TV5M01

**TV5M01** is an investigational, locally administered fixed-dose oral gel/rinse containing 5% green tea extract and 0.1% morphine for treatment of radiation-induced oral mucositis in patients receiving radiotherapy for squamous cell carcinoma of the head and neck. The green tea extract component, including epigallocatechin gallate, is intended to mitigate oxidative and inflammatory mucosal injury, while topical morphine is intended to provide peripheral opioid receptor-mediated analgesia at inflamed oral tissues. TV5M01 is being evaluated against a lidocaine, nystatin, and hydroxides triple-mixture mouthwash in a randomized, double-blind Phase 2 trial.