# Bremelanotide - Canonical: https://residue.info/c/bremelanotide/ - Also called: PT-141, Vyleesi - Evidence grade: A (Approved / regulatory-grade). FDA-approved (Vyleesi, NDA 210557) for acquired, generalized hypoactive sexual desire disorder in premenopausal women, on the basis of two randomized phase 3 trials. Other uses are graded separately. - Status: FDA-approved (Vyleesi) · Prescription - PubChem CID: 9941379 - Updated: 2026-10-19 · Reviewed by: Residue Editorial Team Bremelanotide (PT-141) is a synthetic α-MSH analog with high affinity for the melanocortin type 4 receptor [1]. In two phase 3 trials of 1,267 premenopausal women with hypoactive sexual desire disorder, 1.75 mg as needed improved desire and related distress versus placebo [2]. FDA approved it as Vyleesi in 2019 [3]. Nausea was the commonest side effect [4]. ## Key findings - Across the two RECONNECT trials, the desire score rose by 0.35 points more than placebo and distress about low desire fell by 0.33 points more (both P<.001) [2]. (anchor: https://residue.info/c/bremelanotide/#kf-pmid-31599840) - In the integrated phase 3 data (N=1,247), nausea occurred in 40.0% versus 1.3% on placebo, flushing in 20.3% versus 1.3%, and headache in 11.3% versus 1.9% [4]. (anchor: https://residue.info/c/bremelanotide/#kf-pmid-35147466) - Small, transient but statistically significant blood-pressure increases were seen on ambulatory monitoring [4]. (anchor: https://residue.info/c/bremelanotide/#kf-pmid-35147466-2) - Focal hyperpigmentation was rare at labeled dosing but occurred in more than a third of subjects given up to 16 consecutive daily doses [4]. (anchor: https://residue.info/c/bremelanotide/#kf-pmid-35147466-3) - A 2024 reanalysis argued the trial outcome measures have limited validity evidence and that effect sizes on unpublished endpoints ranged from nil to small [5]. (anchor: https://residue.info/c/bremelanotide/#kf-pmid-36809187) ## Effects by system - Sexual desire (HSDD, premenopausal women) (grade A): Improved desire and reduced distress versus placebo in two phase 3 RCTs [2]. (anchor: https://residue.info/c/bremelanotide/#effect-sexual-desire-hsdd-premenopausal-women) - Body weight (obesity) (grade B): About 1.3 kg more weight loss than placebo over 16 days and roughly 400 kcal/day lower intake in phase 1 RCTs [6]. (anchor: https://residue.info/c/bremelanotide/#effect-body-weight-obesity) - Blood pressure (grade B): Small, transient increases on ambulatory monitoring [4]. (anchor: https://residue.info/c/bremelanotide/#effect-blood-pressure) - Skin (grade B): Focal hyperpigmentation, rare at label dosing, common with daily dosing [4]. (anchor: https://residue.info/c/bremelanotide/#effect-skin) ## What is bremelanotide? Bremelanotide is a synthetic peptide analog of α-MSH [1]. Its PubChem record lists the same seven-residue sequence as melanotan II, with the formula C50H68N14O10 [7][8]. It is a self-administered, on-demand subcutaneous therapy, developed by Palatin Technologies and licensed to AMAG Pharmaceuticals for North America [1]. ## How does bremelanotide work? It is a melanocortin receptor agonist with high affinity for the melanocortin type 4 receptor, thought to be important for sexual function, which may modulate brain pathways involved in sexual response [1]. MC4R also plays a central role in appetite, which is why it was tested for weight [6]. ## What have studies found? **Hypoactive sexual desire disorder.** RECONNECT comprised two identical randomized, double-blind trials in premenopausal women (mean age 39). Over 24 weeks, bremelanotide 1.75 mg as needed increased the Female Sexual Function Index desire score and reduced distress about low desire versus placebo in each study [2]. In the 52-week open-label extension, 684 women enrolled and 272 completed it [9]. **How large is the effect?** A 2024 analysis of the RECONNECT data concluded that bremelanotide's benefits are statistically modest and limited to outcomes with scant validity evidence in HSDD, and that 8 of 11 registered efficacy outcomes had not previously been published [5]. **Weight.