Argatroban (MCI-9038) Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 297

Clinical Trials

Multiple clinical trials evaluate the therapeutic application and monitoring of argatroban across cardiovascular and hematological conditions, primarily focusing on heparin-induced thrombocytopenia, ischemic stroke, extracorporeal membrane oxygenation complications, and acute respiratory distress syndrome. Spanning Phase 1 through Phase 4, these studies assess argatroban as a monotherapy direct thrombin inhibitor and in combination with agents such as tissue plasminogen activator. Sponsored by major medical centers and pharmaceutical entities including GlaxoSmithKline and Assistance Publique - Hôpitaux de Paris, trial statuses range from completed and actively recruiting to terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07499037	NOT_YET_RECRUITING	Pneumonia; Heart Failure	University Hospital Ostrava	2027-01	PHASE2
NCT06442267	RECRUITING	Respiratory Insufficiency; Circulatory Failure; Thromboembolism; Bleeding	Medical University of Vienna	2024-07-30	PHASE4
NCT05226442	COMPLETED	Extracorporeal Membrane Oxygenation Complication; Anticoagulants and Bleeding Disorders	Medical University of Vienna	2021-12-01	PHASE2; PHASE3
NCT04925167	COMPLETED	Respiratory Failure	Beijing Chao Yang Hospital	2021-07-06
NCT03735979	COMPLETED	Acute Ischemic Stroke	Washington University School of Medicine	2019-10-15	PHASE3
NCT06066762	Not yet recruiting	Heparin-induced Thrombocytopenia	Assistance Publique - Hôpitaux de Paris	2023-11-01	--
NCT04275180	COMPLETED	Acute Progressive Ischemic Stroke	Second Affiliated Hospital, Zhejiang University, School of Medicine	2020-03-21	PHASE4
NCT03809481	TERMINATED	Heparin-induced Thrombocytopenia	Aspen Global Incorporated	2019-05-16	PHASE3
NCT05325346	COMPLETED	Heparin-induced Thrombocytopenia	Veralox Therapeutics	2022-03-07	PHASE1
NCT05325346	Completed	Heparin-induced Thrombocytopenia	Veralox Therapeutics\|Celerion	2022-03-07	Phase 1
NCT03740958	COMPLETED	Stroke	General Hospital of Shenyang Military Region	2018-12-21	PHASE4
NCT05226442	Recruiting	Extracorporeal Membrane Oxygenation Complication\|Anticoagulants and Bleeding Disorders	Medical University of Vienna	2021-12-01	Phase 2\|Phase 3
NCT05740371	COMPLETED	Stable Coronary Artery Disease (CAD); Unstable Angina (Troponin Negative)	Tanabe Pharma GmbH	2017-04-18	PHASE4
NCT04406389	TERMINATED	COVID-19	Weill Medical College of Cornell University	2020-10-13	PHASE4
NCT04751357	Unknown status	Heparin-induced Thrombocytopenia	Medical University of Vienna	2020-08-01	--
NCT06038682	Completed	ARDS\|COVID-19	University Hospital Ostrava	2020-04-01	--
NCT03506009	TERMINATED	Argatroban, Rt-PA	Hui-Sheng Chen	2018-07-11	PHASE4
NCT03552354	COMPLETED	Stroke, Ischemic	General Hospital of Shenyang Military Region	2017-10-25	PHASE4
NCT02935530	COMPLETED	Gynecologic Neoplasms; Venous Thromboembolism; Low Molecular Weight Heparin; Argatroban	Huazhong University of Science and Technology	2016-01	PHASE3
NCT02448069	COMPLETED	Stroke; Cerebral Ischemia	The University of Texas Health Science Center, Houston	2015-05	PHASE2
NCT01734252	COMPLETED	Achievement of a Sufficient Thrombosis Prohpylaxis in Clitically Ill Patients With Heparin Resistance	Medical University Innsbruck	2012-07-29	PHASE2
NCT01464788	TERMINATED	Ischemic Stroke	Andrew D. Barreto, MD	2011-10	PHASE2
NCT02448069	Completed	Stroke\|Cerebral Ischemia	The University of Texas Health Science Center Houston	2015-05	Phase 2
NCT01163604	COMPLETED	CVD	Jinling Hospital, China	2010-08	PHASE4
NCT00798525	TERMINATED	Heparin Induced Thrombocytopenia (HIT)	Heinrich-Heine University, Duesseldorf	2009-01	PHASE4
NCT01980316	COMPLETED	CVD	Xinfeng Liu	2010-04	PHASE4
NCT01246011	TERMINATED	Coronary Artery Bypass Graft Surgery; Presence of Heparin/Platelet Factor 4 Antibody	Massachusetts General Hospital	2010-11	PHASE4
NCT00861692	COMPLETED	Heparin-induced Thrombocytopenia Type II	Tanabe Pharma Corporation	2009-04	PHASE2
NCT00268762	COMPLETED	Ischemic Stroke	The University of Texas Health Science Center, Houston	2003-02	PHASE1; PHASE2
NCT00787332	TERMINATED	Suspected Heparin-Induced Thrombocytopenia	Canyon Pharmaceuticals, Inc.	2008-09	PHASE4
NCT00603824	WITHDRAWN	Heparin-Induced Thrombocytopenia	Methodist Healthcare - Memphis	2008-01	PHASE4
NCT00153946	COMPLETED	Stroke	Combination Therapy for Acute Ischemic Stroke Study Group	2004-08	PHASE4
NCT00198588	COMPLETED	Heparin-Induced Thrombocytopenia	Ministry of Health, Labour and Welfare, Japan	2005-06	PHASE3
NCT00035178	COMPLETED	Kidney Failure, Chronic; Renal Disease, End-Stage	Texas Biotechnology Corporation	2002-05	PHASE4
NCT00039858	COMPLETED	Thrombocytopenia; Thrombosis	Encysive Pharmaceuticals	2003-09	PHASE4
NCT00508924	COMPLETED	Coronary Artery Disease; Angina, Unstable	Tanabe Pharma Corporation	2005-08	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-04-02)

Check the Argatroban (MCI-9038) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Argatroban reversibly binds directly to the active catalytic site of thrombin, selectively inhibiting its enzymatic activity to prevent the cleavage of fibrinogen into fibrin monomers and the activation of clotting factors V, VIII, and XIII. By interrupting thrombin-mediated fibrin clot formation and platelet activation, this direct thrombin inhibitor provides critical systemic anticoagulation to prevent thromboembolic complications in clinical conditions such as heparin-induced thrombocytopenia and acute ischemic stroke.

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>).