Compound research
PT-141 (Bremelanotide): Research Overview & Current Status
PT-141 (Bremelanotide) is a Melanocortin receptor agonist (cyclic heptapeptide). Current research status: fda-approved. Bremelanotide was FDA-approved in June 2019 under the brand name Vyleesi (Cosette Pharmaceuticals) for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women, administered as a 1.75 mg subcutaneous injection. FDA approval applies specifically to the Vyleesi finished product; compounded bremelanotide preparations and off-label uses (e.g., in men or postmenopausal women) are not FDA-approved.
Overview
PT-141, known generically as bremelanotide, is a synthetic cyclic heptapeptide that acts as an agonist at melanocortin MC3 and MC4 receptors in the central nervous system. Unlike PDE5-inhibitor erectile dysfunction drugs that act on peripheral blood flow, bremelanotide acts centrally on brain pathways implicated in sexual desire.
Melanocortin receptor agonist (cyclic heptapeptide)
Research timeline
1990s-2000s
Bremelanotide (PT-141) developed as a melanocortin receptor agonist, with earlier intranasal formulation studied in Phase 2 trials for sexual dysfunction.
Source →Phase 2
Intranasal PT-141 studied in Phase 2 trials but never advanced to Phase 3 or approval due to formulation/tolerability issues.
Source →2010s
Subcutaneous autoinjector formulation developed and advanced into the Phase 3 RECONNECT clinical trial program in premenopausal women with HSDD.
Source →2019 (pre-approval)
Two Phase 3 RECONNECT trials (~1,200 premenopausal women) met co-primary endpoints for improved sexual desire and reduced HSDD-related distress; FSFI desire domain effect sizes ranged 0.49-0.61.
Source →2019
FDA approved bremelanotide (Vyleesi) for acquired, generalized HSDD in premenopausal women — the first centrally-acting, non-hormonal peptide therapy approved for this indication.
Source →2019
A 52-week open-label extension safety study (Simon 2019) reported a consistent long-term safety profile.
Source →
Active & recent research
RECONNECT Phase 3 program
Efficacy and safety of subcutaneous bremelanotide for HSDD in premenopausal women
52-week open-label extension safety study
Long-term tolerability and adverse event profile with continued use
Off-label study of bremelanotide in men with PDE5-inhibitor-nonresponsive erectile dysfunction
Response rates in men who did not respond to PDE5 inhibitors, reported as exploratory/off-label rather than an approved indication
Key findings
- Two Phase 3 RECONNECT trials enrolling roughly 1,200 premenopausal women reported statistically significant improvements in sexual desire (FSFI desire domain) and reduced HSDD-related distress, forming the basis of FDA approval.
- A 52-week open-label extension study reported a consistent long-term safety profile, supporting continued-use tolerability beyond the initial 24-week trial period.
- The most commonly reported adverse effects across trials were nausea (up to ~40% with the first dose, diminishing with continued use), flushing, injection-site reactions, and headache, along with a transient rise in blood pressure and decrease in heart rate post-dose.
- Exploratory, off-label research in men with PDE5-inhibitor-nonresponsive erectile dysfunction reported higher response rates than placebo in small studies, but this is explicitly an off-label, non-FDA-approved use.
Safety & regulatory notes
Vyleesi (bremelanotide) is FDA-approved specifically for premenopausal women with acquired, generalized HSDD; it is not recommended for those with uncontrolled hypertension or cardiovascular disease due to transient blood pressure increases observed after dosing. Use in men or postmenopausal women, and use of compounded (non-Vyleesi) bremelanotide preparations, is off-label and outside the FDA-approved indication.
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PT-141 (Bremelanotide) FAQ
Is PT-141 FDA-approved?+
Yes, as bremelanotide under the brand name Vyleesi, FDA-approved in 2019 specifically for acquired, generalized hypoactive sexual desire disorder in premenopausal women. This approval does not extend to compounded preparations or other populations.
What clinical trials supported bremelanotide's approval?+
The Phase 3 RECONNECT trial program, involving about 1,200 premenopausal women, found bremelanotide met co-primary endpoints for improved sexual desire and reduced related distress compared with placebo.
What are the most commonly reported side effects?+
Trial data report nausea as the most common side effect (especially with the first dose), along with flushing, injection-site reactions, headache, and a transient increase in blood pressure with decreased heart rate after dosing.
Has bremelanotide been studied in men?+
Yes, in smaller off-label studies, particularly in men who did not respond to PDE5 inhibitors, but this use is not an FDA-approved indication and is considered investigational/off-label.
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