PT-141 / Bremelanotide
aka Bremelanotide · Vyleesi
PT-141 / Bremelanotide in brief
PT-141 / Bremelanotide (Vyleesi) is a melanocortin receptor agonist approved for hypoactive sexual desire disorder in premenopausal women. Amino Axiom rates its evidence base strong, drawing on 87 PubMed results (62 human studies) and 4 registered trials listed below. Its reported half-life is 2.7 hours. It is filed under Sexual Health & Hormonal in the Amino Axiom compound index.
Research data
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Long-form breakdowns
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Overview
PT-141 (Bremelanotide) is a synthetic peptide analog of alpha-melanocyte stimulating hormone (α-MSH). It acts as a non-selective agonist at melanocortin receptors 1, 3, 4, and 5. Approved by the FDA in 2019 for hypoactive sexual desire disorder (HSDD) in premenopausal women, it is the first drug approved for this indication that works on the central nervous system rather than peripheral blood flow.
PubMed results: 87 · Human studies: 62 · Animal studies: 67
Dosing Ranges
Ranges reflect protocols studied in published research and animal-model extrapolation. Presented for research purposes only, not a recommendation or instruction for human use.
FDA-approved dosing
- Subcutaneous Injection — standard range 1.75 mg, As needed before anticipated sexual activity. Maximum 1 dose per 24 hours, maximum 8 doses per month
Half-Life
2.7 hours (high confidence)
Observed Benefits
- Improved sexual desire (Strong human clinical data): RECONNECT trials demonstrated significant improvements in sexual desire and distress
Side Effects
- Nausea — Moderate, Common (40%)
- Flushing — Mild, Common (20%)
Contraindications
- Uncontrolled hypertension or significant cardiovascular disease (Established): Bremelanotide (PT-141) is associated with transient blood-pressure increases and heart-rate changes in clinical use; product labeling and research protocols exclude subjects with uncontrolled hypertension or high cardiovascular risk
- Known hypersensitivity to bremelanotide or formulation components (Established): As with other approved peptide drugs, prior serious hypersensitivity is a standard contraindication in labeling and clinical research exclusion criteria
Storage
Lyophilized (powder): Refrigerated (2-8°C), Up to 24 months (or per pharmaceutical labeling for commercial product). Light sensitive: yes, store dark
Reconstituted (solution): Refrigerated (2-8°C), Per manufacturer; commercial autoinjector formulations follow labeled storage, research lyophilizates typically 4-6 weeks after reconstitution. Solvent: Bacteriostatic water or as supplied for pharmaceutical bremelanotide products
Clinical Trials
- NCT00425256 — Evaluate the Safety and Efficacy of Bremelanotide in Women With Female Sexual Arousal Disorder (FSAD) (PHASE2), status: COMPLETED. Indications: Sexual Arousal Disorder
- NCT02338960 — 2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (PHASE3), status: COMPLETED. Indications: Hypoactive Sexual Desire Disorder
- NCT02333071 — 1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (PHASE3), status: COMPLETED. Indications: Hypoactive Sexual Desire Disorder
- NCT01382719 — Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder (PHASE2), status: COMPLETED. Indications: Female Sexual Arousal Disorder, Hypoactive Sexual Desire Disorder