PT-141 (BMT-141)
Synthetic cyclic heptapeptide melanocortin receptor agonist (Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-OH). Developed by Palatin Technologies. Bremelanotide (trade name Vyleesi) is FDA-approved exclusively for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Crucially distinct from unapproved research PT-141 vials marketed for male erectile dysfunction or recreational use. Banned by WADA.
60-Second Scientific Briefing
Bremelanotide (Vyleesi / PT-141) is a synthetic cyclic heptapeptide melanocortin receptor agonist approved by the US FDA in June 2019 exclusively for generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. It is NOT approved for male erectile dysfunction or recreational use.
What is PT-141?
Pharmacological Classification & Molecular IdentitySynthetic cyclic heptapeptide melanocortin analogue with sequence Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-OH.
Verified Chemical & Regulatory Registry Identifiers
Mechanism of Action & Receptor Targets
Biological Pathway and Target BindingBiological pathway and target receptor binding mechanism.
Receptor Selectivity: Non-selective agonist at melanocortin receptors, primarily MC4R and MC1R, acting within the central nervous system to modulate sexual desire pathways.
Regulatory & FDA Approval Status
Legal and Regulatory ClassificationsFDA Approved under NDA 210583 (Vyleesi) exclusively for premenopausal women with generalized HSDD. NOT approved for men or male erectile dysfunction.
PT-141 has received regulatory approval for specific medical indications. Commercial distribution and medical usage require appropriate prescription and adherence to approved labeling.
Human Evidence & Clinical Trials
Clinical Study Readouts and Evidence SynthesesPhase 3 RECONNECT trials demonstrated statistically significant increases in sexual desire scores and decreases in distress in premenopausal women.
Clinical Evidence
Phase 3 RECONNECT trials demonstrated statistically significant increases in sexual desire scores and decreases in distress in premenopausal women.
Safety Profile & Clinical Limitations
Documented Adverse Events and Known UncertaintiesNausea (approx. 40% of patients), flushing, headache, injection site reactions, focal skin hyperpigmentation, and transient increases in systolic and diastolic blood pressure.
Cardiovascular risks in patients with uncontrolled hypertension or cardiovascular disease.
Dose Approval Status
Commercial Dosing Status and Policy DirectivesFDA-approved dose for indicated women: 1.75 mg subcutaneously at least 45 minutes prior to anticipated sexual activity (maximum 1 dose per 24 hours, no more than 8 doses per month).
Under Egypt Peptides medical governance policies, no personal dosages, titration intervals, cycles, stacking recommendations, or self-injection instructions may be provided for unapproved investigational compounds. Clinical study protocols represent controlled experimental research parameters exclusively.
What is Known vs. What is Unknown
Evidence Comparison and Clinical Evidence Boundaries✓ Confirmed Scientific Evidence
- Synthetic cyclic heptapeptide melanocortin analogue with sequence Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-OH.
- Targets & Selectivity: Non-selective agonist at melanocortin receptors, primarily MC4R and MC1R, acting within the central nervous system to modulate sexual desire pathways.
- Phase 3 RECONNECT trials demonstrated statistically significant increases in sexual desire scores and decreases in distress in premenopausal women.
- Safety considerations: Nausea (approx. 40% of patients), flushing, headache, injection site reactions, focal skin hyperpigmentation, and transient increases in systolic and diastolic blood pressure.
? Unknown / Under Ongoing Investigation
- Cardiovascular risks in patients with uncontrolled hypertension or cardiovascular disease.
Verified Questions & Answers
10 Verified scientific answers with permanent anchor keysPT-141 is classified as a Melanocortin Receptor Agonist. Molecular structure: Synthetic cyclic heptapeptide melanocortin analogue with sequence Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-OH..
Pharmacological classification and molecular integrity are documented in verified regulatory and scientific literature.
- FDA Drugs@FDA Database: VYLEESI (Bremelanotide) Approval History and Prescribing Information (U.S. Food and Drug Administration, 2019-06-21)
PT-141 exerts biological activity via Non-selective agonist at melanocortin receptors, primarily MC4R and MC1R, acting within the central nervous system to modulate sexual desire pathways..
Receptor binding affinity and selectivity dictate the physiological response observed in laboratory and clinical trials.
