Bremelanotide (PT-141)
Evidence: A — Established Human EvidenceHormone / Fertility
Key facts
- Research areaHormone / Fertility
- Research statusfda_approved
- Study records22 human
- Last updated2026-07-26
Evidence Snapshot
Regulatory Context
FDA-approved as Vyleesi for a specific indication in premenopausal women with acquired, generalized hypoactive sexual desire disorder. It is not labeled for men, postmenopausal women, or enhancement of sexual performance.
In Plain English
A quick, research-focused overview. It does not replace, and cannot outrank, the detailed evidence below.
What is it?
Bremelanotide is the canonical identity of PT-141 and is an FDA-approved cyclic melanocortin agonist for a narrow HSDD indication. Earlier PT-141 studies and off-label discussions must remain separated from the approved use.
Why are researchers interested in it?
Human development programs studied sexual desire in premenopausal women and erectile responses in earlier male studies.
What is it being studied for?
- Hypoactive sexual desire disorder (premenopausal women)Human Studies & Clinical Data
- Erectile response (men)Human Studies & Clinical Data
- Melanocortin receptor mechanismAnimal / Cell / Preclinical Data
What does the evidence look like?
Evidence grade A/D. Human, preclinical, regulatory, review, and anecdotal evidence must remain separated.
Biggest things to know
The FDA label includes transient blood-pressure increases, heart-rate decreases, nausea, focal hyperpigmentation, and contraindications for uncontrolled hypertension or known cardiovascular disease.
What don't we know yet?
Its FDA approval is specific to acquired, generalized hypoactive sexual desire disorder in premenopausal women; it does not establish an erectile-dysfunction indication or general sexual-performance enhancement in men. Early PT-141 erectile-response studies showed pharmacologic activity in men but were never developed into an approved erectile-dysfunction product. The approved safety and efficacy evidence comes from two Phase 3 trials in that specific population, and grey-market or compounded PT-141 products are not established as equivalent to the approved formulation in identity, concentration, purity, sterility, or formulation.
Research status
Reviewed August 25, 2026
Research Takeaway
Bremelanotide is a synthetic cyclic melanocortin-receptor agonist peptide; PT-141 is its historical development name, and the subject must remain distinct from Melanotan II despite their shared melanocortin lineage.
Evidence boundary: Shared melanocortin pharmacology does not make bremelanotide and Melanotan II interchangeable.
See all 6 evidence claims →Quick Summary
Bremelanotide is the canonical identity of PT-141 and is an FDA-approved cyclic melanocortin agonist for a narrow HSDD indication. Earlier PT-141 studies and off-label discussions must remain separated from the approved use.
Mechanism & Research Overview
Bremelanotide is a synthetic cyclic melanocortin-receptor agonist. FDA reviews identify PT-141 as its former development name; clinically relevant activity includes melanocortin receptor signaling in central sexual-response pathways and MC1-related pigmentation effects.
Mechanism pathway
Relationship-support labels describe the type and directness of the research available, not proof of safety or effectiveness. Indirectly supported, inferred and uncertain relationships are not equivalent to directly supported ones.
- CompoundBremelanotide (PT-141)
- Directly supported (Directly supported relationship)Biological targetMelanocortin receptor (MC3R/MC4R)Receptor
- Leads toPathwayMelanocortin Signaling
Relationship details
- Bremelanotide (PT-141) → Melanocortin receptor (MC3R/MC4R) — Directly supportedBremelanotide is a synthetic cyclic melanocortin-receptor agonist with supported activity at MC3R and MC4R.
Relevant tissue/system context: CNS (hypothalamic sexual-response circuitry)
Evidence Claims
Individual scientific statements drawn from the sources cited below, each shown with the specific evidence boundary that statement does not establish.
Supported
Bremelanotide is a synthetic cyclic melanocortin-receptor agonist peptide; PT-141 is its historical development name, and the subject must remain distinct from Melanotan II despite their shared melanocortin lineage.
Does not establish
Evidence boundary: Shared melanocortin pharmacology does not make bremelanotide and Melanotan II interchangeable.
Sources: Double-blind placebo-controlled evaluation of intranasal PT-141 in men with erectile dysfunction
Supported
Vyleesi (bremelanotide) is FDA-approved for acquired, generalized hypoactive sexual desire disorder in premenopausal women under the labeled diagnostic conditions.
Does not establish
Evidence boundary: The approval does not extend to men, postmenopausal women, generalized libido enhancement, or enhancement of sexual performance.
Supported
Two Phase 3 randomized trials demonstrated statistically significant improvement in sexual desire and reduction in distress related to low desire with bremelanotide versus placebo in the approved HSDD population.
Does not establish
Evidence boundary: These results do not establish an erectile-dysfunction indication or generalized sexual-performance enhancement.
