Fimepinostat (CUDC-907) Clinical Trials

Size	Price	Qty
5mg	USD 147

Clinical Trials

Multiple clinical trials spanning Early Phase 1 to Phase 2 have evaluated fimepinostat (CUDC-907) across oncological and endocrine indications, including relapsed or refractory diffuse large B-cell lymphoma, pediatric central nervous system tumors like diffuse intrinsic pontine glioma, triple-negative breast cancer, thyroid neoplasms, and Cushing disease. Sponsored by industry partners such as Curis Inc. alongside academic institutions including the Dana-Farber Cancer Institute, the National Cancer Institute, and UCLA, these studies report recruitment statuses ranging from recruiting and active to completed and terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05971758	RECRUITING	Cushing Disease	University of California, Los Angeles	2025-01-16	PHASE2
NCT02909777	COMPLETED	Lymphoma; Neuroblastoma; Brain Tumor; Solid Tumor	Dana-Farber Cancer Institute	2016-10	PHASE1
NCT03893487	ACTIVE_NOT_RECRUITING	Diffuse Intrinsic Pontine Glioma; Recurrent Anaplastic Astrocytoma; Recurrent Glioblastoma; Recurrent Malignant Glioma; Recurrent Medulloblastoma	Sabine Mueller, MD, PhD	2019-08-07	EARLY_PHASE1
NCT01742988	COMPLETED	Lymphoma; Relapsed Lymphoma; Refractory Lymphoma; Relapsed and/or Refractory Lymphoma; Relapsed Ddiffuse Large B-Cell Lymphoma (DLBCL); Refractory Diffuse Large B-Cell Lymphoma (DLBCL); Relapsed and/or Refractory Diffuse Large B-Cell Lymphoma (DLBCL); Double-hit Lymphoma (DHL); Triple-hit Lymphoma (THL); Double-expressor Lymphoma (DEL); High-grade B-cell Lymphoma (HGBL)	Curis, Inc.	2012-12	PHASE1
NCT02307240	COMPLETED	Triple-Negative Breast Cancer; High-grade Serous Ovarian Cancer; Solid Tumors; NUT Midline Carcinoma	Curis, Inc.	2014-11	PHASE1
NCT02674750	COMPLETED	Relapsed and/or Refractory Diffuse Large B-cell Lymphoma Including With Myc Alterations	Curis, Inc.	2016-07	PHASE2
NCT03002623	TERMINATED	Thyroid Neoplasms; Poorly Differentiated and Undifferentiated Thyroid Cancer; Differentiated Thyroid Cancer	National Cancer Institute (NCI)	2016-12-22	PHASE2
NCT02909777	Active not recruiting	Lymphoma\|Neuroblastoma\|Brain Tumor\|Solid Tumor	Dana-Farber Cancer Institute\|Curis Inc.	2016-10	Phase 1
NCT02307240	Completed	Triple-Negative Breast Cancer\|High-grade Serous Ovarian Cancer\|Solid Tumors\|NUT Midline Carcinoma	Curis Inc.	2014-11	Phase 1
NCT01742988	Completed	Lymphoma\|Relapsed Lymphoma\|Refractory Lymphoma\|Relapsed and/or Refractory Lymphoma\|Relapsed Ddiffuse Large B-Cell Lymphoma (DLBCL)\|Refractory Diffuse Large B-Cell Lymphoma (DLBCL)\|Relapsed and/or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)\|Double-hit Lymphoma (DHL)\|Triple-hit Lymphoma (THL)\|Double-expressor Lymphoma (DEL)\|High-grade B-cell Lymphoma (HGBL)	Curis Inc.\|The Leukemia and Lymphoma Society	2012-12	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-07-17)

Check the Fimepinostat (CUDC-907) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fimepinostat acts as a dual inhibitor targeting phosphoinositide 3-kinase (PI3K) isoforms and histone deacetylases (HDACs), which blocks PI3K/Akt signaling and promotes histone hyperacetylation to induce cell cycle arrest and apoptosis. By disrupting these primary survival and epigenetic pathways, fimepinostat suppresses tumor cell proliferation, underlying its therapeutic evaluation in clinical trials for relapsed diffuse large B-cell lymphoma, brain tumors, and advanced solid malignancies.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).