Indobufen Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Indobufen is currently evaluated in a prospective clinical trial sponsored by the Henan Institute of Cardiovascular Epidemiology to compare its therapeutic utility against aspirin in patients with stable coronary heart disease. Investigating platelet aggregation dynamics and long-term patient prognosis, this unassigned-phase trial currently has an unknown recruitment status. Overall, clinical research on indobufen centers on refining antiplatelet strategies for cardiovascular disease management.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04308551	Unknown status	Stable Coronary Heart Disease	Henan Institute of Cardiovascular Epidemiology	2021-12-30	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Indobufen functions as a reversible inhibitor of cyclooxygenase, suppressing downstream thromboxane synthesis and thereby preventing thromboxane-mediated activation and aggregation of platelets. By reducing intravascular thrombus formation and inhibiting arterial thrombosis, this mechanistic suppression of platelet aggregation is directly relevant to managing ischemic events in patients with stable coronary heart disease.

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>).