Eptifibatide

Overview

Synthetic cyclic hexapeptide that binds to platelet receptor glycoprotein and inhibits platelet aggregation. Derived from venom of the Southeastern pygmy rattlesnake (Sistrurus miliarus barbouri), eptifibatide is a cyclic heptapeptide that belongs to the class of arginin-glycin-aspartat-mimetics.

Indication

For treatment of myocardial infarction and acute coronary syndrome.

Associated Conditions

Acute Coronary Syndrome (ACS)
Percutaneous Coronary Intervention (PCI)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Eptifibatide in Endovascular Treatment of Acute Ischemic Stroke (EPOCH)	2019/02/18	NCT03844594	Phase 3	UNKNOWN	Ministry of Science and Technology of the People´s Republic of China
Multi-arm Optimization of Stroke Thrombolysis	2018/11/08	NCT03735979	Phase 3	Completed	Washington University School of Medicine
Crushed Ticagrelor Versus Eptifibatide Bolus + Clopidogrel	2016/10/06	NCT02925923	Phase 2	Completed	University of Alabama at Birmingham
Study of the Combination Therapy of Rt-PA and Eptifibatide to Treat Acute Ischemic Stroke (CLEAR-FDR)	2013/11/06	NCT01977456	Phase 2	Completed	Arthur Pancioli
Ticagrelor and Eptifibatide Bolus-Only Versus Ticagrelor and Eptifibatide Bolus Plus Abbreviated Infusion	2013/08/09	NCT01919723	Phase 2	Completed	University of Alabama at Birmingham
Clinical Effects of Eptifibatide Administration in High Risk Patients Presenting With Non-ST Segment Elevation Acute Coronary Syndrome (NSTE-ACS) Requiring Urgent Coronary Artery Bypass Graft Surgery in Short- and Long-Term Follow-up	2013/05/27	NCT01863134	Phase 4	Completed	Medical University of Silesia
Integrilin and Ilomedin in Combination in Comparison to Standard Treatment in Severe Pneumonia Patients With Severe Sepsis	2012/02/14	NCT01532544	Phase 2	Terminated	Thrombologic ApS
Shortened Aggrastat® Versus Integrilin in Percutaneous Coronary Intervention	2012/01/31	NCT01522417	Phase 2	Completed	Medicure
The INtegrilin Plus STenting to Avoid Myocardial Necrosis Trial (INSTANT)	2011/10/19	NCT01454440	Phase 4	Terminated	University of Turin, Italy
Effect of Otamixaban Versus Unfractionated Heparin + Eptifibatide in Patients With Unstable Angina/Non ST Elevation Myocardial Infarction Undergoing Early Invasive Strategy	2010/02/26	NCT01076764	Phase 3	Completed	Sanofi

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Eptifibatide	Athenex Pharmaceutical Division, LLC.	70860-305	INTRAVENOUS	0.75 mg in 1 mL	3/3/2024
Eptifibatide	Athenex Pharmaceutical Division, LLC.	70860-303	INTRAVENOUS	2 mg in 1 mL	3/3/2024
Eptifibatide	Hainan Shuangcheng Pharmaceuticals Co., Ltd.	52958-040	INTRAVENOUS	0.75 mg in 1 mL	4/21/2022
Eptifibatide	Avenacy, Inc.	83634-300	INTRAVENOUS	2 mg in 1 mL	1/31/2024
Eptifibatide	Hainan Shuangcheng Pharmaceuticals Co., Ltd.	52958-402	INTRAVENOUS	2 mg in 1 mL	4/21/2022
Eptifibatide	Hainan Poly Pharm. Co., Ltd.	14335-070	INTRAVENOUS	2 mg in 1 mL	4/27/2021
Eptifibatide	USV Private Limited	62147-0600	INTRAVENOUS	2 mg in 1 mL	3/18/2019
Eptifibatide	Amneal Pharmaceuticals LLC	70121-1002	INTRAVENOUS	2 mg in 1 mL	7/25/2021
Eptifibatide	Mylan Institutional LLC	67457-630	INTRAVENOUS	2 mg in 1 mL	12/17/2018
eptifibatide	Sagent Pharmaceuticals	25021-409	INTRAVENOUS	2 mg in 1 mL	3/22/2021

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Eptifibatide Accord	Accord Healthcare S.L.U.,Edificio Este Planta 6a,World Trade Center,Moll De Barcelona S/n,08039 Barcelona,SPAIN	Authorised	1/11/2016
Integrilin	GlaxoSmithKline (Ireland) Limited,12 Riverwalk,Citywest Business Campus,Dublin 24,Ireland	Authorised	7/1/1999

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

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
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
EPTIFIBATIDE MEDSURGE eptifibatide (as acetate) 20 mg/10 mL solution for injection vial	431135	Medsurge Pharma Pty Ltd	Medicine	A	6/20/2025
EPTIFIBATIDE MEDSURGE eptifibatide (as acetate) 75 mg/100 mL solution for injection vial	431136	Medsurge Pharma Pty Ltd	Medicine	A	6/20/2025
EPTIFIBATIDE MEDICIANZ eptifibatide (as acetate) 75 mg/100 mL solution for injection vial	431134	Medsurge Pharma Pty Ltd	Medicine	A	6/20/2025
EPTIFIBATIDE MEDICIANZ eptifibatide (as acetate) 20 mg/10 mL solution for injection vial	431133	Medsurge Pharma Pty Ltd	Medicine	A	6/20/2025

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
EPTIFIBATIDE INJECTION	teva canada limited	02367858	Solution - Intravenous	2 MG / ML	4/29/2013
EPTIFIBATIDE INJECTION	teva canada limited	02405083	Solution - Intravenous	0.75 MG / ML	4/29/2013
EPTIFIBATIDE INJECTION	omega laboratories limited	02410109	Solution - Intravenous	0.75 MG / ML	N/A
EPTIFIBATIDE INJECTION	Strides Pharma Canada Inc	02422859	Solution - Intravenous	2 MG / ML	N/A
EPTIFIBATIDE INJECTION	fresenius kabi canada ltd	02460386	Solution - Intravenous	2 MG / ML	N/A
EPTIFIBATIDE INJECTION	Juno Pharmaceuticals Corp.	02540819	Solution - Intravenous	0.75 MG / ML	5/16/2024
INTEGRILIN	Merck Canada Inc	02240351	Solution - Intravenous	0.75 MG / ML	6/23/1999
EPTIFIBATIDE INJECTION	Juno Pharmaceuticals Corp.	02540827	Solution - Intravenous	2 MG / ML	5/16/2024
EPTIFIBATIDE INJECTION	Accord Healthcare Inc	02454483	Solution - Intravenous	0.75 MG / ML	N/A
INTEGRILIN	Merck Canada Inc	02240352	Solution - Intravenous	2 MG / ML	6/23/1999

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
EPTIFIBATIDA ACCORD 0,75 MG/ML SOLUCION PARA PERFUSION EFG	Accord Healthcare S.L.U.	1151065001	SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Not Commercialized
EPTIFIBATIDA ACCORD 2 MG/ML SOLUCION INYECTABLE EFG	Accord Healthcare S.L.U.	1151065002	SOLUCIÓN INYECTABLE	Uso Hospitalario	Not Commercialized
INTEGRILIN 2 mg/ml, SOLUCION INYECTABLE	Glaxosmithkline (Ireland) Limited	99109002	SOLUCIÓN INYECTABLE	Uso Hospitalario	Not Commercialized
INTEGRILIN 0,75 mg/ml, SOLUCION PARA PERFUSION	Glaxosmithkline (Ireland) Limited	99109001	SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Not 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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