Phase 3 Clinical Trial for Benign Prostatic Hyperplasia Treatment

Dongkook Pharmaceutical 'DKF-313'

[Asia Economy Reporter Seo So-jung] Dongkook Pharmaceutical (Vice Chairman Kwon Ki-beom) held a 'Researcher Meeting' for the Phase 3 clinical trial of 'DKF-313,' a newly improved combination drug for benign prostatic hyperplasia (BPH) under development, and has begun full-scale steps toward the Phase 3 clinical trial.

The DKF-313 researcher meeting, held on the 1st at Seoul Dragon City in Yongsan-gu, Seoul, was attended by researchers from about 20 clinical trial institutions, including Seoul Asan Medical Center, Gangnam Severance Hospital, and Seoul St. Mary's Hospital.

DKF-313, a combination tablet of 'Dutasteride,' which reduces prostate volume, and 'Tadalafil,' which has excellent effects on improving lower urinary tract symptoms, requires only one tablet per day, making it a highly anticipated product in the future prostate combination drug treatment market. Dongkook Pharmaceutical began development in 2012, and after completing toxicity tests, DDI (drug-drug interaction tests), and PK (pharmacokinetic tests), it is now entering Phase 3 clinical trials. If successful, it will become the world's first combination of Dutasteride and Tadalafil.

This Phase 3 clinical trial is designed as a multicenter, randomized, double-blind, double-dummy, three-arm parallel study over 48 weeks to evaluate the efficacy and safety of the combination drug DKF-313 in patients with benign prostatic hyperplasia.

Patient enrollment is scheduled to begin in June, targeting a total of 654 patients aged 45 to 80 diagnosed with benign prostatic hyperplasia. The product launch is aimed for the second half of 2023.