Bremelanotide: research
An as-needed injection for low libido before menopause; nausea is common.
Also called: PT-141, PT141, Vyleesi.
Melanocortin agonists · Melanocortin receptor agonist · Evidence: Approved drug.
A 2022 safety review counted 43 completed studies and 3,500 participants, a minimum, not a complete 2026 count.
Studies
- Dose finding: 0.75–1.75 mg. rct, n=397, Premenopausal women with low desire and/or arousal problems. The 1.75 mg dose advanced to phase 3. (source)
- RECONNECT 301: 1.75 mg. rct, n=643, Premenopausal women with acquired, generalized HSDD; safety population. Desire and distress improved modestly; satisfying event counts did not. (source)
- RECONNECT 302: 1.75 mg. rct, n=604, Premenopausal women with acquired, generalized HSDD; safety population. Desire and distress improved modestly; satisfying event counts did not. (source)
- RECONNECT: one-year extension. open-label, n=684, Core-trial completers who chose continued study. The extension adds longer exposure but has strong survivor bias. (source)
- Early male injection studies. pk-study, Healthy men and men with poor sildenafil response. Single doses up to 10 mg were studied; that is not a safe repeated-dose ceiling. (source)
- Early male nasal studies. pk-study, Healthy men and sildenafil-responsive men. Responses were significant at doses above 7 mg; first erection began at about 30 minutes. (source)
- Nasal PT-141 plus sildenafil. crossover-rct, n=19, Men with erection problems responsive to sildenafil or vardenafil. Combination exceeded sildenafil alone; numerical per-arm values were not in the abstract. (source)
- Women: one 20 mg nasal dose. crossover-rct, n=18, Premenopausal women with female arousal disorder. More women reported moderate/high desire with active drug; P=0.0114. Vaginal blood-flow response did not differ. (source)
- Nasal PT-141 and alcohol. crossover-rct, n=24, 12 healthy men and 12 healthy women. No significant drug-related low or postural blood pressure effects; no clinically significant PK interaction. (source)
- Weight study A: three daily doses. rct, n=58, Inpatient premenopausal women with obesity. Placebo-adjusted least-squares mean difference −1.3 kg, 95% CI −1.9 to −0.8; P<0.0001. (source)
- Weight study B: once or twice daily. crossover-rct, n=27, Otherwise healthy inpatient premenopausal women aged 18–45 with BMI 30–40 kg/m². Twice daily 1.7 kg vs placebo 0.9 kg; P<0.001. (source)
- 43-study safety review. review, n=3500, Participants across the phase 1–3 development program. The review documents a broad development program, not 43 independent efficacy trials. (source)
- RECONNECT reporting reanalysis. meta-analysis, Two phase 3 trials; no new participants. An independent reanalysis found modest benefits and important reporting concerns. (source)
- 2026 sexual-function meta-analysis. meta-analysis, Women with desire, arousal or orgasm problems without pain. Bremelanotide improved desire and arousal scores and reduced distress; pooled effect sizes were not in the abstract. (source)
- Male nasal trial: concern notice. rct, n=342, Men reporting sildenafil failure. A 2023 expression of concern makes this trial unreliable for dosing or benefit claims. (source)
- Retracted female nasal trial. rct, Women with arousal disorder. The PubMed record is marked RETRACTED. Its efficacy data are excluded. (source)
- Older FSAD registration. rct, Women with arousal disorder. COMPLETED; no results posted by 2026-10-18. (source)
- Diabetic kidney disease pilot. open-label, n=16, Adults with diabetic kidney disease. COMPLETED; no results posted by 2026-10-18. (source)
- Tirzepatide combination trial. rct, n=108, Adults with obesity. ACTIVE NOT RECRUITING; no results posted by 2026-10-18. (source)
- HSDD bridging trial. rct, n=193, Premenopausal women with HSDD. COMPLETED; no results posted by 2026-10-18. (source)
- Brain imaging crossover. crossover-rct, n=40, Women with HSDD. Results are posted; they do not establish long-term clinical benefit. (source)
