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Hormone · FDA Approved

PT-141 (Bremelanotide / Vyleesi)

FDA-approved

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Written by Peptide Association Editorial TeamLast reviewed Editorial policy

01 · Overview

A synthetic cyclic heptapeptide melanocortin receptor agonist structurally related to melanotan II. Unlike PDE5 inhibitors that act peripherally on vascular smooth muscle, PT-141 is thought to work centrally, through brain melanocortin signaling that may enhance sexual desire (PMID 36242769).

It is approved as an as-needed injection for premenopausal women with hypoactive sexual desire disorder.

02 · Research summary & key findings

FDA-approved in 2019 (Vyleesi) for hypoactive sexual desire disorder (HSDD) in premenopausal women. The two RECONNECT phase 3 trials showed statistically significant increases in sexual desire and reductions in related distress versus placebo, with more nausea, flushing and headache (PMID 31599840). Independent reviews describe the overall clinical benefit as modest, and nausea affects about 40% of users (PMID 36242769; PMID 36809187).

03 · Regulatory status

PT-141 (Bremelanotide / Vyleesi) has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.

04 · Administration routes

  • Subcutaneous injection (as needed)

References

  1. [1]Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials Obstet Gynecol, 2019. PMID 31599840
  2. [2]An evaluation of bremelanotide injection for the treatment of hypoactive sexual desire disorder Expert Opin Pharmacother, 2023. PMID 36242769
  3. [3]Small Effects, Questionable Outcomes: Bremelanotide for Hypoactive Sexual Desire Disorder J Sex Res, 2024. PMID 36809187

Primary literature

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Disclaimer: This information is provided for educational and research purposes only. It is not intended as medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before starting any peptide therapy. The Peptide Association does not endorse or recommend any specific treatment protocol. See our editorial policy for how this content is produced and reviewed. Clinicians: join the network.