Every FDA-Approved Peptide Drug, Explained (2026 Edition)

How this list is built

A drug is on this list for one reason: Drugs@FDA, the agency's database of approved drugs, records an original approval of a new drug application (NDA) or biologics licence application (BLA) for it, read on October 1, 2026.¹ Not reputation, not a press release, not a clinic's claim. Generic applications, including tentative approvals of generics, never count as a drug's first approval.

That rule matters more than it sounds, because many compounds sold as peptides are described as if they had been approved. Our own encyclopedia records 14 compounds whose development was discontinued before any approval — the database calls them "discontinued", the same word it uses for approved drugs later taken off the market. Building this list from that word would have called all 14 FDA-approved. They are listed further down, by name, because they are the ones most often misdescribed.

Two more things to know when reading the dates. The date shown is the earliest original approval Drugs@FDA records for the drug, which for very old drugs is not always the date it first reached patients: vasopressin was in clinical use for decades before its first approval recorded there, Vasostrict in 2014. And a drug can be approved and not available: approval is a legal status, marketing is a business decision, and the status column says which applies today.

Where FDA draws the line between a peptide and a protein

"Peptide" has no single scientific definition, but FDA has a regulatory one, and it decides how a drug is approved. Under a final rule published in February 2020 and effective March 23, 2020, FDA interprets "protein" to mean any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size.² Proteins are licensed as biologics; a peptide of 40 amino acids or fewer is approved as a drug.

The application type in Drugs@FDA therefore tells you which side of the line FDA put a molecule on, and this article follows FDA rather than the looser scientific habit of calling anything short and hormone-like a peptide. The consequences are worth seeing:

• Just over the line. Tesamorelin and lixisenatide, at 44 amino acids, and corticorelin, at 41, are often called peptides, and are licensed as biologics. They appear in the second table.
• Insulin. At 51 amino acids across its two chains, insulin is a protein under the rule, and insulin products moved from drug applications to biologics licences in March 2020 — which is why every insulin here carries a BLA number.
• Glatiramer. A random polymer of four amino acids with no single defined sequence, so the protein definition does not reach it and it is regulated as a drug. It sits in the peptide table with that noted.
• Old numbers. Two protein hormones that are no longer marketed, urofollitropin and lutropin alfa, still appear under drug application numbers. They are proteins by FDA's definition and sit in the protein table regardless.

Peptides: 56 approved drugs of 40 amino acids or fewer

Sorted by class, then by date. Each name links to its encyclopedia entry; the application number is the one behind the earliest approval. Grades come from our encyclopedia and cover all human evidence for each compound.

Larger peptide hormones and proteins: 35 above FDA's 40-amino-acid line

These are licensed as biologics. The encyclopedia covers them because they sit in the same hormone systems as the peptides above — the insulins, growth hormone and its long-acting versions, the gonadotropins — or because they are sold or discussed alongside them. Two are monoclonal antibodies, marked by class.

The approvals of the 2020s

Of the drugs on both lists, 17 were first approved in 2020 or later: 2 in 2020, 2 in 2021, 2 in 2022, 2 in 2023, 1 in 2025, 8 in 2026. Three patterns stand out in the data.

The first is the move to longer intervals. Growth hormone went weekly with somapacitan (2020), lonapegsomatropin (2021) and somatrogon (2023), and basal insulin followed in 2026 with two once-weekly insulins, insulin icodec and insulin efsitora alfa. The second is peptides taken by mouth, which used to be a contradiction: the 2026 approvals include icotrokinra, an oral peptide that blocks the IL-23 receptor, and enlicitide, an oral macrocyclic peptide that inhibits PCSK9 to lower LDL cholesterol. The third is rare disease: setmelanotide for genetic obesity syndromes (2020), vosoritide (2021) and navepegritide (2026) for achondroplasia, elamipretide for Barth syndrome (2025), and rusfertide, a hepcidin mimetic, in 2026.

Not everything approved in this space is a peptide. Orforglipron, approved in April 2026 as a GLP-1 receptor agonist, is a small molecule, and is left off for that reason along with four others; the 2026 list also includes two monoclonal antibodies, apitegromab and garetosmab, which appear in the protein table by class. FDA's own list of novel approvals for 2026 records the year's new drugs as they are approved.³

Six decades of approvals

Counted by the earliest original approval Drugs@FDA records for each drug on both lists. Read the early decades as a floor: some older hormones were in clinical use long before the first approval recorded there — vasopressin's is 2014 — so a date marks a record, not a debut.