- Ondansetron pretreatment trial. rct, n=228, Healthy premenopausal women. The label reports no nausea-prevention benefit; registry results are not posted. (source)
- Breast-milk PK study. pk-study, n=10, Healthy lactating women, 10 days to 6 months postpartum. COMPLETED; no results posted by 2026-10-18. (source)
- Response to trial reanalysis. review, Commentary on the phase 3 reanalysis; no new participants. A published commentary disputes the independent reanalysis. (source)
Bremelanotide dosage
Typical reported dose: 1.75 mg as needed, at most once in 24 hours
- Vyleesi: 1.75 mg as needed: Inject 1.75 mg subcutaneously via the autoinjector to the abdomen or thigh. as needed; no more than one dose within 24 hours, under the skin. Drug label. Studied in: Premenopausal women with acquired, generalized HSDD. (source)
- Dose finding: 0.75 mg: 0.75 mg as needed; no more than once daily or 16 doses per 4 weeks, under the skin. Studied in a trial. Studied in: Premenopausal women with desire and/or arousal problems. (source)
- Dose finding: 1.25 mg: 1.25 mg as needed; no more than once daily or 16 doses per 4 weeks, under the skin. Studied in a trial. Studied in: Premenopausal women with desire and/or arousal problems. (source)
- Dose finding: 1.75 mg: 1.75 mg as needed; no more than once daily or 16 doses per 4 weeks, under the skin. Studied in a trial. Studied in: Premenopausal women with desire and/or arousal problems. (source)
- RECONNECT: fixed 1.75 mg: 1.75 mg as needed; at least 24 hours apart, under the skin. Studied in a trial. Studied in: Premenopausal women with acquired, generalized HSDD. (source)
- Early injection: 4 mg: 4 mg single study-visit dose, under the skin. Studied in a trial. Studied in: Men with poor sildenafil response. (source)
Highest studied: Single monitored SC dose, not a repeated-dose safety limit..
These are doses reported in labels, trials or user reports, not a personal plan. Check the source behind each one.
Bremelanotide side effects and risks
Reported side effects
- Nausea: 40.0% vs 1.3% placebo; 8% stopped because of nausea., moderate (source)
- Flushing: 20.3% vs 0.3% placebo., mild (source)
- Injection-site reactions: 13.2% vs 8.4% placebo., mild (source)
- Headache: 11.3% vs 1.9% placebo., moderate (source)
- Vomiting: 4.8% vs 0.2% placebo., moderate (source)
- Fatigue: 3.2% vs 0.5% placebo., moderate (source)
- Dizziness: 2.2% vs 0.5% placebo., moderate (source)
- Temporary blood pressure rise: Maximum mean rises 6/3 mmHg; heart rate fell up to 5 beats/min. Usually resolves within 12 hours., serious (source)
- Persistent dark patches: About 1% vs 0% placebo with up to 8 monthly doses. Daily dosing caused much higher rates., moderate (source)
- Acute liver inflammation: One extension case after 10 doses in a year; causality uncertain., serious (source)
Stop and get help if
- Chest pain, fainting, severe headache or new weakness.: Stop dosing and seek emergency care.
- Severe or persistent vomiting, or inability to keep fluids down.: Stop dosing and get prompt medical assessment.
- Yellow eyes, dark urine or severe upper abdominal pain.: Seek urgent assessment for liver injury.
- A new or changing mole, uneven color, bleeding or a fast-growing spot.: Pause use and arrange prompt skin assessment.
- An erection lasting 3–4 hours after off-label use in a man.: Seek emergency care; do not repeat the dose.
Who should avoid it
- uncontrolledBloodPressure: Formal Vyleesi contraindication; each dose can raise blood pressure.
- heartCondition: Known cardiovascular disease is a formal contraindication.
- pregnant: Animal studies found fetal harm. Stop if pregnancy is suspected.
- tryingToConceive: Use effective contraception; pregnancy exposure is insufficiently studied.
- breastfeeding: Infant safety is unknown. A completed milk-PK registration has no posted results.
- under18: Pediatric safety and effectiveness have not been established.
- melanomaOrAtypicalMoles: Precaution for melanocortins. This is not a formal Vyleesi label contraindication.
