 25 mg semaglutide formulation for weight loss (Wegovy oral) was also approved.

For more on the differences between these drugs, see our comparisons of semaglutide vs. tirzepatide and Ozempic vs. Wegovy.


Oncology

Peptide drugs in oncology work primarily through three mechanisms: suppressing hormone-driven tumor growth (GnRH analogs), targeting somatostatin receptors on neuroendocrine tumors, and delivering radioactive payloads directly to cancer cells (peptide receptor radionuclide therapy).

Generic NameBrand Name(s)Approval YearIndicationManufacturer
LeuprolideLupron, Eligard, Fensolvi1985Prostate cancer, endometriosis, uterine fibroids, central precocious pubertyAbbVie / Tolmar
GoserelinZoladex1989Prostate cancer, breast cancer, endometriosisAstraZeneca
OctreotideSandostatin, Sandostatin LAR, Mycapssa1988, 1998, 2020Acromegaly, carcinoid tumors, VIPomasNovartis / Amryt
LanreotideSomatuline Depot2007Acromegaly, gastroenteropancreatic neuroendocrine tumors (GEP-NETs)Ipsen
PasireotideSignifor, Signifor LAR2012, 2014Cushing's disease, acromegalyRecordati (originally Novartis)
DegarelixFirmagon2008Advanced prostate cancerFerring Pharmaceuticals
HistrelinVantas, Supprelin LA2004, 2007Prostate cancer, central precocious pubertyEndo Pharmaceuticals
TriptorelinTrelstar2000Advanced prostate cancerVerity/Debiopharm
AbarelixPlenaxis2003Advanced prostate cancer (withdrawn from US market 2005)Praecis Pharmaceuticals
RomidepsinIstodax2009Cutaneous T-cell lymphoma, peripheral T-cell lymphomaCelgene (BMS)
Lutetium Lu-177 dotatateLutathera2018GEP-NETs (peptide receptor radionuclide therapy)Novartis (Advanced Accelerator Applications)
Gallium Ga-68 dotatateNetspot2016Imaging of somatostatin receptor-positive NETs (diagnostic)Advanced Accelerator Applications
Gallium Ga-68 dotatocDetectnet2019Imaging of somatostatin receptor-positive NETs (diagnostic)RadioMedic
Copper Cu-64 dotatateDetectnet (Cu-64)2020Imaging of NETs---
MotixafortideAphexda2023Stem cell mobilization (with G-CSF) prior to autologous transplant in multiple myelomaBioLineRx

The GnRH agonists (leuprolide, goserelin, triptorelin, histrelin) work by initially stimulating and then desensitizing pituitary GnRH receptors, shutting down testosterone or estrogen production. This "chemical castration" effect makes them cornerstone treatments for hormone-sensitive cancers.


Bone and Calcium Disorders

Generic NameBrand Name(s)Approval YearIndicationManufacturer
Calcitonin (salmon)Miacalcin, Fortical1986Postmenopausal osteoporosis, Paget's disease, hypercalcemiaVarious
TeriparatideForteo, Bonsity2002Osteoporosis (high fracture risk)Eli Lilly / Pfenex
AbaloparatideTymlos2017Postmenopausal osteoporosis (high fracture risk)Radius Health
PalopegteriparatideYorvipath2024Hypoparathyroidism in adultsAscendis Pharma

Teriparatide is a synthetic fragment of parathyroid hormone (PTH amino acids 1--34). Unlike anti-resorptive drugs that slow bone breakdown, teriparatide and abaloparatide are anabolic --- they stimulate new bone formation. Palopegteriparatide, approved in 2024, is a PEGylated PTH(1--34) prodrug that became the first treatment specifically approved for hypoparathyroidism.


