Tirofiban

Overview

Tirofiban prevents the blood from clotting during episodes of chest pain or a heart attack, or while the patient is undergoing a procedure to treat a blocked coronary artery. It is a non-peptide reversible antagonist of the platelet glycoprotein (GP) IIb/IIIa receptor, and inhibits platelet aggregation.

Indication

For treatment, in combination with heparin, of acute coronary syndrome, including patients who are to be managed medically and those undergoing PTCA or atherectomy.

Associated Conditions

Cardiovascular Events

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Intravenous Tirofiban After Delayed Thrombolysis in Stroke	2025/08/08	NCT07111806	Not Applicable	Not yet recruiting	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Endovascular Therapy Combined With Tirofiban for Intracranial Atherosclerotic Acute Ischemic Stroke	2025/06/18	NCT07026318	Not Applicable	Not yet recruiting	Beijing Anzhen Hospital
Intracoronary rhTNK-tPA Versus Tirofiban in Patients With STEMI and High Thrombus Burden	2025/01/10	NCT06769256	Phase 4	Recruiting	Henan Institute of Cardiovascular Epidemiology
Tirofiban for the Prevention of Early Neurological Deterioration After Intravenous Thrombolysis in Acute Ischemic Stroke	2024/09/19	NCT06587347	Phase 2	Not yet recruiting	Capital Medical University
Tirofiban for Successful Endovascular Stroke Thrombectomy	2024/04/18	NCT06373042	Phase 2	Not yet recruiting	Zhongming Qiu
Tirofiban for Patients With intraCranial Artery Stenosis and High-risk Acute Non-disabling Cerebrovascular Events(CHANCE-4）	2024/03/20	NCT06319846	Phase 3	Recruiting	Beijing Tiantan Hospital
Tirofiban After Successful MT Recanalization in AIS	2024/02/20	NCT06265051	Phase 2	Recruiting	Xiang Luo
Tirofiban for Reduction of Thromboembolic Events in Endovascular Unruptured Aneurysm Repair	2024/02/02	NCT06238115	Phase 2	Recruiting	Beijing Tiantan Hospital
Early Tirofiban Administration After Intravenous Thrombolysis in Acute Ischemic Stroke	2023/09/21	NCT06045156	Not Applicable	Recruiting	The First Hospital of Jilin University
Efficacy and Safety of Tirofiban for Patients With BAD (BRANT)	2023/09/14	NCT06037889	Phase 3	Recruiting	Peking Union Medical College Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Tirofiban hydrochloride	Gland Pharma Limited	68083-145	INTRAVENOUS	12.5 mg in 250 mL	5/19/2021
Tirofiban Hydrochloride	Nexus Pharmaceuticals LLC	14789-101	INTRAVENOUS	50 ug in 1 mL	2/15/2024
Tirofiban Hydrochloride	Nexus Pharmaceuticals LLC	14789-102	INTRAVENOUS	50 ug in 1 mL	2/15/2024
AGGRASTAT	Medicure International Inc	25208-001	INTRAVENOUS	3.75 mg in 15 mL	12/24/2020
AGGRASTAT	Medicure International Inc	25208-002	INTRAVENOUS	5 mg in 100 mL	12/24/2020
AGGRASTAT	Medicure International Inc	25208-901	INTRAVENOUS	3.75 mg in 15 mL	1/3/2023
AGGRASTAT	Medicure International Inc	25208-902	INTRAVENOUS	5 mg in 100 mL	1/3/2023
Tirofiban	Eugia US LLC	55150-429	INTRAVENOUS	5 mg in 100 mL	7/13/2023
Tirofiban	Eugia US LLC	55150-430	INTRAVENOUS	12.5 mg in 250 mL	7/13/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
AGGRASTAT CONCENTRATE FOR INFUSION 0.25 mg/ml	Patheon Manufacturing Services LLC	SIN10931P	INJECTION	0.281 mg/mL	5/17/1999

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
AGGRASTAT CONC FOR INFUSION 0.25MG/ML	N/A	PRIMAL CHEMICAL COMPANY, LIMITED	N/A	N/A	3/24/1999

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
AGGRASTAT Tirofiban (as hydrochloride) 25mg/500mL injection bag	65161	Correvio Australia Pty Ltd	Medicine	A	4/30/1999
AGGRASTAT Tirofiban (as hydrochloride) 12.5mg/50mL injection vial	65162	Correvio Australia Pty Ltd	Medicine	A	4/29/1999
TIROFIBAN JUNO tirofiban (as hydrochloride) 12.5mg/50mL Concentrated Injection for infusion Vial	209216	Juno Pharmaceuticals Pty Ltd	Medicine	A	5/9/2014
AGGRASTAT tirofiban 12.5mg/250mL (as hydrochloride) injection bag	75456	Correvio Australia Pty Ltd	Medicine	A	3/22/2001

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
TIROFIBAN ALTAN 50 MICROGRAMOS/ML SOLUCION PARA PERFUSION EFG	Altan Pharmaceuticals Sa	78408	SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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