Phase 3 Clinical Trial Underway... Results Expected in the Second Half of Next Year
[Asia Economy Reporter Lee Gwan-joo] Dongkook Pharmaceutical announced on the 23rd that Dongkoo Bio & Pharma has joined the development of the benign prostatic hyperplasia (BPH) combination drug ‘DKF-313,’ which is currently undergoing Phase 3 clinical trials.
Following the participation of Dong-A ST and Shinpung Pharmaceutical last year, with Dongkoo Bio & Pharma joining, three domestic companies are sharing the development costs and proceeding with the development. If the product is successfully commercialized in the future, each company will obtain product approval and launch simultaneously. However, the lead company will manufacture the drug under contract at its exclusive facility and supply it to the participating companies.
Dongkook Pharmaceutical received approval from the Ministry of Food and Drug Safety in July 2020 for the Phase 3 clinical trial plan of DKF-313 and prepared for clinical trials while recruiting joint developers. The clinical trial began in earnest last year, and patient enrollment and dosing are actively underway. Enrollment is expected to be completed by mid-year, and after one year of administration to evaluate efficacy and safety, results are anticipated as early as the second half of next year.
DKF-313, the world’s first combination drug of ‘dutasteride’ and ‘tadalafil,’ is indicated for reducing prostate size and improving lower urinary tract symptoms caused by benign prostatic hyperplasia. Given the nature of the disease requiring long-term medication, once-daily dosing is expected to enhance patient convenience and quality of life. Upon completion of development, exclusive domestic rights will be secured for six years.
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