New preclinical paper supports KH-001's mechanism for premature ejaculation

Published in The Journal of Sexual Medicine, the study shows that KH-001 produced a dose-dependent delay in ejaculation in a well-established rat model.

A new peer-reviewed Brief Communication in The Journal of Sexual Medicine reports preclinical evidence supporting Kadence Bio's lead candidate, KH-001, as a serotonergic treatment for premature ejaculation (PE), a condition that affects approximately 1 in 5 men worldwide and currently has no FDA-approved therapy.

In the para-chloroamphetamine (PCA) rat model, a well-established assay for ejaculatory pharmacology — KH-001 produced a dose-dependent increase in ejaculatory latency, with statistically significant effects from a minimum dose of 200 μg/kg (p < 0.01). At the highest dose tested (20 mg/kg), no animals ejaculated during the 30-minute observation window. KH-001 also reduced seminal vesicle pressure amplitude without affecting bulbospongiosus muscle activity, consistent with a selective effect on the emission phase of ejaculation.

The findings align with KH-001's pharmacological profile as a high-affinity, selective inhibitor of the serotonin transporter (SERT).

The study was conducted in collaboration with Pelvipharm and Prof. François Giuliano (R. Poincaré Hospital, Versailles-Saint Quentin / Paris-Saclay University). It complements the favourable safety and pharmacokinetic profile previously established in Kadence Bio's completed Phase 1 study and supports continued development of KH-001, which is currently in Phase 2a.

Citation: Pfeiffer T, Gericke N, Razanakolona M, Behr-Roussel D, Bracconi M, Giuliano F, Protzko R. KH-001 delays para-chloroamphetamine-induced ejaculation in anaesthetized rat. J Sex Med. 2026;23(4):qdag044.

Read the paper (open access): https://doi.org/10.1093/jsxmed/qdag044