CUDC-101 Clinical Trials

Size	Price	Qty
10mg	USD 227
1g	USD 2,990

Clinical Trials

Multiple Phase 1 and Phase 1b clinical trials sponsored by Curis, Inc. have evaluated intravenous and oral formulations of CUDC-101 to assess safety, tolerability, and pharmacokinetics in patients with advanced malignancies. These studies targeted conditions including head and neck, liver, breast, gastric, and non-small cell lung cancers, alongside general solid tumors. While several trials were completed, others evaluating oral dose escalation were terminated prior to completion.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01384799	COMPLETED	Head and Neck Cancer	Curis, Inc.	2011-11	PHASE1
NCT01702285	TERMINATED	Cancer	Curis, Inc.	2012-09	PHASE1
NCT01702285	Terminated	Cancer	Curis Inc.	2012-09	Phase 1
NCT01384799	Completed	Head and Neck Cancer	Curis Inc.	2011-11	Phase 1
NCT01171924	COMPLETED	Head and Neck Cancer; Liver Cancer; Breast Cancer; Gastric Cancer; Non-Small Cell Lung Cancer	Curis, Inc.	2010-07	PHASE1
NCT00728793	COMPLETED	Tumors	Curis, Inc.	2008-08	PHASE1
NCT00728793	Completed	Tumors	Curis Inc.	2008-08	Phase 1

(data from https://clinicaltrials.gov, updated on 2018-02-22)

Check the CUDC-101 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

CUDC-101 potently binds to and inhibits histone deacetylases, epidermal growth factor receptor, and human epidermal growth factor receptor 2, thereby blocking downstream receptor autophosphorylation and epigenetic regulation pathways. This concurrent target inhibition suppresses oncogenic cell signaling and induces cell cycle arrest, resulting in reduced cell proliferation and antitumor efficacy against malignancies including head and neck, liver, and non-small cell lung cancers.

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>).