The figures · Recent-research lens
PT-141 Results in the Studies
The quantified outcomes, gathered as a ledger: the Phase 3 endpoints, the year-long extension, the brain-imaging data, and the latest pooled analysis.
The short version
This page collects the PT-141 results — the actual numbers the studies measured — in one place. The headline figures: two Phase 3 trials in 1,267 women found that bremelanotide improved sexual desire by a small, statistically significant amount (FSFI-desire +0.35, P<.001) and lowered desire-related distress (FSDS-DAO −0.33, P<.001) [3].
A 52-week follow-up showed those gains held, with nausea (40.4%) the most common side effect [4]. A brain-imaging study confirmed the central mechanism [5], and a 2026 pooled analysis found improvement across the FSFI total plus desire and arousal subscales [13]. Independent critics counter that the effects, though real, are small [11][12]. The ruled entries below give each figure with its source.
The Phase 3 efficacy results (RECONNECT)
The two pivotal trials are the spine of the PT-141 results record. Enrollment: 1,267 premenopausal women with HSDD across two identical, randomized, placebo-controlled trials [3]. Over 24 weeks, bremelanotide 1.75 mg subcutaneous as-needed produced an integrated FSFI-desire improvement of +0.35 (P<.001) and an integrated FSDS-DAO item-13 reduction of −0.33 (P<.001) versus placebo [3].
Both coprimary endpoints — improved desire and reduced desire-related distress — were met in both trials [3]. The effect is real and reproducible across the matched pair; it is also, by the scale of the instruments, modest, which is the central point of contention in the recent literature [3][12].
Long-term results: the 52-week extension
Durability matters for an as-needed drug, and the open-label extension addressed it directly. 684 women enrolled for up to 52 weeks; no new safety signals emerged and the improvements in sexual desire were sustained over the year [4]. The most common drug-related treatment-emergent adverse events were nausea (40.4%), flushing (20.6%), and headache (12.0%) [4].
The extension's tolerability picture is the source of the most consequential PT-141 result for everyday use: nausea is common and the principal reason people discontinue [4]. Efficacy held; tolerability was the limiting factor.
Mechanistic results: the 2022 fMRI study
The recent-research lens leads to a study that measured the effect inside the brain. In a randomized, double-blind, placebo-controlled crossover fMRI study of 31 premenopausal women with HSDD, MC4R agonism significantly increased sexual desire for up to 24 hours [5]. It also altered task-based brain processing of erotic stimuli, with enhanced amygdala–insula functional connectivity and changes in cerebellar and supplementary-motor activity [5].
This is mechanistic neuroimaging evidence that MC4R agonism modulates central sexual brain processing — the imaging counterpart to the behavioral trial results, and a confirmation that the route of action is central rather than vascular [5].
The most recent pooled and critical results
The newest results sharpen the balance. A 2026 systematic review and meta-analysis of female sexual desire, arousal, and orgasmic dysfunction treatments reported that bremelanotide improved total FSFI plus the desire and arousal subscales across pooled trials [13]. That is the supportive recent reading.
The critical reading is equally recent. Spielmans (2024) re-examines the same trial data and argues the effects on desire and distress, while statistically significant, are small, questioning their clinical meaningfulness and the choice of outcome measures [12]. A 2017 review of HSDD pharmacotherapy similarly notes that bremelanotide showed some clinical benefit but that the trials carry design, dosing, or generalizability limitations [11]. The honest ledger keeps both columns open.