- kidneyDisease: Severe impairment increases exposure and may worsen nausea or vomiting.
- liverDisease: Severe impairment was not studied; moderate impairment increases exposure.
- other: Higher cardiovascular risk needs review even without diagnosed cardiovascular disease.
Interactions
- Oral naltrexone: Can greatly reduce naltrexone exposure. Avoid with oral products used for alcohol or opioid addiction.
- Oral drugs needing reliable absorption: Slower stomach emptying can reduce or delay drug uptake. The label advises avoiding use with threshold-dependent oral drugs.
- Other melanocortin agonists: Duplicate receptor activity may add pigment or systemic effects. This combination has no established dosing safety.
- Sildenafil or tadalafil: A small nasal sildenafil study exists. It does not establish safety of injected PT-141 with tadalafil.
- Ondansetron pretreatment: 8 mg orally 30 minutes before Vyleesi did not prevent nausea and is not recommended for that purpose.
- Alcohol: A small nasal study found no major interaction at 0.6 g/kg. This does not cover heavy drinking or all health conditions.
Product quality risks
- Forensic LC-HRMS identified bremelanotide in seized black-market samples; this did not establish safe strength, sterility or stability.
- Compounded medicines are not FDA-approved. Contamination and incorrect strength can cause serious harm.
How Bremelanotide works
It activates signals in the brain involved in sexual desire and arousal. It also acts on pigment cells, which can darken skin. Its exact pathway for improving low desire is unknown.
- MC4 receptor: Brain signaling linked to desire, appetite and blood pressure.
- MC1 receptor: Can increase skin pigment.
Half-life: Mean 2.7 hours after a single injection; range 1.9–4.0 hours.
Gaps: The 43-study count is the 2022 development-program total. Later studies and unpublished pharmacology work prevent an exact current total. Long-term outcomes in men, postmenopausal women and people with major heart disease remain uncertain. No verified stability or sterile shelf-life data were found for home-mixed PT-141 powder. No robust evidence was found for oral troches, daily libido microdosing or repeated same-day rescue doses. No separate clinician-published alternative schedule was retained; seller protocols and unsupported monographs were excluded.
Related to Bremelanotide
- Melanotan II: An unapproved tanning peptide with small human trials and reports of serious harm.
- Melanotan I / Afamelanotide: The molecule in an approved EPP implant; online tanning powder is a different formulation.
- Setmelanotide: A daily injection approved for specific genetic obesity and acquired hypothalamic obesity.
- Tirzepatide: A weekly GIP/GLP-1 injection with strong diabetes and weight-loss evidence and common stomach side effects.
Bremelanotide: the short version
Sources
- 503B Bulk Drug Substances List, FDA · FDA · 2026
- Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act, FDA · FDA · 2026
- Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, FDA · FDA · 2026
- Compounding and the FDA: Questions and Answers, FDA · FDA · 2026
- Scenesse, INN-afamelanotide, 2026
- The 2026 Prohibited List, World Anti-Doping Agency · WADA · 2026
- Therapeutic Goods (Poisons Standard—October 2026) Instrument 2026, Australian Government · Australian Government · 2026
- DailyMed - VYLEESI- bremelanotide injection, 2025
- Priapism (painful erections) - NHS, NHS · 2023
- NDA 210557 Multi-disciplinary Review and Evaluation: Vyleesi (bremelanotide), 2019
- Female Sexual Desire, Arousal, and Orgasmic Dysfunctions: A Systematic Review and Meta-Analysis of Treatment Options., Toledo RG et al. · Journal of minimally invasive gynecology · 2026
- Effect of bremelanotide on body weight of obese women: Data from two phase 1 randomized controlled trials., Spana C et al. · Diabetes, obesity & metabolism · 2022
- Re-Analyzing Phase III Bremelanotide Trials for "Hypoactive Sexual Desire Disorder" in Women., Spielmans GI et al. · Journal of sex research · 2021
- Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials., Kingsberg SA et al. · Obstetrics and gynecology · 2019
- Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder., Simon JA et al. · Obstetrics and gynecology · 2019
Sources checked: 2026-10-18.
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