INTEGRILIN (eptifibatide)
Development Insights
Details
- Status
- Discontinued
- First Approved
- 1998-05-18
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
INTEGRILIN Approval History
What INTEGRILIN Treats
4 FDA approvalsOriginally approved for its first indication in 1998 . Covers 4 distinct patient populations.
- Other (4)
Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03735979 MOST results posted | 2018-1464 1U01NS100699-01A1 | Ph 3 | completed | Multi-arm Optimization of Stroke Thrombolysis |
| NCT01522417 SAVI-PCI results posted | Medicure 11002 | Ph 2 | completed | Shortened Aggrastat® Versus Integrilin in Percutaneous Coronary Intervention |
| NCT02925923 results posted | F151006002 | Ph 2 | completed | Crushed Ticagrelor Versus Eptifibatide Bolus + Clopidogrel |
| NCT01919723 results posted | ISSBRIL0077 | Ph 2 | completed | Ticagrelor and Eptifibatide Bolus-Only Versus Ticagrelor and Eptifibatide Bolus Plus Abbreviated Infusion |
| NCT01076764 TAO | EFC6204 2009-016568-36 | Ph 3 | completed | Effect of Otamixaban Versus Unfractionated Heparin + Eptifibatide in Patients With Unstable Angina/Non ST Elevation Myocardial Infarction Undergoing Early Invasive Strategy |
| NCT01977456 CLEAR-FDR results posted | P50NS044283-13 P50NS044283-13 | Ph 2 | completed | Study of the Combination Therapy of Rt-PA and Eptifibatide to Treat Acute Ischemic Stroke (CLEAR-FDR) |
| NCT00894803 CLEAR-ER results posted | P50NS04483-06 00894803 | Ph 2 | completed | Study of the Combination Therapy of Rt-PA and Eptifibatide to Treat Acute Ischemic Stroke |
| NCT00834899 results posted | 1R21HL091265-01A1 | Ph 1, Ph 2 | terminated | A Safety Study of Eptifibatide in Patients With Sickle Cell Disease |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
INTEGRILIN FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment