The prostate hyperplasia complex developed by DongKook Pharmaceutical enters Phase III clinical trials.

YuYu Pharma is also developing the same prostate hyperplasia complex, which attracts interest in the competition between the two companies.

On the 9th, the MFDS approved the clinical trial phase III trial (IND) for 'DKF-313', which DongKook Pharmaceutical applied for. DKF-313 is known as a combination of Dutasteride and Tadalafil currently used in prostatic hyperplasia.

This trial is a multicentre, randomized, double-blind, double placebo, parallel group, phase III clinical trial to evaluate the efficacy and safety of DKF-313 in 654 patients with benign prostatic hyperplasia. The test will be conducted at Asan Medical Center.

Dutasteride-Tadalafil combinations are currently not commercially available. It will be the first in the world If developed. YuYu Pharma was approved for a phase III clinical trial plan for 'YY-201,' a candidate for the same ingredient in March 2018. Therefore, it is noted who will succeed in commercialization first.

The size of the domestic prostate hyperplasia treatment market is about ₩200 billion , and the original drugs of foreign pharmaceutical companies occupy most of the market share. Representative drugs include Harnal (Tamsulosin HCl, Astellas Korea), Avodart (Dutasteride, GSK), and Proscar (Finasteride, MSD).


Tadalafil (Cialis, Lilly) is more famous for erectile dysfunction, but is also used for benign prostatic hyperplasia in low doses. For reference, Dutasteride is effective for prostate hyperplasia as well as hair loss. Therefore, if a combination drug is developed, it is expected that it will be spotlighted in patients with erectile dysfunction and hair loss accompanied by prostate hyperplasia.

It seems to be the key to commercialization whether it is possible to increase the solubility of the two components in a single formulation in view of the fact that Dutasteride is a poorly soluble drug that is insoluble in water.