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 |
|---|---|---|---|---|---|
2025/06/18 | Not Applicable | Not yet recruiting | Beijing Anzhen Hospital | ||
2025/01/10 | Phase 4 | Recruiting | Henan Institute of Cardiovascular Epidemiology | ||
2024/09/19 | Phase 2 | Not yet recruiting | Capital Medical University | ||
2024/04/18 | Phase 2 | Not yet recruiting | Zhongming Qiu | ||
2024/03/20 | Phase 3 | Recruiting | Beijing Tiantan Hospital | ||
2024/02/20 | Phase 2 | Recruiting | Xiang Luo | ||
2024/02/02 | Phase 2 | Recruiting | Beijing Tiantan Hospital | ||
2023/09/21 | Not Applicable | Recruiting | |||
2023/09/14 | Phase 3 | Recruiting | |||
2023/05/03 | Phase 4 | Recruiting | Lu Hua |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Gland Pharma Limited | 68083-145 | INTRAVENOUS | 12.5 mg in 250 mL | 5/19/2021 | |
| Nexus Pharmaceuticals LLC | 14789-101 | INTRAVENOUS | 50 ug in 1 mL | 2/15/2024 | |
| Nexus Pharmaceuticals LLC | 14789-102 | INTRAVENOUS | 50 ug in 1 mL | 2/15/2024 | |
| Medicure International Inc | 25208-001 | INTRAVENOUS | 3.75 mg in 15 mL | 12/24/2020 | |
| Medicure International Inc | 25208-002 | INTRAVENOUS | 5 mg in 100 mL | 12/24/2020 | |
| Medicure International Inc | 25208-901 | INTRAVENOUS | 3.75 mg in 15 mL | 1/3/2023 | |
| Medicure International Inc | 25208-902 | INTRAVENOUS | 5 mg in 100 mL | 1/3/2023 | |
| Eugia US LLC | 55150-429 | INTRAVENOUS | 5 mg in 100 mL | 7/13/2023 | |
| 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 | SIN10931P | INJECTION | 0.281 mg/mL | 5/17/1999 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Tirofiban Hydrochloride Injection | H20150589 | 化学药品 | 注射剂 | 11/12/2019 | |
| Tirofiban Hydrochloride Injection | 国药准字H20223802 | 化学药品 | 注射剂 | 11/1/2022 | |
| Tirofiban Hydrochloride and Sodium Chloride Injection | 国药准字H20173030 | 化学药品 | 注射剂 | 7/25/2023 | |
| Tirofiban Hydrochloride and Sodium Chloride Injection | 国药准字H20223248 | 化学药品 | 注射剂 | 4/19/2022 | |
| Tirofiban Hydrochloride and Sodium Chloride Injection | 国药准字H20249445 | 化学药品 | 注射剂 | 11/22/2024 | |
| Tirofiban Hydrochloride and Sodium Chloride Injection | 国药准字H20234239 | 化学药品 | 注射剂 | 12/18/2023 | |
| Tirofiban Hydrochloride and Sodium Chloride Injection | 国药准字H20227060 | 化学药品 | 注射剂 | 4/27/2022 | |
| Tirofiban Hydrochloride and Sodium Chloride Injection | 国药准字H20249446 | 化学药品 | 注射剂 | 11/22/2024 | |
| Tirofiban Hydrochloride and Sodium Chloride Injection | 国药准字H20183440 | 化学药品 | 注射剂 | 7/21/2023 | |
| Tirofiban Hydrochloride and Sodium Chloride Injection | 国药准字H20173032 | 化学药品 | 注射剂 | 8/23/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| AGGRASTAT CONC FOR INFUSION 0.25MG/ML | N/A | 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 | Medicine | A | 4/30/1999 | |
| AGGRASTAT Tirofiban (as hydrochloride) 12.5mg/50mL injection vial | 65162 | Medicine | A | 4/29/1999 | |
| TIROFIBAN JUNO tirofiban (as hydrochloride) 12.5mg/50mL Concentrated Injection for infusion Vial | 209216 | Medicine | A | 5/9/2014 | |
| AGGRASTAT tirofiban 12.5mg/250mL (as hydrochloride) injection bag | 75456 | Medicine | A | 3/22/2001 |
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