CKD-339, an investigational hypertension treatment under development by Chong Kun Dang, has received Phase 3 clinical trial plan (IND) approval from the Ministry of Food and Drug Safety (MFDS).

The MFDS approved the Phase 3 clinical trial plan for CKD-339 on July 27, 2026. Chong Kun Dang had submitted the plan on May 14 of the same year.

■ Clinical Design and Evaluation Methods This clinical trial will enroll patients with essential hypertension whose blood pressure is inadequately controlled with D107 monotherapy. It is a randomized, double-blind, multi-center, therapeutic confirmatory Phase 3 clinical trial designed to evaluate efficacy and safety by comparing a D107 monotherapy arm with arms receiving D107 in combination with either D211 or D311.

The primary efficacy endpoint is based on the change in clinic MSSBP (Mean Sitting Systolic Blood Pressure) at 10 weeks (Visit 4) compared to baseline (Visit 2).

■ Scale and Timeline The trial will be conducted with 300 patients in South Korea and is expected to last approximately 36 months from the date of MFDS approval. However, the timeline may change depending on the rate of subject enrollment.

Chong Kun Dang stated that it plans to evaluate the efficacy and safety of CKD-339 in patients with essential hypertension whose blood pressure is not sufficiently controlled with D107 monotherapy through this clinical trial.

■ Investment Considerations The company disclosed that the probability of an investigational drug receiving final marketing approval is statistically known to be approximately 10%. It also explained that if the results during the clinical trial and product approval process fall short of expectations, there is a possibility that commercialization plans may be altered or discontinued.