How many peptide drugs are FDA approved?

A verified list from FDA records, and why published totals disagree

16 min

Semaglutide as a chain of 31 amino acids with its fatty diacid side chain attached to one lysine.

Semaglutide and tirzepatide made peptides the most talked-about drugs of the decade, but they joined a long list. Vancomycin, cyclosporine, leuprolide and the oxytocin used to induce labor are peptides too. By our count of FDA records, the FDA has approved 98 peptide drugs, each built on a defined chain of 2 to 50 amino acids, and 77 of them are still marketed in the United States as of October 29, 2026.

The total depends more on the definition than on the data. Leave out the 19 antibiotics, antifungals and immunosuppressants that microbes make, and 79 remain. Add the eight insulins, which sit just above the length cutoff, and the total is 106. The "more than 80" quoted in many reviews is a worldwide count that includes insulin. Below are the full list, the rules behind each number and a downloadable dataset.

How many peptide drugs has the FDA approved?

A peptide drug, as counted here, is an approved active ingredient built on a defined chain of 2 to 50 amino acids joined by peptide bonds. Rings, unusual or mirror-image amino acids, fatty acid tails, PEG chains and attached radioactive metals are all allowed. Each molecule counts once, at its first approval, however many brands, salts or formulations followed.

We read approval dates, application numbers and marketing status from the FDA's Drugs@FDA data files released on October 28, 2026, and the licensing status of the few peptides regulated as biologics from the Purple Book.[1][2] Ninety-eight molecules qualify. Twenty-one are no longer sold in the US, and one of those, the peptide-drug conjugate melphalan flufenamide (Pepaxto), lost its approval in February 2024.[3]

CountWhat it counts
94Peptides of 2 to 40 amino acids, the FDA's own line between peptides and proteins
98Peptides of 2 to 50 amino acids, the count used in this guide
77The 98, limited to drugs still marketed in the United States
79The 98 without antibiotics, antifungals and immunosuppressants made by microbes
72The 79 without radiolabelled imaging and therapy agents
106The 98 plus the eight insulin molecules
Table 1. How the count of FDA-approved peptide drugs changes with the definition. ProteinIQ counts of distinct active moieties, as of October 29, 2026. Sources: Drugs@FDA (2026), FDA Purple Book (2026), 21 CFR 600.3.[1][2][4]

Most published lists also stop before the newest approvals. Between February and August 2026 the FDA approved five new peptide drugs: navepegritide for achondroplasia, icotrokinra for plaque psoriasis, bulevirtide for chronic hepatitis delta, enlicitide for high LDL cholesterol and rusfertide for polycythemia vera.[5] Icotrokinra and enlicitide are tablets, which is still unusual for a peptide.

What counts as a peptide drug?

Chemists usually call chains of up to about 50 amino acids peptides and longer ones proteins, but the line is a convention. The FDA drew its own in 2020. Since then a protein, for regulatory purposes, is an amino acid polymer with a defined sequence longer than 40 amino acids, and chains that pair up as they do in nature are counted together.[4]

That rule moved products. On March 23, 2020, the FDA converted the drug applications of every product above the line into biologics licenses, including all insulins and three peptides of 41 to 44 amino acids: corticorelin (Acthrel), tesamorelin (Egrifta) and lixisenatide (Adlyxin).[6] Bulevirtide (Hepcludex), a 47-amino acid lipopeptide, was licensed as a biologic from the start when the FDA approved it in May 2026.[2][7]

We count up to 50 amino acids so that these four stay on the list; they are made and used like the shorter peptides around them. The dataset records each drug's length, so anyone who prefers the FDA's line can recount at 40, which gives 94.

Fifty also leaves insulin just outside. Human insulin has 51 amino acids in two chains held together by disulfide bonds, and its analogs carry 50 to 53. We list the eight insulin molecules approved by the FDA in the dataset and count them separately, so that the family is never split by a residue or two.

Some drugs are built from amino acids without being peptides in this sense. Bortezomib, ixazomib and carfilzomib are short amino acid chains that end in a reactive boronic acid or epoxyketone, and they work as covalent small-molecule proteasome inhibitors.

