Fimepinostat (CUDC-907): A Comprehensive Report on Development and Clinical Evaluation

I. Fimepinostat (CUDC-907): Overview and Background

A. Identification and Chemical Properties

Fimepinostat, also known by its code name CUDC-907, is an investigational small molecule drug developed for the treatment of various cancers.[1] Identified by the DrugBank Accession Number DB11891 and CAS Number 1339928-25-4, Fimepinostat is classified chemically as a thienopyrimidine derivative.[3] It is formulated as an orally available agent, typically appearing as a solid powder soluble in dimethyl sulfoxide (DMSO). While specific details on its exact chemical formula and molecular weight are not consistently provided across the source materials, its identity as CUDC-907/Fimepinostat with the specified CAS number is well-established.[3]

B. Developer and Development History

Fimepinostat was developed internally by Curis, Inc., a biotechnology company focused on oncology therapeutics.[1] Clinical development commenced in 2013 with the initiation of a Phase 1 trial (NCT01742988) evaluating the drug in patients with relapsed or refractory (R/R) lymphomas and multiple myeloma.[7] Based on encouraging preliminary results, particularly in Diffuse Large B-cell Lymphoma (DLBCL), Curis advanced Fimepinostat into Phase 2 development in the first quarter of 2016 (NCT02674750).[7]