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For Research & Educational Discussion Only. Not Medical Advice

Bremelanotide (PT-141)

Melanocortin receptor agonist

Also known as PT-141

A melanocortin agonist approved for hypoactive sexual desire disorder in premenopausal women. Approved on a real but modest effect size, which the discussion around it frequently inflates.

Guide updated Sep 2, 2026Literature checked Sep 2, 20261 curated study30 literature recordsBaseline editorial

Overview

In shortA peptide for low sexual desire in premenopausal women, developed out of the melanotan II work once the sexual effects were separated from the tanning ones. The approval is instructive: the trials hit their targets, the effects were small, and the gap between statistically significant on a questionnaire and noticeable in someone's life is the whole argument about it.

Bremelanotide is a cyclic heptapeptide melanocortin receptor agonist, developed from work on melanotan II after the sexual-response effects observed in early trials were separated from the tanning effects.

It is approved for acquired, generalised hypoactive sexual desire disorder in premenopausal women. The approval is instructive: the trials met their endpoints, the effect sizes are small, and the gap between "statistically significant on a validated instrument" and "noticeable in someone's life" is the entire argument about this compound.

Mechanism

In shortIt acts on receptors in the brain rather than on blood flow, so it is not Viagra and does not work like it. The same receptor family explains its side effects: one drives the skin pigment changes, and signalling in the brainstem is the likely route for the nausea that dominates its side effect profile.

Bremelanotide activates melanocortin receptors, with relevant activity at MC1R, MC3R, and MC4R. The sexual-response effect is attributed to central MC4R signalling in hypothalamic pathways rather than to any peripheral vascular mechanism. It is not a PDE5 inhibitor and does not work like one.

MC1R activity is what produces the pigmentation effects seen across this receptor family, and MC4R signalling in the brainstem is the likely route for the nausea that dominates its adverse effect profile.

Evidence

In shortGood enough for the approved use, with a small effect and nothing outside that group. Trials showed significant improvement against placebo on validated questionnaires, but the change was modest, and far fewer people reported a difference they personally found meaningful than showed a change on paper. No properly sized evidence in men or postmenopausal women.

Adequate for the approved indication, with a small effect size and no evidence outside that population.

The RECONNECT trials reported statistically significant improvements versus placebo on validated desire and distress instruments. The magnitude of change was modest, and the proportion of participants reporting a change they considered meaningful was substantially smaller than the proportion showing a statistical change.

There is no adequately powered evidence in men, in postmenopausal women, or for any general use.

Safety

In shortNausea is the big one and the main reason people stop, affecting a large minority. Flushing, headache, injection site reactions and vomiting are common. Blood pressure rises briefly after a dose, which is why uncontrolled high blood pressure and known heart disease rule it out. Patchy skin darkening can happen and does not always fade.

Nausea is the dominant adverse effect and the leading cause of discontinuation, affecting a large minority of participants. Flushing, headache, injection site reactions, and vomiting are common.

Transient increases in blood pressure and decreases in heart rate occur after dosing, which is why uncontrolled hypertension and known cardiovascular disease are contraindications. Focal hyperpigmentation can occur and does not always fully resolve.

Prescription medicine with defined contraindications, in a population where it needs to be prescribed after a diagnosis rather than acquired on a hunch.

Regulatory status

In shortApproved in the United States for one specific diagnosis in premenopausal women. Availability elsewhere is limited and inconsistent. Not approved for men, or for general sexual function, in any major country.

Approved in the United States for acquired generalised HSDD in premenopausal women. Availability elsewhere is limited and inconsistent. Not approved for use in men or for general sexual function in any major jurisdiction.

The literature

1 study indexed. Findings and limitations get equal weight, on purpose.

Always check the primary source

Members area

The Bremelanotide literature needs an account

Everything above is free to read. What an account opens is the evidence underneath it: 1 study with their limitations, and the regimen each trial actually reported.

  • Every study, with what it found and what it cannot show
  • The limitations, given the same weight as the findings
  • The dose each named trial administered, where recorded

Free to create. A membership is separate, and you can decide about that later.

Reading is free, an account is not the same as paying. 43 compound guides, every study with its limitations written underneath, and the regimens those trials actually used. A free account opens all of it. A membership is a separate decision, and it opens the forum. What membership costs.

The wider literature

20 indexed papers and 10 registered trials mentioning Bremelanotide, straight from PubMed and ClinicalTrials.gov. 10 of 10 administer it; the rest measure it. These have not been read by us. Unlike the studies above, they carry no findings and no limitations written by anyone here, because writing either would mean claiming a reading nobody has done. They are a starting point for yours.