** In two phase 1 randomized trials in women with obesity, bremelanotide reduced caloric intake by roughly 400 kcal/day and body weight by 1.3 kg more than placebo over 16 days [6]. ## What is its safety record? The development program covered 3,500 subjects in 43 studies. There were no deaths. Nausea was the most common adverse event and reason for discontinuation; the review advises caution in people at cardiovascular risk because of transient blood-pressure increases, and notes interactions that lowered plasma levels of indomethacin and naltrexone [4]. Drugs@FDA lists Vyleesi (autoinjector), a subcutaneous solution with prescription status and an original approval on June 21, 2019 [3]. Approval covers its labeled use only. Bremelanotide is not on FDA's compounding-risk lists [10]. ## What is still unknown? - **Use outside the label**, including in men and postmenopausal women; the phase 3 trials enrolled premenopausal women [2]. - **Whether the measured gains are clinically meaningful**, which a 2024 reanalysis disputes [5]. ## Frequently asked questions **Is PT-141 the same as bremelanotide?** Yes. PubChem lists PT-141 as a synonym of bremelanotide [7], which is sold in the US as Vyleesi [3]. **Is bremelanotide FDA-approved?** Yes. Vyleesi (autoinjector) is listed in Drugs@FDA with an original approval on June 21, 2019 [3], for premenopausal women with acquired, generalized hypoactive sexual desire disorder [1]. **What dose of bremelanotide was used in trials?** The phase 3 trials used 1.75 mg injected under the skin as needed [2], the dose chosen from the phase 2b study [11]. **What are the side effects of bremelanotide?** In phase 3, nausea (40.0%), flushing (20.3%), headache (11.3%) and injection-site reactions (5.4%) were more common than on placebo; small transient blood-pressure rises were also seen [4]. **Does bremelanotide work for men?** Its approval and phase 3 trials are in premenopausal women [2][1]. The erection trials in men were of the related peptide melanotan II [12]. ## Sources [1] Bremelanotide: First Approval. Dhillon S & Keam SJ Drugs. 2019. https://pubmed.ncbi.nlm.nih.gov/31429064/ [2] Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. Kingsberg SA et al. Obstet Gynecol. 2019. https://pubmed.ncbi.nlm.nih.gov/31599840/ [3] Drugs@FDA: VYLEESI (AUTOINJECTOR) (NDA210557). COSETTE; original approval 2019-06-21; Prescription. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210557 [4] Safety Profile of Bremelanotide Across the Clinical Development Program. Clayton AH et al. J Womens Health (Larchmt). 2022. https://pubmed.ncbi.nlm.nih.gov/35147466/ [5] Small Effects, Questionable Outcomes: Bremelanotide for Hypoactive Sexual Desire Disorder. Spielmans GI & Ellefson EM J Sex Res. 2024. https://pubmed.ncbi.nlm.nih.gov/36809187/ [6] Effect of bremelanotide on body weight of obese women: Data from two phase 1 randomized controlled trials. Spana C et al. Diabetes Obes Metab. 2022. https://pubmed.ncbi.nlm.nih.gov/35170192/ [7] PubChem compound record: Bremelanotide. C50H68N14O10 · MW 1025.2 g/mol. https://pubchem.ncbi.nlm.nih.gov/compound/9941379 [8] PubChem compound record: melanotan-II. C50H69N15O9 · MW 1024.2 g/mol. https://pubchem.ncbi.nlm.nih.gov/compound/92432 [9] Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder. Simon JA et al. Obstet Gynecol. 2019. https://pubmed.ncbi.nlm.nih.gov/31599847/ [10] Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. U.S. FDA, content current as of 04/22/2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks [11] Responder Analyses from a Phase 2b Dose-Ranging Study of Bremelanotide. Althof S et al. J Sex Med. 2019. https://pubmed.ncbi.nlm.nih.gov/31277966/ [12] Synthetic melanotropic peptide initiates erections in men with psychogenic erectile dysfunction: double-blind, placebo controlled crossover study. Wessells H et al. J Urol. 1998. https://pubmed.ncbi.nlm.nih.gov/9679884/ --- From Residue. Research and education only; not medical advice. 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