Dongkook Pharmaceutical announced Wednesday that it has successfully completed Phase 3 clinical trials for a three-month formulation of Lorellin Depot, a long-acting injectable treatment for prostate cancer containing leuprorelin.
The three-month injectable is based on Dongkook Pharmaceutical's proprietary microsphere technology. Lorellin Depot uses leuprorelin to suppress gonadotropin secretion, reducing testosterone and estrogen levels in the blood to treat the disease. Beyond prostate cancer, the drug is also used to treat hormone-related conditions including endometriosis and precocious puberty.
Dongkook Pharmaceutical plans to complete the clinical trial report by year-end and proceed with regulatory approval sequentially, targeting a launch 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.