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Eptifibatide

Phase 3FDA approved

Myocardial Ischemia | Small molecule | Cardiovascular |Organon & Co.|Trials Updated: May 17, 2024

Eptifibatide development status

FDA approval on record May 18, 1998 as Integrilin
Approval holderMsd Sub Merck
ApplicationNDA020718
Highest phase Phase 3
Registered trials 4 across 3 sponsors since Apr 2006

Eptifibatide target and mechanism

Molecular targetITGB3, ITGA2B
Target classInhibitor
ModalitySmall molecule

Also known as Eptifibatide (Integrilin)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment9,406

FDA Designations

No designations recorded

Eptifibatide clinical trials

Eptifibatide · 1 trial · 2 indications

Phase 3 1
NCT00089895EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED)Myocardial Ischemia
COMPLETED9,406 Analytics
PHASE3COMPLETED
EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED)
Myocardial IschemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of the Composite of Death, Myocardial Infarction (MI), Recurrent Ischemia Requiring Urgent Revascularization (RI-UR), and Thrombotic Bail-out.
96 hours after randomization

Secondary Endpoints

Incidence of the Composite of Death/MI.
30 days after randomization
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
EptifibatideEXPERIMENTALEptifibatide in addition to standard of care such as standard doses of aspirin, unfractionated heparin or low-molecular-weight heparin.
PlaceboPLACEBO_COMPARATORPlacebo in addition to standard of care such as standard doses of aspirin, unfractionated heparin or low-molecular-weight heparin.

Interventions

NameTypeDescription
Eptifibatide (Integrilin)DRUGintravenous; 180 mcg/kg bolus followed by infusion of 2 mcg/kg/min for 12 to 96 hours (or longer if necessary to complete the 18- to 24-hour post-PCI infusion period, or up to 120 hours in patients who proceed to CABG \[coronary artery bypass graft\]); second bolus of 180 mcg/kg administered 10 minutes after first bolus.
PlaceboDRUGintravenous; delivery to match eptifibatide to maintain blind
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Willing and able to give informed consent and comply with study procedures and follow-up through 1 year. * Plan to undergo an invasive strategy after receiving study drug for 12 to 96 hours. * Able to be randomized into the trial within 12 hours of having symptoms of acute cor...

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Frequently asked questions about Eptifibatide

What is Eptifibatide used for?

Eptifibatide is used in patients with myocardial ischemia and acute coronary syndrome. It is a small molecule studied for early glycoprotein IIb/IIIa inhibition in non-ST-segment elevation acute coronary syndrome. It is given to adults 18 years and older and is not intended for healthy volunteers.

What does Eptifibatide target?

Eptifibatide targets ITGB3 and ITGA2B, which together form the glycoprotein IIb/IIIa receptor on platelets. It acts as an inhibitor of this receptor, which is the mechanism studied in its cardiovascular program for myocardial ischemia and acute coronary syndrome.

Who makes Eptifibatide?

Eptifibatide is developed by Organon & Co., which trades under the ticker OGN. The company is the sponsor associated with the Phase 3 program evaluating the drug in myocardial ischemia and acute coronary syndrome.

What phase is Eptifibatide in?

Eptifibatide is in Phase 3 development for myocardial ischemia. It is an investigational small molecule and is not described as approved for this use. The Phase 3 trial in the program has completed, and no trials are currently active.

What clinical trials is Eptifibatide in?

Eptifibatide was studied in the Phase 3 EARLY ACS trial, NCT00089895, titled Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome. That randomized, double-blind, placebo-controlled trial enrolled 9,406 adults and is completed.

Is Eptifibatide the same as Integrilin?

Yes, Eptifibatide is also known as Integrilin. Both names refer to the same small molecule developed by Organon & Co. under the ticker OGN, studied as an ITGB3 and ITGA2B inhibitor in myocardial ischemia and acute coronary syndrome.