What each approved drug is for

One line per drug, grouped by class and in order of approval, taken from each drug's own encyclopedia entry, where the indication, the trials behind it and the label are set out in full with their sources.

Anti-infectives

• Bacitracin — The topical first-aid antibiotic — one of the most widely used over-the-counter peptide antibiotics, found in virtually every household first-aid kit.
• Polymyxin B — The gram-negative last resort — a cyclic lipopeptide antibiotic revived from the 1950s as a critical weapon against carbapenem-resistant Acinetobacter, Pseudomonas, and Klebsiella.
• Colistin — Polymyxin B's sibling — a cyclic lipopeptide antibiotic revived from the 1950s as the ultimate weapon against pan-drug-resistant gram-negative bacteria, despite significant nephrotoxicity.
• Gramicidin — One of the first antibiotics, isolated in 1939: too toxic to swallow or inject, still used in combination eye and ear drops.
• Vancomycin — The IV antibiotic for resistant staphylococci and the oral one for C. difficile, now dosed by drug levels and beaten head-to-head by newer drugs.
• Daptomycin — A last-resort lipopeptide antibiotic — the first-in-class cyclic peptide that kills MRSA and VRE by depolarizing bacterial membranes, without resistance through traditional mechanisms.

Blood cell production

• Erythropoietin (EPO) — A glycoprotein hormone that drives red blood cell production; recombinant forms are FDA-approved standards of care for anemia of chronic kidney disease and chemotherapy-induced anemia, and have a notorious history of misuse in endurance sport.
• Romiplostim — A peptibody that boosts platelet production — an Fc-fused peptide mimicking thrombopoietin, FDA-approved for immune thrombocytopenia.

Bone and growth plate

• Calcitonin — The hormone that switches off bone-dissolving cells: one 1,255-woman fracture trial, and a later option now that stronger drugs exist.
• Teriparatide — The first 34 amino acids of parathyroid hormone, injected at 20 micrograms once a day to build bone. Approved as Forteo for osteoporosis at high fracture risk: in the 1,360-woman VERO trial, new spine fractures occurred in 5.4% against 12.0% on risedronate over two years. Fracture-healing trials found no clear benefit.
• Vosoritide — The first drug approved for achondroplasia — a CNP analog that stimulates endochondral bone growth by counteracting overactive FGFR3 signaling.
• Navepegritide — The weekly achondroplasia treatment — a PEGylated CNP prodrug approved in 2026 that provides continuous growth plate stimulation with once-weekly dosing.

Digestive system

• Cholecystokinin — The gut hormone that empties the gallbladder after meals; its octapeptide, sincalide (Kinevac), is FDA-approved for diagnostic tests.
• Secretin — The first hormone ever discovered — a 27-amino-acid gut peptide that stimulates pancreatic bicarbonate secretion and opened the entire field of endocrinology in 1902.
• Linaclotide — An oral peptide that works inside the bowel, approved for IBS with constipation and for constipation from the age of two.
• Plecanatide — A uroguanylin copy that draws water into the gut: approved as Trulance for chronic constipation and IBS-C, boxed warning under age 6.

