FDA-approvedHuman evidence

Bremelanotide

Also referred to as PT-141, Vyleesi

A melanocortin agonist with two phase 3 randomised trials in premenopausal women with hypoactive sexual desire disorder. Effect sizes were modest.

Molecule class: Melanocortin receptor agonist
Category: Melanocortin
Last evidence review: 2026-08-23

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Human studies

Animal / in vitro

Graded claims

2,534

Participants

Derived from qualifying human evidence

Most commonly studied duration: 24 weeks. Most frequently reported duration among 2 qualifying human studies with a stated duration.
Longest qualifying human study: 24 weeks. Longest duration among qualifying human studies with a stated duration.

These figures are computed from the study records shown below. Records without a verified source identifier are excluded from the calculation.

Mechanism

What is being studied

Non-selective melanocortin receptor agonist acting centrally, principally at MC4R, on pathways associated with sexual desire.

Evidence

Claims, graded individually

Each statement below carries its own evidence level, its own confidence rating, and its own account of what remains unestablished. A compound does not have a single grade.

Sexual Health Research

AStrongHigh confidenceHuman evidence

In premenopausal women with hypoactive sexual desire disorder, bremelanotide 1.75 mg as needed was associated with statistically significant improvement in desire and reduction in associated distress versus placebo.

What is not established

Effect sizes were modest and their clinical meaningfulness has been debated. Evidence in men and postmenopausal women is not established.

Supporting sources (2)

Randomised controlled trialHuman Identifier verified

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

Kingsberg SA, Clayton AH, Portman D, et al. · Obstetrics & Gynecology · 2019 · n = 1,267

Population: Premenopausal women with hypoactive sexual desire disorder
Endpoint: Change in FSFI desire domain and FSDS-DAO item 13 distress score
Route: Subcutaneous, as-needed
Quantity as reported: 1.75 mg as needed
Frequency: As needed, not more than once in 24 hours
Duration: 24 weeks

Result. Statistically significant improvement in desire and reduction in associated distress versus placebo. Effect sizes were modest.

Adverse events. Nausea, flushing, headache; transient blood-pressure increase and heart-rate decrease after dosing.

Limitations. Premenopausal women only. Effect sizes modest and of debated clinical meaningfulness. Not studied in men in these trials.

PMID31599840 NCTNCT02333071

Randomised controlled trialHuman Identifier verified

Prespecified and Integrated Subgroup Analyses from the RECONNECT Phase 3 Studies of Bremelanotide

Multiple · Journal of Women's Health · 2022 · n = 1,267

Population: Premenopausal women with HSDD, subgroup analysis
Endpoint: Subgroup consistency of desire and distress endpoints
Route: Subcutaneous
Quantity as reported: 1.75 mg as needed
Frequency: As needed
Duration: 24 weeks

Result. Reported broadly consistent direction of effect across prespecified subgroups.

Adverse events. As reported in the parent trials.

Limitations. Subgroup analyses are hypothesis-generating and underpowered individually.

PMID35230162

Last evidence review: 2026-08-23

Human evidence

2 human studies catalogued

Human and non-human evidence are kept strictly separate. They are never pooled, averaged, or presented as a single body of support.

Randomised controlled trialHuman Identifier verified

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

Kingsberg SA, Clayton AH, Portman D, et al. · Obstetrics & Gynecology · 2019 · n = 1,267

Population: Premenopausal women with hypoactive sexual desire disorder
Endpoint: Change in FSFI desire domain and FSDS-DAO item 13 distress score
Route: Subcutaneous, as-needed
Quantity as reported: 1.75 mg as needed
Frequency: As needed, not more than once in 24 hours
Duration: 24 weeks

Result. Statistically significant improvement in desire and reduction in associated distress versus placebo. Effect sizes were modest.

Adverse events. Nausea, flushing, headache; transient blood-pressure increase and heart-rate decrease after dosing.

Limitations. Premenopausal women only. Effect sizes modest and of debated clinical meaningfulness. Not studied in men in these trials.

PMID31599840 NCTNCT02333071

Randomised controlled trialHuman Identifier verified

Prespecified and Integrated Subgroup Analyses from the RECONNECT Phase 3 Studies of Bremelanotide

Multiple · Journal of Women's Health · 2022 · n = 1,267

Population: Premenopausal women with HSDD, subgroup analysis
Endpoint: Subgroup consistency of desire and distress endpoints
Route: Subcutaneous
Quantity as reported: 1.75 mg as needed
Frequency: As needed
Duration: 24 weeks

Result. Reported broadly consistent direction of effect across prespecified subgroups.

Adverse events. As reported in the parent trials.

Limitations. Subgroup analyses are hypothesis-generating and underpowered individually.

PMID35230162

Pharmacology

Reported parameters

Half-life

2.7 hours

Approximately 2.7 hours, consistent with as-needed administration.

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Routes studied

Subcutaneous
Intranasal (earlier programme)

Evidence from one route does not transfer to another. Topical, oral, and injected administration can produce entirely different exposure from the same quantity.

Regulatory status

FDA-approved for acquired, generalised hypoactive sexual desire disorder in premenopausal women. Not approved in men or postmenopausal women.

Storage as documented

Per approved product labelling; the approved product is a single-use autoinjector.

Safety

Signals reported in the literature

This lists what has been reported. It is not a complete safety profile, and for several compounds in this catalogue no systematic safety surveillance exists at all.

Nausea is common, particularly with the first administration
Transient blood-pressure increase and heart-rate decrease after dosing
Focal hyperpigmentation reported with repeated use
Labelling contraindicates use in uncontrolled hypertension or known cardiovascular disease

Interactions

Register entries involving this compound

bremelanotide ↔ antihypertensive medications

Approved labelling contraindicates use in uncontrolled hypertension or known cardiovascular disease and describes the transient haemodynamic effect.

Limitations. Effect is transient but the contraindication is categorical in the labelling.

bremelanotide ↔ naltrexone

Addressed in approved labelling.

Limitations. Consult the current labelling for the specific advisory.

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Limitations

What the evidence cannot tell you

Given as much prominence as the findings, because for most compounds in this category it is the more important half.

Studied population is premenopausal women only
Effect sizes were modest and their clinical meaningfulness has been debated
The earlier intranasal programme was discontinued after blood-pressure findings

Reference

Evidence grading key

AStrong

Multiple high-quality human trials, or strong systematic-review or meta-analytic evidence.

BModerate

Human controlled evidence exists, but replication or sample size is limited.

CPreliminary

Small human studies, observational evidence, or early-phase clinical work.

DPreclinical

Predominantly animal or in-vitro evidence. No adequate human outcome data.

EMechanistic

Biological plausibility or mechanistic reasoning without adequate outcome evidence.

XInsufficient / conflicting

Evidence is absent, irreconcilable, or too weak to support any directional statement.

Other compounds studied in the same research areas

Melanotan II

Retained in the catalogue primarily to document a substantial body of reported harm. The published case literature is the relevant evidence here.