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Sexual & HormonalGrade AMultiple human RCTs3 primary sources

PT-141

Also known as Bremelanotide · Vyleesi

FDA-approved melanocortin agonist for hypoactive sexual desire disorder in premenopausal women. Two phase 3 randomized trials support the approval.

Overview

PT-141 works in the brain rather than on blood vessels, which is what separates it from erectile dysfunction drugs like sildenafil. It activates melanocortin receptors in the hypothalamus, a region involved in sexual desire and arousal. Because the pathway is central rather than vascular, it does not depend on nitric oxide signalling. It is approved for low sexual desire in premenopausal women, taken as needed rather than daily.

Research areas

Sexual functionNeuroendocrineCentral nervous system

Community-specified data

Community dosage information

Unverified
Community protocol

PT-141 10mg

Third-party
01Reconstitution solution
2 mL
02Dose
0.75 mg
03Syringe units
15 units
04Frequency
As needed
05Cycle length
Not specified
06Bacteriostatic water
2 mL
07Bottle size
10 mg
08Bottles needed
Not specified

Source note: Men: start at displayed dose, bump by 5 units (max 25 units). Women: start at 0.5mg, bump by 5s

Track this schedule
Community protocol

PT-141 Nasal Spray

Third-party
01Reconstitution solution
Not specified
02Dose
0.5 mg
03Syringe units
5 units
04Frequency
As needed
05Cycle length
Not specified
06Bacteriostatic water
Not specified
07Bottle size
10 mg
08Bottles needed
Not specified

Source note: 5 sprays per dose. No reconstitution needed.

Community protocol

PT-141 Nasal Spray (Women)

Third-party
01Reconstitution solution
Not specified
02Dose
0.3 mg
03Syringe units
3 units
04Frequency
As needed
05Cycle length
Not specified
06Bacteriostatic water
Not specified
07Bottle size
10 mg
08Bottles needed
Not specified

Source note: 3 sprays per dose. No reconstitution needed.

Not medical guidance. These third-party figures have not been independently verified, clinically reviewed, or endorsed by DB Peptide. They may be inaccurate or unsafe and should not replace product labelling or advice from a qualified clinician.

Dosing reported in the literature

Every protocol below is reproduced from a published study or approved labelling, with its source named. These are records of what was studied — not recommendations, and not a suggestion that any of them is appropriate for any person.

Protocol as reportedSource
1.75 mg subcutaneously, at least 45 minutes before anticipated sexual activity, no more than once per 24 hours and no more than 8 doses per monthRECONNECT phase 3 protocol and FDA approved labelling

Trial status

Approved. Two identical phase 3 randomized double-blind placebo-controlled trials (RECONNECT) completed.

  1. Phase 2b

    Completed2016

    Dose-ranging study in premenopausal women with HSDD established the 1.75 mg dose taken forward to phase 3.

  2. Phase 3 — RECONNECT

    Completed2019

    Two identically designed trials with 1,247 premenopausal women. Both met co-primary endpoints for improvement in sexual desire and reduction in desire-related distress versus placebo over 24 weeks.

Reported safety signals

  • Nausea was the most common adverse event, reported by roughly 40% of participants in phase 3, and drove most discontinuations.
  • Transient increases in blood pressure and decreases in heart rate occur after each dose; it is contraindicated in uncontrolled hypertension and known cardiovascular disease.
  • Focal hyperpigmentation can occur with repeated use, more likely with more frequent dosing and in people with darker skin.
  • The monthly dose cap in labelling exists specifically because of the hyperpigmentation and blood pressure findings.

Common questions

How is PT-141 different from melanotan II?

PT-141 is the active metabolite of melanotan II. Melanotan II retains far stronger MC1R activity, which is why it produces pronounced tanning and pigmentation. PT-141 was developed specifically to retain the central MC4R sexual-desire effect while reducing pigmentary activity, and it is the one that completed phase 3 trials and reached approval.

Primary sources

3 citations
  1. 01

    Bremelanotide for Hypoactive Sexual Desire Disorder in Premenopausal Women: Two Randomized Phase 3 Trials

    Obstetrics & Gynecology2019PMID 31599840

  2. 02

    Efficacy and Safety of Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: A Phase 2b Study

    Obstetrics & Gynecology2016PMID 27882417

  3. 03

    The role of melanocortin receptor agonists in the treatment of sexual dysfunction

    Sexual Medicine Reviews2020PMID 32307220

Medical disclaimer

This page is for informational and research purposes only. Nothing here constitutes medical advice. The compounds discussed are research chemicals. Consult a qualified clinician before starting any protocol.

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