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Pt15.0
PT-141 – Forschung
Überwiegend Mechanismus / Beobachtung
14 begutachtete Studien
Was die Evidenz sagt
Überwiegend Mechanismus / Beobachtung
Die meisten Studien zu PT-141 sind mechanistisch oder beobachtend statt RCTs, die einen klinischen Effekt messen — betrachte die Ergebnisse als vorläufig.
Die meiste Evidenz stammt aus mittelwertigen Meta-Analysen und randomisierten Studien, veröffentlicht 2003–2026 mit einer typischen Studiengröße von 397 Teilnehmenden.
Basierend auf 14 Studien · 2 Meta-Analysen · 5 RCTs · 2,728 Teilnehmende insgesamt
Konfidenz
Hohe Konfidenz
Nach Outcome
Sexual desire & HSDD
Überwiegend Mechanismus / Beobachtung10 Studien
Safety profile
Überwiegend Mechanismus / Beobachtung4 Studien
Erectile function (earlier ED trials)In den Phase-3-Studien RECONNECT führte bedarfsweise verabreichtes Bremelanotid im Vergleich zu Placebo zu signifikanten Steigerungen des sexuellen Verlangens und zu einer Verringerung des mit dem Verlangen verbundenen Leidensdrucks (prämenopausale Frauen mit HSDD); der Effekt ist real, aber klinisch gering · Bedarfsweise (pro Dosis)
Zu wenige bewertete Studien2 Studien
Heart & blood pressure
Zu wenige bewertete Studien1 Studie
Aktives Forschungsgebiet
6 Studien in den letzten 5 Jahren · Neueste Meta-Analyse: 2026
200320142026
1Systematische Übersicht2026
Further research with standardized methodologies and comprehensive reporting is needed to strengthen the evidence base.
Ashour AM. · Frontiers in medicine (2026)
Safety data were inconsistently reported, with adverse events reflecting the pharmacological mechanisms of the agents studied.
Conclusion The findings highlight both progress and persistent gaps in the pharmacological treatment landscape for HSDD.
Variability in trial design, outcome measures, and reporting practices limits cross-trial comparison and clinical interpretation.
2Systematische Übersichtn=20 · very small study2026
While FDA-approved agents demonstrate clinical potential, investigational peptides require rigorous validation through well-designed clinical trials to establish safety and efficacy for healthspan extension.
Mavrych V, Shypilova I, Bolgova O. · Frontiers in aging (2026)
Non-approved peptides showed promising preclinical and limited clinical evidence but lack long-term safety data and systematic validation.
Significant knowledge gaps include optimal dosing regimens, combination therapy effects, and biomarkers for monitoring efficacy.
Conclusion Therapeutic peptides offer mechanistically diverse approaches to multiple aging hallmarks.
Women taking bremelanotide had statistically significant increases in sexual desire and statistically significant reductions in distress related to low sexual desire compared with placebo.
Kingsberg SA, Clayton AH, Portman D, et al. · Obstet Gynecol (2019)
Two identical phase-3, randomized, double-blind, placebo-controlled, multicenter trials (RECONNECT) of bremelanotide 1.75 mg subcutaneously as-needed over 24 weeks
1,267 premenopausal women with HSDD randomized 1:1 (mean age 39)
Met coprimary endpoints: significant gains in FSFI desire-domain score (integrated +0.35, P<.001) and reduced desire-related distress (integrated -0.33, P<.001) vs placebo
Responder analyses... were used to determine whether changes... are clinically meaningful... in a large, controlled, phase 2b, dose-finding study of bremelanotide in premenopausal women with HSDD.
Althof S, Derogatis LR, Greenberg S, et al. · J Sex Med (2019)
Phase-2b, randomized, controlled dose-ranging study in premenopausal women with HSDD and mixed HSDD/FSAD
Derived minimal clinically important differences (MCIDs) for desire and distress endpoints
Established the dose and responder framework carried into the phase-3 RECONNECT trials
Increases in ambulatory SBP relative to placebo of... 3.1 and 3.2 mmHg (1.75 mg)... occurred following two doses... peak increases typically lasted less than 15 min.
