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Tablets

Dossier type
CTD
Dossier status
Under development
Country of origin
United States
GMP approvals
FDA
Comments
Indication: IDH1 R132-mutant glioma (low-grade glioma and GBM at recurrence) Clinical stage: Phase 2 ongoing Modality: Small molecule Mechanism / Target: Mutant IDH1 (R132H/C/S) inhibitor — blocks neomorphic enzyme activity reducing 2-HG production; allows epigenetic normalisation and differentiation of IDH1-mutant tumour cells; CNS-penetrant design Route / form: Oral tablet Differentiation: CNS penetration designed for glioma (unlike ivosidenib with poor BBB crossing); specifically targets IDH1 R132 mutations prevalent in glioma; potential to delay malignant progression in low-grade glioma
Manufacturer #39189

Oncology company with an FDA-approved ROS1/NTRK inhibitor and next-generation solid tumour pipeline. Focuses on CNS-penetrant kinase inhibitors for molecularly defined lung and other cancers. Wholly owned US/global development with China territory licensed to Innovent Biologics.
 

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