FDA Approved Peptides
FDA ApprovedPeptide medicines that have completed FDA review and carry an approved label for one or more specific uses. These are prescription products dispensed through licensed pharmacies under physician supervision.
AI Summary
FDA Approved Peptides on Peptides.cafe are approved by the u.s. fda for one or more specific indications. This hub lists 70 peptides in this classification, each with a mechanism of action, commonly researched wellness goals, a research summary, safety considerations, and primary references. Classification is educational and describes regulatory status only — it is not medical advice and does not indicate suitability for any individual.
All fda approved peptides (70)
PTHrP analog for postmenopausal osteoporosis.
Echinocandin lipopeptide for invasive Candida infections.
Direct thrombin inhibitor peptide for PCI anticoagulation.
Melanocortin receptor agonist for hypoactive sexual desire disorder in premenopausal women.
32-amino-acid peptide for osteoporosis and hypercalcemia.
Echinocandin lipopeptide for invasive Candida and Aspergillus infections.
GnRH antagonist used in IVF to prevent premature ovulation.
Last-resort lipopeptide antibiotic for multidrug-resistant Gram-negatives.
Synthetic ovine CRH for differential diagnosis of Cushing's syndrome.
Synthetic ACTH(1-24) for adrenal function testing.
Long-acting lipoglycopeptide for skin and soft tissue infections.
Cyclic lipopeptide antibiotic for serious Gram-positive infections.
GnRH antagonist providing immediate testosterone suppression in prostate cancer.
Synthetic vasopressin analog for diabetes insipidus and nocturnal enuresis.
Once-weekly GLP-1 agonist with cardiovascular benefit.
Plasma kallikrein inhibitor for hereditary angioedema.
First-in-class HIV fusion inhibitor peptide.
GP IIb/IIIa inhibitor cyclic peptide for ACS and PCI.
Calcimimetic peptide for secondary hyperparathyroidism on hemodialysis.
First-in-class GLP-1 receptor agonist for type 2 diabetes.
GnRH antagonist for IVF cycles.
Synthetic random peptide copolymer for relapsing multiple sclerosis.
29-amino-acid peptide hormone for severe hypoglycemia.
GnRH agonist implant for hormone-sensitive cancers.
GnRH agonist implant for central precocious puberty and prostate cancer.
Bradykinin B2 receptor antagonist for hereditary angioedema attacks.
Rapid-acting mealtime insulin analog.
Ultra-long-acting basal insulin with >42-hour duration.
Long-acting basal insulin analog for type 1 and type 2 diabetes.
Rapid-acting mealtime insulin analog.
Long-acting somatostatin analog for acromegaly and NETs.
GnRH agonist used for prostate cancer, endometriosis, and precocious puberty.
Guanylate cyclase-C agonist peptide for IBS-C and chronic constipation.
FDA-approved daily GLP-1 receptor agonist.
Short-acting GLP-1 agonist focused on postprandial glucose.
Long-acting pegylated growth hormone, once-weekly.
Oral ghrelin agonist for diagnosing adult growth hormone deficiency.
GLP-1/glucagon dual agonist in Phase 3 development.
Recombinant human IGF-1 for severe primary IGF-1 deficiency.
Echinocandin antifungal for Candida infections and prophylaxis.
CXCR4 antagonist peptide that mobilizes stem cells for autologous transplant in multiple myeloma.
Intranasal GnRH agonist for endometriosis and central precocious puberty.
Recombinant BNP for acute decompensated heart failure.
Synthetic somatostatin analog for acromegaly and neuroendocrine tumors.
Single-dose lipoglycopeptide for acute bacterial skin and skin structure infections.
Neuropeptide studied for social bonding and stress modulation.
Multi-receptor somatostatin analog for Cushing's disease and acromegaly.
Pegylated GH receptor antagonist for acromegaly.
Uroguanylin analog for chronic constipation.
Amylin analog adjunct to mealtime insulin.
Melanocortin agonist researched for sexual desire and arousal.
Once-weekly echinocandin for candidemia and invasive candidiasis.
Thrombopoietin-receptor peptibody for immune thrombocytopenia.
FDA-approved GLP-1 agonist for diabetes and obesity.
MC4R agonist for rare genetic obesity disorders.
Synthetic C-terminal octapeptide of cholecystokinin for gallbladder imaging.
Once-weekly growth hormone analog for adults and children with GHD.
Long-acting recombinant human growth hormone for pediatric GH deficiency — weekly dosing.
27-amino-acid peptide used to stimulate pancreatic secretions for diagnosis.
GLP-2 analog for short bowel syndrome dependent on parenteral support.
Lipoglycopeptide for complicated skin infections and HABP/VABP.
Recombinant PTH(1-34) for severe osteoporosis.
GHRH analog FDA-approved for HIV-associated visceral fat.
FDA-approved GLP-1/GIP dual agonist.
GnRH agonist depot for advanced prostate cancer.
Glycopeptide antibiotic for serious Gram-positive infections including MRSA.
Nonapeptide hormone used for vasodilatory shock.
C-type natriuretic peptide analog for achondroplasia.
Synthetic ω-conopeptide for severe chronic pain via intrathecal infusion.
Macrocyclic peptide complement C5 inhibitor for generalized myasthenia gravis.
Frequently asked questions
What makes a peptide FDA approved?
An FDA-approved peptide has completed the agency's review process and carries an approved label describing the indication, dosing, and safety information supported by clinical trial data. Approval applies to the specific product and indication reviewed, not to the peptide molecule in every possible use.
How many FDA approved peptides are covered in this library?
Peptides.cafe currently documents 70 peptides with an approved FDA label, each with a mechanism overview, commonly researched wellness goals, safety considerations, and primary references.
Are FDA approved peptides available without a prescription?
No. FDA-approved peptide medicines are prescription products dispensed through licensed pharmacies under the supervision of a licensed healthcare provider.
Is an FDA approved peptide safer than a compounded or research peptide?
FDA-approved products have been evaluated for manufacturing quality, purity, and labelled safety in clinical trials, which compounded and research peptides have not. That does not make any product risk-free — every peptide has a safety profile that should be reviewed with a licensed clinician.
Other classifications
Prepared by licensed compounding pharmacies under a prescription. (10 peptides)
Studied in preclinical or early clinical research only. (46 peptides)
Educational Wellness Information Only
This platform provides peer-reviewed research summaries and educational content about peptides for wellness and optimization purposes. Nothing on this site is intended as medical advice, diagnosis, or treatment. We do not claim any peptide can diagnose, treat, cure, or prevent any disease. Always consult a licensed healthcare provider before beginning any wellness protocol.
Statements on this site have not been evaluated by the FDA. Compounded preparations are subject to applicable state and federal regulations. Availability and eligibility vary.