{"entity":{"id":"safusidenib","kind":"drug","name":"Safusidenib","aka":["DS-1001b"],"tldr":"Safusidenib is an experimental small molecule inhibitor from Nuvation Bio in phase 3 trials for glioma & glioblastoma, aimed at IDH1 / IDH2.","summary":"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; no efficacy results are recorded here.","status":"phase-3","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov: trials of Safusidenib","url":"https://clinicaltrials.gov/search?intr=AB-218"},{"label":"Sponsor page","url":"https://www.nuvationbio.com/pipeline"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["glioblastoma","idh-mutant-astrocytoma","oligodendroglioma"],"sections":[],"technologies":[],"targets":["idh"],"drugs":[],"companies":["nuvation-bio"],"institutions":[],"pathways":[],"terms":[],"trials":["nct05303519","nct04458272"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor pipeline pages)","editedOn":"2026-09-11"},"code":"AB-218","modality":"small molecule inhibitor","mechanism":"novel, oral, potent, brain-penetrant, targeted inhibitor of mutant IDH1.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/safusidenib/","neighbours":{"cancer":[{"id":"idh-mutant-astrocytoma","kind":"cancer","name":"Astrocytoma, IDH-mutant (grades 2 to 4)","route":"/cancers/idh-mutant-astrocytoma/"},{"id":"glioblastoma","kind":"cancer","name":"Glioma & glioblastoma","route":"/cancers/glioblastoma/"},{"id":"oligodendroglioma","kind":"cancer","name":"Oligodendroglioma, IDH-mutant and 1p/19q-codeleted","route":"/cancers/oligodendroglioma/"}],"target":[{"id":"idh","kind":"target","name":"IDH1 / IDH2","route":"/targets/idh/"}],"company":[{"id":"nuvation-bio","kind":"company","name":"Nuvation Bio","route":"/companies/nuvation-bio/"}],"trial":[{"id":"nct04458272","kind":"trial","name":"A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma","route":"/trials/nct04458272/"},{"id":"nct05303519","kind":"trial","name":"SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)","route":"/trials/nct05303519/"}]}}