FDA Approval Directory
Peptide therapeutics and related drugs covered by this reference, with approval status and labeled indications shown for each record.
FDA approval applies only to the labeled indication, population, and dosing.
Showing 28 of 28 approval records
Bulevirtide
FDA ApprovedApproval applies only to specific labeled indications, populations, and dosing.Hepcludex · 22 May 2026 · HBV/HDV entry inhibitor (lipopeptide)
Indication: Chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis. Granted accelerated approval based on reduction in HDV RNA and ALT normalization (Phase 3 MYR301, Week 48); clinical-outcome benefit not yet established and continued approval may depend on confirmatory trial.
Dosing, mechanism & source
Mechanism: 47-amino-acid myristoylated pre-S1-derived lipopeptide that binds and inactivates the sodium taurocholate co-transporting polypeptide (NTCP) on hepatocytes, blocking viral entry. Administered by subcutaneous injection.
Icotrokinra
FDA ApprovedApproval applies only to specific labeled indications, populations, and dosing.Icotyde · 17 March 2026 · IL-23 Receptor Antagonist (oral macrocyclic peptide)
Indication: Moderate-to-severe plaque psoriasis in patients 12 years and older weighing at least 40 kg who are candidates for systemic therapy or phototherapy
Dosing, mechanism & source
Mechanism: Oral macrocyclic peptide that selectively blocks the IL-23 receptor, inhibiting the IL-23/Th17 inflammatory pathway. First-in-class oral peptide for autoimmune disease.
Navepegritide
FDA ApprovedApproval applies only to specific labeled indications, populations, and dosing.Yuviwel · 27 February 2026 · CNP Analog (PEGylated C-type Natriuretic Peptide)
Indication: Increase linear growth in pediatric patients 2 years and older with achondroplasia with open epiphyses
Dosing, mechanism & source
Mechanism: PEGylated CNP analog activates NPR-B receptor signaling to promote endochondral bone growth at growth plates. SC injection.
Orforglipron
FDA ApprovedApproval applies only to specific labeled indications, populations, and dosing.Foundayo · 1 April 2026 · GLP-1 Receptor Agonist (oral small molecule)
Indication: Obesity or overweight with at least one weight-related comorbidity in adults; combined with reduced-calorie diet and increased physical activity
Dosing, mechanism & source
Mechanism: Non-peptide small molecule that activates GLP-1 receptors orally, reducing appetite and improving glycemic signaling. First oral GLP-1 RA approved for weight management.
Pegzilarginase-nbln
FDA ApprovedApproval applies only to specific labeled indications, populations, and dosing.Loargys · 23 February 2026 · PEGylated Recombinant Enzyme (arginase 1)
Indication: Hyperarginemia in adults and pediatric patients 2 years and older with Arginase 1 Deficiency, in conjunction with dietary protein restriction
Dosing, mechanism & source
Mechanism: PEGylated recombinant human arginase 1 degrades L-arginine to prevent toxic accumulation in Arginase 1 Deficiency. IV infusion.
Rusfertide
FDA ApprovedApproval applies only to specific labeled indications, populations, and dosing.MIMRYLO · 28 August 2026 · Hepcidin-mimetic peptide
Indication: Treatment of erythrocytosis in adults with polycythemia vera. Approved as an addition to standard-of-care therapy (phlebotomy and/or cytoreductive agents), based on the Phase 3 VERIFY trial. This is a narrow hematology-oncology indication; the approval does not extend to polycythemia vera generally.
Dosing, mechanism & source
Mechanism: Binds ferroportin and induces its internalization and degradation, blocking cellular iron export and limiting the iron supply available for erythropoiesis.
Elamipretide
FDA ApprovedAccelerated approval — Barth syndrome onlyApproval applies only to specific labeled indications, populations, and dosing.Forzinity · 19 September 2025 · Mitochondria-targeted tetrapeptide
Indication: Accelerated approval — Barth syndrome only. Indicated to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. This approval does not cover research, wellness, or other uses of SS-31/elamipretide.
Dosing, mechanism & source
Mechanism: Binds cardiolipin on the inner mitochondrial membrane, improving mitochondrial structure and function.
