Betrixaban Clinical Trials

Size	Price	Qty
5mg	USD 107

Clinical Trials

Multiple Phase 1 clinical trials sponsored by Alexion Pharmaceuticals, Portola Pharmaceuticals, and Merck Sharp & Dohme have evaluated betrixaban across diverse participant groups. These investigations focused on venous thromboembolism prophylaxis, pharmacokinetics in healthy subjects, and safety parameters in patients with renal impairment, while assessing drug tolerability, bioequivalence, and pharmacodynamics. Currently, recruitment statuses for these studies range from completed trials to terminated pediatric evaluations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03346083	Terminated	VTE Prophylaxis	Alexion Pharmaceuticals Inc.\|Portola Pharmaceuticals LLC (a wholly owned subsidiary of Alexion Pharmaceuticals)	2018-07-13	Phase 1
NCT02596100	Completed	Healthy	Portola Pharmaceuticals\|Alexion Pharmaceuticals Inc.	2015-09	Phase 1
NCT00999336	Completed	Renal Impairment	Portola Pharmaceuticals\|Merck Sharp & Dohme LLC\|Alexion Pharmaceuticals Inc.	2009-07-31	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Betrixaban acts as a selective inhibitor of Factor Xa, directly binding to the active site of the enzyme to prevent the conversion of prothrombin to thrombin within the coagulation cascade. By suppressing prothrombinase activity and downstream thrombin generation, the compound attenuates fibrin clot formation, providing therapeutic efficacy for venous thromboembolism prophylaxis.

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>).