Dongkook Pharmaceutical's Improved New Drug for Benign Prostatic Hyperplasia Confirms Efficacy and Safety in Phase 3 Trial

New Drug 'DKF-313'
World's First Dutasteride-Tadalafil Combination
Exclusive Domestic Rights Secured for 6 Years

Dongkook Pharmaceutical recently announced that it has confirmed the efficacy and safety of the improved new drug combination for benign prostatic hyperplasia (BPH), 'DKF-313,' in its Phase 3 clinical trial.

Exterior view of Dongkook Pharmaceutical Cheongdam Building. [Photo by Dongkook Pharmaceutical]

DKF-313 is the world's first combination of 'dutasteride' and 'tadalafil.' Dongkook Pharmaceutical explained that through its dual effect of reducing prostate size while improving urinary symptoms caused by BPH, it is expected to provide superior therapeutic effects compared to single agents. Additionally, given the nature of the disease requiring long-term medication, once-daily single-tablet dosing is expected to enhance patient convenience.

Professor Kim Cheong-su, head of the Prostate Cancer Center at Ewha Mokdong Hospital and the clinical trial coordinator (CI) for this study, stated, "The combination drug showed superior improvement in the International Prostate Symptom Score (IPSS) compared to each single agent, and there was no statistically significant difference in adverse drug reactions between the combination and single agents." He added, "If this leads to product launch, it is expected to provide new and significant help in the treatment and quality of life improvement for patients with BPH."

Globally, except for one product from a multinational pharmaceutical company, there are almost no combination drugs for BPH. In this context, Dongkook Pharmaceutical explained that the development of DKF-313 is highly significant as it could signal the beginning of combination drug development for BPH treatment, similar to treatments for hypertension and diabetes.

Dongkook Pharmaceutical plans to complete the Phase 3 clinical trial report for DKF-313 within this year and proceed sequentially with product approval and launch. Upon completion of product development, the company will secure exclusive domestic rights for six years and accelerate its entry into the global market. A Dongkook Pharmaceutical representative stated, "Based on our domestic and international networks and sales capabilities, we plan to strengthen our dominance in the domestic market and expand our reach overseas to pioneer the global market."

In July 2020, Dongkook Pharmaceutical received approval from the Ministry of Food and Drug Safety for the Investigational New Drug (IND) application to conduct the Phase 3 clinical trial of DKF-313 and began the trial in 2021, targeting the enrollment of approximately 650 patients across 18 hospitals nationwide. Dongkook Pharmaceutical served as the sponsor for the development of DKF-313, with Dong-A ST, Shinpung Pharmaceutical, and Donggu BioPharmaceutical participating as collaborators sharing the costs. If commercialization is successful, each company will obtain product approval and launch simultaneously. The improved new drug combination will be manufactured and supplied at Dongkook Pharmaceutical’s dedicated facility, the sponsor company.

Benign prostatic hyperplasia is a condition where the prostate enlarges with age, causing various urinary dysfunctions. Treatment with '5α-reductase inhibitors (finasteride and dutasteride),' which reduce prostate size, is effective; however, since improvement does not appear immediately, multiple medications are often combined to alleviate symptoms.

According to 2022 data from Ubist, the domestic market for BPH treatments is estimated at approximately 500 billion KRW. According to GlobalData, a pharmaceutical market analysis firm, the global BPH treatment market is expected to grow at an average annual rate of over 8%, reaching about 4.5 billion USD (approximately 6 trillion KRW) by 2024.