CKD-339 Hypertension Drug: MFDS Phase 3 Clinical Trial Application Submitted
Applied for MFDS approval of Phase 3 clinical trial for CKD-339 (D107) combination therapy in essential hypertension (application date: 2026-05-14)
Target: Patients inadequately controlled on D107 monotherapy, 300 patients in Korea, multicenter randomized double-blind
Primary efficacy endpoint: change in clinic MSSBP from baseline at 10 weeks
Trial duration: approximately 36 months after MFDS approval
Investment caution: clinical trial success rate approx. 10%, final approval uncertain
KOSPI Filing Information
Filing: Major Management Matters related to Investment Decisions (Application for Approval of Phase 3 Clinical Trial Plan for CKD339, a Hypertension Drug under Development, Submitted to the MFDS)
Company: Chong Kun Dang Pharmaceutical (185750)
Submission: Chong Kun Dang Pharmaceutical Corp.
Receipt: 05-14-2026
Under KRX KOSPI Market Division