Dongkook Pharmaceutical said on the 24th that it completed a phase 3 clinical trial of Lorelin Depot Injection, a long-acting leuprorelin-based prostate cancer treatment, in the 3-month formulation (development code DKF-MA102).
The company said it will finalize the clinical study report within the year, then begin the product approval process, with a goal of launching next year.
Lorelin Depot Injection suppresses the secretion of gonadotropins, lowering blood testosterone and estrogen levels. It is used to treat hormone-related diseases such as prostate cancer, endometriosis, and precocious puberty.
This phase 3 study was conducted on 161 patients with prostate cancer at eight institutions, including Mokdong Hospital, the affiliated hospital of Ewha Womans University School of Medicine. Leuprorelin 11.25 mg was administered subcutaneously twice at 12-week intervals. Dongkook Pharmaceutical received approval for the investigational new drug (IND) application for this clinical trial from the Ministery of Food and Drug Safety in Oct. 2023.
In Korea, there is currently only one product of the leuprorelin 11.25 mg 3-month formulation injection on the market. Dongkook Pharmaceutical plans to expand its market share with the 3-month formulation, which extends the dosing interval compared with the 1-month formulation.
The domestic leuprorelin formulation market is estimated at about 80 billion won. The global market is about 5 trillion won, and among this, the U.S. market is known to be more than 2.5 trillion won, growing at an average annual rate of 9%.