White WB, Myers MG, Jordan R, et al. · J Hypertens (2017)
Randomized, double-blind, placebo-controlled ambulatory-BP trial of bremelanotide (0.75/1.25/1.75 mg) in 397 premenopausal women with FSD (normotensive or controlled-hypertensive)
Small, transient increases in systolic and diastolic BP (peaks typically <15 min) with reflex heart-rate reduction (-4.6 to -4.7 bpm at 1.75 mg)
26 participants discontinued for prespecified BP increases (similar across arms)
flibanserin improves desire; and bremelanotide improves both desire and arousal; and all 3 treatments reduce distress.
Toledo RG, Winkelman WD, Reyes-Gonzalez D, Bergeron S, Fladger A, Hacker MR, Anand M. · J Minim Invasive Gynecol (2026)
Systematic review and meta-analysis of treatments for female sexual desire/arousal/orgasm dysfunction (36 studies, 26 RCTs); meta-analyses were conducted for mindfulness-based CBT, flibanserin and bremelanotide
Bremelanotide significantly improved total FSFI and its desire and arousal subscales vs placebo
Bremelanotide (like flibanserin and CBT) reduced sexual distress
Positive clinical results were seen in 51 (33.5%) patients in the bremelanotide group compared with 13 (8.5%) patients in the placebo group.
Safarinejad MR, Hosseini SY. · J Urol (2008)
Randomized, double-blind, placebo-controlled trial of INTRANASAL bremelanotide 10 mg in 342 men with erectile dysfunction who did not respond to sildenafil
Positive clinical results in 33.5% (bremelanotide) vs 8.5% (placebo); greater intercourse satisfaction
More drug-related adverse effects in the bremelanotide group
In clinical trials, flibanserin led to an average of only one additional enjoyable sexual experience every two months, bremelanotide to none... Bremelanotide, with even weaker efficacy, capitalised on the regulatory precedent set by the approval of flibanserin.
Mintzes B, Tiefer L, Cosgrove L. · Drug Ther Bull (2021)
Critical appraisal of the FDA approvals of bremelanotide and flibanserin for HSDD
Argues bremelanotide's trials showed no increase in satisfying sexual events vs placebo on key measures
Highlights shifts in primary outcomes and a contested indication
Bremelanotide is an MCR agonist... of which subtype 4 (MC4R) is the most relevant at therapeutic doses... predominantly expressed in the medial preoptic area (mPOA) of the hypothalamus.
Pfaus JG, Sadiq A, Spana C, et al. · CNS Spectr (2022)
Review of HSDD neurobiology and bremelanotide's mechanism
MC4R, expressed in the hypothalamic medial preoptic area, is the relevant target at therapeutic doses
Frames HSDD as an imbalance of central excitation vs inhibition that melanocortin agonism shifts toward desire
Bremelanotide (Vyleesi) is a melanocortin receptor agonist recently approved in the USA for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD).
Dhillon S, Keam SJ. · Drugs (2019)
Regulatory-milestone review of the 2019 FDA approval of bremelanotide (Vyleesi)
A self-administered, on-demand subcutaneous melanocortin-receptor agonist (high MC4R affinity)
Approved for acquired, generalized HSDD in premenopausal women
Administration of PT-141 to normal men and to patients with erectile dysfunction resulted in a rapid dose-dependent increase in erectile activity.
Molinoff PB, Shadiack AM, Earle D, et al. · Ann N Y Acad Sci (2003)
Early translational report: PT-141 is an alpha-MSH analogue agonist at MC3R/MC4R, expressed mainly in the CNS
In rats, systemic PT-141 activated hypothalamic neurons (c-Fos) and produced penile erections; same CNS region traced from the penis via pseudorabies virus
Early human dosing produced rapid, dose-dependent increases in erectile activity