“Monotherapy Is Insufficient”: Chong Kun Dang Receives Phase 3 Approval for Hypertension Drug ‘CKD-339’

Chong Kun Dang will begin a domestic phase 3 clinical trial of its investigational hypertension treatment ‘CKD-339.’

Chong Kun Dang announced on the 27th that it had received approval from the Ministry of Food and Drug Safety for the phase 3 investigational new drug application (IND) for ‘CKD-339,’ which is being developed as a treatment for hypertension. The company submitted the clinical trial application on May 14.

This phase 3 trial will enroll patients with essential hypertension whose blood pressure is not adequately controlled with ‘D107’ monotherapy. The trial is designed to compare the efficacy and safety of the ‘D107’ monotherapy group with those of combination-therapy groups receiving ‘D107’ together with either ‘D211’ or ‘D311.’

The multicenter, randomized, double-blind trial will be conducted in 300 patients in South Korea. The primary efficacy endpoint is the change in mean sitting systolic blood pressure (MSSBP) 10 weeks after administration. The total clinical trial period is expected to be approximately 36 months from the date of approval.

Through this trial, Chong Kun Dang plans to determine whether combination therapy with ‘CKD-339’ can provide a new treatment option for patients who have not responded to existing monotherapy, while evaluating its efficacy and safety.