PT-141 (Bremelanotide)
Melanocortin receptor agonist (Vyleesi) FDA-approved for hypoactive sexual desire disorder in premenopausal women. Acts on central pathways, not peripheral hormones.
Educational only — not medical advice. SmartPeptide does not prescribe, diagnose, or treat. Always consult a licensed healthcare provider before using any peptide, supplement, medication, or protocol.
What the research shows
Two Phase 3 trials (RECONNECT) in HSDD: small but statistically significant improvements on sexual desire and distress vs placebo. FDA-approved 2019.
What's still experimental
Off-label use in men, postmenopausal women, and for general sexual function outside the HSDD indication. Long-term cardiovascular safety beyond trial duration.
Anecdotal / community reports
Off-label use is widespread in community discussions. Effect-size claims often inflated vs actual trial data.
Anecdotal reports are NOT scientific evidence. They reflect personal experience and may not generalize.
FDA approval status
Source: openFDA + DailyMed (NIH/NLM)Doses studied in research
Source: FDA-approved labelWhat published trials tested or FDA-approved labels specify. Reporting research facts — not a SmartPeptide recommendation.
FDA-approved dose
Open calculatorNotes from the source: Maximum 8 doses per month per label. Not for daily use.
FDA enforcement & recalls
Live · openFDA Drug Enforcement API- Class IITerminated· Voluntary: Firm initiatedFDA record
PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
Reason: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Apr 5, 2022·North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
Mechanism & targets
ChEMBL · UniProt · Open TargetsMolecule (ChEMBL)
View on ChEMBL- CHEMBL259agonistMelanocortin receptor 4 agonist
Live research
PubMed · ClinicalTrials.gov · Europe PMC · OpenAlexRecent PubMed studies
- Goldilocks-Inspired Design of Mid-Size Macrocycles for Selective Targeting of Human Melanocortin Receptors.Merlino F, Jia L, Boccino I, et al. · Journal of medicinal chemistry · 2026 Jun 24
- ReviewFDA-Approved Drugs Containing D-Amino Acids: A Historical and Developmental Perspective.Tran L, Nguyen TD, Gad AG, et al. · Drug development research · 2026 May
- Should Bremelanotide Be Considered for the Treatment of Sexual Arousal and Desire Disorders in Men?Pfaus JG, Balon R · Journal of clinical psychopharmacology · 2026 May-Jun 01
- ReviewTherapeutic Peptides in Aesthetic, Metabolic and Endocrine Conditions: Effects, Safety, Clinical Applications, and Future Perspectives.Renke G, Chinellato L · International journal of molecular sciences · 2026 Apr 27
- ReviewTherapeutic peptides in gerontology: mechanisms and applications for healthy aging.Mavrych V, Shypilova I, Bolgova O, et al. · Frontiers in aging · 2026
Clinical trials (ClinicalTrials.gov)
- A Phase 3, Bridging, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (With or Without Decreased Arousal)COMPLETEDNCT04943068 · PHASE3 · n=193 · 2021-05-10
- 2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire DisorderCOMPLETEDNCT02338960 · PHASE3 · n=714 · 2015-01
- Study to Evaluate Rate of Nausea in Healthy Premenopausal Female Subjects Treated With Single Dose of Bremelanotide Alone or With ZofranCOMPLETEDNCT03973047 · PHASE1 · n=228 · 2019-06-17
- Evaluate the Safety and Efficacy of Bremelanotide in Women With Female Sexual Arousal Disorder (FSAD)COMPLETEDNCT00425256 · PHASE2 · 2006-02
- Single Dose of Vyleesi in Lactating Female Subjects to Measure the Concentration of Bremelanotide in Breast MilkCOMPLETEDNCT06867835 · PHASE4 · n=10 · 2025-07-11
Europe PMC — 43,239 additional records
Includes EU/UK studies and PubMed Central full-text articles. Often surfaces research weeks before PubMed indexes it.
- Interpol review of fingermark composition and visualization 2022-2025Bécue A. · 2026Open access
- Risk stratification for in-hospital mortality in sepsis-associated acute kidney injury patients receiving continuous renal replacement therapy: an interpretable, externally validated machine learning studyZheng Y, Gao J, Hua T, et al. · 2026Open access
- Enhancer RNAs: similarities with both lncRNAs and mRNAs reveal novel functionsVlasov PA, Manley JL. · 2026Open access
- Eukaryotic cell-free protein synthesis: Chassis diversification, system engineering, and emerging applicationsTong S, Wang Y, Wang X, et al. · 2026Open access
Research volume (OpenAlex topic graph)
Human clinical evidence
Semantic Scholar · AI TLDRs · influence-rankedMost influential human studies
- Melanocortins in the treatment of male and female sexual dysfunction.Review1 influential / 57 citedA. Shadiack, SHUBH D. Sharma, D. Earle · Current Topics in Medicinal Chemistry · 2007
TLDR Investigations of melanocortin agonists for the treatment of sexual dysfunction are discussed with emphasis on proposed sites and mechanisms of action in the central nervous system that appear to be involved in melanoc Cortinergic modulation of sexual function.
