Is eptifibatide FDA-approved, and what does the research show?

What is eptifibatide?

Eptifibatide is a man-made peptide, and FDA's label classes it as a platelet aggregation inhibitor ¹. Platelets are the small cell fragments in blood that clump together to plug a wound, and aggregation is that clumping. On the surface of each platelet sits a receptor called glycoprotein IIb/IIIa; fibrinogen, the protein that bridges one platelet to the next, binds there. The label says eptifibatide binds that receptor and prevents fibrinogen from binding, so the bridge does not form ¹.

The molecule is a ring of six amino acids and one modified unit, closed by a sulfur bond ¹. It is built by chemical synthesis, not taken from an animal ¹.

Its design, though, comes from barbourin, a protein in the venom of the southeastern pigmy rattlesnake that blocks the same receptor ², ³. Barbourin was the first venom peptide of its family to carry a lysine-glycine-aspartate sequence instead of the usual arginine ². That one change appears to be what made it specific for glycoprotein IIb/IIIa ². The label's chemical name carries a lysine modified on its side chain, then glycine and aspartate ¹.

It is given into a vein by a care team, around a heart emergency or a coronary procedure ¹. It is not a wellness, weight or performance peptide. Its label names no use for weight loss, muscle or aging ¹.

Is eptifibatide FDA-approved?

Yes. Eptifibatide is approved by FDA as a prescription medicine, with "Initial U.S. Approval: 1998" and "Rx only" on its label ¹. The label indicates it for "Treatment of acute coronary syndrome (ACS) managed medically or with percutaneous coronary intervention (PCI)" and for "Treatment of patients undergoing PCI (including intracoronary stenting)" ¹. In the first setting the aim is "to decrease the rate of a combined endpoint of death or new myocardial infarction" ¹. In the second it is "death, new MI, or need for urgent intervention" ¹.

Acute coronary syndrome is the emergency in which a clot suddenly narrows a heart artery, causing chest pain at rest or a heart attack. The label's indication covers unstable angina, chest pain at rest from a narrowed artery, and heart attacks without the ST-elevation pattern on the heart tracing, which it abbreviates NSTEMI ¹. Percutaneous coronary intervention opens the narrowed artery from inside, with a balloon or a stent. The tools reach the heart through a thin tube passed in from an artery, most often in the groin. A myocardial infarction is a heart attack.

FDA approved the original application, NDA 020718 for Integrilin, on May 18, 1998, as a new molecular entity, a drug not approved before ⁴, ⁹. The approval letter names the same two uses the label carries today ⁹. The application is now held by Merck Sharp & Dohme, and Drugs@FDA gives the brand's marketing status as "Discontinued" as of November 9, 2026, the date of its data ⁴. In a Federal Register notice of August 9, 2022, FDA listed Integrilin among products "not withdrawn from sale for reasons of safety or effectiveness" ⁶. Generic versions may therefore still be approved ⁶.

Generics supply the drug as of November 9, 2026, the date of Drugs@FDA's data ⁵. Drugs@FDA lists 14 abbreviated applications, the route for generics, with eptifibatide as the active ingredient, the first approved in June 2015 ⁵. Eight of them carry a product with marketing status "Prescription" ⁵. The brand's own prescribing information, revised March 2021, carries the same indications as the generic label ¹⁰, ¹.

The only route on the label is intravenous, a bolus, one quick injection, followed by an infusion ¹. Before the infusion, the label has the care team check blood counts, kidney function and clotting times ¹. It is given with aspirin and heparin, the standard anticlotting drugs in these settings, and the label says that heparin "should" accompany it ¹. Nothing on the label is for a patient to take at home ¹.

See the FDA status of every peptide, updated weekly.

How does eptifibatide work?

Eptifibatide "reversibly inhibits platelet aggregation by preventing the binding of fibrinogen, von Willebrand factor, and other adhesive ligands to GP IIb/IIIa" ¹. Those ligands are the proteins platelets use to link up, so blocked receptors cannot build the platelet plug that starts a clot in a heart artery ¹, ⁷. The effect shows immediately after the first bolus ¹. In PURSUIT's regimen, platelet aggregation was inhibited by 84 percent at 15 minutes and by more than 90 percent at steady state, once the blood level is constant ¹.

