What is PT-141 (Bremelanotide)?
PT-141 (Bremelanotide) is a synthetic cyclic heptapeptide melanocortin receptor agonist studied in premenopausal women with hypoactive sexual desire disorder and female sexual arousal disorder. This page summarises the c
What is PT-141 (Bremelanotide)?
PT-141, formally named Bremelanotide, is a synthetic cyclic heptapeptide and a melanocortin receptor agonist. It is also referred to in the research literature and trial registries by the abbreviation BMT. The compound is a metabolite analogue of the endogenous peptide alpha-melanocyte-stimulating hormone (alpha-MSH), engineered for improved stability and receptor selectivity relative to the parent hormone. In the clinical research record, bremelanotide has been formulated for subcutaneous (SC) and intranasal administration, and has been investigated primarily in premenopausal women with hypoactive sexual desire disorder (HSDD), female sexual arousal disorder (FSAD), or mixed FSAD/HSDD [1][2][3][4].
The research programme centres on the melanocortin receptor family, a group of G-protein-coupled receptors that mediate the downstream effects of alpha-MSH and related pro-opiomelanocortin-derived peptides. Bremelanotide acts as an agonist at melanocortin receptors, and the clinical studies described below were designed to evaluate whether that receptor-level activity translates into measurable changes in the specified patient populations.
Research Studies
Bremelanotide and subcutaneous dosing in premenopausal women with HSDD
Two Phase 3 trials — NCT02338960 and NCT02333071 — were randomised, double-blind, placebo-controlled, parallel-group studies with optional open-label extensions. Both evaluated bremelanotide administered subcutaneously on an as-needed basis for the treatment of HSDD, with or without decreased arousal, in premenopausal females [1][2]. The two studies share an identical design description in the registry record, indicating a coordinated Phase 3 programme rather than a single isolated trial.
| Registry ID | Phase | Design | Route | Population |
|---|---|---|---|---|
| NCT02338960 | Phase 3 | Randomised, double-blind, placebo-controlled, parallel-group, optional open-label extension | Subcutaneous, as needed | Premenopausal females with HSDD (with or without decreased arousal) |
| NCT02333071 | Phase 3 | Randomised, double-blind, placebo-controlled, parallel-group, optional open-label extension | Subcutaneous, as needed | Premenopausal females with HSDD (with or without decreased arousal) |
Bremelanotide and fixed subcutaneous dose levels in FSAD, HSDD, or mixed FSAD/HSDD
NCT01382719 was designed to evaluate the efficacy and safety of three fixed dose levels of bremelanotide, administered subcutaneously on an as-needed basis under conditions of home use. The trial population comprised premenopausal women with female sexual arousal disorder (FSAD), hypoactive sexual desire disorder (HSDD), or mixed FSAD/HSDD [3]. The three-dose-level design distinguishes this study from the two Phase 3 trials above, which are described in the registry record without a fixed-dose-level comparison in their summary text.
Bremelanotide and intranasal administration in women with FSAD
NCT00425256 was an 8-week at-home study designed to explore efficacy endpoints and evaluate the safety of intranasal bremelanotide in women with female sexual arousal disorder. Efficacy was assessed against a parallel placebo group [4]. This study is notable within the evidence set for its intranasal route of administration, in contrast to the subcutaneous route used in the Phase 3 HSDD trials and the fixed-dose FSAD/HSDD trial [1][2][3].
| Registry ID | Route | Duration | Population | Comparison |
|---|---|---|---|---|
| NCT00425256 | Intranasal | 8 weeks, at home | Women with FSAD | Parallel placebo group |
| NCT01382719 | Subcutaneous, as needed | Not specified in registry summary | Premenopausal women with FSAD, HSDD, or mixed FSAD/HSDD | Three fixed dose levels |
Bremelanotide and the melanocortin receptor pathway
Across the studies in this evidence set, the mechanistic premise is consistent: bremelanotide is a melanocortin receptor agonist, and the trials were designed to test whether activating that receptor family produces measurable efficacy in the specified female sexual dysfunction populations [1][2][3][4]. The registry records do not, in the excerpts available here, report receptor-binding affinities, selectivity ratios, or downstream signalling data. Those parameters are not addressed in the evidence block and are therefore not stated on this page.
Bremelanotide and the premenopausal HSDD population
The two Phase 3 trials and the fixed-dose trial all specify premenopausal women as the study population [1][2][3]. The intranasal FSAD study describes its population as women with FSAD without specifying menopausal status in the registry summary [4]. Any statement about effects in postmenopausal women, men, or other populations is not supported by the evidence block and is not made here.
Bremelanotide and as-needed subcutaneous dosing schedules
Three of the four studies in the evidence set describe an as-needed dosing schedule: the two Phase 3 HSDD trials and the fixed-dose FSAD/HSDD trial [1][2][3]. The intranasal FSAD study is described as an 8-week at-home study without the as-needed qualifier in its registry summary [4]. The evidence block does not provide the specific dose amounts, dosing intervals, or maximum dosing frequency used in any of these studies.
Bremelanotide and placebo-controlled efficacy assessment
All four studies in the evidence set include a placebo comparison. The two Phase 3 trials are described as placebo-controlled [1][2]; the fixed-dose trial evaluates three active dose levels [3]; and the intranasal study states that efficacy will be assessed versus a parallel placebo group [4]. The registry summaries do not report the efficacy results, effect sizes, or statistical outcomes of any of these trials. This page therefore describes what was studied, not what was found.
Bremelanotide and safety evaluation across routes of administration
Safety evaluation is named as an objective in all four studies: the two Phase 3 trials include safety in their title [1][2], the fixed-dose trial is designed to evaluate efficacy and safety [3], and the intranasal study is designed to explore efficacy endpoints and evaluate safety [4]. The evidence block does not report adverse event rates, severity, or discontinuation data for any route of administration. No safety claims are made on this page beyond the fact that safety was an evaluated endpoint in the listed studies.
Bremelanotide and the limits of the current evidence set
The evidence block consists entirely of clinical trial registry records for studies in women with FSAD, HSDD, or mixed FSAD/HSDD [1][2][3][4]. It contains no animal-only studies, no in vitro studies, and no preclinical characterisation data. Where this page describes a mechanism, it does so only at the level stated in the registry records — that bremelanotide is a melanocortin receptor agonist evaluated in these populations. No receptor subtype selectivity, pharmacokinetic parameter, or metabolic pathway is asserted, because the evidence block does not supply one.
If you are reading this for personal health reasons
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Sources
- [1] Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder — ClinicalTrials.gov
- [2] Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder — ClinicalTrials.gov
- [3] Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder — ClinicalTrials.gov
- [4] Evaluate the Safety and Efficacy of Bremelanotide in Women With Female Sexual Arousal Disorder (FSAD) — ClinicalTrials.gov