PT-141: clinical evidence record
Also known as: Bremelanotide, Vyleesi
Oliver Mackman · Editorial director · Best Business Loans Ltd (16833937)
Last updated 2026-05-22
Editorial with affiliate links. We earn from purchases via outbound retailer / clinic links. How we are funded.
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 hypoactive sexual desire disorder in women: RECONNECT phase 3 trial
Kingsberg SA, Clayton AH, Portman D, et al.. Obstetrics and Gynecology, 2019.
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Melanocortin receptor agonists and sexual function
Pfaus J, Giuliano F, Gelez H. Journal of Sexual Medicine, 2007.
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Bremelanotide for erectile dysfunction phase 2 trial
Diamond LE, Earle DC, Heiman JR, et al.. Journal of Urology, 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.
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
- Most published efficacy claims for PT-141 require careful interpretation. Read the cited papers in full before drawing conclusions.
- Purity of UK research-peptide supply varies between retailers. Certificates of analysis and HPLC documentation differ.
- Cold-chain handling between manufacture and delivery is not standardised across the research-peptide market.
- Independent replication of single-group findings is the key check on any preclinical claim.
Open questions in the literature
- Where human pharmacokinetics have not been formally characterised, dose translation from animal models is not reliable.
- Long-term safety profile beyond the duration of published studies remains an open question.
- Interactions with other prescribed or unlicensed substances are typically not studied.
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.