Policy & Regulation
Kanna Health's KH-001 Besylate IND and CTA applications receive FDA and MHRA approval
17 November 2023 -

Kanna Health, a UK-based clinical-stage biopharmaceutical company, announced on Thursday that it has received approval from the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the Investigational New Drug (IND) application and Clinical Trial Application (CTA), respectively, to commence participant enrolment in a Phase one first-in-human clinical trial assessing the safety and pharmacokinetics of KH-001 Besylate (KH-001) in Healthy Male subjects.

The company said that KH-001 is a unique, proprietary on-demand drug being produced as the first FDA-approved treatment for premature ejaculation, and that these regulatory approvals represent a potential breakthrough in the management of a widespread condition, affecting up to 20% of men and their partners globally.

The Phase one study will be carried out in the UK by Simbec-Orion, an experienced full-service Contract Research Organisation (CRO).

Dr Ryan Protzko, Kanna Health's president, said, 'Our clinical trial approval on both sides of the Atlantic represents a critical milestone as we officially become a clinical stage company. The study marks the start of a journey towards understanding the therapeutic potential of KH-001 in humans, in cooperation with regulatory bodies in our priority markets.'