Glatiramer acetate is a random polymer of four amino acids with no defined sequence. PSMA agents such as lutetium Lu 177 vipivotide tetraxetan (Pluvicto) bind their target through a urea joining two amino acids rather than through a peptide chain. All are in the dataset, marked as not counted.

Peptides sold online as research chemicals are a different matter. BPC-157, TB-500 and similar products appear in neither Drugs@FDA nor the Purple Book, so none of them is an FDA-approved drug.[1][2]

How has the number of peptide approvals changed?

Peptide approvals came in two waves. Twenty-two of the 98 date from before 1982: hormones purified from animal glands or made by early peptide synthesis, such as corticotropin in 1950, glucagon in 1960 and desmopressin in 1978, alongside antibiotics such as bacitracin, polymyxin B and vancomycin.[1]

Figure 1. Peptide drugs by decade of first FDA approval. ProteinIQ count of 98 peptide drugs of 2 to 50 amino acids, dated by the earliest original approval in Drugs@FDA. "Before 1982" includes six drugs whose old applications carry no date, and the 2020s run to October 29, 2026. Source: Drugs@FDA data files (2026). Reuse under CC BY 4.0.

Approvals slowed in the 1980s and 1990s, when the new drugs were mostly analogs of known hormones, such as leuprolide, octreotide and goserelin. They picked up again after 2000 with longer-acting designs: the 2000s brought exenatide and the first echinocandin antifungals, and the 2010s the lipidated GLP-1 drugs among 21 peptide approvals. The 2020s matched that total in less than seven years.

As a share of new drugs, peptides remain small. From 2015 through 2022 the FDA's drug center approved 360 novel drugs, and 21 of them were peptides by our definition, or 5.8%.[8] The figure of about 10% for the same years comes from a 2023 review that also counted antibody-drug conjugates, an insulin, a proteasome inhibitor and, for 2022, several antibodies and other proteins, against 350 approvals in total.[9]

2026 is the exception so far. Five of the 47 novel drugs the FDA approved through October are peptides, 10.6% of the year's approvals and the most in one year since 2021, when there were six.[5]

Why do published counts of peptide drugs disagree?

Most published totals are right by their own rules. They differ in whether they count the world or only the US, whether insulin and fusion proteins are peptides, and whether radiolabelled tracers, imaging agents and microbial antibiotics belong on the list.

CountWhat it counts
More than 80Peptide drugs that have reached the market anywhere in the world since insulin
33Peptides other than insulin approved anywhere in the world since 2000, as counted in 2022, including GLP-1 fusion proteins
About 10%Share of FDA novel approvals from 2015 to 2022 (36 of 350), counting antibody-drug conjugates and some proteins
5Peptides among the FDA's 2023 novel approvals, including a PSMA imaging agent
98FDA-approved peptide drugs of 2 to 50 amino acids, ever, as counted in this guide
Table 2. Where commonly quoted peptide drug counts come from. Each count with the population it describes. Sources: Muttenthaler et al. (2021), Wang et al. (2022), Baradaran (2023), Al Shaer et al. (2024), Drugs@FDA (2026).[10][11][9][12][1]

The most quoted number comes from Markus Muttenthaler and colleagues, who wrote in 2021 that more than 80 peptide drugs had reached the market since insulin was introduced almost a century earlier.[10] It counts approvals anywhere in the world and includes insulin, so it is not comparable with an FDA list.

Lei Wang and colleagues repeated "more than 80" a year later and added that 33 peptides other than insulin had been approved worldwide since 2000.[11] Their table of those approvals includes albiglutide, dulaglutide and romiplostim, which are fusion proteins, and drugs never approved in the United States, such as atosiban and carbetocin. It leaves out daptomycin and the echinocandin antifungals, which are peptides made by microbes.

That last group is the main reason our total is larger than most. Vancomycin, daptomycin, cyclosporine and the echinocandins are peptides by structure, assembled by bacterial or fungal enzymes rather than ribosomes, and 19 of them are on our list. Without them the FDA count is 79.

Yearly reviews of FDA approvals, such as the TIDES harvests by Fernando Albericio and colleagues, cast a wider net in the other direction. The 2023 edition counted nine peptide and oligonucleotide approvals, four of them oligonucleotides, leaving five peptides.[12] We count four, because the fifth, flotufolastat F 18, binds its PSMA target through a urea rather than a peptide chain.