Growth hormone and somatostatin axis

• Somatropin (HGH) — FDA-approved recombinant human growth hormone — the direct hormone replacement, with multiple clinical indications, prescription-only status, and specific federal criminal provisions against off-label distribution.
• Octreotide — The first-generation somatostatin analog (FDA-approved as Sandostatin, 1988) — the pharmacological counterweight to growth-hormone excess. Used for acromegaly, carcinoid syndrome, and VIPoma; now available in injectable, LAR-depot, and oral (Mycapssa, 2020) formulations.
• Sermorelin — GHRH's first 29 amino acids, sold in the US as Geref (approved 1990 and 1997) to test and treat childhood growth hormone deficiency until it was discontinued, not for safety reasons.
• Pegvisomant — Pfizer's GH receptor antagonist (Somavert) — FDA-approved in 2003 for acromegaly; important to distinguish from GH agonists because it does the opposite (blocks GH action rather than supplementing it).
• Mecasermin — Ipsen's recombinant human IGF-1 (Increlex) — FDA-approved in 2005 for severe primary IGF-1 deficiency; the direct replacement for IGF-1 in patients whose own IGF-1 production is inadequate despite normal GH levels.
• Mecasermin rinfabate — IGF-1 delivered bound to its carrier protein: approved in 2005 as iPlex, now listed as discontinued in the US.
• Lanreotide — A long-acting somatostatin analogue injected every 28 days, sold as Somatuline Depot for acromegaly, gastroenteropancreatic neuroendocrine tumours and carcinoid syndrome. In the 204-patient CLARINET trial it more than halved the risk of progression or death, with 65% progression-free at 24 months against 33% on placebo.
• Tesamorelin — An FDA-approved GHRH analog for reducing excess visceral fat in HIV-associated lipodystrophy.
• Pasireotide — The somatostatin analog for Cushing's disease — the only FDA-approved medical therapy targeting pituitary ACTH secretion, with uniquely broad somatostatin receptor affinity.
• Lutetium-177 DOTATATE — A targeted radiotherapy peptide — a somatostatin analog armed with a radioactive warhead that delivers lethal radiation directly to neuroendocrine tumor cells expressing sst2 receptors.
• Somapacitan — Novo Nordisk's once-weekly growth hormone (Sogroya) — FDA-approved in 2020 for adult GH deficiency and in 2023 for pediatric GH deficiency in children aged 2.5+ years.
• Lonapegsomatropin — Ascendis Pharma's once-weekly growth hormone prodrug (Skytrofa) — the first weekly GH to receive FDA approval (August 2021) for pediatric GH deficiency in patients aged 1+ years weighing at least 11.5 kg.
• Somatrogon — Pfizer/OPKO's once-weekly growth hormone (Ngenla) — FDA-approved in June 2023 for pediatric GH deficiency in children aged 3+ years; uses a CTP-fusion strategy borrowed from long-acting follitropin alfa.

Heart, blood vessels and clotting

• Eptifibatide — A cyclic heptapeptide that blocks platelet glycoprotein IIb/IIIa, modelled on barbourin from the venom of the southeastern pigmy rattlesnake. FDA-approved as Integrilin on May 18, 1998 for acute coronary syndromes and coronary intervention; now sold as generics.
• Bivalirudin — Angiomax — the workhorse direct thrombin inhibitor for percutaneous coronary intervention. FDA-approved December 2000 (The Medicines Company, now Sandoz); the first synthetic peptide DTI to achieve broad PCI adoption. REPLACE-2, ACUITY, and HORIZONS-AMI trials established the anticoagulant profile; subsequent MATRIX trial outcomes shifted practice in some populations back toward heparin.
• Nesiritide — Recombinant human B-type natriuretic peptide, sold in the US as Natrecor for acute heart failure. In the 7,141-patient ASCEND-HF trial it did not change death or readmission and had only a small, non-significant effect on breathlessness; Drugs@FDA lists Natrecor as discontinued.
• Icatibant — The bradykinin blocker for angioedema — a synthetic decapeptide B2 receptor antagonist that stops acute swelling attacks within 30 minutes.
• Angiotensin II — The body's blood-pressure hormone as an ICU drug: Giapreza raised pressure in seven of ten patients in shock; survival did not significantly change.
• SS-31 (Elamipretide) — The first FDA-approved mitochondria-targeted peptide therapeutic — approved September 2025 as Forzinity for Barth syndrome, with broader investigation in heart failure, macular degeneration, and aging.

Immune system and antibodies

• Glatiramer Acetate — A synthetic peptide polymer for multiple sclerosis — one of the first disease-modifying therapies for MS, mimicking myelin basic protein to shift the immune response from attack to tolerance.
• Zilucoplan — A self-injectable complement inhibitor — a synthetic macrocyclic peptide that blocks C5 complement activation, FDA-approved for generalized myasthenia gravis as a daily subcutaneous injection.
• Icotrokinra — Johnson & Johnson's oral IL-23 receptor-blocking peptide, approved by FDA as Icotyde on March 17, 2026 for moderate-to-severe plaque psoriasis from age 12: in two phase 3 trials 68-70% had clear or almost clear skin at week 16.
• Garetosmab — An anti-activin A antibody approved in 2026 for fibrodysplasia ossificans progressiva, after a phase 2 that missed its primary endpoint.
• Apitegromab — ⚠ Monoclonal antibody, not a peptide. Scholar Rock's antibody against the proforms of myostatin, FDA-approved on September 11, 2026 as Isembyld for spinal muscular atrophy in patients 2 and older already on an SMN2-targeted treatment.

