Evaluation of the safety, pharmacokinetics and pharmacodynamic effects of subcutaneously administered PT-141, a melanocortin receptor agonist, in healthy male subjects and in patients with an inadequate response to Viagra

Kingsberg S.A. et al.

The pivotal RECONNECT trials (Studies 301 and 302) that got bremelanotide FDA-approved for HSDD in premenopausal women. Statistically significant improvements in desire and distress on validated scales; effect sizes are real but modest, and discontinuation for nausea is the practical limiter.

Simon J.A. et al.

The 52-week open-label extension to RECONNECT. Tolerability stays bumpy — nausea, flushing, transient blood-pressure rises — but the women who continued kept the desire and distress gains. The longest-duration PT-141 dataset that exists in humans.

Comninos A.N. et al.

Resting-state fMRI follow-up: kisspeptin alters default-mode connectivity in ways that track with self-reported sexual and emotional improvements. Same lab, same population — and the most provocative paper for the idea that kisspeptin might one day target HSDD upstream of bremelanotide.

Comninos A.N. et al.

The Dhillo group's fMRI work showing IV kisspeptin shifts limbic activity in heterosexual men during sexual and emotional image processing. Mechanism, not therapy — but the cleanest human evidence that kisspeptin acts above the hypothalamus, not just within it.