Which GLP-1 drugs are peptides?

Five of the 98 peptides activate the GLP-1 receptor: exenatide, liraglutide, lixisenatide, semaglutide and tirzepatide, which also activates the receptor for GIP, a second gut hormone. They are 31 to 44 amino acids long. Liraglutide, semaglutide and tirzepatide also carry a fatty acid that binds albumin in the blood and slows their clearance, which is why semaglutide and tirzepatide are injected once a week.[7]

Drug (brands)TypeAmino acidsFirst FDA approvalUS status
Exenatide (Byetta, Bydureon)Peptide39April 2005Marketed
Liraglutide (Victoza, Saxenda)Lipidated peptide31January 2010Marketed
Albiglutide (Tanzeum)Albumin fusion protein, not countedOver 50April 2014Discontinued
Dulaglutide (Trulicity)Fc fusion protein, not countedOver 50September 2014Marketed
Lixisenatide (Adlyxin, Soliqua)Peptide, regulated as a biologic since 202044July 2016Only in Soliqua
Semaglutide (Ozempic, Rybelsus, Wegovy)Lipidated peptide31December 2017Marketed
Tirzepatide (Mounjaro, Zepbound)Lipidated peptide, GIP and GLP-1 receptor agonist39May 2022Marketed
Orforglipron (Foundayo)Small molecule, not countedNoneApril 2026Marketed
Table 3. GLP-1 receptor agonists approved by the FDA. Every GLP-1 drug, including the two fusion proteins and the small molecule that are not counted as peptide drugs, as of October 29, 2026. Sources: Drugs@FDA (2026), FDA Purple Book (2026), FDA (2026).[1][2][5]

Semaglutide was also the first GLP-1 peptide approved as a tablet, Rybelsus, in September 2019.[1] Orforglipron, approved in April 2026 as Foundayo for weight reduction, reaches the same receptor as a small molecule, so it is not a peptide drug at all.[5] Lixisenatide's own brand, Adlyxin, no longer has a license, but the peptide is still sold in Soliqua, combined with insulin glargine.[2]

What do approved peptide drugs look like?

Most approved peptides are small. The median length is 10 amino acids, more than half (52 of the 97 with a stated length) have 10 or fewer, and only 20 are longer than 30.[7] Fifty-two of the 98 are rings, closed by a disulfide bond, a head-to-tail amide or another cross-link. A ring hides the chain ends that many proteases need and holds the peptide in the shape that binds its target.

Figure 2. FDA-approved peptide drugs by structure. ProteinIQ classification of 98 peptide drugs, each counted once under its most distinctive feature in the order radiolabelled, PEGylated, drug conjugate, glycopeptide, lipidated, cyclic and linear. Many lipidated, radiolabelled and glycopeptide drugs are also cyclic. Sources: Drugs@FDA (2026), DailyMed (2026). Reuse under CC BY 4.0.

Hormone receptors dominate the targets. Ten drugs act on the gonadotropin-releasing hormone receptor, from leuprolide to degarelix, and nine bind somatostatin receptors, six of them as radiolabelled tracers or therapy. Most are injected; 12 have an approved oral form, among them semaglutide, linaclotide, cyclosporine, icotrokinra and enlicitide.[1]

Their small size is also what makes peptides practical to model and make. PeptideBuilder turns a sequence into an all-atom structure in a chosen backbone conformation, and HighFold predicts the structures of head-to-tail and disulfide-bonded cyclic peptides, which standard structure predictors treat as linear chains.

For peptide design from a known binder, PepMimic generates short peptides that copy the binding interface of an antibody or receptor on its target. Short chains are also cheap to make: custom peptides list at about $2 to $4.50 per amino acid before purification, after the peptide mass calculator and isoelectric point calculator have covered the routine checks.

