Bremelanotide (PT-141)
Evidence: A — Established Human EvidenceHormone / Fertility
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.
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.
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.
- 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
Human Studies & Clinical Data
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| Bremelanotide for the treatment of hypoactive sexual desire disorder: two randomized phase 3 trials | 2019 | Premenopausal women with acquired, generalized HSDD in the RECONNECT trials | Bremelanotide improved sexual desire and related distress on co-primary endpoints compared with placebo; effect sizes and discontinuation from adverse events require context. | 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 | 2004 | Men with erectile dysfunction | Intranasal PT-141 produced erectile responses in this early controlled study. | 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.