What Is PT-141? Benefits, Research & Safety
An FDA-approved melanocortin receptor agonist for treatment of hypoactive sexual desire disorder in premenopausal women.
UK summary: Bremelanotide is FDA-approved as Vyleesi for HSDD in premenopausal women in the US, but is not licensed in the UK. Cardiovascular effects (blood-pressure rise) are documented. Sport status uncertain; confirm before competition.
Quick Facts
Overview
PT-141 — evidence and risk at a glance
Twenty standard modules scored against the Peptide Authority evidence grading methodology. Missing modules indicate the field has not yet been characterised editorially — treat absences as uncertainty rather than reassurance.
01Evidence snapshot
Bremelanotide is FDA-approved as Vyleesi for HSDD in premenopausal women in the US, but is not licensed in the UK. Cardiovascular effects (blood-pressure rise) are documented. Sport status uncertain; confirm before competition.
02Human evidence grade
03Preclinical evidence grade
04Regulatory status
- UK: Not approved. Available only through specialist channels or as research compound.
- EU: Not approved by EMA. Not available as licensed medicine.
- Notes: PT-141 (bremelanotide/Vyleesi) is FDA-approved in the United States for HSDD in premenopausal women since 2019. It is not approved in UK or EU. WADA prohibits its use in competitive sport.
05Approved medical uses
- Hypoactive sexual desire disorder (HSDD) in premenopausal women (FDA-approved as Vyleesi in the US; NOT MHRA-licensed in the UK).
06Unapproved / promotional claims
- Safer than Viagra for erectile dysfunction.
- Works for everyone with no responder variability.
- Available routinely on UK prescription.
- Safe to combine with PDE5 inhibitors or recreational stimulants.
07Common internet claims
- Marketed online as a unisex 'sexual arousal' peptide.
- Sold by grey-market clinics on the FDA approval for the US-only Vyleesi indication.
- Promoted as a Viagra alternative for men with normal vascular function.
08Claim vs evidence
| Claim | Evidence | Human evidence? | Regulatory concern | Safer wording |
|---|---|---|---|---|
| “FDA-approved for sexual dysfunction” | A | Yes | Low | Vyleesi is FDA-approved for HSDD in premenopausal women in the US; this is not the same as UK MHRA approval. |
| “Available in the UK on prescription” | E | No | High | PT-141 / bremelanotide is not a UK-licensed medicine; some specialist routes may exist but not via standard NHS prescription. |
| “Safer than Viagra” | E | No | High | Comparative-safety claims need comparative trials. PDE5 inhibitors have substantial UK clinical use; bremelanotide has its own cardiovascular profile. |
| “Works for everyone” | C | Limited | Moderate | Trial response rates are moderate; significant non-responder fraction. |
09Safety uncertainty score
Safety profile partly characterised; some signals from observational or preclinical data.
10Known adverse signals
- Transient blood-pressure rise (documented; major reason for FDA dose-frequency limits).
- Nausea, flushing, headache (common in trials).
- Skin hyperpigmentation with repeated use.
- Contraindicated in uncontrolled hypertension or cardiovascular disease.
11Drug-interaction uncertainty
Some interaction data published; check with a prescriber for your specific medicines.
12Anti-doping status
13UK legal position
Not approved. Available only through specialist channels or as research compound.
Read the full UK legal guide → Are peptides legal in the UK?
14EU legal position
Not approved by EMA. Not available as licensed medicine.
15What this page cannot tell you
- Whether a UK-purchased vial actually contains bremelanotide at the labelled concentration.
- Whether off-label male ED use carries the same safety profile as licensed female-HSDD use.
- How it interacts with PDE5 inhibitors (sildenafil, tadalafil) — not formally studied.
- Whether you have undiagnosed cardiovascular risk that would make the BP rise dangerous.
16Last reviewed
17Citation quality score
18Research gaps
- Male ED Phase 3 trials not published despite extensive promotion.
- Long-term cardiovascular safety beyond ~12 months unstudied.
- Combination safety with PDE5 inhibitors uncharacterised.
- No UK regulatory submission pathway active.
19Safer alternatives / established care pathways
- GP review for ED — licensed PDE5 inhibitors (sildenafil, tadalafil) are first-line, available NHS in selected groups, widely available privately.
- GP / psychosexual therapy referral for HSDD in women — talking therapy is NICE first-line.
- Cardiovascular risk assessment before any pharmacological sexual-health intervention.