Incretins, glucagon, amylin and gut hormones

• Glucagon — Insulin's counterweight and the rescue drug for severe low blood sugar, now sold as a nasal powder and a ready-filled pen.
• Pramlintide — The FDA-approved amylin analog (Symlin, 2005) — taken at mealtimes alongside insulin in T1D and T2D. The pharmacological proof-of-concept for amylin agonism that petrelintide and cagrilintide are now building on.
• Exenatide — The first GLP-1 receptor agonist (Byetta, 2005), a synthetic copy of a Gila monster venom peptide: safe for the heart in EXSCEL without proving benefit, outperformed by weekly semaglutide head to head, and negative in a phase 3 Parkinson's trial.
• Liraglutide — The first once-daily GLP-1 analog to be FDA-approved for both type 2 diabetes (Victoza) and chronic weight management (Saxenda).
• Teduglutide — FDA-approved GLP-2 analog (Gattex/Revestive, 2012) for short-bowel syndrome — the first disease-modifying treatment for SBS, reducing parenteral nutrition dependence by promoting intestinal mucosal growth.
• Albiglutide — A once-weekly GLP-1 receptor agonist made by fusing two copies of GLP-1 to human albumin. FDA-approved in 2014 as Tanzeum and now discontinued, it cut major cardiovascular events by 22% against placebo in Harmony Outcomes.
• Dulaglutide — A once-weekly GLP-1 receptor agonist built on an antibody fragment (Trulicity), approved since 2014 for type 2 diabetes in adults and children 10 and older. In REWIND it cut major cardiovascular events by 12%; semaglutide beat it head to head.
• Lixisenatide — A short-acting, prandial GLP-1 agonist primarily used to target postprandial glucose excursions.
• Semaglutide — A once-weekly GLP-1 receptor agonist FDA-approved for type 2 diabetes and chronic weight management.
• Tirzepatide — A once-weekly GLP-1/GIP dual agonist that produced unprecedented weight loss in SURMOUNT trials — up to ~21% at highest dose.

Insulins

• NPH insulin (isophane) — The classical intermediate-acting insulin — regular human insulin co-crystallized with protamine to produce ~12-hour action; still widely used for cost reasons despite being largely superseded by analog basal insulins for T1DM.
• Regular human insulin — The original recombinant human insulin (Humulin R, 1982) — unmodified native sequence, short-acting kinetics driven by hexamer self-association; U-500 concentration for severely insulin-resistant patients.
• Insulin lispro — The first FDA-approved rapid-acting insulin analog (Humalog, Lilly, 1996) — the B28–B29 position swap prevents hexamer self-association, producing faster subcutaneous absorption than regular human insulin.
• Insulin glargine — The dominant once-daily basal insulin for two decades (Lantus, Sanofi, 2000) — the pI-shift design causes microprecipitation in subcutaneous tissue for a nearly peakless 24-hour absorption profile; Toujeo (U-300) is the same molecule at 3× concentration.
• Insulin aspart — Novo Nordisk's rapid-acting insulin analogue (NovoLog / NovoRapid, approved 2000): one amino-acid change at B28 brings its peak to 40–50 minutes after injection, against 80–120 for regular human insulin. Fiasp (2017) adds niacinamide and L-arginine for faster early absorption, and US biosimilars followed from 2025.
• Insulin glulisine — Sanofi's rapid-acting insulin analog (Apidra, 2004) — the third rapid-acting analog approved, differentiated by being zinc-free in formulation, which gives it slightly faster monomeric onset than lispro or aspart.
• Insulin detemir — Novo Nordisk's fatty-acid-acylated basal insulin (Levemir, 2005) — the myristoyl chain enables reversible albumin binding, extending the half-life; Novo Nordisk announced global discontinuation in December 2023 (US supply ended 2024).
• Insulin degludec — Novo Nordisk's ultra-long-acting insulin (Tresiba, 2015) — forms soluble multi-hexamers in SC tissue that slowly dissociate for a >42-hour half-life and a flat, forgiving dosing window; the basal insulin with the lowest hypoglycemia risk profile.
• Insulin degludec / liraglutide (IDegLira) — Insulin degludec and liraglutide in one daily pen at a fixed ratio: more HbA1c lowering than either alone, with a boxed thyroid warning.
• Insulin glargine / lixisenatide (iGlarLixi) — Sanofi's fixed-ratio insulin/GLP-1 combo pen (Soliqua, FDA 2016) — 100 units/mL insulin glargine + 33 mcg/mL lixisenatide; a parallel to Xultophy, differentiated by using short-acting prandial-biased lixisenatide rather than liraglutide.
• Insulin icodec — The first once-weekly basal insulin: better HbA1c than daily insulin in type 2 diabetes, nearly double the serious hypos in type 1.
• Insulin efsitora alfa — Lilly's once-weekly basal insulin, an insulin variant fused to an antibody Fc fragment, FDA-approved in September 2026 as Onswik for adults with type 2 diabetes after four QWINT trials found HbA1c lowering non-inferior to daily basal insulin.

