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Testing safusidenib for Grade 2 glioma with an IDH1 gene change

Original title: Safety and Efficacy Study of Safusidenib in Participants With Grade 2 IDH1-Mutant Glioma

How far along is this research?

This is a trial that is enrolling or has been updated. It is not a finding yet.

This is a large late stage study, so the drug has already been tested in smaller groups, but it is still being tested.

Status: Not yet recruiting. It has not opened yet. Ask your care team to watch for it if it looks like a fit.

The trial team last updated this record on . Always check the trial page for the latest.

The short version

This study is testing a drug called safusidenib in people with a Grade 2 brain tumor that has a change in the IDH1 gene.

Who this trial is for. This trial is for people with a Grade 2 glioma: A tumor that starts in the glial cells, the support cells of the brain and spinal cord. Gliomas are graded 1 to 4 by how fast they tend to grow. See the glossary, either an oligodendroglioma or an astrocytoma, that has a change in the IDH1 gene. It is for people whose tumor is still there or has come back after surgery, who have had no other treatment yet, and who do not need chemotherapy or radiation right away. Some people take safusidenib and some take a placebo, which is a treatment with no medicine in it. The patients and their doctors are not told which one they got.

Where it stands. There are no results yet. The trial is measuring how well safusidenib works compared to a placebo, and how safe it is. Until the study is done, no one knows if it helps.

What this means, and what it doesn't

What it could mean: This is one place researchers are looking for treatment options for this kind of tumor. If this sounds like your situation, you can ask your care team about it. They know your case and can tell you if a trial like this is worth looking into.

What it doesn't mean: This does not mean safusidenib is a proven treatment. A trial is a test. The whole point is that no one knows yet if the drug helps. Joining a study is not a guarantee that you will get better, and some people in this study receive a placebo instead of the drug. This is not a promise of a cure.

Source: ClinicalTrials.gov, July 17, 2026 · Read the original

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