Glioma is the most common type of adult brain cancer. Approximately 30,000 patients are diagnosed with IDH1-mutant gliomas in the United States, Europe, and China annually. Patients are typically diagnosed in the prime of their life in their mid-forties to early-fifties. IDH1 mutations are present in the majority of lower-grade diffuse gliomas and IDH-mutant gliomas are recognized as distinct tumor subtypes by the World Health Organization (WHO).

There are no targeted treatments approved for IDH-mutant glioma. Current options include surgery, radiation, and chemotherapy.

Safusidenib is an investigational mIDH1 inhibitor that has demonstrated high blood-brain barrier penetration in pre-clinical studies and promising early results in a Phase 1 trial (NCT0303006).

A Phase 2 clinical trial evaluating safusidenib (G203, NCT05303519) in patients with IDH1-mutant Grades 2 and 3 glioma is enrolling patients at clinical sites in the United States.