Tirzepatide
FDA ApprovedApproval applies only to specific labeled indications, populations, and dosing.Mounjaro, Zepbound · 2022
Indication: Type 2 diabetes (Mounjaro). Chronic weight management (Zepbound). Moderate-to-severe obstructive sleep apnea in adults with obesity (Zepbound), approved 2024-12-20, based on the SURMOUNT-OSA trials. Reduction of major adverse cardiovascular events (cardiovascular death, non-fatal heart attack, or non-fatal stroke) in adults with type 2 diabetes at high cardiovascular risk (Mounjaro), approved 2026-08-28, based on the SURPASS-CVOT trial versus dulaglutide as active comparator (hazard ratio 0.92, 95.3% CI 0.83-1.01) — a non-inferiority result; the sponsor states superiority to dulaglutide was not established.
Dosing, mechanism & source
Typical dosing: 2.5-15 mg (weekly)
Bremelanotide
FDA ApprovedApproval applies only to specific labeled indications, populations, and dosing.Vyleesi · 21 June 2019 · Melanocortin receptor agonist
Indication: Acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women
Dosing, mechanism & source
Typical dosing: 1.75 mg (As needed, at least 45 minutes before anticipated sexual activity (maximum one dose per 24 hours, no more than 8 doses per month))
Mechanism: Cyclic 7-amino-acid melanocortin receptor agonist (non-selective, with activity at the melanocortin-4 receptor, MC4R) thought to act on neural pathways regulating sexual response. Also known as PT-141. Administered by subcutaneous injection.
Abaloparatide
FDA ApprovedApproval applies only to specific labeled indications, populations, and dosing.Tymlos · 2017
Indication: Postmenopausal osteoporosis
Dosing, mechanism & source
Typical dosing: 80 mcg (daily)
Semaglutide
FDA ApprovedApproval applies only to specific labeled indications, populations, and dosing.Ozempic, Wegovy, Rybelsus · 2017
Indication: Type 2 diabetes (Ozempic). Chronic weight management (Wegovy). Cardiovascular risk reduction in adults with known cardiovascular disease and obesity or overweight (Wegovy), approved 2024-03-08, based on the SELECT trial. Reduction of the risk of kidney disease progression, kidney failure, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease (Ozempic), approved 2025-01-28, based on the FLOW trial. Noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate-to-advanced liver fibrosis, but not cirrhosis (Wegovy) — accelerated approval; continued approval for this indication may depend on an ongoing confirmatory trial, approved 2025-08-15. Oral tablet formulation (Wegovy) for chronic weight management and cardiovascular risk reduction, approved 2025-12-22 — the first oral GLP-1 receptor agonist peptide approved for weight management. Higher-dose 7.2 mg injection (Wegovy HD) for chronic weight management, approved 2026-03-19 under the FDA Commissioner's National Priority Voucher program.
Dosing, mechanism & source
Typical dosing: 0.25-2.4 mg (weekly)
Dulaglutide
FDA ApprovedApproval applies only to specific labeled indications, populations, and dosing.Trulicity · 2014
Indication: Type 2 diabetes (Trulicity). Reduction of major adverse cardiovascular events in adults with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk factors (Trulicity), approved 2020-02-21, based on the REWIND trial.
