Chong Kun Dang Receives MFDS Approval for Triple Combination Diabetes Drug "Duviempol Extended Release Tablet"

Expanding Treatment Options for Patients Inadequately Controlled by Existing Combination Therapies

Chong Kun Dang has obtained domestic product approval for "Duviempol Extended Release Tablet (CKD-383)," a triple fixed-dose combination drug for the treatment of type 2 diabetes.

Jongkundang Headquarters building. Jongkundang

On March 11, Chong Kun Dang announced that it had received product approval for Duviempol Extended Release Tablet from the Ministry of Food and Drug Safety. This product is an extended-release fixed-dose combination containing lobeglitazone sulfate, empagliflozin L-proline, and metformin hydrochloride.

The approved dosages are 0.5/25/1000mg, 0.5/10/1000mg, and 0.25/12.5/1000mg. The approved indication is for adult patients with type 2 diabetes for whom combination therapy with lobeglitazone, empagliflozin, and metformin is appropriate.

This approval was granted approximately 11 months after Chong Kun Dang submitted the product application to the Ministry of Food and Drug Safety on April 23, 2025.

Duviempol Extended Release Tablet is a triple fixed-dose combination drug that adds the PPAR-γ agonist lobeglitazone to the combination therapy of empagliflozin, an SGLT2 inhibitor, and metformin, a biguanide, for patients whose blood glucose is not sufficiently controlled. Its key feature is the integration of multiple medications into a single formulation, which improves convenience for patients.

The company expects that this combination drug will offer a new treatment option for type 2 diabetes patients whose blood sugar is not adequately controlled with existing therapies.

Chong Kun Dang plans to launch the product in the domestic market in 2026 after completing production and distribution preparations.

This content was produced with the assistance of AI translation services.