List of FDA-approved peptide drugs

Drug (first brand)Amino acidsClassTargetFirst FDA approvalUS status
Ceruletide (Tymtran)10LinearCholecystokinin receptorsBefore 1982Discontinued
Lypressin (Diapid)9CyclicVasopressin receptorsBefore 1982Discontinued
Saralasin (Sarenin)8LinearAngiotensin II type 1 receptorBefore 1982Discontinued
Porcine secretin (Secretin-Ferring)27LinearSecretin receptorBefore 1982Marketed
Vasopressin (Pitressin Tannate)9CyclicVasopressin V1a and V2 receptorsBefore 1982Marketed
Viomycin (Viocin)5CyclicBacterial ribosomeBefore 1982Discontinued
Bacitracin (Baciguent)12CyclicUndecaprenyl pyrophosphate (cell wall synthesis)September 1948Marketed
Corticotropin (Acthar)39LinearMelanocortin 2 receptor (ACTH receptor)July 1950Marketed
Polymyxin B (Neo-Polycin)10LipidatedLipopolysaccharide of the Gram-negative outer membraneApril 1954Marketed
Glucagon29LinearGlucagon receptorNovember 1960Marketed
Colistin (Coly-Mycin S)10LipidatedLipopolysaccharide of the Gram-negative outer membraneMay 1962Marketed
Vancomycin (Vancocin)7GlycopeptideD-Ala-D-Ala terminus of peptidoglycan precursorsNovember 1964Marketed
Dactinomycin (Cosmegen)10CyclicDNA (intercalation, blocks transcription)December 1964Marketed
Gramicidin (Neosporin)15LinearBacterial membrane (ion channel)July 1968Marketed
Cosyntropin (Cortrosyn)24LinearMelanocortin 2 receptor (ACTH receptor)April 1970Marketed
Capreomycin (Capastat)5CyclicBacterial ribosomeJune 1971Discontinued
Pentagastrin (Peptavlon)5LinearCholecystokinin B (gastrin) receptorJuly 1974Discontinued
Sincalide (Kinevac)8LinearCholecystokinin A receptorJuly 1976Marketed
Protirelin (Thypinone)3LinearThyrotropin-releasing hormone receptorNovember 1976Discontinued
Desmopressin (DDAVP)9CyclicVasopressin V2 receptorFebruary 1978Marketed
Calcitonin salmon (Calcimar)32CyclicCalcitonin receptorApril 1978Marketed
Oxytocin (Syntocinon)9CyclicOxytocin receptorApril 1980Marketed
Gonadorelin (Factrel)10LinearGonadotropin-releasing hormone receptorSeptember 1982Discontinued
Cyclosporine (Sandimmune)11CyclicCyclophilin-calcineurinNovember 1983Marketed
Leuprolide (Lupron)9LinearGonadotropin-releasing hormone receptor (agonist)April 1985Marketed
Calcitonin human (Cibacalcin)32CyclicCalcitonin receptorOctober 1986Discontinued
Octreotide (Sandostatin)8CyclicSomatostatin receptors 2 and 5October 1988Marketed
Goserelin (Zoladex)10LinearGonadotropin-releasing hormone receptor (agonist)December 1989Marketed
Nafarelin (Synarel)10LinearGonadotropin-releasing hormone receptor (agonist)February 1990Marketed
Sermorelin (Geref)29LinearGrowth hormone-releasing hormone receptorDecember 1990Discontinued
Histrelin (Supprelin)9LinearGonadotropin-releasing hormone receptor (agonist)December 1991Marketed
Indium In 111 pentetreotide (OctreoScan)8RadiolabelledSomatostatin receptor 2June 1994Marketed
Corticorelin ovine triflutate (Acthrel)41LinearCorticotropin-releasing hormone receptor 1May 1996Discontinued
Eptifibatide (Integrilin)7CyclicIntegrin alphaIIb beta3 (GPIIb/IIIa)May 1998Marketed
Technetium Tc 99m apcitide (AcuTect)13RadiolabelledIntegrin alphaIIb beta3 (GPIIb/IIIa)September 1998Discontinued
Ganirelix10LinearGonadotropin-releasing hormone receptor (antagonist)July 1999Marketed
Technetium Tc 99m depreotide (NeoTect)10RadiolabelledSomatostatin receptors 2, 3 and 5August 1999Discontinued
Quinupristin (Synercid)6CyclicBacterial 50S ribosomeSeptember 1999Marketed
Triptorelin (Trelstar)10LinearGonadotropin-releasing hormone receptor (agonist)June 2000Marketed
Cetrorelix (Cetrotide)10LinearGonadotropin-releasing hormone receptor (antagonist)August 2000Marketed
Bivalirudin (Angiomax)20LinearThrombinDecember 2000Marketed
Caspofungin (Cancidas)6LipidatedBeta-1,3-glucan synthaseJanuary 2001Marketed
Nesiritide (Natrecor)32CyclicNatriuretic peptide receptor AAugust 2001Discontinued
Teriparatide (Forteo)34LinearParathyroid hormone 1 receptorNovember 2002Marketed
Enfuvirtide (Fuzeon)36LinearHIV-1 gp41March 2003Discontinued
Daptomycin (Cubicin)13LipidatedBacterial cell membrane (calcium dependent)September 2003Marketed
Abarelix (Plenaxis)10LinearGonadotropin-releasing hormone receptor (antagonist)November 2003Discontinued
Human secretin (ChiRhoStim)27LinearSecretin receptorApril 2004Marketed
Ziconotide (Prialt)25CyclicN-type calcium channel (Cav2.2)December 2004Marketed
Micafungin (Mycamine)6LipidatedBeta-1,3-glucan synthaseMarch 2005Marketed
