Overview

Fimepinostat (CUDC-907) has been used in trials studying the treatment of lymphoma, solid tumors, breast cancer, multiple myeloma, and NUT midline carcinoma, among others.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Research Report

Published: Apr 30, 2025

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]

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Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Fimepinostat, Combination HDAC and Pi3-kinase Inhibitor Tumor-Directed Therapy for Cushing Disease	2023/08/02	NCT05971758	Phase 2	Recruiting	University of California, Los Angeles
Fimepinostat in Treating Brain Tumors in Children and Young Adults	2019/03/28	NCT03893487	Early Phase 1	Active, not recruiting	Sabine Mueller, MD, PhD
CUDC-907 Treatment in People With Metastatic and Locally Advanced Thyroid Cancer	2016/12/26	NCT03002623	Phase 2	Terminated	National Cancer Institute (NCI)
Trial of CUDC-907 in Children and Young Adults With Relapsed or Refractory Solid Tumors, CNS Tumors, or Lymphoma	2016/09/21	NCT02909777	Phase 1	Active, not recruiting	Dana-Farber Cancer Institute
Study to Evaluate the Efficacy and Safety of CUDC-907 in Patients With RR DLBCL, Including Patients With MYC Alterations	2016/02/04	NCT02674750	Phase 2	Completed	Curis, Inc.
Open Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of CUDC-907 in Subjects With Advanced/Relapsed Solid Tumors	2014/12/04	NCT02307240	Phase 1	Completed	Curis, Inc.
Study to Assess the Safety, Tolerability and Pharmacokinetics of Fimepinostat (CUDC-907) in Patients With Lymphoma	2012/12/06	NCT01742988	Phase 1	Completed	Curis, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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