Registered trials (10)

  1. Single Dose of Vyleesi in Lactating Female Subjects to Measure the Concentration of Bremelanotide in Breast Milk

    Cosette Pharmaceuticals, Inc.2025NCT06867835

    interventionalphase4completedn=10

  2. A Phase 2 Study Evaluating the Co-Administration of Bremelanotide With Tirzepatide for the Treatment of Obesity

    Palatin Technologies, Inc2024NCT06565611

    interventionalphase2active not recruitingn=108

  3. A Phase IIb, Multicenter, Open-Label, Prospective Study of Bremelanotide in Diabetic Kidney Disease

    Palatin Technologies, Inc2022NCT05709444

    interventionalphase2completedn=16

  4. A Phase 3, Bridging, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (With or Without Decreased Arousal)

    Kwang Dong Pharmaceutical co., ltd.2021NCT04943068

    interventionalphase3completedn=193

  5. Study to Evaluate Rate of Nausea in Healthy Premenopausal Female Subjects Treated With Single Dose of Bremelanotide Alone or With Zofran

    AMAG Pharmaceuticals, Inc.2019NCT03973047

    interventionalphase1completedn=228

  6. Role of the Melanocortin-4 Receptor in Hypoactive Sexual Desire Disorder

    Imperial College Healthcare NHS Trust2019NCT04179734

    interventionalphase4completedn=40

  7. 2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder

    Palatin Technologies, Inc2015NCT02338960

    interventionalphase3completedn=714

  8. 1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder

    Palatin Technologies, Inc2014NCT02333071

    interventionalphase3completedn=723

  9. Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder

    Palatin Technologies, Inc2011NCT01382719

    interventionalphase2completedn=612

  10. Evaluate the Safety and Efficacy of Bremelanotide in Women With Female Sexual Arousal Disorder (FSAD)

    Palatin Technologies, Inc2006NCT00425256

    interventionalphase2completed

Papers (20)

  1. Therapeutic Peptides in Aesthetic, Metabolic and Endocrine Conditions: Effects, Safety, Clinical Applications, and Future Perspectives.

    Renke G, et al.International journal of molecular sciences2026PMID 42123471

    journal articlereview

  2. Female Sexual Desire, Arousal, and Orgasmic Dysfunctions: A Systematic Review and Meta-Analysis of Treatment Options.

    Toledo RG, et al.Journal of minimally invasive gynecology2026PMID 40543759

    journal articlesystematic reviewmeta-analysis

  3. Polymorphism of Melanocortin Receptor Genes-Association with Inflammatory Traits and Diseases.

    Bardhan M, et al.Diseases (Basel, Switzerland)2025PMID 41002740

    journal articlereview

  4. Targeting the central melanocortin system for the treatment of metabolic disorders.

    Sweeney P, et al.Nature reviews. Endocrinology2023PMID 37365323

    journal articlereviewresearch support, n.i.h., extramuralresearch support, non-u.s. gov't

  5. Medical Treatment of Female Sexual Dysfunction.

    Nappi RE, et al.The Urologic clinics of North America2022PMID 35428435

    journal articlereview

  6. Finding Our Way From the Bench to the Bedside: The Ethos, Logos, and Pathos of Biomedical Research.

    Kim NNSexual medicine reviews2022PMID 35772848

    editorial

  7. Bremelanotide for Treatment of Female Hypoactive Sexual Desire.

    Edinoff AN, et al.Neurology international2022PMID 35076581

    journal articlereview

  8. Safety Profile of Bremelanotide Across the Clinical Development Program.

    Clayton AH, et al.Journal of women's health (2002)2022PMID 35147466

    clinical trial, phase iiijournal articlerandomized controlled trialresearch support, non-u.s. gov't

  9. Pharmacotherapy for Sexual Dysfunction in Women.

    Lee JH, et al.Current psychiatry reports2022PMID 35102537

    journal articlereview

  10. Hypoactive Sexual Desire Disorder in Women: Physiology, Assessment, Diagnosis, and Treatment.

    Pettigrew JA, et al.Journal of midwifery & women's health2021PMID 34510696

    journal articlereview

  11. Structural insights into ligand recognition and activation of the melanocortin-4 receptor.

    Zhang H, et al.Cell research2021PMID 34433901

    journal articleresearch support, non-u.s. gov't

  12. Bremelanotide: New Drug Approved for Treating Hypoactive Sexual Desire Disorder.

    Mayer D, et al.The Annals of pharmacotherapy2020PMID 31893927

    journal articlesystematic review

  13. 2019 FDA TIDES (Peptides and Oligonucleotides) Harvest.

    Al Shaer D, et al.Pharmaceuticals (Basel, Switzerland)2020PMID 32151051

    journal articlereview

  14. Bremelanotide (Vyleesi) for hypoactive sexual desire disorder.

    The Medical letter on drugs and therapeutics2019PMID 31381550

    journal articlereview

  15. Bremelanotide: First Approval.

    Dhillon S, et al.Drugs2019PMID 31429064

    journal articlereview

  16. Bremelanotide.

    2012PMID 34436837

    review

  17. Bremelanotide.

    2006PMID 31369224

    review

  18. An effect on the subjective sexual response in premenopausal women with sexual arousal disorder by bremelanotide (PT-141), a melanocortin receptor agonist.

    Diamond LE, et al.The journal of sexual medicine2006PMID 16839319

    journal articlerandomized controlled trial

  19. Melanocortin peptide therapeutics: historical milestones, clinical studies and commercialization.

    Hadley ME, et al.Peptides2006PMID 16412534

    historical articlejournal articleresearch support, n.i.h., extramuralresearch support, non-u.s. gov'treview

  20. PT-141 Palatin.

    Hedlund PCurrent opinion in investigational drugs (London, England : 2000)2004PMID 15134289

    journal articlereview

Discussion

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For Research & Educational Discussion Only. Not Medical Advice

This guide is educational reference material compiled from published literature. It is not medical advice, not a recommendation, and not a substitute for a clinician who knows your history. Nothing here should be used to make a decision about your own health without one.

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