PT-141 vs Bremelanotide
It is sold online as a sex-drive booster, mostly to men. The approved form, bremelanotide, was tested in 1,267 women with small gains; for men there are only two small studies from 2004. It is an injection for women who have low sexual desire. Two trials in 1,267 women found small gains on questionnaires, and about 40% of users felt sick.
Both sit at grade B: some human evidence. PT-141: Not approved. Bremelanotide: FDA approved.
Evidence
BSome human evidence
BSome human evidence
Human studies cited
Animal or cell studies cited
Why the grade
For the approved use there are two randomized, placebo-controlled phase 3 trials (RECONNECT, 1,267 women combined), which is A-level evidence, though a re-analysis argues the effect on desire is small. For the use PT-141 is actually sold for online, libido and erections in men, the evidence is two small 2004 studies, one of a nasal spray that was later abandoned and one of an injection, so the compound as marketed sits at B.
Approval rests on the two RECONNECT phase 3 trials, which randomized 1,267 premenopausal women and met their co-primary endpoints on desire and distress questionnaires. The effect sizes were small, the number of satisfying sexual events did not increase, dropout for nausea was high, and an independent reanalysis questioned the validity of the outcome questionnaires. Approved on RCTs but with surrogate questionnaire endpoints and contested benefit is grade B.
FDA
Not approved
PT-141 is the development code for bremelanotide, which the FDA approved in June 2019 as Vyleesi for premenopausal women with acquired, generalized hypoactive sexual desire disorder. Products sold online as PT-141 are not Vyleesi, are not approved by the FDA for any use, and are sold as research chemicals, most often to men, a population the drug was never approved for.
FDA approved
Bremelanotide is FDA-approved and sold as Vyleesi, a self-administered subcutaneous autoinjector, approved in June 2019 for premenopausal women with acquired, generalised hypoactive sexual desire disorder (HSDD). It is not approved for men or for postmenopausal women.
Sold for
PT-141 is sold on the gray market as a libido and erection booster for men and women that works through the brain instead of blood flow.
Bremelanotide is marketed as an on-demand injection for low sexual desire in women and is sold online, often as PT-141, as a libido booster for anyone.
Studies say
Two phase 3 trials support a modest effect on sexual desire in premenopausal women with HSDD, which is what the FDA approved; the evidence in men is two small 2004 studies, one nasal and one injected, from a program that was abandoned, and nausea affects about 40 percent of users.
Two randomized trials in 1,267 women showed statistically significant but small improvements in questionnaire scores for desire and distress, no increase in satisfying sexual events, and nausea in about 40% of users (grade B).
Class
MC4R agonist
MC4R agonist
Route
Injection
Injection