CXD101 Clinical Trials

Size	Price	Qty
5mg	USD 197

Clinical Trials

Multiple Phase 1 and Phase 2 clinical trials evaluate the therapeutic efficacy and safety of CXD101, both as monotherapy and combined with immune checkpoint inhibitors, across malignancies including advanced cancer, diffuse large B-cell lymphoma, and colorectal, pancreatic, and hepatocellular carcinomas. Sponsored by academic institutions and pharmaceutical entities—such as Oxford University, University College London, Celleron Therapeutics, and Merck Sharp & Dohme—these studies report statuses of completed, active not recruiting, withdrawn, and unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05873244	ACTIVE_NOT_RECRUITING	HCC	Stephen Chan Lam	2023-08-21	PHASE2
NCT07488884	WITHDRAWN	Pancreatic Cancer Resectable; Pancreatic Cancer	ImmunityBio, Inc.	2026-09-01	PHASE1
NCT03873025	WITHDRAWN	Diffuse Large B Cell Lymphoma	University College, London	2019-10	PHASE1; PHASE2
NCT03993626	UNKNOWN	Colorectal Neoplasms Malignant	Celleron Therapeutics Ltd.	2018-05-22	PHASE1; PHASE2
NCT01977638	COMPLETED	Advanced Cancer	Oxford University Hospitals NHS Trust	2014-02-14	PHASE1
NCT03873025	Withdrawn	Diffuse Large B Cell Lymphoma	University College London\|Celleron Therapeutics Ltd.\|Merck Sharp & Dohme LLC	2019-10	Phase 1\|Phase 2
NCT01977638	Completed	Advanced Cancer	Oxford University Hospitals NHS Trust\|University of Oxford\|National Institute for Health Research United Kingdom\|Cancer Research UK	2014-02-14	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-06-18)

Check the CXD101 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

CXD101 selectively binds and inhibits class I histone deacetylases, specifically HDAC1, HDAC2, and HDAC3 with IC50 values of 63 nM, 570 nM, and 550 nM, respectively, thereby blocking histone deacetylation and inducing chromatin hyperacetylation. This biochemical block alters gene expression to trigger cell cycle arrest and apoptosis, ultimately suppressing tumor growth across clinically evaluated indications including advanced solid tumors, diffuse large B-cell lymphoma, colorectal cancer, and hepatocellular carcinoma.

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>).