PT-141: clinical evidence record
Also known as: Bremelanotide, Vyleesi
Oliver Mackman · Editorial director · Best Business Loans Ltd (16833937)
Last updated 2026-05-22
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AI-friendly summary · PT-141
FDA-approved as Vyleesi by Palatin Technologies in 2019 for premenopausal Hypoactive Sexual Desire Disorder. Phase 3 RECONNECT trial data submitted for approval. Not MHRA-licensed in the UK.
Mechanism of action
How PT-141 works
Synthetic cyclic heptapeptide melanocortin-receptor agonist. Acts on central nervous system MC1R and MC4R receptors rather than peripheral vasculature, producing arousal effects via brain pathways distinct from PDE5 inhibitors like sildenafil.
Top peer-reviewed citations
Selection of the most-cited peer-reviewed literature on PT-141. Where a verified PMID or DOI is shown, the citation links to the original record. Other citations list the title, authors, journal and year so the reader can locate the paper through the journal index or the PubMed search linked below. PeptideClear publishes editorial commentary, not clinical guidance.
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Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials
Kingsberg SA, Clayton AH, Portman D, et al.. Obstetrics and gynecology, 2019.
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Bremelanotide: an overview of preclinical CNS effects on female sexual function
Pfaus J, Giuliano F, Gelez H. The journal of sexual medicine, 2007.
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Double-blind, placebo-controlled evaluation of the safety, pharmacokinetic properties and pharmacodynamic effects of intranasal PT-141, a melanocortin receptor agonist, in healthy males and patients with mild-to-moderate erectile dysfunction
Diamond LE, Earle DC, Heiman JR, et al.. International journal of impotence research, 2004.
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Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder
Simon JA, Kingsberg SA, Portman D, et al.. Obstetrics and gynecology, 2019.
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Safety Profile of Bremelanotide Across the Clinical Development Program
Clayton AH, Kingsberg SA, Portman D, et al.. Journal of women's health (2002), 2022.
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Bremelanotide: New Drug Approved for Treating Hypoactive Sexual Desire Disorder
Mayer D, Lynch SE. The Annals of pharmacotherapy, 2020.
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An evaluation of bremelanotide injection for the treatment of hypoactive sexual desire disorder
Cipriani S, Alfaroli C, Maseroli E, et al.. Expert opinion on pharmacotherapy, 2023.
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Phase I Randomized Placebo-controlled, Double-blind Study of the Safety and Tolerability of Bremelanotide Coadministered With Ethanol in Healthy Male and Female Participants
Clayton AH, Lucas J, DeRogatis LR, et al.. Clinical therapeutics, 2017.
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Small Effects, Questionable Outcomes: Bremelanotide for Hypoactive Sexual Desire Disorder
Spielmans GI, Ellefson EM. Journal of sex research, 2024.
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Targeting the central melanocortin system for the treatment of metabolic disorders
Sweeney P, Gimenez LE, Hernandez CC, et al.. Nature reviews. Endocrinology, 2023.
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Therapeutic Peptides in Aesthetic, Metabolic and Endocrine Conditions: Effects, Safety, Clinical Applications, and Future Perspectives
Renke G, Chinellato L. International journal of molecular sciences, 2026.
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FDA-Approved Drugs Containing D-Amino Acids: A Historical and Developmental Perspective
Tran L, Nguyen TD, Gad AG, et al.. Drug development research, 2026.
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Clinical trial evidence on emerging pharmacological therapies for hypoactive sexual desire disorder in women: a systematic review and analysis of completed studies registered on ClinicalTrials.gov
Ashour AM. Frontiers in medicine, 2026.
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Quantification of "Mercy Sex" in Heterosexual Women
Guptan N, Simon JA. Journal of sex & marital therapy, 2026.
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Therapeutic peptides in gerontology: mechanisms and applications for healthy aging
Mavrych V, Shypilova I, Bolgova O. Frontiers in aging, 2026.
Full PubMed search: https://pubmed.ncbi.nlm.nih.gov/?term=bremelanotide+PT-141.
Registered clinical trials
As of 2026-07-13, PT-141 has 4 interventional trials listed on ClinicalTrials.gov and the ISRCTN registry. Registration means a study is planned, running or completed. It is not evidence of efficacy, and a listing is not an endorsement.
| Study | Phase | Status | Location | Registry |
|---|---|---|---|---|
| Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder NCT01382719 | Phase 2 | Completed | Canada, United States | ClinicalTrials.gov |
| 1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder NCT02333071 | Phase 3 | Completed | Canada, United States | ClinicalTrials.gov |
| Evaluate the Safety and Efficacy of Bremelanotide in Women With Female Sexual Arousal Disorder (FSAD) NCT00425256 | Phase 2 | Completed | United States | ClinicalTrials.gov |
| 2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder NCT02338960 | Phase 3 | Completed | Canada, United States | ClinicalTrials.gov |
Source: ClinicalTrials.gov and the ISRCTN registry, refreshed 2026-07-13. See the peptide clinical-trials tracker for the full picture across compounds.
UK regulatory status
Plain-English summary of where PT-141 sits under the four UK and international frameworks that govern peptide supply. Editorial commentary, not legal advice.
- Misuse of Drugs Act 1971: Not controlled under the Misuse of Drugs Act 1971.
- Psychoactive Substances Act 2016: Not scheduled under the Psychoactive Substances Act 2016.
- MHRA medicines classification: No UK marketing authorisation as a medicine.
- WADA Prohibited List: Not currently listed on the WADA Prohibited List.
Risks and unknowns
What the literature does not yet show about PT-141
Known concerns
- PT-141 has been studied in randomised human trials, which is a materially stronger position than most compounds on this site. Trial populations, endpoints and durations are still narrower than everyday use, so results describe the trial, not every person.
- 4 registered interventional trials exist for PT-141, none currently recruiting. Registered trials can be completed, suspended or terminated without ever publishing.
- PT-141 holds no UK marketing authorisation, so nothing you can buy has been assessed by a regulator, released by batch, or dispensed by an accountable pharmacy. Purity, dose accuracy and sterility rest entirely on the seller's own documentation.
Open questions in the literature
- Long-term outcomes beyond the duration of the published trials are unknown, and the published trials are considerably shorter than the periods over which people actually use these compounds.
- Interactions between PT-141 and prescribed medicines are not systematically studied, which matters most for anyone already on treatment for a long-term condition.
Regulatory note
No UK marketing authorisation as a medicine. Not currently listed on the WADA Prohibited List. The moment a UK seller or commentator makes a therapeutic claim, MHRA can treat the product as an unlicensed medicinal product.
Important: PeptideClear publishes encyclopedia commentary only and does not recommend human use. Speak to a UK-registered prescriber before any medical decision.
Related reading on PeptideClear
Frequently asked questions
What is the evidence level for PT-141?
What is the UK regulatory status of PT-141?
Has PT-141 been tested in human clinical trials?
Where can I read the source literature for PT-141?
Last verified 2026-05-22. Editorial commentary, not legal or clinical advice. Citations without a linked identifier can be located through the PubMed search and the journal index.