Dongkook Pharmaceutical is drawing the industry’s attention by completing the phase 3 clinical trial of its new therapy for benign prostatic hyperplasia (BPH), which combines dutasteride and tadalafil.

Dongkook Pharm said Monday that it has confirmed the efficacy and safety of DKF-313, an improved combination drug for BPH, in the phase 3 study. Dongkook plans to complete the phase 3 result report within the year and proceed with product approval application and market launch.

DKF-313 is a combination of dutasteride and tadalafil. According to Dongkook, it is expected to reduce the size of the prostate while improving the symptoms of dysuria caused by BPH, resulting in a better treatment effect than single drugs.

In July 2020, the company received approval for DKF-313's phase 3 IND (Investigational New Drug) application from the Ministry of Food and Drug Safety. In 2021, the company began clinical trials at 18 hospitals nationwide, intending to enroll 650 patients.

In particular, the development of DKF-313 involved Dongkook and three other Korean companies -- Dong-A ST, Shinpoong Pharm, and Dong Koo Bio & Pharma -- which shared the costs as participants. If the product is successfully commercialized, each company will proceed with simultaneous release after acquiring a marketing license. Dongkook Pharm will manufacture it.

Dongkook expected DKF-313 to improve the convenience and quality of life for patients needing long-term medication, as they only need one tablet daily.

In addition, Dongkook believes that developing DKF-313 will pave the way for developing combination drugs, such as those for hypertension and diabetes, as there are few combination drugs for prostate cancer.

"The combination showed superiority in improving the International Prostate Symptom Score (IPSS) compared to each single agent, and there was no statistically significant difference between the combination and single agents in adverse drug reactions," said Professor Kim Cheong-soo of the Department of Urology at Ewha Womans University Mokdong Hospital and head of the Prostate Cancer Center. He was the principal investigator (CI) for the trial.

If this leads to future product launches, it is expected to provide new and significant help in improving the treatment and quality of life of patients with BPH, Professor Kim added.

"We plan to strengthen our dominance in the domestic market based on our domestic and overseas networks and sales power and expand overseas to explore the global market,” a Dongkook Pharm official said.

Meanwhile, Ubist said the Korean prostate cancer treatment market was estimated to be worth about 500 billion won in 2022. The global market will likely grow more than 8 percent a year to reach about $4.5 billion next year, according to GlobalData, a pharmaceutical market analysis firm.