20Doctor discussion prompts
Questions to ask a qualified clinician
These are starter questions you can adapt for a GP, specialist, pharmacist, or anti-doping advisor. The aim is to help you have a better-informed conversation — not to replace one.
- Is PT-141 / bremelanotide licensed in the UK?
- What licensed UK alternatives exist for the sexual-health concern I'm asking about?
- Do I have cardiovascular risk factors that would make bremelanotide unsuitable?
- If accessed privately, what is the supply-chain provenance?
Discovery & History
Mechanism of Action
Researched Benefits
Based on preclinical and clinical research findings:
- 1Increased sexual desire in women with HSDD (approved indication)
- 2Reduced distress associated with low sexual desire
- 3Enhanced sexual arousal independent of peripheral mechanisms
- 4Potential efficacy in male erectile dysfunction (research)
- 5Works through novel central mechanism
- 6On-demand use (not daily medication)
Claim vs Evidence
How popular claims about PT-141 stack up against the current research, graded using our public evidence grading methodology.
| Claim | Evidence | Human evidence? | Regulatory concern | Safer wording |
|---|---|---|---|---|
| “FDA-approved for sexual dysfunction” | A | Yes | Low | Vyleesi is FDA-approved for HSDD in premenopausal women in the US; this is not the same as UK MHRA approval. |
| “Available in the UK on prescription” | E | No | High | PT-141 / bremelanotide is not a UK-licensed medicine; some specialist routes may exist but not via standard NHS prescription. |
| “Safer than Viagra” | E | No | High | Comparative-safety claims need comparative trials. PDE5 inhibitors have substantial UK clinical use; bremelanotide has its own cardiovascular profile. |
| “Works for everyone” | C | Limited | Moderate | Trial response rates are moderate; significant non-responder fraction. |
Theoretical Dosing & Protocols
| Theoretical Dosage | 1.75 mg subcutaneous injection (approved dose for women) |
| Frequency | As needed, at least 45 minutes before anticipated sexual activity |
| Duration | Maximum 8 doses per month (per approved labeling) |
| Notes | Vyleesi is FDA-approved for HSDD in premenopausal women. Use is on-demand, not daily. Not approved for use in men or postmenopausal women. Should be prescribed by a healthcare professional familiar with the medication. |
Administration Routes
Routes studied in research settings (educational only):
- Subcutaneous injection (approved route)
- Intranasal (studied but not approved due to blood pressure effects)
| Half-Life | Stability |
|---|---|
| Approximately 2.7 hours | Commercial product (Vyleesi) has defined stability per manufacturer specifications |
Safety Profile & Known Risks
Commonly Reported Side Effects
- Nausea (40% in trials, often diminishes with use)
- Flushing
- Injection site reactions
- Headache
- Transient blood pressure increase
Rare Risks & Concerns
- Focal hyperpigmentation (darkening of skin, gums, or breast)
- Severe hypotension in certain patients
- Severe nausea requiring antiemetics
Contraindications
- Uncontrolled hypertension
- Cardiovascular disease
- Concurrent use of naltrexone (drug interaction)
- Pregnancy (Category X)
- Breastfeeding
UK & EU Regulatory Context
🇬🇧 United Kingdom
Not approved. Available only through specialist channels or as research compound.
🇪🇺 European Union
Not approved by EMA. Not available as licensed medicine.
Clinical Studies Summary
An effect on the subjective sexual response in premenopausal women with sexual arousal disorder by bremelanotide (PT-141), a melanocortin receptor agonist.
This preliminary evaluation suggests the potential for bremelanotide to positively affect desire and arousal in women with female sexual arousal disorder and indicates that bremelanotide is a promising candidate for further evaluation in an at-home study.
Co-administration of low doses of intranasal PT-141, a melanocortin receptor agonist, and sildenafil to men with erectile dysfunction results in an enhanced erectile response.
Co-administration of intranasal PT-141 and a phosphodiesterase type 5 inhibitor may constitute a treatment alternative for patients in whom higher doses of a single therapy are not effective or well tolerated.
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.
Flushing and nausea were the most common adverse events reported in both studies and no clinically significant changes in vital signs, laboratory tests, ECGs, or physical exams were observed. Based upon its erectogenic potential and tolerability profile, PT-141 is a promising candidate for further evaluation as a treatment for male ED.
Evaluation of the safety, pharmacokinetics and pharmacodynamic effects of subcutaneously administered PT-141, a melanocortin receptor agonist, in healthy male subjects and in patients with an inadequate response to Viagra.