Cardiovascular and Hematologic

Generic NameBrand Name(s)Approval YearIndicationManufacturer
VasopressinVasostrict2014 (current formulation)Vasodilatory shock (ICU setting)Endo/Par
DesmopressinDDAVP, Stimate, Nocdurna1978Diabetes insipidus, hemophilia A/von Willebrand disease (bleeding), nocturnal enuresisVarious
TerlipressinTerlivaz2022Hepatorenal syndrome type 1Mallinckrodt
NesiritideNatrecor2001Acute decompensated heart failureJanssen (J&J)
EptifibatideIntegrilin1998Acute coronary syndrome, percutaneous coronary interventionMerck (originally COR Therapeutics)
BivalirudinAngiomax2000Anticoagulation during PCI, HITThe Medicines Company

Desmopressin, a synthetic analog of vasopressin (with modifications that boost antidiuretic activity and eliminate vasopressor effects), has accumulated six separate FDA approvals across different indications and formulations --- more than any other peptide by approval count.


Reproductive Health and Fertility

Generic NameBrand Name(s)Approval YearIndicationManufacturer
OxytocinPitocin1980 (synthetic; natural use predates)Labor induction, postpartum hemorrhage controlVarious
NafarelinSynarel1990Endometriosis, central precocious pubertyPfizer
GanirelixGanirelix Acetate Injection1999GnRH antagonist for controlled ovarian stimulation in IVFOrganon (MSD)
CetrorelixCetrotide2000GnRH antagonist for controlled ovarian stimulationEMD Serono
CarbetocinDuratocin (available internationally)Not FDA-approved (WHO Essential Medicine)Prevention of postpartum hemorrhageFerring

GnRH antagonists (ganirelix, cetrorelix) prevent premature ovulation during IVF cycles by blocking pituitary GnRH receptors without the initial stimulatory "flare" that GnRH agonists cause.


Gastrointestinal Disorders

Generic NameBrand Name(s)Approval YearIndicationManufacturer
LinaclotideLinzess2012IBS with constipation (IBS-C), chronic idiopathic constipationAbbVie (Ironwood/Allergan)
PlecanatideTrulance2017IBS-C, chronic idiopathic constipationSalix Pharmaceuticals
TeduglutideGattex2012Short bowel syndrome (dependence on parenteral nutrition)Takeda
Larazotide---Phase 3 completedCeliac disease (investigational)9 Meters Biopharma

Linaclotide and plecanatide are guanylate cyclase-C agonists --- 14-amino-acid peptides that work locally in the gut to increase fluid secretion and accelerate transit. They're minimally absorbed into the bloodstream, which limits systemic side effects. Teduglutide is an analog of GLP-2 that promotes intestinal adaptation and growth.


Neurological and Pain

Generic NameBrand Name(s)Approval YearIndicationManufacturer
ZiconotidePrialt2004Severe chronic pain (intrathecal)Jazz Pharmaceuticals
DifelikefalinKorsuva2021CKD-associated pruritus (chronic itch in dialysis patients)Vifor Pharma / CSL
TrofinetideDaybue2023Rett syndromeAcadia Pharmaceuticals

Ziconotide is a synthetic version of a 25-amino-acid peptide from the cone snail Conus magus. It blocks N-type calcium channels in the spinal cord and is delivered directly into cerebrospinal fluid via an intrathecal pump. It remains one of only a handful of non-opioid options for severe chronic pain.

Trofinetide is a synthetic tripeptide analog of IGF-1's terminal tripeptide. Approved in 2023, it became the first drug ever approved for Rett syndrome.


Infectious Disease

Generic NameBrand Name(s)Approval YearIndicationManufacturer
EnfuvirtideFuzeon2003HIV-1 infection (treatment-experienced patients)Roche/Genentech
VancomycinVancocin1958Serious Gram-positive infections, C. difficile colitisVarious
DaptomycinCubicin2003Skin infections, S. aureus bacteremiaMerck (originally Cubist)
TelaprevirIncivek2011Hepatitis C (withdrawn 2014; superseded by newer agents)Vertex
BoceprevirVictrelis2011Hepatitis C (discontinued)Merck

Enfuvirtide is a 36-amino-acid peptide that blocks HIV entry into cells by preventing the conformational change in gp41 needed for viral-cell membrane fusion. While effective, its twice-daily subcutaneous injection requirement limited its widespread adoption.

