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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)
No FDA-approved drug label exists for “PT-141 (Bremelanotide)”. This peptide is not currently approved by the FDA as a finished pharmaceutical product. Any commercial product claiming FDA approval should be treated with suspicion.

Doses studied in research

Source: FDA-approved label

What published trials tested or FDA-approved labels specify. Reporting research facts — not a SmartPeptide recommendation.

FDA-approved labelVyleesi FDA label (DailyMed)
Indication studied: Hypoactive sexual desire disorder (HSDD) in premenopausal women
Typical
1.75mg(1,750 µg)
as needed (≥45 min before activity) · subcutaneous

FDA-approved dose

Open calculator

Notes from the source: Maximum 8 doses per month per label. Not for daily use.

Important framing: The numbers above are what published trials tested or what FDA-approved labels specify. They are NOT a SmartPeptide recommendation for you. Trial doses come paired with screening, monitoring, and clinician oversight. Always consult a licensed clinician before any peptide use.

How clinicians typically protocol this

Third-party reference · not our recommendation

Dosing phases, cycle lengths, and administration timing as listed in a compounding-pharmacy clinician reference guide. Shown so you can see what a real protocol looks like — and bring informed questions to a licensed clinician.

Third-party protocol referenceCompounding-pharmacy clinician protocol reference (Nov 2025)

Dose numbers, frequencies, and cycle lengths in this panel are extracted from a clinician-facing reference protocol distributed by a US-based compounding pharmacy in November 2025. SmartPeptide has paraphrased all descriptive text and adds no endorsement. Always consult a licensed clinician.

Sexual Wellness

Melanocortin receptor agonist; FDA-approved as Vyleesi for HSDD in premenopausal women.

Protocol phases

Men — starting
1–2 mgas needed, ≤1×/24 hr, ≤8×/month
subcutaneous

may titrate up to 4 mg cautiously

Women — starting
500 µg – 1 mgas needed, same frequency limits
subcutaneous

administered ≥45 min pre-activity

Administration timing

Onset 30–60 min; effects last 2–6 hours.

Reported side effects
NauseaFlushingHeadacheTransient blood-pressure elevationInjection-site reactions

Protocol notes: Monitor blood pressure; PT-141 can cause short transient rises.

Reconstitution calculator Storage & reconstitution guide
Not medical advice. SmartPeptide does not prescribe, diagnose, or treat. The protocol above reproduces dose figures from a third-party clinician reference so you can see what compounding-pharmacy guidance typically looks like — it is not a recommendation for you, and it has not been validated against peer-reviewed dose-ranging trials. Many of these compounds are not FDA-approved for human use. Work with a licensed clinician familiar with peptide therapy before considering anything here.

FDA enforcement & recalls

Live · openFDA Drug Enforcement API
Total actions
1
recalls + withdrawals
Ongoing
0
not yet completed
Class I (serious)
0
health hazard / death risk
  • Class IITerminated· Voluntary: Firm initiated
    FDA 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
FDA classifications: Class I = reasonable probability of serious adverse health consequences or death. Class II = temporary or medically reversible adverse consequences. Class III = unlikely to cause adverse health consequences.

Mechanism & targets

ChEMBL · UniProt · Open Targets

Molecule (ChEMBL)

View on ChEMBL
Formula
C50H68N14O10
Known mechanisms of action
  • CHEMBL259
    agonistMelanocortin receptor 4 agonist

Live research

PubMed · ClinicalTrials.gov · Europe PMC · OpenAlex
PubMed papers
121
total
Human studies
0
MeSH: humans
Clinical trials
0
published
Active trials
0
10 total registered

Clinical trials (ClinicalTrials.gov)

All trials for "bremelanotide"

Europe PMC — 58,131 additional records

Includes EU/UK studies and PubMed Central full-text articles. Often surfaces research weeks before PubMed indexes it.

Research volume (OpenAlex topic graph)

Total works
599,243
all years
Last 5 years
268,369
recent activity
Open access
589,951
freely readable
OA share
98%
of all works

Human clinical evidence

Semantic Scholar · AI TLDRs · influence-ranked
Semantic Scholar API is currently rate-limited.

Human-study summaries for “bremelanotide OR PT-141” are available on Semantic Scholar but the shared free-tier API quota is exhausted right now. Try refreshing in a few minutes, or check the PubMed and Europe PMC panels above for the same literature.

Research funding & verification

NIH RePORTER · CrossRef DOI registry

Publication landscape

CrossRef · DOI registry
Indexed works (CrossRef)
817,378
all DOIs registered
Retracted papers
0
no retractions on record
Top funders of indexed research
  • National Natural Science Foundation of China17,544 works
  • National Science Foundation2,180 works
  • National Key Research and Development Program of China2,115 works
  • Fundamental Research Funds for the Central Universities1,810 works
  • National Institutes of Health1,764 works
  • National Research Foundation of Korea1,587 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 PMC

Preprints have NOT been peer-reviewed. They are early research shared by authors before formal validation. Treat findings as preliminary.

Showing 6 of 352 preprints indexed by Europe PMC.

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 FDA
No reports found in the FDA Adverse Event Reporting System for “PT-141 (Bremelanotide)”. This is normal for research-only peptides that are not marketed as FDA-approved drugs.

What 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?

Editorially curated references

Discussions about PT-141 (Bremelanotide)

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