- FDA Drugs@FDA Database: VYLEESI (Bremelanotide) Approval History and Prescribing Information (U.S. Food and Drug Administration, 2019-06-21)
- Prespecified and Integrated Subgroup Analyses from the RECONNECT Phase 3 Studies of Bremelanotide (Journal of Womens Health, 2022-03-01)
Regulatory status: FDA Approved under NDA 210583 (Vyleesi) exclusively for premenopausal women with generalized HSDD. NOT approved for men or male erectile dysfunction.
Prescription use requires a verified medical diagnosis and adherence to approved labeling.
- FDA Drugs@FDA Database: VYLEESI (Bremelanotide) Approval History and Prescribing Information (U.S. Food and Drug Administration, 2019-06-21)
Clinical evaluation status: Phase 3 RECONNECT trials demonstrated statistically significant increases in sexual desire scores and decreases in distress in premenopausal women.
Clinical trial readouts and systematic analyses establish the boundary between demonstrated findings and experimental hypotheses.
- FDA Drugs@FDA Database: VYLEESI (Bremelanotide) Approval History and Prescribing Information (U.S. Food and Drug Administration, 2019-06-21)
- Prespecified and Integrated Subgroup Analyses from the RECONNECT Phase 3 Studies of Bremelanotide (Journal of Womens Health, 2022-03-01)
Reported safety profile: Nausea (approx. 40% of patients), flushing, headache, injection site reactions, focal skin hyperpigmentation, and transient increases in systolic and diastolic blood pressure.
Adverse reaction monitoring and contraindications are critical parameters in pharmacological risk-benefit evaluation.
- FDA Drugs@FDA Database: VYLEESI (Bremelanotide) Approval History and Prescribing Information (U.S. Food and Drug Administration, 2019-06-21)
Key scientific uncertainties: Cardiovascular risks in patients with uncontrolled hypertension or cardiovascular disease.
Egypt Peptides enforces strict transparency regarding scientific limitations and gaps in longitudinal clinical data.
- FDA Drugs@FDA Database: VYLEESI (Bremelanotide) Approval History and Prescribing Information (U.S. Food and Drug Administration, 2019-06-21)
FDA-approved dose for indicated women: 1.75 mg subcutaneously at least 45 minutes prior to anticipated sexual activity (maximum 1 dose per 24 hours, no more than 8 doses per month).
Under medical governance mandates, clinical study dosages represent strictly controlled experimental parameters and must never be interpreted as individual therapeutic advice.
- FDA Drugs@FDA Database: VYLEESI (Bremelanotide) Approval History and Prescribing Information (U.S. Food and Drug Administration, 2019-06-21)
Storage status: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C. Protect from light and freezing.
Peptide integrity degrades rapidly when exposed to elevated temperatures, repeated freeze-thaw cycles, or direct UV light exposure.
- FDA Drugs@FDA Database: VYLEESI (Bremelanotide) Approval History and Prescribing Information (U.S. Food and Drug Administration, 2019-06-21)
Athletic status depends on WADA category classification; peptide hormones, growth factor mimetics, and related substances are prohibited under WADA Section S2.
Athletes subject to drug testing face strict liability and multi-year competition bans upon detection of prohibited peptides or their metabolites.
- FDA Drugs@FDA Database: VYLEESI (Bremelanotide) Approval History and Prescribing Information (U.S. Food and Drug Administration, 2019-06-21)
Egypt Peptides provides peer-reviewed scientific reference monographs for research documentation. We strictly prohibit individual medical consultations, reconstitution guides, stacking recipes, or off-label use instructions.
All scientific claims must link to verified authoritative sources (FDA, PubMed, ClinicalTrials.gov) with zero tolerance for ungrounded marketing claims.
- FDA Drugs@FDA Database: VYLEESI (Bremelanotide) Approval History and Prescribing Information (U.S. Food and Drug Administration, 2019-06-21)
Authoritative Sources & Literature Registry
Regulatory dossiers, clinical trial registries, and peer-reviewed studiesFDA Drugs@FDA Database: VYLEESI (Bremelanotide) Approval History and Prescribing Information ↗
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210583
Prespecified and Integrated Subgroup Analyses from the RECONNECT Phase 3 Studies of Bremelanotide ↗
https://doi.org/10.1089/jwh.2021.0225