Cothera Bioscience’s Zotiraciclib Receives the US FDA Fast Track Designation for Recurrent IDH-Mutated High-Grade Glioma
Shots:
- The US FDA has granted FTD to zotiraciclib (ZTR/TG02) for the treatment of pts with recurrent high-grade gliomas (rHGG) harboring IDH1 or IDH2 mutations (IDHmut rHGG)
- Designation was backed by the completion of the P-I trial of zotiraciclib, showing preliminary efficacy & favorable safety as a monotx. in IDHmut rHGG pts, which was presented at the 2025 WFNOS & SNO under the title “Phase I/II study of zotiraciclib for recurrent malignant gliomas with IDH mutations: results of the phase I study.”
- Zotiraciclib (PO) is a brain-penetrant multi-kinase inhibitor primarily targeting CDK9, suppressing anti-apoptotic protein transcription, disrupting tumor survival, & creating synthetic-lethal vulnerability in IDH-mutant gliomas
Ref: Cothera Bioscience | Image: Cothera Bioscience | Press Release
Related News: The EC Approves Servier’s Voranigo (vorasidenib) for Grade 2 IDH-Mutant Glioma in the EU
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