Pramlintide (Symlin)37CyclicAmylin receptorsMarch 2005Discontinued
Exenatide (Byetta)39LinearGLP-1 receptorApril 2005Marketed
Anidulafungin (Eraxis)6LipidatedBeta-1,3-glucan synthaseFebruary 2006Marketed
Lanreotide (Somatuline Depot)8CyclicSomatostatin receptors 2 and 5August 2007Marketed
Degarelix (Firmagon)10LinearGonadotropin-releasing hormone receptor (antagonist)December 2008Marketed
Telavancin (Vibativ)7GlycopeptideD-Ala-D-Ala terminus of peptidoglycan precursors; bacterial membraneSeptember 2009Marketed
Liraglutide (Victoza)31LipidatedGLP-1 receptorJanuary 2010Marketed
Tesamorelin (Egrifta)44LinearGrowth hormone-releasing hormone receptorNovember 2010Marketed
Icatibant (Firazyr)10LinearBradykinin B2 receptorAugust 2011Marketed
Lucinactant (Surfaxin)21LinearLung surfactant (mimics surfactant protein B)March 2012Discontinued
Peginesatide (Omontys)21PEGylatedErythropoietin receptorMarch 2012Discontinued
Linaclotide (Linzess)14CyclicGuanylate cyclase CAugust 2012Marketed
Pasireotide (Signifor)6CyclicSomatostatin receptors 1, 2, 3 and 5December 2012Marketed
Teduglutide (Gattex)33LinearGLP-2 receptorDecember 2012Marketed
Dalbavancin (Dalvance)7GlycopeptideD-Ala-D-Ala terminus of peptidoglycan precursorsMay 2014Marketed
Oritavancin (Orbactiv)7GlycopeptideD-Ala-D-Ala terminus of peptidoglycan precursors; bacterial membraneAugust 2014Marketed
Gallium Ga 68 dotatate (NETSPOT)8RadiolabelledSomatostatin receptor 2June 2016Marketed
Lixisenatide (Adlyxin)44LinearGLP-1 receptorJuly 2016Marketed
Plecanatide (Trulance)16CyclicGuanylate cyclase CJanuary 2017Marketed
Etelcalcetide (Parsabiv)8LinearCalcium-sensing receptorFebruary 2017Marketed
Abaloparatide (Tymlos)34LinearParathyroid hormone 1 receptorApril 2017Marketed
Semaglutide (Ozempic)31LipidatedGLP-1 receptorDecember 2017Marketed
Angiotensin II (Giapreza)8LinearAngiotensin II type 1 receptorDecember 2017Marketed
Lutetium Lu 177 dotatate (Lutathera)8RadiolabelledSomatostatin receptor 2January 2018Marketed
Bremelanotide (Vyleesi)7CyclicMelanocortin receptors (MC4R)June 2019Marketed
Gallium Ga 68 edotreotide8RadiolabelledSomatostatin receptor 2August 2019Marketed
Afamelanotide (Scenesse)13LinearMelanocortin 1 receptorOctober 2019Marketed
Copper Cu 64 dotatate (Detectnet)8RadiolabelledSomatostatin receptor 2September 2020Marketed
Setmelanotide (Imcivree)8CyclicMelanocortin 4 receptorNovember 2020Marketed
Voclosporin (Lupkynis)11CyclicCyclophilin-calcineurinJanuary 2021Marketed
Melphalan flufenamide (Pepaxto)2Peptide-drug conjugateDNA (alkylating payload released by aminopeptidases)February 2021Withdrawn
Dasiglucagon (Zegalogue)29LinearGlucagon receptorMarch 2021Discontinued
Pegcetacoplan (Empaveli)15PEGylatedComplement C3May 2021Marketed
Difelikefalin (Korsuva)4LinearKappa opioid receptor (peripheral)August 2021Marketed
Vosoritide (Voxzogo)39CyclicNatriuretic peptide receptor BNovember 2021Marketed
Tirzepatide (Mounjaro)39LipidatedGIP and GLP-1 receptorsMay 2022Marketed
Terlipressin (Terlivaz)12CyclicVasopressin V1 receptor (prodrug of lysine vasopressin)September 2022Marketed
Trofinetide (Daybue)3LinearNot established (IGF-1 tripeptide analog)March 2023Marketed
Rezafungin (Rezzayo)6LipidatedBeta-1,3-glucan synthaseMarch 2023Marketed
Motixafortide (Aphexda)14CyclicCXCR4September 2023Marketed
Zilucoplan (Zilbrysq)15LipidatedComplement C5October 2023Marketed
Palopegteriparatide (Yorvipath)34PEGylatedParathyroid hormone 1 receptorAugust 2024Marketed
Elamipretide (Forzinity)4LinearCardiolipin (inner mitochondrial membrane)September 2025Marketed
Navepegritide (Yuviwel)38PEGylatedNatriuretic peptide receptor BFebruary 2026Marketed
Icotrokinra (Icotyde)13CyclicInterleukin-23 receptorMarch 2026Marketed
Bulevirtide (Hepcludex)47LipidatedSodium taurocholate cotransporting polypeptide (NTCP)May 2026Marketed
Enlicitide (Lipfendra)Not statedCyclicPCSK9July 2026Marketed
Rusfertide (Mimrylo)17LipidatedFerroportin (hepcidin mimetic)August 2026Marketed
Table 4. Peptide drugs approved by the FDA. All 98 molecules of 2 to 50 amino acids, in order of first approval, as of October 29, 2026. The brand is the first approved product, which for some old antibiotics is a combination; length counts amino acid residues, and status is the US marketing status in Drugs@FDA or the Purple Book. Sources: Drugs@FDA (2026), FDA Purple Book (2026), DailyMed (2026), FDA (2024).[1][2][7][3]

