PT-141

PT-141 (bremelanotide) is a synthetic cyclic seven-amino-acid peptide analogue of alpha-melanocyte-stimulating hormone (alpha-MSH), developed by Palatin Technologies from melanotan II. Small early trials were run in men with erectile dysfunction. In the US it was approved in 2019, as for premenopausal women with acquired, generalised hypoactive sexual desire disorder (HSDD): low sexual desire that causes marked distress or difficulty between partners and is not due to another medical or mental health condition, relationship problems or a medicine. It is not approved for men or for women after the menopause, and it is not licensed in the UK or EU. The approval rests mainly on two identical 24-week randomised, placebo-controlled phase 3 trials (RECONNECT) that enrolled 1,267 women, almost all at US sites (Kingsberg et al., Obstet Gynecol 2019). Both trials were funded by the developers. Nausea, flushing and headache were more common than with placebo. The US label states that how it acts in HSDD is unknown, and it warns of a short-lived rise in blood pressure and of darker patches of skin in a small number of patients. These research materials are not the licensed medicine. Supplied for laboratory research use only.