Dongkook Pharmaceutical announced on the 24th that it has successfully completed Phase 3 clinical trials for Lorellin Depot Injection, a long-acting injectable treatment for prostate cancer containing leuprorelin, in a three-month formulation.
The three-month formulation is based on Dongkook Pharmaceutical's microsphere technology. Lorellin Depot Injection contains leuprorelin, which suppresses gonadotropin secretion to reduce blood testosterone and estrogen levels, thereby treating the disease. Beyond prostate cancer, it is also used to treat hormone-related conditions including endometriosis and precocious puberty.
Dongkook Pharmaceutical previously received approval from the Ministry of Food and Drug Safety in October 2023 for clinical trial plans for DKF-MA102 in prostate cancer treatment. The trial was conducted at eight hospitals including Ewha Womans University Mokdong Hospital, involving 161 prostate cancer patients who received subcutaneous injections of 11.25mg leuprorelin twice at 12-week intervals.
The company aims to complete the clinical trial report within this year, proceed with product licensing sequentially, and launch the product next year.
The domestic leuprorelin market is estimated at approximately 80 billion won. The global market is valued at around 5 trillion won. The U.S. market alone exceeds 2.5 trillion won and is growing at approximately 9% annually.