FutureChem said on Monday that it has received approval from the Ministry of Food and Drug Safety (MFDS) for its phase 3 clinical trial plan of the prostate cancer radiopharmaceutical FC705 in Korea.

The trial will target patients with metastatic castration-resistant prostate cancer (mCRPC). It is a randomized clinical study comparing a standard of care (SoC)/best supportive care (BSC) monotherapy group with a group receiving combination therapy with FC705. A total of 114 patients will be enrolled across eight medical institutions in the Seoul metropolitan area, including the Catholic University of Korea Seoul St. Mary’s Hospital.

Key evaluation variables include radiographic progression-free survival (rPFS), overall survival (OS), objective response rate (ORR), and disease control rate (DCR), all measured by imaging assessments. These diverse metrics, aligned with global standards, will jointly validate both efficacy and safety.

In a previously conducted phase 2 trial, FC705 demonstrated the highest rate of prostate-specific antigen (PSA) reduction by 50 percent or more and the highest radiographic ORR compared with other radiopharmaceuticals with the same mechanism. Meanwhile, the ongoing phase 2a trial in the U.S. has completed enrollment of 20 subjects. To date, the total number of patients enrolled in clinical trials in Korea and the U.S., including those under treatment, is 136.

“This phase 3 clinical trial approval is the fruit of our R&D team’s efforts and a significant milestone that will provide patients with new treatment opportunities, serving as a stepping stone for future global expansion,” a FutureChem official said. “Based on the domestic and U.S. clinical results secured to date for conditional approval, we will actively communicate with the MFDS to proceed as quickly as possible.”