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18F-FC303 is a fluorine-18 labeled small molecule radiopharmaceutical developed by FutureChem Pharma for the diagnostic imaging of prostate cancer. It functions as a high-affinity ligand for Prostate-Specific Membrane Antigen (PSMA), also known as glutamate carboxypeptidase II, which is significantly overexpressed in prostate adenocarcinoma cells and their metastases. By utilizing Positron Emission Tomography (PET), 18F-FC303 allows for the precise localization of primary tumors and metastatic spread in lymph nodes and bone tissue. Compared to first-generation Gallium-68 labeled PSMA tracers, 18F-FC303 offers potential advantages including improved image resolution due to the lower positron energy of F-18 and the ability for large-scale, centralized production and distribution. FutureChem has completed clinical trials and filed a New Drug Application (NDA) for the agent in South Korea.
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