Brequinar Sodium Clinical Trials

Size	Price	Qty
5mg	USD 187
25mg	USD 567

Clinical Trials

Multiple clinical trials evaluate Brequinar across several disease areas, including viral respiratory infections such as COVID-19, hematologic malignancies like acute myeloid leukemia, and pediatric gastrointestinal disorders. Spanning Phase 1 and Phase 2 evaluations alongside behavioral interventions, these studies are sponsored by biopharmaceutical companies like Clear Creek Bio, Inc. and academic institutions such as Karolinska Institutet. Recruitment statuses across these protocols vary, encompassing active, completed, and terminated trials.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05945251	Recruiting	Functional Abdominal Pain Syndrome	Karolinska Institutet\|Child and Adolescent Psychiatry Stockholm	2023-11-01	--
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
NCT04294420	Completed	Functional Gastrointestinal Disorders	Karolinska Institutet	2020-05-01	Not Applicable
NCT03252743	Completed	Functional Gastrointestinal Disorders\|Irritable Bowel Syndrome\|Dyspepsia\|Functional Abdominal Pain	Karolinska Institutet	2017-09-01	Not Applicable
NCT02873078	Completed	Functional Abdominal Pain Disorders	Karolinska Institutet	2016-08	Not Applicable
NCT02475096	Completed	Functional Gastrointestinal Disorders	Karolinska Institutet	2015-07	Not Applicable

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Brequinar Sodium potently and selectively inhibits dihydroorotate dehydrogenase (DHODH), blocking the de novo pyrimidine biosynthesis pathway and depleting intracellular pyrimidine nucleotide pools to promote cellular differentiation and inhibit cellular proliferation. This disruption of pyrimidine availability limits host nucleotide resources necessary for viral replication in COVID-19 while suppressing leukemic expansion in 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>).