pp-163 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.
None