Hormones & growth

Bremelanotide

Peptilex evidence grade ABCDEUpdated 19 Oct 2026 How grades work

Type: Melanocortin receptor agonist
Main use or focus: Low sexual desire causing distress in premenopausal women (HSDD)
Also known as: Vyleesi, PT-141

Key studies from the book

1,267 premenopausal women with HSDD, 24 weeks; significantly more sexual desire and less related distress than on placebo.
RECONNECT 301 and 302 – Obstetrics & Gynecology, 2019
684 women, 52 weeks; the improvements were maintained.
Open-label extension – Obstetrics & Gynecology, 2019

All key studies, risks and open questions are in the book.

Research at a glance

Publications by typePubMed, all years

All papers95

Human studies67

Animal studies only5

Randomized trials11

Meta-analyses & systematic reviews5

Source: PubMed and ClinicalTrials.gov via the Peptilex study database

Registered trials by phaseClinicalTrials.gov · name in study title

ongoing / startingcompleted / other

Phase 11

Phase 24

Phase 33

Phase 41

Source: PubMed and ClinicalTrials.gov via the Peptilex study database

Trial starts per yearClinicalTrials.gov · by start date (planned starts included)

2016

2018

2020

12022

12024

2026

Source: PubMed and ClinicalTrials.gov via the Peptilex study database

Go deeper

Full profile in the book

What it is, how it acts, the key studies, risks and open questions.

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Registered trials

ClinicalTrials.gov · name in study title · ongoing first

Study	Phase	Status	Participants	Start
A Phase 2 Study Evaluating the Co-Administration of Bremelanotide With Tirzepatide for the Treatment of Obesity NCT06565611Palatin Technologies, Inc	Phase 2	Running	108	Aug 2024
1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder NCT02333071Palatin Technologies, Inc	Phase 3	Completed	723	Dec 2014
2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder NCT02338960Palatin Technologies, Inc	Phase 3	Completed	714	Jan 2015
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) NCT04943068Kwang Dong Pharmaceutical co., ltd.	Phase 3	Completed	193	May 2021
Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder NCT01382719Palatin Technologies, Inc	Phase 2	Completed	612	Jun 2011
A Phase IIb, Multicenter, Open-Label, Prospective Study of Bremelanotide in Diabetic Kidney Disease NCT05709444Palatin Technologies, Inc	Phase 2	Completed	16	Dec 2022
Evaluate the Safety and Efficacy of Bremelanotide in Women With Female Sexual Arousal Disorder (FSAD) NCT00425256Palatin Technologies, Inc	Phase 2	Completed	–	Feb 2006

Showing 7 of 9 matching registered studies. See all on ClinicalTrials.gov.

Latest key papers

PubMed · newest first

2026
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
Systematic reviewAshour AM et al. · Frontiers in MedicinePMID 42254382
2026
Female Sexual Desire, Arousal, and Orgasmic Dysfunctions: A Systematic Review and Meta-Analysis of Treatment Options
Meta-analysisToledo RG et al. · Journal of Minimally Invasive GynecologyPMID 40543759
2022
Prespecified and Integrated Subgroup Analyses from the RECONNECT Phase 3 Studies of Bremelanotide
Human RCTPhase 3Simon JA et al. · Journal of Women's HealthPMID 35230162
2022
Safety Profile of Bremelanotide Across the Clinical Development Program
Human RCTPhase 3Clayton AH et al. · Journal of Women's HealthPMID 35147466
2021
Re-Analyzing Phase III Bremelanotide Trials for "Hypoactive Sexual Desire Disorder" in Women
Meta-analysisSpielmans GI et al. · Journal of Sex ResearchPMID 33678061
2021
The Patient Experience of Premenopausal Women Treated with Bremelanotide for Hypoactive Sexual Desire Disorder: RECONNECT Exit Study Results
Human RCTKoochaki P et al. · Journal of Women's HealthPMID 33538638
2020
Bremelanotide: New Drug Approved for Treating Hypoactive Sexual Desire Disorder
Systematic reviewMayer D et al. · The Annals of PharmacotherapyPMID 31893927
2019
Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials
Human RCTPhase 3Kingsberg SA et al. · Obstetrics and GynecologyPMID 31599840

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