Safusidenib

Safusidenib (AB-218) is a small molecule inhibitor developed by Nuvation Bio. Its target is IDH1 / IDH2 (the sponsor names IDH1-mutant glioma). The sponsor states: novel, oral, potent, brain-penetrant, targeted inhibitor of mutant IDH1. ClinicalTrials.gov describes the intervention as: safusidenib administered continuously as dosed single agent orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with agent safusidenib until disease progression or development of other unacceptable toxicity. It is the investigational product in 1 recruiting or active industry-led phase 2 and phase 3 interventional cancer trial, including the phase 3 study NCT05303519 (SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)), in glioma & glioblastoma. The largest, NCT05303519, plans to enrol 365 participants with primary completion expected 2028-12-01. Status reflects the highest phase registered on ClinicalTrials.gov at the 2026-09-11 check; no efficacy results are recorded here.