PT-141 was safe and well tolerated in both studies. The erectogenic potential of PT-141, its tolerability profile and its ability to cause significant erections in patients who do not have an adequate response to a PDE5 inhibitor suggest that PT-141 may provide an alternative treatment for ED with a potentially broad patient base.
Gateways to clinical trials.
Com. This issue focuses on the following selection of drugs: Abetimus sodium, ademetionine, agalsidase alfa, agalsidase beta, alemtuzumab, alfimeprase, AMG-162, androgel, anidulafungin, antigastrin therapeutic vaccine, aripiprazole, atomoxetine hydrochloride; Bazedoxifene acetate, bevacizumab, bosentan; Caldaret hydrate, canfosfamide hydrochloride, choriogonadotropin alfa, ciclesonide, combretastatin A-4 phosphate, C…
PT-141: a melanocortin agonist for the treatment of sexual dysfunction.
Administration of PT-141 to normal men and to patients with erectile dysfunction resulted in a rapid dose-dependent increase in erectile activity. The results suggest that PT-141 holds promise as a new treatment for sexual dysfunction.
Registered Trials & Regulatory Status
5 of 9 completed trials have never posted results. Unreported trials are not neutral: results that go unpublished are more often negative ones.
Single Dose of Vyleesi in Lactating Female Subjects to Measure the Concentration of Bremelanotide in Breast Milk
Status: Completed · 10 participants · Cosette Pharmaceuticals, Inc.
Conditions: Lactating Mother
A Phase 2 Study Evaluating the Co-Administration of Bremelanotide With Tirzepatide for the Treatment of Obesity
Status: Active Not Recruiting · 108 participants · Palatin Technologies, Inc
Conditions: Obesity
A Phase IIb, Multicenter, Open-Label, Prospective Study of Bremelanotide in Diabetic Kidney Disease
Status: Completed · 16 participants · Palatin Technologies, Inc
Conditions: Kidney Disease
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)
Status: Completed · 193 participants · Kwang Dong Pharmaceutical co., ltd.
Conditions: Hypoactive Sexual Desire Disorder
Role of the Melanocortin-4 Receptor in Hypoactive Sexual Desire Disorder
Status: Completed · 40 participants · Imperial College Healthcare NHS Trust
Conditions: Hypoactive Sexual Desire Disorder
Study to Evaluate Rate of Nausea in Healthy Premenopausal Female Subjects Treated With Single Dose of Bremelanotide Alone or With Zofran
Status: Completed · 228 participants · AMAG Pharmaceuticals, Inc.
Conditions: Nausea
2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder
Status: Completed · 714 participants · Palatin Technologies, Inc
Conditions: Hypoactive Sexual Desire Disorder
1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder
Status: Completed · 723 participants · Palatin Technologies, Inc
Conditions: Hypoactive Sexual Desire Disorder
Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder
Status: Completed · 612 participants · Palatin Technologies, Inc
Conditions: Female Sexual Arousal Disorder, Hypoactive Sexual Desire Disorder
Evaluate the Safety and Efficacy of Bremelanotide in Women With Female Sexual Arousal Disorder (FSAD)
Status: Completed · Palatin Technologies, Inc
Conditions: Sexual Arousal Disorder
Adverse event reports (FDA FAERS)
Not applicable: no licensed product contains this peptide, so it is not reported through FAERS. This is an absence of surveillance, not evidence of safety.
Source: ClinicalTrials.gov and openFDA. Updated automatically.
Looking for PT-141?
Source research-grade PT-141 from a trusted UK supplier — third-party tested with certificate of analysis.
View at SupplierFrequently Asked Questions
Questions to ask a qualified clinician about PT-141
These are starter questions you can adapt for a GP, specialist, pharmacist, or anti-doping advisor. The aim is to help you have a better-informed conversation — not to replace one.
- Is PT-141 / bremelanotide licensed in the UK?
- What licensed UK alternatives exist for the sexual-health concern I'm asking about?
- Do I have cardiovascular risk factors that would make bremelanotide unsuitable?
- If accessed privately, what is the supply-chain provenance?
UK regulatory & safety context
Related Research Guides
Related Peptides
Melanotan II
A synthetic analogue of alpha-melanocyte stimulating hormone researched for tanning effects and sexual function enhancement.
Learn moreOxytocin
A natural hormone and neurotransmitter involved in social bonding, childbirth, lactation, and emotional regulation with therapeutic applications.
Learn moreAlpha-MSH
A melanocortin peptide with pigmentation, anti-inflammatory, and appetite-regulating effects, the natural basis for several therapeutic developments.
Learn more