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Trials
Study of Olutasidenib and Temozolomide in HGG

trialsTrialRecruiting

Study of Olutasidenib and Temozolomide in HGG

A phase 2 trial of Olutasidenib in diffuse midline glioma, h3 k27-altered, run by Rigel Pharmaceuticals, now recruiting.

Overview Connected5

Overview

Study of Olutasidenib and Temozolomide in HGG is a phase 2 interventional study registered as NCT06161974 by Rigel Pharmaceuticals, with 60 participants planned, started 2025-02-01 and due to reach its primary completion in 2029-06. Interventions recorded: Olutasidenib + TMZ. Conditions listed: High Grade Glioma, Astrocytoma, Astrocytoma, Grade III, Astrocytoma, Grade IV. No results are recorded here; the registry entry is the source.

Setting

Phase 2 Study of Olutasidenib With Temozolomide as Maintenance Therapy in Pediatric and Young Adult Patients Newly Diagnosed With High-Grade Glioma (HGG), Including Diffuse Intrinsic Pontine Glioma (DIPG), Which Harbor IDH1 Mutations

Phase

Phase 2

Sponsor

Rigel Pharmaceuticals

Registry

Started

2025-02-01

Enrolled

60 enrolled

Connected

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cancers

Diffuse midline glioma, H3 K27-altered (including DIPG)

technologies

Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET)IDH inhibitors

drugs

ApprovedSmall-molecule IDH1 inhibitor

Olutasidenib · Rezlidhia

companies

Rigel Pharmaceuticals

Evidence strength29/100 · Preliminary

How much and what kind of evidence, not how big the benefit. Click for the breakdown.

Phase 2+15
60 enrolled+9
No structured primary endpoint0
Result: recruiting0
No independent replication recorded0
A linked product is approved+5

Formula disclosed on the evidence page.

ProvenanceLast edited 2026-09-22 · Jude Gomila · Wave 2 corpus-only joins applied · diff · file

Sources & links

ClinicalTrials.gov NCT06161974

Data

JSON ·

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Cancers

Diffuse midline glioma, H3 K27-altered (including DIPG)

Technologies

Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET)
IDH inhibitors

Products

Olutasidenib

Companies

Rigel Pharmaceuticals

Not yet reviewedNeeds expert (clinical) review. Review this page or see the review queue and roster.

Model panel commentary is coming to this page: machine commentary, not clinical review.

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