Eptifibatide

Also known as: Integrilin

FDA-approved

Last verified: October 30, 2026

At a glance

FDA approval FDA-approved 15 applications

Randomized controlled trials 172 of 1,133 publications on PubMed

Registered clinical trials 35 1 active

Adverse event reports 2,516 2,065 classified as serious

Eptifibatide is an FDA-approved drug, marketed as Eptifibatide (first approval: June 12, 2015).
PubMed lists 1,133 publications mentioning it, including 172 randomized controlled trials and 48 animal-only studies.
ClinicalTrials.gov lists 35 registered studies testing it (1 active).
FDA's adverse event system (FAERS) holds 2,516 reports mentioning it; 2,065 classified as serious. Reports do not prove causation.

Research topics

Platelet Aggregation Inhibitors 77
Platelet Glycoprotein GPIIb-IIIa Complex 35
Blood Platelets 27
Percutaneous Coronary Intervention 22
Thrombosis 22
Platelet Aggregation 20
Stents 15
Fibrinolytic Agents 14
Stroke 13
Aspirin 12

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

Application	Product	Status	First approval	Sponsor
NDA020718	INTEGRILIN	Approved, discontinued	May 18, 1998	MSD SUB MERCK
ANDA091555	EPTIFIBATIDE	Approved, discontinued	June 5, 2015	TEVA PHARMS USA
ANDA090854	EPTIFIBATIDE	Approved, marketed	June 12, 2015	TEVA PHARMS USA
ANDA206127	EPTIFIBATIDE	Approved, marketed	December 8, 2015	EUGIA PHARMA
ANDA204589	EPTIFIBATIDE	Approved, discontinued	April 18, 2017	RISING
ANDA205557	EPTIFIBATIDE	Approved, discontinued	November 6, 2017	ACCORD HLTHCARE
ANDA204693	EPTIFIBATIDE	Approved, marketed	March 7, 2018	SAGENT PHARMS INC
ANDA203258	EPTIFIBATIDE	Approved, marketed	July 20, 2018	MYLAN LABS LTD
ANDA208554	EPTIFIBATIDE	Approved, marketed	November 23, 2018	BAXTER HLTHCARE CORP
ANDA209864	EPTIFIBATIDE	Approved, marketed	January 25, 2019	HAINAN POLY
ANDA204362	EPTIFIBATIDE	Approved, discontinued	March 11, 2019	USV
ANDA204361	EPTIFIBATIDE	Approved, discontinued	March 14, 2019	USV
ANDA207864	EPTIFIBATIDE	Approved, discontinued	March 20, 2020	HYBIO
ANDA213081	EPTIFIBATIDE	Approved, marketed	September 7, 2021	QUAGEN
ANDA213599	EPTIFIBATIDE	Approved, marketed	May 9, 2024	MEITHEAL

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

All publications 1,133
Human (MeSH) 929
Animal only 48
Clinical trials 224
Randomized controlled trials 172
Systematic reviews & meta-analyses 34
Case reports 124
Retracted 0

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Evaluation of the Rational use of Eptifibatide among Patients with Acute Coronary Syndrome Referred to Shahid Chamran Heart Hospital. Unclassified 2026 Journal of research in pharmacy practice
Delayed Aneurysmal Rupture following Flow Diverter Placement despite Adjunctive Coiling: Case Report. Case report 2026 Case reports in neurology
Injectable antiplatelet therapies in acute coronary syndromes: Current status and Emerging Therapies. A position paper of the Task Force of Antithrombotic therapy of the ACVC. Unclassified 2026 European heart journal. Acute cardiovascular care
Transmembrane Protein Disulfide Isomerase TMX3 Potentiates Platelet Aggregation and Arterial Thrombosis in Mice. Human study 2026 Arteriosclerosis, thrombosis, and vascular biology
Pharmacovigilance analysis of glycoprotein IIb/IIIa inhibitors: A FAERS-based signal detection study. Human study 2026 Medicine
A Therapeutic Dilemma: Catastrophic ST-Elevation Myocardial Infarction Following Antiplatelet Therapy Interruption in a Patient With JAK2-Positive Polycythemia Vera. Unclassified 2026 Clinical case reports
Impact of Using Blended Polymers on the Structural and Functional Attributes of Eptifibatide-Loaded Microspheres. Unclassified 2026 ACS omega
Commentary: Evaluation of the real-world safety of eptifibatide in the treatment of ARDS: results of a disproportionality analysis of FAERS data. Unclassified 2026 Frontiers in medicine
Adaptive Antithrombotic Strategy for Tandem Occlusion Stroke: Escalating Therapy After Thrombectomy and Stenting. Unclassified 2026 Diagnostics (Basel, Switzerland)
Galectin-3 Binds to the Allosteric Site and Activates Integrins αvβ3, αIIbβ3, and α5β1, and Lactose Inhibits This Activation. Human study 2026 Biomolecules

