Posted by Michael Wonder on 26 Nov 2025
FDA grants fast track designation to Cothera Bioscience’s zotiraciclib for treatment of recurrent high grade glioma with IDH1/2 mutations
26 November 2025 - Cothera Bioscience today announced that the US FDA has granted fast track designation to zotiraciclib (ZTR/TG02) for the treatment of patients with recurrent high-grade gliomas harbouring IDH1 or IDH2 mutations.
Zotiraciclib is a potent, oral, brain penetrant multi-kinase inhibitor that primarily targets CDK9.