Lipids and iron

• Enlicitide — Merck's oral macrocyclic peptide PCSK9 inhibitor, approved by FDA as Lipfendra on July 15, 2026: one 20 mg tablet a day cut LDL cholesterol by about 56% more than placebo in its phase 3 trial.
• Rusfertide — The first hepcidin mimetic approved anywhere: it controls polycythaemia vera by starving red-cell production of iron, replacing repeated phlebotomy.

Melanocortins

• PT-141 — An FDA-approved melanocortin agonist for acquired, generalized hypoactive sexual desire disorder in premenopausal women.
• Afamelanotide — An FDA-approved selective MC1R agonist marketed as Scenesse — the first-in-class treatment for erythropoietic protoporphyria (EPP), delivered as a subdermal implant.
• Setmelanotide — An MC4 receptor agonist peptide sold as Imcivree, approved in the US for obesity due to Bardet-Biedl syndrome or POMC, PCSK1 or LEPR deficiency (from age 2) and acquired hypothalamic obesity (from age 4). In hypothalamic obesity, BMI fell 16.5% against a 3.3% rise on placebo over 52 weeks.

Nervous system and diagnostics

• Protirelin — Synthetic thyrotropin-releasing hormone (pGlu-His-Pro-NH2), once FDA-approved as the pituitary diagnostics Thypinone (1976) and Thyrel TRH (1978), both now discontinued; tried experimentally in depression, ALS and preterm lung disease.
• Corticorelin — Ferring Pharmaceuticals' synthetic ovine CRH (Acthrel) — FDA-approved diagnostic peptide used to distinguish pituitary Cushing disease from ectopic ACTH secretion via inferior petrosal sinus sampling or peripheral ACTH/cortisol response testing.
• Botulinum Toxin — A bacterial toxin that cleaves SNAP-25 to silence nerve endings: approved for migraine, bladder, spasticity and more, under a boxed warning.
• Ziconotide — A cone snail venom peptide turned FDA-approved painkiller — the first non-opioid intrathecal analgesic for severe chronic pain.