The block wears off when the infusion stops. Inhibition fell below 50 percent four hours after the infusion ended, which the label says is thought to come from the drug leaving the platelet ¹. Its half-life in plasma is about 2.5 hours, about half of it is cleared by the kidneys, and clearance falls by about half when kidney function is poor ¹. Given alone, it has no measurable effect on the standard clotting-time tests ¹. This account is the label's, for an approved drug, from studies in healthy men and in patients with acute coronary syndrome or undergoing a coronary procedure ¹.

What does the research show?

The evidence is at the top tier: FDA approval in 1998, and a label that now rests on three placebo-controlled, randomized trials ¹. Each ran on top of heparin and, in most or all patients, aspirin ¹. The label names them PURSUIT, for acute coronary syndrome, and IMPACT II and ESPRIT, for patients about to undergo percutaneous coronary intervention ¹. It counts 16,782 patients treated across the three; their enrollments were 10,948 in PURSUIT, 4,010 in IMPACT II and 2,064 in ESPRIT ¹, ⁷, ⁸. Their regimens differed, so the label does not pool their results ¹.

Studied in people with acute coronary syndrome: PURSUIT, published in August 1998, randomized 10,948 patients at 726 centers in 27 countries ⁷, ¹. It was double-blind, eptifibatide or placebo on top of standard care for up to 72 hours, or 96 if a coronary procedure came late ⁷. Patients qualified with chest pain at rest within the previous 24 hours plus electrocardiogram changes or a raised heart enzyme, without persistent ST elevation ⁷, ¹.

The lower of two infusion arms was stopped at the first interim analysis, a planned look at the data before the end ¹. The label reports the higher arm against placebo ¹. That comparison held 4,722 patients on the higher arm and 4,739 on placebo ¹. At 30 days, death or a new heart attack occurred in 672 (14.2 percent) on eptifibatide and 745 (15.7 percent) on placebo, a difference unlikely to be chance (p=0.042) ¹.

Death alone was 3.5 against 3.7 percent, and nonfatal heart attack 10.7 against 12 percent ¹. The difference appeared by 96 hours and held through 30 days, and at 165 days the rate was 12.1 against 13.6 percent ⁷, ¹. The effect was consistent in most subgroups except women: the odds ratio, the odds of death or heart attack against placebo, was 0.8 in men and 1.1 in women ⁷. The label says this "may be a true treatment difference, the effect of other differences in these subgroups, or a statistical anomaly" ¹.

Studied in people having a coronary stent placed: ESPRIT, published in December 2000, randomized 2,064 patients in the United States and Canada, double-blind, to a double-bolus regimen or placebo ⁸, ¹. The trial was stopped early for efficacy ⁸.

The primary endpoint at 48 hours was death, heart attack, urgent repeat treatment of the vessel or rescue with open-label eptifibatide, given without blinding ⁸, ¹. It occurred in 69 of 1,040 (6.6 percent) on eptifibatide and 108 of 1,024 (10.5 percent) on placebo ⁸, ¹. At 30 days, death, heart attack or urgent revascularization was 6.8 against 10.4 percent, and most of the benefit was fewer heart attacks, 5.4 against 9 percent at 48 hours ¹. At one year, death or heart attack was 8 against 12.4 percent, a hazard ratio of 0.63, a rate over time about a third lower ¹.

Studied in people having a coronary procedure, mostly balloon angioplasty: IMPACT II, run in the United States, randomized 4,010 patients to placebo or one of two eptifibatide regimens ¹. At 30 days, death, heart attack or urgent intervention occurred in 11.6 percent of 1,285 on placebo ¹. It occurred in 9.1 percent of 1,300 on the lower regimen and 10 percent of 1,286 on the higher ¹. Only the lower regimen's difference was statistically significant, unlikely to be chance, and at six months neither arm differed from placebo on death or heart attack ¹.