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered: 35
Active: 1
With posted results: 14

Conditions studied

Acute Coronary Syndrome 6
Acute Ischemic Stroke 4
Myocardial Infarction 4
Stroke 3
Coronary Artery Disease 3
Acute Myocardial Infarction 2
Brain Infarction 2
Acute Coronary Syndromes 2
Unstable Angina 2
Ischemic Stroke 2
Coronary Ischemia 1
Angina, Unstable 1

Study	Status	Phase	Start
Eptifibatide for Extended Window Ischemic Stroke After Thrombolysis NCT07347626 Xinqiao Hospital of Chongqing	Not yet recruiting	Phase 3	March 1, 2026
Platelet Function in Patients With Ischemic Stroke Treated With Anti-thrombotic or Thrombolytic NCT05415150 Baylor College of Medicine	Unknown status	Phase 1, Phase 2	February 18, 2022
Multi-arm Optimization of Stroke Thrombolysis NCT03735979 Washington University School of Medicine Results posted	Completed	Phase 3	October 15, 2019
Eptifibatide in Endovascular Treatment of Acute Ischemic Stroke (EPOCH) NCT03844594 Ministry of Science and Technology of the People´s Republic of China	Unknown status	Phase 3	April 6, 2019
Pharmacologic Treatment of Myocardial Ischemia Detected by Intracoronary ECG NCT03383393 Alexandrovska University Hospital	Unknown status	—	January 3, 2018
Crushed Ticagrelor Versus Eptifibatide Bolus + Clopidogrel NCT02925923 University of Alabama at Birmingham Results posted	Completed	Phase 2	November 1, 2016
Co-administration of Iloprost and Eptifibatide in Septic Shock Patients NCT02204852 Sisse R. Ostrowski, MD PhD DMSc	Completed	Phase 2	Sep 2014
Ticagrelor and Eptifibatide Bolus-Only Versus Ticagrelor and Eptifibatide Bolus Plus Abbreviated Infusion NCT01919723 University of Alabama at Birmingham Results posted	Completed	Phase 2	Feb 2014
Should Integrilin be an Integral Part of Adjunctive Therapy in Patients Undergoing Primary PCI for ST-Elevation MI? NCT01991366 Medstar Health Research Institute	Withdrawn	—	Oct 2013
Study of the Combination Therapy of Rt-PA and Eptifibatide to Treat Acute Ischemic Stroke (CLEAR-FDR) NCT01977456 Arthur Pancioli Results posted	Completed	Phase 2	Sep 2013