Reproductive and pituitary hormones

• HCG — A prescription fertility hormone that acts like LH: the IVF trigger and a treatment for male hypogonadism, used off-label beside testosterone on the strength of two small studies, and shown not to work for weight loss.
• Desmopressin — DDAVP — the classic V2-selective vasopressin analog. FDA-approved February 1978 for central diabetes insipidus; decades of label expansion added primary nocturnal enuresis, nocturia (Noctiva / Nocdurna), and hemostatic use in mild hemophilia A and type 1 von Willebrand disease. WHO Essential Medicines List.
• Oxytocin — An endogenous nine-amino-acid hormone with roles in labor, lactation, and social-affiliative behavior; also explored off-label for social/anxiety research.
• Gonadorelin — Synthetic GnRH, the hypothalamus's pulse signal for LH and FSH: pumped every 60 to 120 minutes it restored ovulation and sperm production in trials, but as an occasional injection beside testosterone it has never been studied.
• Leuprolide — The prototypical long-acting GnRH agonist: after a brief flare it shuts down testosterone and oestrogen, FDA-approved since 1985 in forms from a daily pen to six-month depots for prostate cancer, endometriosis, fibroids and central precocious puberty.
• Urofollitropin — Ferring's Bravelle (and earlier Fertinex) — highly purified urinary-derived FSH used for ovulation induction and IVF controlled ovarian stimulation. FDA-approved 2002; branded Bravelle was withdrawn from the US market in 2015 due to manufacturing/potency concerns but the molecule class remains available via urinary-derived menotropin combination products.
• Goserelin — Zoladex, a GnRH agonist set in a biodegradable implant placed under the skin every 28 days (3.6 mg) or 12 weeks (10.8 mg, men only). US-approved since 1989 and labelled for prostate cancer and, at 3.6 mg only, for advanced breast cancer before menopause, endometriosis and endometrial thinning.
• Nafarelin — Pfizer's Synarel — the only FDA-approved intranasal GnRH agonist. Approved for endometriosis and central precocious puberty; offers a depot-free alternative to injectable leuprolide for patients who prefer nasal dosing.
• Histrelin — A GnRH agonist implant that suppresses puberty for twelve months at a time; the prostate-cancer version has been discontinued.
• Menotropin — The urine-derived FSH and LH preparation used for IVF ovarian stimulation, still about equal to recombinant FSH in trials.
• Follitropin alfa — Recombinant human FSH (Gonal-f), approved in the US on September 29, 1997, the same day as follitropin beta: daily injections that grow ovarian follicles for ovulation induction and IVF and, with hCG, restart sperm production in men with hypogonadotropic hypogonadism.
• Follitropin beta — Organon/Merck's Follistim AQ (Puregon internationally) — a recombinant human FSH produced independently of follitropin alfa but clinically equivalent; FDA-approved 1997 for ovulation induction and IVF controlled ovarian stimulation.
• Ganirelix — The GnRH antagonist that keeps an IVF cycle from ovulating early, and cut the protocol from weeks of injections to days.
• Triptorelin — A widely used long-acting GnRH agonist — FDA-approved as Trelstar for advanced prostate cancer and as Triptodur for pediatric central precocious puberty; approved internationally (Decapeptyl, Gonapeptyl) for endometriosis, uterine fibroids, and female infertility protocols.
• Cetrorelix — Merck Serono's Cetrotide — a GnRH antagonist used during IVF controlled ovarian stimulation to block premature LH surges. Unlike GnRH agonists, produces immediate gonadotropin suppression without a flare, shortening IVF cycles.
• Abarelix — The first injectable GnRH antagonist for prostate cancer — a synthetic decapeptide that achieved castration without testosterone flare, later supplanted by degarelix and oral alternatives.
• Lutropin alfa — Recombinant human LH, given with FSH rather than alone; its largest trial found the endpoints comparable either way.
• Degarelix — An approved GnRH antagonist (Firmagon) for advanced prostate cancer: castrate testosterone by day 3 in 96% of men, no flare, but frequent injection-site reactions and an unsettled heart-safety question.
• Vasopressin — The antidiuretic hormone as an ICU vasopressor (Vasostrict, 2014): added to norepinephrine in shock, it was safe but did not lower mortality in VASST or pooled trials, did better after cardiac surgery, and its price rose steeply after a 2014 rebranding.
• Terlipressin — Terlivaz — the first and only FDA-approved drug for hepatorenal syndrome (HRS). FDA-approved September 2022 (Mallinckrodt) for adults with HRS with rapid reduction in kidney function, after a multi-decade regulatory history including four prior Complete Response Letters and the successful CONFIRM Phase 3 trial (NEJM 2021).

Approved, but not what you can buy

10 drugs on these lists have an approval and no ordinary US supply, or a supply that is ending: Sermorelin, Mecasermin rinfabate, Nesiritide, Pramlintide, Albiglutide, Insulin detemir, Protirelin, Gonadorelin, Abarelix, Lutropin alfa.