Note: Vancomycin and daptomycin are technically cyclic lipopeptide antibiotics rather than traditional peptides, but they're widely classified alongside peptide drugs.


Immune and Inflammatory Disorders

Generic NameBrand Name(s)Approval YearIndicationManufacturer
Glatiramer acetateCopaxone, Glatopa1996Relapsing forms of multiple sclerosisTeva / Sandoz
IcatibantFirazyr2011Acute hereditary angioedema attacksTakeda (originally Jerini)
PegcetacoplanEmpaveli2021Paroxysmal nocturnal hemoglobinuria (PNH)Apellis Pharmaceuticals
ZilucoplanZilbrysq2023Generalized myasthenia gravis (anti-AChR antibody positive)UCB Pharma
VoclosporinLupkynis2021Lupus nephritisAurinia Pharmaceuticals

Glatiramer acetate is unusual --- it's a random polymer of four amino acids (glutamic acid, lysine, alanine, tyrosine) that mimics myelin basic protein. After nearly three decades on the market, it remains a first-line therapy for relapsing MS, though its exact mechanism is still debated.


Rare and Genetic Diseases

Generic NameBrand Name(s)Approval YearIndicationManufacturer
SetmelanotideImcivree2020Genetic obesity (POMC, PCSK1, LEPR deficiency)Rhythm Pharmaceuticals
VosoritideVoxzogo2021Achondroplasia (short-limbed dwarfism) in childrenBioMarin
ElamipretideForzinity2025Barth syndromeStealth BioTherapeutics

Setmelanotide is an MC4R agonist --- it activates the same melanocortin receptor pathway that alpha-MSH uses to regulate appetite. But unlike weight-loss drugs for the general population, setmelanotide is approved only for patients with genetically confirmed defects in the leptin-melanocortin pathway.

Elamipretide, approved in 2025, targets the inner mitochondrial membrane. It became the first disease-specific treatment for Barth syndrome, a rare genetic condition causing cardiomyopathy and muscle weakness.


Diagnostic and Imaging Agents

Generic NameBrand Name(s)Approval YearIndicationManufacturer
Pentetreotide (Indium In-111)OctreoScan1994Imaging of neuroendocrine tumorsMallinckrodt
Gallium Ga-68 dotatateNetspot2016PET imaging of somatostatin receptor-positive NETsAdvanced Accelerator Applications
Gallium Ga-68 dotatocDetectnet2019PET imaging of NETsRadioMedic
Gallium Ga-68 gozetotideLocametz2022PET imaging of PSMA-positive prostate cancerNovartis
Fluoroestradiol F-18Cerianna2020PET imaging of ER-positive breast cancerZionexa
PegulicianineLumisight2024Fluorescence imaging of breast cancer during lumpectomyLumicell
Secretin (synthetic)SecreFlo, ChiRhoStim2002, 2004Diagnostic: pancreatic function testing, aid in MRCP imagingVarious
CosyntropinCortrosyn1970ACTH stimulation test (adrenal function)Various
Pentagastrin---Historical useDiagnostic: gastric acid secretion testing (largely replaced)---

Peptide-based imaging agents have become workhorses of oncology diagnostics. The somatostatin receptor-targeting agents (OctreoScan, Netspot, Detectnet) allow physicians to locate neuroendocrine tumors anywhere in the body. Lumisight, approved in 2024, takes a different approach: the peptide prodrug is optically inactive until cleaved by tumor-associated enzymes, making residual cancer tissue glow during surgery.