Show 25 more studies

Study	Status	Phase	Start
Genotype Guided Versus Conventional Approach in Selection of Oral P2Y12 Receptor Blocker in Chinese Patients Suffering From Acute Coronary Syndrome NCT01994941 The University of Hong Kong	Completed	Phase 4	Aug 2013
Integrilin and Ilomedin in Combination in Comparison to Standard Treatment in Severe Pneumonia Patients With Severe Sepsis NCT01532544 Thrombologic ApS	Terminated	Phase 2	Jun 2012
Shortened Aggrastat® Versus Integrilin in Percutaneous Coronary Intervention NCT01522417 Medicure Results posted	Completed	Phase 2	Apr 2012
Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX NCT01433627 Italian Society of Invasive Cardiology	Unknown status	Phase 3	Oct 2011
Effect of Otamixaban Versus Unfractionated Heparin + Eptifibatide in Patients With Unstable Angina/Non ST Elevation Myocardial Infarction Undergoing Early Invasive Strategy NCT01076764 Sanofi	Completed	Phase 3	Apr 2010
European Ambulance Acute Coronary Syndrome (ACS) Angiography Trial NCT01087723 The Medicines Company Results posted	Completed	Phase 3	Mar 2010
Effectiveness of Intracoronary Injection of Eptifibatide in Primary Coronary Intervention in STEMI Patients NCT00945308 Assaf-Harofeh Medical Center	Unknown status	Phase 2	Aug 2009
Study of the Combination Therapy of Rt-PA and Eptifibatide to Treat Acute Ischemic Stroke NCT00894803 University of Cincinnati Results posted	Completed	Phase 2	Jul 2009
A Safety Study of Eptifibatide in Patients With Sickle Cell Disease NCT00834899 University of North Carolina, Chapel Hill Results posted	Terminated	Phase 1, Phase 2	Jan 2009
INSTANT: INtegrilin Plus STenting to Avoid Myocardial Necrosis Trial NCT00638976 Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS	Completed	Phase 3	Nov 2007
A Safety/Efficacy Study of Intracoronary Integrilin to Improve Balloon Angioplasty Outcomes for the Treatment of Heart Attacks NCT00719914 Brigham and Women's Hospital Results posted	Terminated	Phase 2	Nov 2007
The INtegrilin Plus STenting to Avoid Myocardial Necrosis Trial (INSTANT) NCT01454440 University of Turin, Italy	Terminated	Phase 4	Oct 2007
Eptifibatide and ST Segment Resolution Following Primary PCI NCT00812435 Medstar Health Research Institute	Terminated	Phase 3	Aug 2007
Aspirin Resistance and Percutaneous Coronary Intervention (PCI) NCT01103440 Icahn School of Medicine at Mount Sinai Results posted	Completed	Phase 2	Apr 2007
Efficacy Of Eptifibatide Compared To Abciximab In Primary Percutaneous Coronary Intervention (PCI) For Acute ST Elevation Myocardial Infarction (STEMI) NCT00426751 GlaxoSmithKline Results posted	Completed	Phase 3	Oct 2006
Study of Otamixaban Versus Unfractionated Heparin (UFH) and Eptifibatide in Non-ST Elevation Acute Coronary Syndrome NCT00317395 Sanofi	Completed	Phase 2	Jun 2006
Randomized Study of Aspirin Resistant Patients Undergoing Angioplasty NCT00289601 Brigham and Women's Hospital	Terminated	Phase 4	Mar 2006
Peri-Procedural Myocardial Infarction, Platelet Reactivity, Thrombin Generation, and Clot Strength: Differential Effects of Eptifibatide + Bivalirudin Versus Bivalirudin NCT00370045 LifeBridge Health	Unknown status	Phase 4	Mar 2006
Safety and Efficacy Study of Eptifibatide in Primary Percutaneous Coronary Intervention (PCI) NCT00251823 Ottawa Heart Institute Research Corporation	Completed	Phase 3	Jul 2005
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 NCT01863134 Medical University of Silesia Results posted	Completed	Phase 4	Jan 2005
BRIEF-PCI: Brief Infusion of Eptifibatide Following Percutaneous Coronary Intervention NCT00111566 Cardiology Research UBC	Completed	Phase 4	Dec 2004
EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED) NCT00089895 Organon and Co Results posted	Completed	Phase 3	November 1, 2004
Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke (CLEAR Stroke) Trial NCT00250991 University of Cincinnati	Completed	Phase 1, Phase 2	Jul 2003
PROTECT-TIMI 30 Trial NCT00250471 Millennium Pharmaceuticals, Inc.	Completed	Phase 3	May 2003
Combination Anti-Platelet and Anti-Coagulation Treatment After Lysis of Ischemic Stroke Trial (CATALIST) NCT00061373 National Institute of Neurological Disorders and Stroke (NINDS) Results posted	Completed	Phase 2	May 2003

All 35 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports: 2,516
Serious: 2,065
With death outcome: 547

Most reported reactions

Thrombocytopenia 317
Myocardial infarction 307
Haemorrhage 148
Hypotension 131
Drug ineffective 114
Haemorrhage intracranial 101
Platelet count decreased 97
Renal failure 92
Gastrointestinal haemorrhage 90
Haemoglobin decreased 90
Acute myocardial infarction 82
Death 82

Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.

Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query

FDA prescribing information

Official US prescribing information. Dosing sections are intentionally not shown.

Eptifibatide HUMAN PRESCRIPTION DRUG Slate Run Pharmaceuticals, LLC February 9, 2026
Eptifibatide HUMAN PRESCRIPTION DRUG Slate Run Pharmaceuticals, LLC February 9, 2026
Eptifibatide HUMAN PRESCRIPTION DRUG Hainan Shuangcheng Pharmaceuticals Co., Ltd. October 20, 2025
eptifibatide HUMAN PRESCRIPTION DRUG Sagent Pharmaceuticals August 15, 2024
Eptifibatide HUMAN PRESCRIPTION DRUG Baxter Healthcare Company May 29, 2024
Eptifibatide HUMAN PRESCRIPTION DRUG Meitheal Pharmaceuticals Inc. May 14, 2024
Eptifibatide HUMAN PRESCRIPTION DRUG Eugia US LLC January 4, 2024
Eptifibatide HUMAN PRESCRIPTION DRUG Mylan Institutional LLC May 28, 2021
Eptifibatide HUMAN PRESCRIPTION DRUG Mylan Institutional LLC May 28, 2021

Source: DailyMed / openFDA

Change history

No changes since monitoring began on October 30, 2026.