Kadence Bio is developing its lead asset KH-001 as the first FDA-approved treatment for premature ejaculation (PE), and a pipeline of compounds to target mood disorders.

Our development programs

Our Lead asset: KH-001

Kadence Bio is developing a small molecule, KH-001, as an on-demand orally-administered treatment for premature ejaculation.

Premature ejaculation (PE) is a distressing condition in which patients ejaculate too quickly before or shortly after penetration (often within one minute). There are currently no treatments approved by the FDA, despite the condition affecting up to 20% of men. These men report lower levels of sexual functioning and satisfaction, decreased self-esteem, and higher levels of personal distress. Partners of these men also suffer, and report sexual dissatisfaction and frustration, as well as problems in the relationship.          

KH-001 has shown promising results in proof-of-concept animal studies and a Phase 1 first-in-human clinical study which completed dosing in Q3 2024. A first efficacy proof-of-concept study is in progress, being conducted by our Australian subsidiary, Kanna Health Pty Ltd. If you are a male affected by premature ejaculation aged between 18 and 64 and interested in participating in our trial, please contact: info@kadencebio.com.

Pipeline Program

We are developing proprietary new chemical entities (NCEs) whose pharmacological and pharmacokinetic properties can be fine-tuned to target a range of neuropsychiatric disorders with high unmet needs.

Phase 2a data readout for KH-001 for use in premature ejaculation expected Q1 2027. Study being conducted at Kanna Health Pty Ltd.

Register Your Interest in Our Clinical Trial Program

If you’re experiencing premature ejaculation and would like to learn more about our upcoming clinical trials, please complete the form below.

By completing the form, you consent to Kadence Bio storing your contact information for future correspondence.

❝The short half-life seen in the Phase 1 results offers a key advantage in sexual medicine, overcoming prolonged exposure issues with Dapoxetine, and potentially representing a 'holy grail' for premature ejaculation.❞

Dr Emmanuele A. Jannini, Scientific Advisor and Professor of Endocrinology, Andrology and Sexual Medicine

Kadence Bio is geared for success