Tirofiban Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 470

Clinical Trials

Multiple clinical trials evaluate tirofiban across Phase I, Phase III, Phase IV, and unassigned phase classifications for conditions including ST-elevation myocardial infarction, acute myocardial infarction, coronary artery disease, and renal insufficiency. Sponsored by diverse academic institutions, healthcare systems, and pharmaceutical organizations, these investigations assess various dosing regimens, pharmacokinetics, and antiplatelet strategies. The recruitment statuses across these studies encompass completed, not yet recruiting, and unknown status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05793671	Not yet recruiting	STEMI	Assiut University	2023-04-01	Not Applicable
NCT03797729	Unknown status	ST Elevation Myocardial Infarction	Shanghai Zhongshan Hospital	2019-05-14	Phase 4
NCT01766154	Completed	Renal Insufficiency	Medicure	2013-01	Phase 1
NCT01336348	Completed	ST Segment Elevation Myocardial Infarction	Università degli Studi di Ferrara	2010-04	Phase 3
NCT00407771	Unknown status	Coronary Artery Disease	Jordan Hospital\|Merck Sharp & Dohme LLC	2007-11	Phase 4
NCT00538317	Completed	Acute Myocardial Infarction	Hospices Civils de Lyon	2007-07	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tirofiban selectively binds to the platelet glycoprotein IIb/IIIa (GPIIb/IIIa) receptor with an IC50 of 9 nM, thereby competitively blocking fibrinogen binding and preventing cross-linking between adjacent platelets. This inhibition suppresses platelet aggregation and thrombus formation, mitigating ischemic complications in clinical settings such as acute myocardial infarction and coronary artery 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>).