29 March 2023 - EpicentRx announced today that the US FDA granted fast track designation to RRx-001, a direct NLRP3 inhibitor and Nrf2 up-regulator with anti-inflammatory and anti-oxidant properties, for the prevention/attenuation of severe oral mucositis in chemotherapy and radiation-treated head & neck cancer patients.
RRx-001 is a highly selective NLRP3 inhibitor under investigation in a Phase 3 trial for the treatment of small cell lung cancer, and a planned Phase 2b trial for protection against oral mucositis in first-line head and neck cancer.