PT-141 Reference

Educational, not medical advice reference for PT-141: Sexual Health; regulatory status, evidence posture, source review, and schedule notes. Als…

Plain English

What it is
PT-141 (also called bremelanotide) is a lab-made peptide that acts on melanocortin receptors, which sit partly in the brain. The FDA approved it in 2019 under the brand name Vyleesi for premenopausal women who have a lasting drop in sexual desire that causes real distress. Research vials sold online are not the approved Vyleesi product and have not been checked by the FDA for purity or identity.
What people use it for
The only approved use is for premenopausal women with low sexual desire that bothers them. It is not approved for men or for women past menopause. Outside that approved use, people in the peptide community use research-vial versions for libido and arousal, including men and couples, but that use is off-label and not backed by approval.
What the science shows
In two large company trials in premenopausal women, it raised sexual desire and lowered the related distress more than a placebo. The differences were statistically real but small. It works through the brain rather than blood flow, which is a different path than common erection pills, and its benefit in men or postmenopausal women is not established.
The catch
Nausea is very common and was the most reported side effect in the trials. It can darken patches of skin, including the face, and that change is not always reversible. It can briefly raise blood pressure, so it is not allowed for people with uncontrolled high blood pressure or known heart disease, and the research-vial and nasal versions sold online are not the FDA-reviewed product.

Reference summary

Bremelanotide is a synthetic cyclic heptapeptide melanocortin receptor agonist (binds MC1R through MC5R; central HSDD effect attributed primarily to MC4R) developed by Palatin Technologies. Phase 2b dose-finding work (Clayton 2016 and related reports) compared 0.75 mg, 1.25 mg, and 1.75 mg subcutaneous doses and selected the 1.75 mg dose for Phase 3 on the balance of efficacy and tolerability. The pivotal Phase 3 RECONNECT program (Kingsberg 2019, Obstet Gynecol, PMID 31599840) consisted of two identically designed double-blind placebo-controlled trials (Study 301 NCT02333071 and Study 302 NCT02338960) in premenopausal women with acquired generalized HSDD, randomized 1,267 women (1,247 in the safety population, 1,202 in the mITT efficacy population). Both trials met the co-primary endpoints (FSFI desire-domain score and FSDS-DAO item 13 distress score) with statistically significant but modest absolute effect sizes versus placebo. This entry displays Vyleesi label-reference fields plus pivotal-trial and dose-finding context; it does not approve research-vial or intranasal PT-141 protocols.

Regulatory and posture

Categories
Sexual Health
Aliases
Bremelanotide, Vyleesi
Evidence posture
human
Regulatory status
FDA-approved as Vyleesi (bremelanotide) on June 21, 2019 (NDA 210557) for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance. Not indicated for men, postmenopausal women, or sexual-performance enhancement. Research-vial intranasal and lyophilized-powder preparations sold online are not the FDA-approved product and have not been reviewed by FDA for purity, identity, or dose accuracy.
Content review status
label verified

Selected public sources

Related tools

For research and educational purposes only. Not medical advice.