PT-141

Sexual Health

aka Bremelanotide · Vyleesi · PT141

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Formula

MW (Da)

Half-life

~2 hours

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Overview

PT-141 (bremelanotide, brand name Vyleesi) is a nonselective melanocortin receptor agonist and the only peptide in this batch with a current FDA therapeutic label. It is approved for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. It acts centrally on melanocortin signaling — not as a vasodilator.

Mechanism

Bremelanotide is a nonselective melanocortin agonist. The FDA label ranks receptor potency as MC1R, MC4R, MC3R, MC5R, MC2R; mechanistic reviews identify MC4R as the subtype most relevant to therapeutic sexual-response effects. The drug acts centrally, distinguishing it from peripheral vasodilator approaches to sexual medicine. Initial U.S. approval was in 2019 under NDA 210557; the DailyMed label remains active with January 2025 update.

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Reported benefits

FSFI Desire Domain improvement in phase 3 trials

Phase 3 trials NCT02333071 and NCT02338960 (n=1247 premenopausal women) showed FSFI Desire mean changes of 0.5 vs 0.2 (Study 1, p=0.0002) and 0.6 vs 0.2 (Study 2, p<0.0001) versus placebo.

[vyleesi-fda-label]

clinical

FSDS-DAO Q13 distress reduction

Mean changes on the FSDS-DAO Question 13 distress endpoint were -0.7 vs -0.4 in both studies (p<0.0001 and p=0.0053).

[vyleesi-fda-label]

clinical

Modest effect size with reproducible significance

No significant difference in satisfying sexual events (the secondary endpoint; p=0.76 and 0.70). The effect size is small but reproducible across two large randomized trials.

[vyleesi-dailymed]

clinical

Reported side effects

Nausea is the dominant side effect
clinical
In pooled placebo-controlled phase 3 data, nausea occurred in 40.0% of patients, required anti-emetic therapy in 13%, and led to discontinuation in 8%.
Common: flushing, injection-site reactions, headache, vomiting
clinical
Flushing 20.3%, injection-site reactions 13.2%, headache 11.3%, vomiting 4.8% in the pooled phase 3 safety dataset.
Transient blood-pressure rise and heart-rate reduction
clinical
Maximal average increases of 6 mmHg systolic and 3 mmHg diastolic, plus heart-rate reduction up to 5 bpm. Contraindicated in uncontrolled hypertension or known cardiovascular disease.
Focal hyperpigmentation with frequent use
clinical
Focal hyperpigmentation occurred in 1% of patients using up to 8 doses per month; risk rises with more frequent use.

Dosing notes

Approved dose: 1.75 mg subcutaneously in abdomen or thigh, as needed, at least 45 minutes before sexual activity. Maximum 1 dose per 24 hours and no more than 8 doses per month. Contraindicated in uncontrolled hypertension or known cardiovascular disease.

Research use only. Information on this page is editorial reference, not medical or dosing advice. Always consult qualified medical guidance before use.

Storage

Per FDA label: store at or below 25 °C, protect from light, do not freeze.

Vendors carrying PT-141

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Discussion

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References

[vyleesi-dailymed]
Vyleesi (bremelanotide) DailyMed product label
FDA DailyMed (label updated January 2025) · 2025 · FDA DailyMed
Source
[vyleesi-fda-label]
Vyleesi (bremelanotide) FDA full prescribing information (2019)
FDA · 2019 · FDA accessdata
Source

Reported benefits

FSFI Desire Domain improvement in phase 3 trials

FSDS-DAO Q13 distress reduction

Modest effect size with reproducible significance

Nausea is the dominant side effect

Common: flushing, injection-site reactions, headache, vomiting

Transient blood-pressure rise and heart-rate reduction

Focal hyperpigmentation with frequent use

Discussion