Last updated October 21, 2026. Approval line checked October 21, 2026. No compounding source date is assigned.
FDA status
Approved
Approved. Bremelanotide is the active ingredient in Vyleesi, FDA-approved for hypoactive sexual desire disorder in premenopausal women. Approval is specific to that product and indication.
Drugs@FDA: Vyleesi (NDA 210557)By signing up you agree to get PeptideX update emails. Unsubscribe anytime. Educational only, not medical advice.
Evidence tier
Human RCT. The tier is the highest indexed study type. It is not a safety rating and it is not an FDA approval. Confidence score 5/5. 310 PubMed citations indexed.
Melanocortin MC3R/MC4R agonist acting centrally in the hypothalamus to stimulate sexual arousal pathways independent of vascular mechanisms.
What the literature studies
Sexual Function & Arousal
Evidence tier
Human RCT
Compounding record
Status not verified
Status not verified. No product-specific FDA primary source is recorded for this entry. FDA approval and compounding eligibility are not verified. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route.
Regulatory source not verified; no checked date is assigned.
off-label use common.
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Educational only. Not medical advice. This page does not give doses or sourcing. See the medical and editorial disclaimer.
PT-141 is bremelanotide, an FDA-approved melanocortin receptor agonist (Vyleesi) for acquired, generalized hypoactive sexual desire disorder in premenopausal women - research-chemical "PT-141" sold online is not the approved product.
Cyclic heptapeptide melanocortin agonist (bremelanotide). Approved branded product: Vyleesi (Palatin / licensees), subcutaneous as-needed autoinjector [R1].
FDA-approved as Vyleesi for premenopausal women with acquired, generalized HSDD. Label and clinical sections describe indicated population, contraindications (including uncontrolled hypertension / cardiovascular disease per label), and use limits [R1]. Non-approved research vials marketed as "PT-141" are not the same as dispensed Vyleesi and are not covered by that approval.
Not central; Phase 3 human data exist for the labeled indication.
Per label: nausea (often treatment-limiting), transient blood-pressure increases / heart-rate decreases after dosing, focal hyperpigmentation, and other listed warnings/contraindications [R1]. Not approved for men, postmenopausal women, or as a general "libido peptide." Gray-market PT-141: identity, strength and sterility unverified.
No change to the approved Vyleesi indication identified as of this check. Research-chemical market remains outside the approved pathway.
Last checked 2026-10-27
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