FutureChem’s prostate cancer drug FC705 shows phase 2 progress, eyes fast-track approval

FutureChem has reported positive signals from the phase 2 clinical trial of its domestically developed radiopharmaceutical FC705 for prostate cancer, raising expectations for rapid domestic approval.

The company said Tuesday that part of the phase 2 trial results for FC705, a treatment for metastatic castration-resistant prostate cancer (mCRPC), has been accepted for poster presentation at the European Society for Medical Oncology (ESMO 2025) conference, to be held in Berlin, Germany, from Wednesday to Sunday.

FutureChem also said it is preparing an application for conditional approval of FC705 in Korea. The company plans to expand compassionate use to cover more than 100 critically ill mCRPC patients.

“We previously presented the results of FC705’s phase 1 trial in Korea at the 2024 European Association of Nuclear Medicine (EANM) Congress. This ESMO poster acceptance is significant as it marks our second presentation at an international conference,” FutureChem said.

FC705 is now moving toward a phase 3 clinical trial in Korea, involving 114 patients across eight medical institutions in the Seoul metropolitan area, including Seoul St. Mary’s Hospital of the Catholic University of Korea. Seoul National University Hospital has recently confirmed participation as a new clinical site, and the Institutional Review Board (IRB) review at St. Mary’s Hospital has also been scheduled.

The phase 3 study is designed as a randomized trial comparing the efficacy and safety of FC705 in combination therapy versus best supportive care (BSC/SoC) alone in patients with mCRPC. The trial aims to demonstrate efficacy using multiple endpoints consistent with global standards for new drug approval.

“We are actively pursuing phase 3 clinical trials in Korea with the goal of conditional approval. We also aim to complete the ongoing phase 2a trial in the U.S. as soon as possible, targeting submission of a Clinical Study Report (CSR) in the first half of 2026,” a FutureChem official said. “We expect to showcase our global competitiveness early through this parallel domestic and international development strategy.”