Dermatology and Sexual Health

Generic NameBrand Name(s)Approval YearIndicationManufacturer
BremelanotideVyleesi2019Hypoactive sexual desire disorder (premenopausal women)Palatin Technologies
AfamelanotideScenesse2019Erythropoietic protoporphyria (phototoxicity prevention)Clinuvel

Bremelanotide is a cyclic heptapeptide melanocortin agonist --- a close relative of the research peptide Melanotan II but with a more targeted pharmacology. Read more in our PT-141 profile.


Recent Approvals: 2023--2026

The pace of peptide drug approvals has accelerated. Here are the most recent additions.

YearDrugBrandIndicationSignificance
2023TirzepatideZepboundChronic weight managementFirst dual GIP/GLP-1 agonist for obesity
2023TrofinetideDaybueRett syndromeFirst-ever Rett syndrome treatment; oral tripeptide
2023ZilucoplanZilbrysqGeneralized myasthenia gravisFirst subcutaneous complement inhibitor peptide
2023MotixafortideAphexdaStem cell mobilization (multiple myeloma)First peptide CXCR4 antagonist approved
2024PalopegteriparatideYorvipathHypoparathyroidismFirst treatment specifically for hypoparathyroidism; PEGylated PTH prodrug
2024PegulicianineLumisightBreast cancer fluorescence imagingFirst peptide-based intraoperative fluorescence agent
2025ElamipretideForzinityBarth syndromeFirst mitochondria-targeted peptide drug; first Barth syndrome treatment
2025Semaglutide (oral, 25 mg)Wegovy (oral)Weight management / CV risk reductionFirst oral GLP-1 for weight loss

The Approval Timeline: Peptide Drugs by Decade

DecadeApproximate ApprovalsNotable Milestones
1920s--1950s2--5Insulin (1922/1982 recombinant), vasopressin, ACTH
1960s--1970s5--8Oxytocin (synthetic), desmopressin, calcitonin
1980s8--12Leuprolide, goserelin, octreotide, recombinant human insulin
1990s10--15Glatiramer acetate, ganirelix, cetrorelix, eptifibatide
2000s15--20Exenatide, enfuvirtide, teriparatide, ziconotide, bivalirudin
2010s20--25Liraglutide, semaglutide, tirzepatide (2022 technically), linaclotide, teduglutide, multiple GnRH agents
2020s (to date)15+Tirzepatide, trofinetide, pegcetacoplan, zilucoplan, motixafortide, elamipretide, Lutathera, palopegteriparatide

The highest number of peptide approvals occurred between 2020 and 2024, driven by metabolic disease (GLP-1 drugs), rare diseases, and oncology.


FAQ

How many peptide drugs are FDA-approved?

The commonly cited figure is around 80--100, depending on how you count insulin analogs, reformulations, and peptide-adjacent molecules like cyclic lipopeptide antibiotics. The THPdb2 database catalogs 85 distinct peptide/polypeptide drugs and 380 drug variants (different formulations and brand names).

What is the most prescribed peptide drug?

By prescription volume, insulin remains number one globally. By revenue growth, semaglutide (Ozempic/Wegovy) and tirzepatide (Mounjaro/Zepbound) are the clear leaders, with combined annual sales exceeding $40 billion.

Are compounded peptides the same as FDA-approved peptides?

No. Compounded peptides are prepared by compounding pharmacies and are not subject to the same manufacturing standards, testing, or approval processes as FDA-approved drugs. The FDA has increasingly restricted compounding of certain peptides, including placing BPC-157 and TB-500 on its Category 2 list of substances with safety concerns. For more, see our article on the FDA compounding crackdown.

Which peptide drug was approved most recently?

As of early 2026, the most recent peptide approvals include elamipretide (Forzinity) for Barth syndrome and oral semaglutide 25 mg (Wegovy oral) for weight management, both in 2025.

How many peptide drugs are currently in clinical trials?

