Dordaviprone FDA Approval Status
Last updated by Judith Stewart, BPharm on Feb 19, 2025.
FDA Approved: No
Generic name: dordaviprone
Company: Chimerix, Inc.
Treatment for: Malignant Glioma
Dordaviprone is a first-in-class, small molecule imipridone in development for the treatment of patients with recurrent H3 K27M-mutant diffuse glioma.
- A glioma is brain tumor that originates from glial cells normally present in the central nervous system. The H3 K27M mutation is a specific mutation in one of the genes that encode for proteins called histone H3. The mutation is found in the majority of diffuse midline gliomas, which includes tumors located in central regions of the central nervous system such as the brainstem and thalamus.
- Dordaviprone (ONC201) is a novel first-in-class small molecule imipridone that selectively binds to the G-protein coupled dopamine receptor D2 (DRD2) and the mitochondrial protease ClpP.
- A New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for dordaviprone as a treatment for patients with recurrent H3 K27M-mutant diffuse glioma. Dordaviprone has received Rare Pediatric Disease Designation for H3 K27M-mutant glioma and an application for a Rare Pediatric Disease Priority Review Voucher (PRV) has been included as part of the NDA submission.
Development timeline for dordaviprone
Further information
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