PT-141

The pivotal programme was two identically designed Phase 3 trials, NCT02333071 with 723 participants and NCT02338960 with 714, both randomised, double-blind and placebo-controlled in premenopausal women. Phase 2 work in the same population preceded them. The approved label documents what the safety database measured: transient blood pressure increase and heart rate reduction after each dose, focal hyperpigmentation in 1 percent of patients dosed up to eight times monthly, and nausea in 40 percent, of whom 13 percent required anti-emetic medication and 8 percent discontinued. Post-approval work includes a lactation study and a mechanistic study of the melanocortin-4 receptor.

What is not established

The label states explicit limitations of use. Nothing outside the approved premenopausal female population is established, and the label does not support use in postmenopausal women or in men. Post-marketing requirements on pregnancy and on fetal, neonatal and infant outcomes were still running at approval, with final reports due in 2030, so pregnancy safety is formally unresolved.

What distinguishes PT-141

PT-141 is one of very few compounds in this catalogue that carries an actual FDA new drug application. Its pharmacology, dosing, contraindications and adverse-event rates come from a reviewed prescribing information document rather than from inference off animal work. It is also, unusually, a melanocortin-pathway peptide absent from the WADA Prohibited List, where essentially every growth-hormone-axis peptide sold alongside it is named in S2. PT-141 and Melanotan II are distinct compounds and their literatures should not be mixed.

Sources

1. US FDA. NDA 210557 approval letter, VYLEESI (bremelanotide) injection, 21 June 2019
2. US FDA. VYLEESI (bremelanotide injection) prescribing information, NDA 210557, revised June 2019
3. DailyMed, US National Library of Medicine. Label: VYLEESI, bremelanotide injection
4. ClinicalTrials.gov. Pivotal Phase 3 trial NCT02333071, 723 participants
5. ClinicalTrials.gov. Pivotal Phase 3 trial NCT02338960, 714 participants

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