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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.

Development timeline for dordaviprone

DateArticle
Feb 18, 2025Chimerix Announces FDA Acceptance and Priority Review of New Drug Application for Dordaviprone as Treatment for Recurrent H3 K27M-Mutant Diffuse Glioma
Dec 30, 2024Chimerix Submits Dordaviprone New Drug Application for Accelerated Approval to U.S. FDA for Patients with Recurrent H3 K27M-Mutant Diffuse Glioma
Dec  9, 2024Chimerix to Submit Dordaviprone for Accelerated Approval to U.S. FDA for Patients with Recurrent H3 K27M-Mutant Diffuse Glioma Before Year-End

Further information

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