Peptide Price Finder

Home · Research · Sexual health & hormones

PT-141 research

What published studies found for PT-141: 8 papers, 7 in humans, with sample sizes and key results, plus 10 registered clinical trials.

A
Strong human evidence
Why: Approved for low desire in women based on two phase 3 RCTs (1,267 women) showing modest but significant gains; a meta-analysis agrees.

Bremelanotide (PT-141) is FDA-approved for low sexual desire (HSDD) in premenopausal women based on two phase 3 RCTs (about 1,250 women) showing statistically significant but modest gains in desire and less distress; a 2026 meta-analysis agrees, while a critical reanalysis argues the benefits are small. Nausea is very common (about 40%), with flushing and headache also frequent.

✓ 5 positive~ 3 mixed

US compounding: FDA-approved drug. FDA-approved as bremelanotide (Vyleesi) for low sexual desire in premenopausal women. Status for every peptide.

Browse and filter these papersPT-141 prices and vendors

Reported side effects

Registered clinical trials

10 trials of PT-141 on ClinicalTrials.gov: 1 active, 9 completed, 4 with posted results. Registered trials include ones that haven't published yet.

TrialStatusPhasePeopleSponsor
A Phase 2 Study Evaluating the Co-Administration of Bremelanotide With Tirzepatide for the Treatment of ObesityNCT06565611 · started 2024-08-05Active, not recruitingPhase 2108Palatin Technologies, Inc
1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire DisorderNCT02333071 · started 2014-12 · results postedCompletedPhase 3723Palatin Technologies, Inc
2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire DisorderNCT02338960 · started 2015-01 · results postedCompletedPhase 3714Palatin Technologies, Inc
Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire DisorderNCT01382719 · started 2011-06 · results postedCompletedPhase 2612Palatin Technologies, Inc
Role of the Melanocortin-4 Receptor in Hypoactive Sexual Desire DisorderNCT04179734 · started 2019-10-07 · results postedCompletedPhase 440Imperial College Healthcare NHS Trust
Study to Evaluate Rate of Nausea in Healthy Premenopausal Female Subjects Treated With Single Dose of Bremelanotide Alone or With ZofranNCT03973047 · started 2019-06-17CompletedPhase 1228AMAG Pharmaceuticals, Inc.
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)NCT04943068 · started 2021-05-10CompletedPhase 3193Kwang Dong Pharmaceutical co., ltd.
A Phase IIb, Multicenter, Open-Label, Prospective Study of Bremelanotide in Diabetic Kidney DiseaseNCT05709444 · started 2022-12-26CompletedPhase 216Palatin Technologies, Inc
Single Dose of Vyleesi in Lactating Female Subjects to Measure the Concentration of Bremelanotide in Breast MilkNCT06867835 · started 2025-07-11CompletedPhase 410Cosette Pharmaceuticals, Inc.
Evaluate the Safety and Efficacy of Bremelanotide in Women With Female Sexual Arousal Disorder (FSAD)NCT00425256 · started 2006-02CompletedPhase 2–Palatin Technologies, Inc

All 10 PT-141 trials, with countries and recruiting status

Meta-analyses & systematic reviews

✓ Positivemeta-analysisJ Minim Invasive Gynecol · 2026

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

36 studies (26 RCTs, 10 single-arm); bremelanotide meta-analysed alongside CBT and flibanserinSystematic review and meta-analysis

Systematic review and meta-analysis of treatments for female desire/arousal/orgasm dysfunction: bremelanotide improved total FSFI and its desire and arousal subscales and reduced distress.

Studied
Women with sexual desire, arousal or orgasm dysfunction without sexual pain conditions
Main outcome
FSFI total and desire/arousal/orgasm subscales, FSDS
Authors' conclusion
Bremelanotide improved total FSFI and desire and arousal subscales; CBT improved all domains and flibanserin improved desire; all three reduced distress.
Limitations
No direct CBT vs drug comparisons; heterogeneous terminology and outcome measures limited other conclusions.
PubMed 40543759DOI
✓ Positivesystematic reviewAnn Pharmacother · 2020

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

Review of 2 phase 3 and 2 phase 2 trial reportsSystematic literature review of phase 2 and 3 trials

Review of phase 2 and 3 trials: significant improvement in desire and reduced distress, though clinical benefit 'may only be modest'; nausea 39.9%, flushing 20.4%, headache 11%.

Key resultMost common adverse effects: nausea (39.9%), facial flushing (20.4%) and headache (11%)
Studied
Women with hypoactive sexual desire disorder
Main outcome
Desire, distress and adverse effects
Authors' conclusion
Bremelanotide significantly improves desire and reduces distress, but the clinical benefit may only be modest; its place in therapy is unknown.
Limitations
Based on a small number of trial reports.
PubMed 31893927DOI

Human studies

~ Mixedhuman RCTJ Womens Health (Larchmt) · 2022

Safety Profile of Bremelanotide Across the Clinical Development Program.

n = 3,500 humansReview of safety data from the clinical development programUp to 18 months in phase 3

Integrated safety data (3,500 subjects, 43 studies): nausea 40.0% vs 1.3% placebo, flushing 20.3%, headache 11.3%, injection-site reactions 5.4%; small transient blood-pressure rises; focal hyperpigmentation rare at labeled dosing but in over a third after 16 consecutive daily doses.

