# Safusidenib

Source: https://onco.cc/drugs/safusidenib/  
OnCo record `safusidenib` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Treatment
- Status: phase-3
- Last checked: 2026-09-11
- Also known as: DS-1001b
- Tags: pipeline; ctgov-ingest
- Code: AB-218
- Modality: small molecule inhibitor
- Mechanism: novel, oral, potent, brain-penetrant, targeted inhibitor of mutant IDH1.

## Sources

- ClinicalTrials.gov: trials of Safusidenib: https://clinicaltrials.gov/search?intr=AB-218
- Sponsor page: https://www.nuvationbio.com/pipeline

## Connected records

- cancers: [Astrocytoma, IDH-mutant (grades 2 to 4)](https://onco.cc/cancers/idh-mutant-astrocytoma/), [Glioma & glioblastoma](https://onco.cc/cancers/glioblastoma/), [Oligodendroglioma, IDH-mutant and 1p/19q-codeleted](https://onco.cc/cancers/oligodendroglioma/)
- targets: [IDH1 / IDH2](https://onco.cc/targets/idh/)
- companies: [Nuvation Bio](https://onco.cc/companies/nuvation-bio/)
- trials: [A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma](https://onco.cc/trials/nct04458272/), [SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)](https://onco.cc/trials/nct05303519/)

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