Kyungdong Pharmaceutical's Combination Drug for Benign Prostatic Hyperplasia Succeeds in Phase 3 Clinical Trial: "Improvement Confirmed"

Kyungdong Pharmaceutical announced on the 12th that it has successfully completed the domestic Phase 3 clinical trial of KDF1905-2BO, an improved new drug combination for benign prostatic hyperplasia (BPH).

KDF1905-2BO is a combination drug that merges tamsulosin (KDF1905-R1), a representative alpha-blocker for BPH, with mirabegron (KDF1905-R2), an ingredient for treating overactive bladder. Tamsulosin and mirabegron are widely prescribed drugs in the urological field.

The Phase 3 clinical trial was conducted to demonstrate the efficacy and safety of KDF1905-2BO in patients with BPH. The trial was carried out at 25 institutions in Korea, including Dong-A University Hospital, involving 795 patients. It was designed as a randomized, double-blind, parallel, placebo-controlled, therapeutic confirmation study.

Through the clinical trial, the company demonstrated the improvement of lower urinary tract symptoms in the group receiving combined administration of KDF1905-R1 and KDF1905-R2. The combination group showed superior effects compared to the KDF1905-R1 monotherapy group in the primary efficacy endpoint, the change in urgency and frequency scores (TUFS) at 12 weeks after administration. Additionally, the combination group confirmed non-inferiority in the change of the total International Prostate Symptom Score (IPSS) at 12 weeks after administration.

A company representative stated, "Due to population aging and changes in dietary habits, the number of patients with BPH, a representative urological disease, is on the rise. With the success of the Phase 3 clinical trial, we will expedite the approval of the improved new combination drug for BPH with enhanced therapeutic effects and actively pursue market entry.”