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OtherFDA approvedRx required

PT-141

Also known as: Bremelanotide · Vyleesi
Brands: Vyleesi

Melanocortin receptor agonist FDA-approved for hypoactive sexual desire disorder in women.

A
Grade A
Multiple human RCTs
Human studies28
PubMed citations28
Typical dose1.8 mg
Routesubcutaneous
Regulatory (US)FDA approved · Rx
Last verified2 days ago
TL;DR · 30-second summary
  • Statistically significant improvement in sexual desire
  • Reduced distress related to low desire
  • Effects within 45 minutes of administration
  • Works through central mechanisms unlike PDE5i

Mechanism of action

Activates melanocortin receptors (MC3R and MC4R) in the CNS, distinct from PDE5 inhibitors. Works on central nervous system rather than vascular mechanisms.

Evidence summary

28
Human studies
28
PubMed citations
3
Clinical trials
A
Evidence grade

Phase 3 RECONNECT trials demonstrated significant improvement in sexual desire and distress in premenopausal women with HSDD. FDA approved in 2019.

Dosing protocols

Educational information only. Consult a licensed provider before using any peptide.
Dose range
1.8 mg

FDA-approved dose: 1.75mg subcutaneous, at least 45 minutes before anticipated activity. Max 8 doses/month.

Administration routes
subcutaneous

Side effects & safety

From the FDA label
Source
abdominal painarthralgiadiarrheadizzinessfatigueheadacheinjection site painnauseapruritusvomiting

Terms pulled directly from the referenced source. We don't fabricate frequencies — when a label doesn't publish a percentage, we don't either.

Contraindications
  • Uncontrolled hypertension
  • Cardiovascular disease
  • Use with naltrexone

Interactions

No documented drug interactions on file.

Regulatory status

United States
FDA approved

FDA approved (Vyleesi) for HSDD in premenopausal women

Compounding
Permitted

Available through compounding pharmacies with valid prescription.

Regulatory data last verified 4/17/2026

Citations

PMID 38161863Ronghe V, Pannase K et al. · Understanding Hypoactive Sexual Desire Disorder (HSDD) in Women: Etiology, Diagnosis, and Treatment.Cureus (2024)HumanPMID 36809187Spielmans GI, Ellefson EM · Small Effects, Questionable Outcomes: Bremelanotide for Hypoactive Sexual Desire Disorder.Journal of sex research (2024)HumanPMID 36242769Cipriani S, Alfaroli C et al. · An evaluation of bremelanotide injection for the treatment of hypoactive sexual desire disorder.Expert opinion on pharmacotherapy (2023)HumanPMID 37365323Sweeney P, Gimenez LE et al. · Targeting the central melanocortin system for the treatment of metabolic disorders.Nature reviews. Endocrinology (2023)HumanPMID 33455598Pfaus JG, Sadiq A et al. · The neurobiology of bremelanotide for the treatment of hypoactive sexual desire disorder in premenopausal women.CNS spectrums (2022)HumanPMID 35170192Spana C, Jordan R et al. · Effect of bremelanotide on body weight of obese women: Data from two phase 1 randomized controlled trials.Diabetes, obesity & metabolism (2022)HumanPMID 35230162Simon JA, Kingsberg SA et al. · Prespecified and Integrated Subgroup Analyses from the RECONNECT Phase 3 Studies of Bremelanotide.Journal of women's health (2002) (2022)HumanPMID 35428435Nappi RE, Tiranini L et al. · Medical Treatment of Female Sexual Dysfunction.The Urologic clinics of North America (2022)HumanPMID 35147466Clayton AH, Kingsberg SA et al. · Safety Profile of Bremelanotide Across the Clinical Development Program.Journal of women's health (2002) (2022)HumanPMID 36291616Yuan XC, Tao YX · Ligands for Melanocortin Receptors: Beyond Melanocyte-Stimulating Hormones and Adrenocorticotropin.Biomolecules (2022)HumanPMID 34433901Zhang H, Chen LN et al. · Structural insights into ligand recognition and activation of the melanocortin-4 receptor.Cell research (2022)HumanPMID 35076581Edinoff AN, Sanders NM et al. · Bremelanotide for Treatment of Female Hypoactive Sexual Desire.Neurology international (2022)HumanPMID 33678061Spielmans GI · Re-Analyzing Phase III Bremelanotide Trials for "Hypoactive Sexual Desire Disorder" in Women.Journal of sex research (2021)HumanPMID 34510696Pettigrew JA, Novick AM · Hypoactive Sexual Desire Disorder in Women: Physiology, Assessment, Diagnosis, and Treatment.Journal of midwifery & women's health (2021)HumanPMID 34642243Mintzes B, Tiefer L et al. · Bremelanotide and flibanserin for low sexual desire in women: the fallacy of regulatory precedent.Drug and therapeutics bulletin (2021)HumanPMID 31599847Simon JA, Kingsberg SA et al. · Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder.Obstetrics and gynecology (2020)HumanPMID 31429064Dhillon S, Keam SJ · Bremelanotide: First Approval.Drugs (2020)HumanPMID 28203348Gelman F, Atrio J · Flibanserin for hypoactive sexual desire disorder: place in therapy.Therapeutic advances in chronic disease (2020)HumanPMID 31599840Kingsberg SA, Clayton AH et al. · Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials.Obstetrics and gynecology (2020)HumanPMID 31277966Althof S, Derogatis LR et al. · Responder Analyses from a Phase 2b Dose-Ranging Study of Bremelanotide.The journal of sexual medicine (2020)Human

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