OQL036

OQL036 is a novel topical gel developed by OnQuality Pharmaceuticals for the prophylaxis of capecitabine-induced hand-foot syndrome (HFS). HFS is a common and potentially dose-limiting side effect of fluoropyrimidine chemotherapy, such as capecitabine, which is used to treat colorectal and breast cancers. OQL036 is designed to locally alleviate the toxicities induced by capecitabine metabolites and reduce the inflammation associated with HFS. The FDA cleared the Investigational New Drug (IND) application for OQL036 in April 2023, enabling the initiation of a global multi-center, double-blind, placebo-controlled Phase 2 trial in cancer patients receiving capecitabine-based therapy.