The reasons differ. Some were superseded by newer drugs in the same class; some were commercial decisions; a withdrawal is a stronger step than a discontinuation. Insulin detemir is the case where the sources disagree: Drugs@FDA still lists a marketed product, while its manufacturer has announced US discontinuation, so its status says both. In every case the approval stands as a historical fact and says nothing about whether a pharmacy can fill it today.

Never approved, though often described as if they were

These 14 compounds are in our encyclopedia, and none has an NDA or BLA approval in Drugs@FDA: ACE-031, CJC-1295, Cotadutide, Danuglipron, Elsiglutide, Ipamorelin, Langlenatide, Lixivaptan, MK-677, Omiganan, Pexiganan, Tabimorelin, Taspoglutide, Ularitide.

Several of them — CJC-1295, ipamorelin and MK-677 especially — are sold widely as research chemicals and marketed in language that implies an approval history they do not have. Some reached phase 3 and stopped; others never got that far. Each entry records how far its development went and why it ended, sourced at the time the entry was written.

Also left off, each for a stated reason: 5 FDA-approved small molecules that sit in the encyclopedia because of the hormone systems they act on (Alprostadil, Elagolix, Macimorelin, Orforglipron, Relugolix); hyaluronic acid, which is approved as a medical device rather than a drug; and the IGF-1 entry, which describes the same approved drug as the mecasermin entry and is listed once, under mecasermin.

How this list stays current

The tables are not typed by hand. They are generated from a dataset that is rebuilt from Drugs@FDA, entry by entry, and refuses to build if any lookup fails: a rate-limited or failed request is recorded as a failure, never as "no approval found". When FDA approves a new peptide, adding it to the encyclopedia and rebuilding puts it here with its application number and date. Drugs@FDA's public data feed can lag the agency's announcements by days or weeks, so for the newest approvals FDA's own novel approvals page is the faster signal.³

Corrections are welcome and are made at the source: if a row is wrong, the fix is to the entry or the lookup behind it, so the table and the encyclopedia cannot disagree.

Frequently asked questions

How many peptide drugs has FDA approved?

By FDA's own definition of a peptide — 40 amino acids or fewer — 56 on this list, each with an original approval in Drugs@FDA. Counting the larger peptide hormones and proteins the encyclopedia also covers, licensed as biologics, adds 35 more.

What peptides did FDA approve in 2026?

On these lists: navepegritide, icotrokinra, enlicitide and rusfertide among the peptides, and two once-weekly insulins plus two monoclonal antibodies in the protein table. Orforglipron was also approved in 2026 but is a small molecule, not a peptide.

Is semaglutide a peptide?

Yes. It is a modified GLP-1 analogue of 31 amino acids, approved under drug applications: first as Ozempic in December 2017, then Rybelsus and Wegovy.

Why is insulin not in the peptide table?

Because FDA defines a protein as more than 40 amino acids, and insulin has 51 across its two chains. Insulin products moved to biologics licences in March 2020.

Are CJC-1295, ipamorelin and BPC-157 FDA-approved?

No. CJC-1295 and ipamorelin both had development discontinued without approval, and neither has an NDA or BLA in Drugs@FDA. BPC-157 has no FDA approval of any kind either. Our entries set out how far each got.

Does approved mean available?

No. Approval is a legal status and marketing is a commercial decision; several drugs on this list are approved and no longer sold in the US, and the status column says which.

Related on Grey Peptides

• Regulatory tracker: FDA, 503A/503B and WADA
• Peptide encyclopedia
• Peptides vs SARMs vs steroids vs TRT
• Semaglutide

Sources

1. US Food and Drug Administration. Drugs@FDA, queried for every entry through the openFDA drugsfda endpoint on October 1, 2026: original NDA and BLA approvals, application numbers, sponsors and product marketing status. FDA
2. Food and Drug Administration (2020). Definition of the Term "Biological Product". Final rule, 85 FR 10057, published February 21, 2020, effective March 23, 2020. Read October 1, 2026. Federal Register
3. US Food and Drug Administration. Novel Drug Approvals for 2026. Content current as of September 28, 2026; read October 1, 2026. FDA

This list reports regulatory facts from FDA's own records as of October 1, 2026. It is not medical advice, and an approval says nothing about whether a drug is right for any particular person.