Drugs / Safusidenib
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial · 1 met primary | ||||||
| Phase 0 | NCT05577416 | Oct 2022 → Mar 2025 | glioma | Melbourne Health | Completed | Met primary |
| Phase 21 trial | ||||||
| Phase 2 | NCT07703436 | Mar 2027 → Sep 2030 expected | IDH-mutant and 1p/19q-codeleted oligodendroglioma, astrocytoma, IDH-mutant, grade 2, astrocytoma, IDH-mutant, grade 3, oligodendroglioma | Nuvation Bio Inc. | Not yet recruiting | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT07712757 | Mar 2027 → May 2029 expected | IDH-mutant and 1p/19q-codeleted oligodendroglioma, astrocytoma, IDH-mutant, grade 2, oligodendroglioma | Nuvation Bio Inc. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05303519 | Jun 2023 → Dec 2028 expected | IDH-mutant and 1p/19q-codeleted oligodendroglioma, astrocytoma, IDH-mutant, grade 2, astrocytoma, IDH-mutant, grade 3, astrocytoma, IDH-mutant, grade 4 +1 | Nuvation Bio Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-08-20 | Nuvation Bio Inc. | Regulatory Nuvation Bio Granted FDA Fast Track Designation for Safusidenib for Treatment of IDH1-Mutant Glioma nuvationbio.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for safusidenib, the company's investigational, oral, brain-penetrant selective inhibitor of mutant IDH1. |
| 2026-08-06 | Nuvation Bio Inc. | Results Nuvation Bio Reports Second Quarter 2026 Financial Results and Provides Business Update nuvationbio.com ↗
Announced positive updated long-term Phase 2 data for safusidenib and significant expansion of clinical program to address broad spectrum of IDH1-mutant glioma |
| 2026-07-20 | Nuvation Bio Inc. | Results Nuvation Bio Announces Positive Updated Phase 2 Data and Expansion of Safusidenib Clinical Program with Two New Studies to Explore Broad Spectrum of IDH1-Mutant Glioma nuvationbio.com ↗ |
| 2025-12-03 | Nuvation Bio Inc. | Results Nuvation Bio Announces Publication of Positive Phase 2 Study Results for Safusidenib for the Treatment of Grade 2 IDH1-Mutant Glioma in Neuro-Oncology nuvationbio.com ↗
Safusidenib demonstrated durable responses, with an ORR of 44% and 88% of patients were progression-free at 24 months |
All press releases naming this drug 7 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Safusidenib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07712757 ↗ |
| Known as | AB-218 | “with safusidenib (AB-218/DS-1001b), an orally available small-molecule inhibitor of mIDH1.” PMID 40841487 ↗ Aug 2025 |
| Known as | DS-1001b | “with safusidenib (AB-218/DS-1001b), an orally available small-molecule inhibitor of mIDH1.” PMID 40841487 ↗ Aug 2025 |
| Action | Inhibit | “inhibitor of mutated IDH1” NCT05577416 ↗ |
| Modality | Small molecule | “an orally available, small molecular inhibitor of mutated IDH1” NCT05577416 ↗ |
| Route | Oral | “safusidenib administered continuously as dosed single agent orally on Days 1 to 28 of a 28-day cycle.” NCT05303519 ↗ |
| Target | IDH1 | “inhibitor of mutated IDH1” NCT05577416 ↗ |