Dongkook Pharmaceutical said that the Ministry of Food and Drug Safety has given the go-ahead for its phase 3 clinical trial into DKF-313, the world's first benign prostatic hyperplasia (BPH) combination treatment that combines dutasteride and tadalafil.
|Dongkook Pharmaceutical received regulatory approval to conduct phase 3 clinical trials into the world’s first benign prostatic hyperplasia combination treatment. (Dongkook)|
BPH, a very common disease for males, increases the size of the prostate gland as the patient ages, which, in turn, impairs various urination functions.
To treat the disease, hospitals conventionally use a 5α-reductase inhibitor, a drug that reduces the prostate's size. However, as the improvement effect does not appear immediately, hospitals also have to use several other drugs for symptom improvement.
DKF-313 is an incrementally modified drug that combines dutasteride with tadalafil, which is excellent in improving BPH symptoms, that patients can take once a day, the company said.
"The pipeline for treating prostatic hyperplasia is very poor worldwide," a company official said. "Therefore, we expect that DKF-313, which is the world's first combination treatment to receive approval for clinical trials, will lead the global market."
According to GlobalData, a drug market analysis agency, the global market for BPH is expected to grow by more than 8 percent annually and reach about $4.5 billion by 2024.
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