How we counted

We started from every active ingredient in the Drugs@FDA data files of October 28, 2026 whose name carries a peptide naming stem (such as -tide, -relin, -relix, -pressin or -fungin) or names a known peptide hormone or antibiotic, then checked every new molecular entity approved from 2015 to 2026 in the same files, and the FDA's 2026 novel approvals list, for anything the names missed.[1][8]

Lengths and structures come from section 11 of each drug's prescribing information.[7] Each molecule's first approval is the earliest dated original approval across all of its applications. Melphalan flufenamide, removed from Drugs@FDA after its approval was withdrawn, is dated from the FDA's withdrawal decision, which records its February 2021 approval.[3]

Drugs@FDA leaves applications approved before 1982 undated, so six drugs whose only early records are undated old applications are dated "before 1982". Very old antibiotics appear under former antibiotic certifications, whose dates can be later than the drug's first sale.

Marketing status is "marketed" when any approved product containing the peptide, alone or in a combination, is listed for prescription or over-the-counter sale. For the peptides now licensed as biologics we used the Purple Book's status instead.[2] Share of novel approvals uses the yearly totals published by the FDA's Center for Drug Evaluation and Research.[8]

The full dataset lists each peptide's INN, first brand, length, structure, modification, class, origin, target, therapeutic area, first approval date and application, all application numbers, biologic status, routes and US status, plus 19 related products that are not counted, with the reason.

A summary file holds the counts by decade, class, origin, therapeutic area, route and year. The data are free to reuse under CC BY 4.0 with credit to ProteinIQ; we last checked them on October 29, 2026 and recheck them every quarter.