Dosing, mechanism & source
Typical dosing: 0.75-4.5 mg (weekly)
Metreleptin (No profile yet)
FDA ApprovedApproval applies only to specific labeled indications, populations, and dosing.Myalept · 2014
Indication: Leptin deficiency in generalized lipodystrophy
Dosing, mechanism & source
Typical dosing: 2.5-10 mg (Daily subQ)
Pasireotide
FDA ApprovedApproval applies only to specific labeled indications, populations, and dosing.Signifor · 2012
Indication: Cushing's disease
Dosing, mechanism & source
Typical dosing: 0.3-0.9 mg (twice daily)
Liraglutide
FDA ApprovedApproval applies only to specific labeled indications, populations, and dosing.Victoza, Saxenda · 2010
Indication: Type 2 diabetes (Victoza), Weight management (Saxenda)
Dosing, mechanism & source
Typical dosing: 0.6-3.0 mg (daily)
Tesamorelin
FDA ApprovedApproval applies only to specific labeled indications, populations, and dosing.Egrifta · 2010
Indication: HIV-associated lipodystrophy
Dosing, mechanism & source
Typical dosing: 2 mg (daily)
Lanreotide
FDA ApprovedApproval applies only to specific labeled indications, populations, and dosing.Somatuline · 2007
Indication: Acromegaly, neuroendocrine tumors
Dosing, mechanism & source
Typical dosing: 60-120 mg (monthly)
Exenatide
FDA ApprovedApproval applies only to specific labeled indications, populations, and dosing.Byetta, Bydureon · 2005
Indication: Type 2 diabetes
Dosing, mechanism & source
Typical dosing: 5-10 mcg or 2 mg (twice-daily or weekly)
Pramlintide
FDA ApprovedApproval applies only to specific labeled indications, populations, and dosing.Symlin · 2005
Indication: Diabetes (adjunct to insulin)
Dosing, mechanism & source
Typical dosing: 60-120 mcg (with meals)
Teriparatide
FDA ApprovedApproval applies only to specific labeled indications, populations, and dosing.Forteo · 2002
Indication: Osteoporosis
Dosing, mechanism & source
Typical dosing: 20 mcg (daily)
Bivalirudin
FDA ApprovedApproval applies only to specific labeled indications, populations, and dosing.Angiomax · 2000
Indication: Anticoagulation during cardiac procedures
Dosing, mechanism & source
Typical dosing: IV administration (procedural)
Sermorelin
Approval withdrawnNo longer FDA-approved. Withdrawal may reflect safety, efficacy, or commercial reasons — review the primary source.Sermorelin Acetate · 1997
Indication: Growth hormone deficiency in children
Dosing, mechanism & source
Typical dosing: 200-500 mcg (daily)
Octreotide
FDA ApprovedApproval applies only to specific labeled indications, populations, and dosing.Sandostatin · 1988
Indication: Acromegaly, carcinoid syndrome
Dosing, mechanism & source
Typical dosing: 50-500 mcg (multiple times daily)
Calcitonin
FDA ApprovedApproval applies only to specific labeled indications, populations, and dosing.Miacalcin, Fortical · 1984
Indication: Osteoporosis, Paget's disease
Dosing, mechanism & source
Typical dosing: 100-200 IU (daily)
Insulin
FDA ApprovedApproval applies only to specific labeled indications, populations, and dosing.Humalog, Novolog, Lantus, many others · 1982
Indication: Diabetes management
Dosing, mechanism & source
Typical dosing: Individualized (varies)
Gonadorelin
DiscontinuedNot currently marketed. This describes availability, not whether the approval remains in effect.Factrel · 1980
Indication: Hypogonadotropic hypogonadism
Dosing, mechanism & source
Typical dosing: 100 mcg (as prescribed)
Oxytocin
FDA ApprovedApproval applies only to specific labeled indications, populations, and dosing.Pitocin · 1980
Indication: Labor induction, postpartum bleeding
Dosing, mechanism & source
Typical dosing: IV administration (as prescribed)
Desmopressin
FDA ApprovedApproval applies only to specific labeled indications, populations, and dosing.DDAVP, Stimate · 1978
Indication: Diabetes insipidus, hemophilia A
Dosing, mechanism & source
Typical dosing: 0.1-0.4 mg (varies)
About this directory
This is a curated directory. It reflects the approval records currently indexed by PeptideSciences101 and is not an exhaustive list of every FDA-approved drug.
Each record shows the status of one specific approval. Approval covers only the labeled indication, population and dosing recorded against it, and never a whole molecule or drug class. Approval status and marketing status are recorded separately, so a product whose approval was withdrawn and one that is simply no longer marketed are not shown as the same thing.
Compounded preparations are excluded. Compounding is not FDA approval and does not establish safety or efficacy, even where a licensed pharmacy may prepare a substance against a valid prescription.
Research-only and investigational compounds are not approval records and are not listed here. They live in the main peptide index; see FDA-approved vs research-only peptides for how the categories differ.
Where a record has no linked profile, or a profile has no approval record, that gap is listed under Data coverage below rather than being filled with an assumption.
Data coverage
28 FDA approval records · 27 with a linked peptide profile · latest approval 28 August 2026 · Source: FDA Drugs@FDA ↗
- Metreleptin currently has an approval record but no linked profile.
- Somatropin has a profile but is not yet represented in the approval-record dataset.
- These two figures count different things and are not expected to match: this directory counts FDA approval records, the peptide index counts profiles.