PT-141
Cyclic α-MSH analogue approved as Vyleesi for hypoactive sexual desire disorder in premenopausal women.
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Also: Bremelanotide · Vyleesi
Cyclic α-MSH analogue approved as Vyleesi for hypoactive sexual desire disorder in premenopausal women.
Evidence Intelligence Score™
- Preclinical
- Pilot human
- RCT← current
- Multi-RCT
- Meta-analysis
Confidence aggregates eight dimensions of evidence — human data, safety maturity, mechanism, clinical readiness, momentum, consistency, long-term follow-up, and translational signal. It is a measure of what is known, not a recommendation. Methodology.
- Human evidenceWeight of RCT and observational data8.8
- Safety maturityFollow-up depth and adverse-event signal6.9
- Mechanism confidencePathway specificity and clarity6.3
- Clinical readinessDistance to physician-prescribable use7.8
- Research momentumRecency of indexed clinical evidence5.0
- Study consistencyEffect direction across cohorts3.0
- Long-term dataFollow-up beyond initial trial windows5.4
- Translational confidenceAnimal → human signal preservation7.6
Effects on the indexed outcomes are supported by randomized human data, with 1 citation on file.
Effect sizes outside trial populations and durations beyond the studied window remain less characterized.
Interactions outside listed contraindications, long-term safety, and effect heterogeneity across age and sex are not fully resolved.
Outlook: maturing. Expect the consensus to harden as multi-site replications publish.
Erectile function
1 study- moderateDiamond LE, Earle DC, Rosen RC, Willett MS, Molinoff PB
Intranasal bremelanotide produced statistically significant improvements in erectile response in men with ED, including PDE5-inhibitor non-responders.
RCTn=2712006unreviewed
Libido & arousal
1 study- strongKingsberg SA, Clayton AH, Portman D, et al.
Bremelanotide 1.75 mg SC significantly improved sexual desire (FSFI-D) and reduced distress (FSDS-DAO) vs placebo in premenopausal women with HSDD across the RECONNECT trials.
RCTn=1,2472019unreviewed
Libido & arousal
1 regimenMost common AEs: nausea (40%), flushing, injection-site reactions, headache. Transient BP increase; contraindicated with uncontrolled hypertension or known CV disease.
Discontinue after 8 weeks if no improvement in HSDD symptoms per label.
Erectile function
1 regimenTransient blood pressure elevation observed; intranasal program halted by sponsor in 2008.
Open-label safety/efficacy evaluation; intranasal program was discontinued in favor of SC formulation due to BP signals.
These are observed research regimens drawn from approved labels, clinical trials, or preclinical literature — not dosing recommendations. Suggestive, never prescriptive.
- —Long-term safety beyond reported study durations.
- —Effect size in populations under-represented in the cited trials.
- —Interactions with concomitant medications outside listed contraindications.
We surface uncertainty next to every claim. Suggestive, never prescriptive — discuss with a clinician.
3 brands across three tiers.
Medicine
1 brandRegulator-approved finished medicines. Prescribed for specific indications, manufactured under GMP, distributed through licensed pharmacies.
Compounded (US 503A)
1 brandPatient-specific preparations from US 503A compounding pharmacies. Require a valid prescription, not FDA-approved as finished drugs. Check the pharmacy's licence and the active ingredient's status on the FDA 503A bulks list.
Research-use only
1 brandSold by chemical suppliers labelled 'for laboratory research only — not for human consumption'. No pharmaceutical-grade QC, no medical oversight. Listed for transparency.