Brequinar (DUP785) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Several Phase 1 and Phase 2 clinical trials sponsored by Clear Creek Bio, Inc. have evaluated Brequinar across viral infection and hematologic malignancy indications, specifically COVID-19 and acute myeloid leukemia. These studies, encompassing both completed and terminated trials, investigated safety, pharmacokinetics, and clinical response to determine the efficacy of host nucleotide synthesis inhibition. Collectively, these trials assess Brequinar's therapeutic potential for treating acute respiratory viral infections and hematologic malignancies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05166876	TERMINATED	COVID-19	Clear Creek Bio, Inc.	2022-02-01	PHASE2
NCT04575038	COMPLETED	COVID-19 Infection	Clear Creek Bio, Inc.	2020-11-19	PHASE2
NCT03760666	TERMINATED	Acute Myeloid Leukemia	Clear Creek Bio, Inc.	2018-12-20	PHASE1; PHASE2
NCT04425252	COMPLETED	COVID-19	Clear Creek Bio, Inc.	2020-08-19	PHASE1; PHASE2
NCT03760666	Terminated	Acute Myeloid Leukemia	Clear Creek Bio Inc.	2018-12-20	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2023-11-07)

Check the Brequinar (DUP785) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Brequinar acts as a potent inhibitor of dihydroorotate dehydrogenase (DHODH), blocking de novo pyrimidine nucleotide biosynthesis and depleting intracellular pyrimidine pools required for RNA and DNA synthesis. By impairing nucleic acid production and cellular proliferation, this mechanism suppresses viral replication and arrests malignant cell growth, supporting its evaluation in clinical trials for COVID-19 and acute myeloid leukemia.

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>).