Asundexian Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

Multiple clinical trials evaluate the small-molecule coagulation factor XIa inhibitor asundexian across Phase 1, Phase 3, and unstated study phases, primarily sponsored by Bayer alongside healthcare organizations like the East and North Hertfordshire NHS Trust. These studies assess conditions including atrial fibrillation, acute non-cardioembolic ischemic stroke, high-risk transient ischemic attack, acute myocardial infarction, hepatic impairment, and fibrinolysis. Across these trials, recruitment statuses encompass active recruitment, completed studies, and terminated protocols.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05686070	COMPLETED	Prevention of Ischemic Stroke; Acute Non-cardioembolic Ischemic Stroke; High-risk Transient Ischemic Attack	Bayer	2023-01-26	PHASE3
NCT05643573	TERMINATED	Prevention of Stroke or Systemic Embolism; Atrial Fibrillation	Bayer	2022-12-05	PHASE3
NCT05419635	COMPLETED	Prevention of Thromboembolic Events; Atrial Fibrillation; Acute Myocardial Infarction; Non-cardioembolic Ischemic Stroke; Hepatic Impairment	Bayer	2022-06-14	PHASE1

(data from https://clinicaltrials.gov, updated on 2025-11-12)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Asundexian reversibly binds to the active site of human coagulation factor XIa with high affinity (IC50 = 1 nM), potently blocking its enzymatic activity to suppress the intrinsic coagulation cascade and downstream thrombin generation. By attenuating factor XIa-driven thrombus amplification while sparing primary hemostasis, asundexian reduces pathologic clot formation to prevent thromboembolic events such as ischemic stroke and systemic embolism in clinical settings like atrial fibrillation.

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>).