PT-141 (bremelanotide): research, legal status and who sells it

What it is

PT-141 is bremelanotide, a synthetic peptide analogue of alpha-melanocyte-stimulating hormone that activates melanocortin receptors, notably MC4R [8][9]. It was developed as an analogue of melanotan II [10].

Research status

Two phase 3 RECONNECT trials enrolled 1,267 premenopausal women with hypoactive sexual desire disorder [11]. Compared with placebo, bremelanotide produced statistically significant but modest increases in sexual desire and reductions in related distress; nausea, flushing and headache each affected 10% or more of users [11]. A 2024 reanalysis argued that the benefits were small and that several of the outcome measures used had questionable validity for this condition [12]. An earlier small trial in 18 premenopausal women with sexual arousal disorder found that more women reported moderate or high desire after bremelanotide than after placebo [8]. There is no good-quality evidence for uses beyond the approved indication in the sources we reviewed.

Regulatory status

The FDA approved bremelanotide as Vyleesi in June 2019 for premenopausal women with acquired, generalized hypoactive sexual desire disorder [1][9]. No bremelanotide medicine is authorized in the UK, the EU or Canada [2][3][5]. It is not named in Australia’s Poisons Standard [6] or on WADA’s 2026 Prohibited List [7].

Quality and testing considerations

Vyleesi is a prescription autoinjector [1]. Vials sold as “PT-141” by research-chemical vendors are not Vyleesi, the FDA-approved prescription product [1]. Because PT-141 and melanotan II are closely related melanocortin peptides [10], a lab report should confirm the exact molecule by mass spectrometry, not just a purity figure.

Where it’s sold

In the US, the FDA-approved bremelanotide product is the prescription autoinjector Vyleesi [1]; the tables below track “research” PT-141 listings.