Over 150 peptides are in active clinical trials, with another 400--600 in preclinical development. ClinicalTrials.gov lists roughly 1,400 trials involving peptide therapeutics, and 38 peptide drugs were in Phase III trials as of 2024. For help navigating clinical trial data, see our guide to peptide databases and research resources.

Can I look up the approval history of a specific peptide drug?

Yes. The FDA's Drugs@FDA database (accessdata.fda.gov/scripts/cder/daf) provides approval letters, labeling, and review documents for every approved drug. The Purdue CDEK database also maintains a searchable list of FDA-approved peptide drugs.

Why are some peptides "FDA-approved" for one condition but used off-label for others?

FDA approval is indication-specific. A drug approved for diabetes (like semaglutide/Ozempic) can be legally prescribed off-label for weight loss by a physician, even before it received a separate obesity approval (Wegovy). Off-label prescribing is legal and common, but the evidence supporting it varies. Always discuss the evidence base with your doctor --- our guide on how to talk to your doctor about peptides can help.


The Bottom Line

The FDA-approved peptide drug list spans more than a century of pharmaceutical development, from the isolation of insulin in the 1920s to the mitochondria-targeted elamipretide in 2025. The trend line is clear: peptide approvals are accelerating, driven by advances in peptide chemistry (PEGylation, acylation, cyclization), oral delivery technology, and a deeper understanding of peptide hormone biology.

The GLP-1 revolution in particular has brought peptide drugs into mainstream awareness. But approved peptide drugs extend far beyond weight loss --- into oncology, rare diseases, pain management, infectious disease, and diagnostics.

If you're exploring peptide therapy options, the critical distinction to understand is between FDA-approved medications (manufactured to strict standards, backed by clinical trials) and unapproved peptides (research-grade, compounded, or imported without regulatory oversight). For guidance on navigating this terrain, see our articles on what peptide therapy is and how it works and how to choose a peptide therapy clinic.


References

  1. 2024 FDA TIDES (Peptides and Oligonucleotides) Harvest. Pharmaceuticals. 2025;18(3):291. https://pmc.ncbi.nlm.nih.gov/articles/PMC11945313/

  2. 2025 FDA TIDES (Peptides and Oligonucleotides) Harvest. Pharmaceuticals. 2026;19(2):244. https://www.mdpi.com/1424-8247/19/2/244

  3. FDA's stamp of approval: Unveiling peptide breakthroughs in cardiovascular diseases, ACE, HIV, CNS, and beyond. Journal of Peptide Science. 2024. https://onlinelibrary.wiley.com/doi/full/10.1002/psc.3627

  4. Exploring FDA-Approved Frontiers: Insights into Natural and Engineered Peptide Analogues in the GLP-1, GIP, GHRH, CCK, ACTH, and alpha-MSH Realms. Biomolecules. 2024;14(3):264. https://pmc.ncbi.nlm.nih.gov/articles/PMC10968328/

  5. THPdb2: compilation of FDA approved therapeutic peptides and proteins. Drug Discovery Today. 2024. https://www.sciencedirect.com/science/article/abs/pii/S1359644624001727

  6. Advance in peptide-based drug development: delivery platforms, therapeutics and vaccines. Signal Transduction and Targeted Therapy. 2024. https://www.nature.com/articles/s41392-024-02107-5

  7. Purdue CDEK FDA Peptide Approvals Database. https://cdek.pharmacy.purdue.edu/fda-approvals/Peptide/

  8. THPdb: Database of FDA-approved peptide and protein therapeutics. PLoS One. 2017;12(7):e0181748. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0181748

  9. FDA Approves YORVIPATH (palopegteriparatide) as the First and Only Treatment for Hypoparathyroidism in Adults. Ascendis Pharma press release. August 12, 2024. https://investors.ascendispharma.com/news-releases/news-release-details/fda-approves-yorvipathr-palopegteriparatide-first-and-only

  10. Drugs@FDA: FDA-Approved Drugs. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/