Every trial above enrolled patients in a coronary emergency or procedure, and no trial of eptifibatide for any other purpose appears in the sources cited, as of November 10, 2026 ⁷, ¹, ⁸, ³. The label says its safety and effectiveness in children have not been studied, and no studies have been done in liver disease ¹. No long-term animal studies of its cancer risk have been performed ¹.

What are the side effects?

Bleeding leads. The label says bleeding and low blood pressure "are the most commonly reported adverse reactions," and that eptifibatide "can cause serious bleeding" ¹. In PURSUIT, major bleeding occurred in 10.8 percent on eptifibatide against 9.3 percent on placebo, minor bleeding in 13.1 against 7.6 percent, and transfusions in 12.8 against 10.4 percent ¹. In ESPRIT, major bleeding was 1.3 against 0.4 percent, with most of it at the vascular access site, where the catheter enters ¹, ⁸. Bleeding that forced the drug to be stopped was 8 against 1 percent in PURSUIT and 4.6 against 0.9 percent in ESPRIT ¹.

Bleeding inside the skull was rare: in PURSUIT, five patients on the approved regimen and three on placebo had a hemorrhagic stroke, and in ESPRIT two against one ¹. Major bleeding rose as body weight fell, most clearly below 70 kilograms, and was higher in older patients ¹. Those 65 and over made up 45 percent of PURSUIT and IMPACT II ¹. Low blood pressure was the only serious non-bleeding reaction of 1 percent or more that was more common on eptifibatide in PURSUIT, 7 against 6 percent ¹.

The label's second warning is thrombocytopenia, a sharp fall in platelets: "There have been reports of acute, profound thrombocytopenia (immune-mediated and non-immune mediated)" ¹. In ESPRIT it occurred in 1.2 percent on eptifibatide against 0.6 percent on placebo; in the other two trials the rates were similar to placebo ¹. The label says such a fall "can develop as a result of naturally occurring drug-dependent antibodies or those induced by prior exposure to eptifibatide injection" ¹. Post-marketing reports add "cerebral, GI, and pulmonary hemorrhage," bleeding in the brain, gut and lungs, and the label says, "Fatal bleeding reactions have been reported" ¹.

The label contraindicates eptifibatide in seven situations ¹. In its words, they are "a history of bleeding diathesis, or evidence of active abnormal bleeding within the previous 30 days," and severe hypertension not controlled by treatment ¹. They include "major surgery within the preceding 6 weeks" and "history of stroke within 30 days or any history of hemorrhagic stroke" ¹. The last three are another injected glycoprotein IIb/IIIa inhibitor given at the same time, "dependency on renal dialysis," and hypersensitivity, which has included anaphylaxis and hives ¹.

Other antiplatelet drugs, clot-dissolving drugs, heparin, aspirin and long-term use of NSAIDs, the common anti-inflammatory painkillers, increase the risk of bleeding ¹. In pregnancy the data are "insufficient," but the label says treatment "should not be withheld" from a pregnant woman with a heart attack ¹. Because it is a peptide, the label expects it to be destroyed in a breastfed infant's gut ¹.

In sport

Eptifibatide is not named on WADA's 2026 Prohibited List, and neither glycoprotein IIb/IIIa inhibitors nor antiplatelet drugs appear on it as a class ¹¹. WADA is the World Anti-Doping Agency. The list's method M2.2 covers infusions: it prohibits "Intravenous infusions and/or injections of more than a total of 100 mL per 12-hour period except for those legitimately received in the course of hospital treatments, surgical procedures or clinical diagnostic investigations" ¹¹. Eptifibatide is given only by intravenous bolus and infusion, around a heart emergency or a coronary procedure ¹.

What JumpstartMD offers

JumpstartMD does not prescribe eptifibatide. Our peptide library covers it so you have the facts on its FDA status and the evidence, current as of November 10, 2026.

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Compounded medications are not FDA-approved, and FDA does not review their safety, effectiveness, or quality before they are marketed. A licensed clinician decides after an evaluation whether a peptide is appropriate for you, and not every patient will qualify.