Sources: Bremelanotide for the treatment of hypoactive sexual desire disorder: two randomized phase 3 trials
Supported
Bremelanotide labeling and clinical trials identify clinically important adverse effects including nausea and transient blood-pressure effects, with contraindications and precautions defined in the approved prescribing information.
Does not establish
Evidence boundary: This is not an exhaustive substitute for the current label and does not quantify individual risk.
Sources: Bremelanotide for the treatment of hypoactive sexual desire disorder: two randomized phase 3 trials
Supported
Early PT-141 erectile-response studies demonstrate pharmacologic activity in men but do not establish an FDA-approved erectile-dysfunction indication for bremelanotide.
Does not establish
Evidence boundary: A positive physiologic response in early trials is not equivalent to a completed approved indication.
Sources: Double-blind placebo-controlled evaluation of intranasal PT-141 in men with erectile dysfunction
Supported
Grey-market or compounded products sold as PT-141 are not automatically equivalent to FDA-approved Vyleesi in identity, concentration, purity, sterility, formulation, or device performance; only label or named-study dosing may appear as Study/Trial Dosing.
Does not establish
Evidence boundary: This does not provide a consumer dosing or injection protocol.
Safety & Evidence Limitations
Considerations reported in the sources cited on this page — not a complete list of every possible risk, and not medical advice.
Safety Consideration
Transient blood-pressure increases and heart-rate decreases occur after dosing; the FDA label contraindicates use with uncontrolled hypertension or known cardiovascular disease.Safety Consideration
Nausea is common and focal hyperpigmentation may persist.Safety Consideration
The approved indication does not cover men, postmenopausal women, or sexual-performance enhancement.
Research Areas Being Studied
Research areas discussed on this page reflect the Hormone / Fertility category and the sources cited below.
Findings Reported in Studies
Educational summary only — reported in cited studies, not a claim of proven benefit.
Show findings from 2 human studies
- Bremelanotide for the treatment of hypoactive sexual desire disorder: two randomized phase 3 trials (2019):
- Double-blind placebo-controlled evaluation of intranasal PT-141 in men with erectile dysfunction (2004):
Study Tables by Evidence Type
2 study records
Human Studies & Clinical Data(2)
Bremelanotide for the treatment of hypoactive sexual desire disorder: two randomized phase 3 trials
2019PMID 31599840
- Population / Model
- Premenopausal women with acquired, generalized HSDD in the RECONNECT trials
- Dose / Duration / Finding
Bremelanotide improved sexual desire and related distress on co-primary endpoints compared with placebo; effect sizes and discontinuation from adverse events require context.
Safety note
Nausea and other adverse effects were common; cardiovascular labeling was informed by the broader program.
Double-blind placebo-controlled evaluation of intranasal PT-141 in men with erectile dysfunction
2004PMID 14963471
- Population / Model
- Men with erectile dysfunction
- Dose / Duration / Finding
Intranasal PT-141 produced erectile responses in this early controlled study.
Safety note
The intranasal development program is not the same formulation or approved indication as Vyleesi.
Animal / Cell / Preclinical Data
No Animal / Cell / Preclinical Data Listed Yet
This section will be updated as sources are added.
Regulatory Documents & Official Trial Registries
No Regulatory Documents & Official Trial Registries Listed Yet
This section will be updated as sources are added.
Anecdotal Reported Patterns — Not Medical Advice
Anecdotal Reported Patterns — Not Medical Advice
Reported dosing patterns are included for educational context only. They are self-reported, unverified, not medical advice, and not instructions for human use. Community-submitted patterns are not yet available in this Phase 1 prototype; this section is a placeholder reserved for moderated, aggregated community data.
Lab Markers to Discuss With a Clinician
Educational topics only — not self-monitoring instructions.
FAQ
Disclaimer
Educational information only. This page summarizes published and official research and does not provide medical advice, a recommendation, or instructions for human use.
Educational use only. This content is provided for informational and research-summary purposes only. It is not medical advice, not a treatment recommendation, not a dosing guide, and not a substitute for care from a licensed medical professional. Nothing here is intended to diagnose, treat, cure, prevent, or mitigate disease. Reported dosing patterns, when shown elsewhere on the site, must be labeled either as Study / Trial Dosing or Anecdotal Reported Patterns — Not Medical Advice. Community reports are self-reported, unverified, and not scientific proof.
Community-reported experiences, once enabled, must be displayed only as moderated, anonymized, or aggregated data. They are anecdotal, self-reported, unverified, and should never be presented as proof of safety, efficacy, or expected results.
Content status: Published. Last updated 2026-07-26.
Follow research updates for Bremelanotide (PT-141)
Get notified in your MitoCore account when this profile is updated, a new study is added, or its evidence grade changes.
Get updates when new studies or safety notes are added for this peptide.
Get educational updates on new studies, evidence-grade changes, and safety notes. Educational content only — not medical advice.