Key resultNausea 40.0% vs 1.3%, flushing 20.3% vs 1.3%, headache 11.3% vs 1.9% with bremelanotide vs placebo
Studied
Subjects across phase 1 to 3 bremelanotide studies
Compared with
Placebo in double-blind phase 3 portion
Main outcome
Adverse events
Sample
Development program of 3500 subjects in 43 completed studies; 1247 in integrated double-blind phase 3 safety population
Authors' conclusion
Adverse events were mostly mild to moderate; caution is advised in patients at risk of cardiovascular disease and blood pressure should be well controlled.
Limitations
Sponsor-program safety review; small transient blood pressure increases observed.
PubMed 35147466DOI
✓ Positivehuman RCTObstet Gynecol · 2019

Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials.

n = 1,267 humansTwo identical phase 3 randomized, double-blind, placebo-controlled multicenter trials (RECONNECT); bremelanotide 1.75 mg subcutaneously as needed24 weeks

Two phase 3 RCTs (RECONNECT; 1,267 premenopausal women with HSDD) of 1.75 mg as needed for 24 weeks: desire scores rose (integrated +0.35 vs placebo, P<.001) and distress about low desire fell (-0.33, P<.001); nausea, flushing and headache occurred in 10% or more.

Key resultDesire increased vs placebo (integrated 0.35, P<.001) and distress fell (integrated -0.33, P<.001); nausea, flushing and headache occurred in 10% or more
Studied
Premenopausal women with hypoactive sexual desire disorder (mean age 39)
Compared with
Placebo
Main outcome
Change in FSFI-desire domain score and FSDS-DAO item 13 (distress)
Sample
1,267 women randomized in two identical phase 3 trials (1,202 in the modified intent-to-treat efficacy population)
Authors' conclusion
Bremelanotide significantly improved sexual desire and related distress in premenopausal women with HSDD, with a favorable safety profile; most adverse events were mild or moderate.
Limitations
Mostly white women (85.6%) from US sites (96.6%); industry-sponsored.
PubMed 31599840DOIFree full text
✓ Positivehuman RCTJ Sex Med · 2019

Responder Analyses from a Phase 2b Dose-Ranging Study of Bremelanotide.

HumansPost hoc and planned responder analyses of a phase 2b dose-finding trial

Phase 2b dose-ranging study in premenopausal women with HSDD and/or arousal disorder: at 1.75 mg, responder rates beat placebo on all 7 endpoints (P <= .03).

Key resultResponder rates at 1.75 mg achieved significance vs placebo for all 7 endpoints (P ≤ .03)
Studied
Premenopausal women with HSDD and/or FSAD in a phase 2b dose-ranging study
Main outcome
Responder rates on 7 patient-reported endpoints
Authors' conclusion
Bremelanotide was safe and well tolerated and showed significant efficacy vs placebo; responder analyses offer a way to determine clinically important effects.
Limitations
Several analyses were post hoc.
PubMed 31277966DOI
~ Mixedhuman RCTJ Sex Med · 2006

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

Eighteen premenopausal women (crossover)Randomized, double-blind crossover; single intranasal 20 mg doseSingle dose, assessed within 24 hours

18 premenopausal women with arousal disorder, single intranasal dose crossover: more reported moderate/high desire after bremelanotide (P=0.011), but measured vaginal vasocongestion did not change.

Key resultMore women reported moderate or high sexual desire after bremelanotide vs placebo (P = 0.0114); vaginal vasocongestion did not change significantly
Studied
Premenopausal women with female sexual arousal disorder
Compared with
Placebo
Main outcome
Vaginal pulse amplitude and subjective sexual response
Authors' conclusion
This preliminary evaluation suggests bremelanotide may positively affect desire and arousal and is a promising candidate for further at-home study.
Limitations
Preliminary, small crossover study with a single dose.
PubMed 16839319DOI
✓ Positivehuman RCTDiabetes Obes Metab · 2022

Effect of bremelanotide on body weight of obese women: Data from two phase 1 randomized controlled trials.

Two phase 1 trials: Study A 30 per bremelanotide group; Study B 27 subjectsTwo phase 1 single-centre randomized, double-blind, placebo-controlled trials (parallel and crossover)Study A days 1-15; Study B three 4-day periods

Two phase 1 RCTs in obese premenopausal women: 16 days of bremelanotide three times daily cut intake by about 400 kcal/day and weight by 1.3 kg more than placebo.

Key resultStudy A: body weight reduction vs placebo -1.3 (-1.9 to -0.8) kg (p < .0001); caloric intake down about 400 kcal/day (p < .01)
Studied
Premenopausal women with BMI >30 kg/m2
Compared with
Placebo
Main outcome
Body weight and caloric intake
Authors' conclusion
Agonist activity at the MC4R may aid in reducing caloric intake and weight loss in obese women.
Limitations
Short phase 1 trials; only 15 of 27 subjects completed all phases of Study B.
PubMed 35170192DOIFree full text

Reviews

~ MixedreviewJ Sex Res · 2024

Small Effects, Questionable Outcomes: Bremelanotide for Hypoactive Sexual Desire Disorder.

HumansRe-analysis of measurement validity and unpublished outcomes from the RECONNECT trials

Reanalysis of RECONNECT outcomes: effect sizes on 8 previously unpublished efficacy outcomes ranged from nil to small, and benefits were limited to measures with weak validity evidence for HSDD.

Studied
Women with HSDD in the RECONNECT phase III bremelanotide trials
Main outcome
Validity of efficacy measures and effect sizes of unpublished outcomes
Authors' conclusion
Bremelanotide's benefits are statistically modest and limited to outcomes with scant evidence of validity among women with HSDD; unpublished outcome effect sizes ranged from nil to small.
Limitations
Several modest-benefit outcomes were likely derived post hoc.
PubMed 36809187DOI

Verdicts are judged on each paper's own main outcome; grades run from A (strong human evidence) to D (little or none). Details are read from the abstracts, and figures are reproduced only from openly licensed full texts. Not medical advice.