- (349) Therapeutic Peptides in Sexual Medicine: A Narrative ReviewReviewE. Burchfiel, N. Mills, G. Saffati · Journal of Sexual Medicine · 2025
TLDR The central mechanisms of action of several peptides suggest potential for use as either primary or adjunct therapies in sexual medicine, particularly for conditions where current treatments are limited or ineffective.
- An Effect on the Subjective Sexual Response in Premenopausal Women with Sexual Arousal Disorder by Bremelanotide (pt-141), a Melanocortin Receptor Agonist Bremelanotide Treatment of Women with Sexual Disorder 629Journal articleL. E. Diamond, D. C. Earle, J. R. Heiman
TLDR This preliminary evaluation suggests the potential for bremelanotide to positively affect desire and arousal in women with female sexual arousal disorder and indicates that breMelanotide is a promising candidate for further evaluation in an at-home study.
- An effect on the subjective sexual response in premenopausal women with sexual arousal disorder by bremelanotide (PT-141), a melanocortin receptor agonist.Journal articleL. Diamond, D. Earle, J. Heiman · Journal of Sexual Medicine · 2006
TLDR This preliminary evaluation suggests the potential for breMelanotide to positively affect desire and arousal in women with female sexual arousal disorder and indicates that bremelanotide is a promising candidate for further evaluation in an at-home study.
- An Effect on the Subjective Sexual Response in Premenopausal Women with Sexual Arousal Disorder by Bremelanotide (PT-141), a Melanocortin Receptor AgonistJournal articleC. Brown · 2007
Research funding & verification
NIH RePORTER · CrossRef DOI registryPublication landscape
CrossRef · DOI registry- National Natural Science Foundation of China17,227 works
- National Science Foundation2,154 works
- National Key Research and Development Program of China2,040 works
- Fundamental Research Funds for the Central Universities1,783 works
- National Institutes of Health1,759 works
- National Research Foundation of Korea1,562 works
Funder diversity is a credibility signal. Research concentrated in a single drug company's funding warrants more scrutiny than research funded across NIH, charities, and academic grants.
Preprints — cutting edge
bioRxiv · medRxiv · via Europe PMCPreprints have NOT been peer-reviewed. They are early research shared by authors before formal validation. Treat findings as preliminary.
- PreprintMapping the evolutionary path towards multi-drug resistance in the pandemic <i>Escherichia coli</i> ST131 lineagePöntinen AK, Trung NV, Mallawaarachchi S, et al. · 2025-12-10
- PreprintCross-species meta-analysis reveals determinants of homing gene drive performanceVerkuijl SAN, Ivimey-Cook ER, Liu B, et al. · 2026-03-03
- PreprintPlant Kelch phosphatases are Ser/Thr phosphatases involved in cell cycle regulationRico-Resendiz F, Pri-Tal O, Raia P, et al. · 2026-01-06
- PreprintEvaluation of Research Grade Peptides Marketed Directly to Consumers Reveals Extensive Variability in Purity and Measured AbundanceMendias CL, Awan TM. · 2026-04-24
- PreprintGenetic substructure in Latin American individuals reveals novel associations, mechanistic insights, and variable polygenic risk score transferability for alcohol traitsMontalvo-Ortiz J, Martínez-Magaña J, Brito DA, et al. · 2026-02-27
- PreprintPeptide nanoparticles for systemic mRNA delivery in rodents and non-human primatesLehto T, Sork H, Lorents A, et al. · 2025-11-30 · cited 1×
Known risks
Transient blood pressure elevation (~6 mm Hg systolic for ~12 hours), nausea (40%+ in trials), hyperpigmentation, headache. Contraindicated in uncontrolled hypertension or cardiovascular disease.
Reported side effects
Nausea (very common), injection-site reactions, headache, vomiting, flushing.
FDA adverse event reports (FAERS)
Updated quarterly by FDAWhat requires medical supervision
Prescription required. Cardiovascular and BP screening recommended before use.
Questions for your clinician
- Is my BP/CV history compatible with this drug?
- How long can we trial before deciding it's not working?
- What's the right plan for nausea management?