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A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, for Stroke Prevention After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack

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Trial Profile

A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, for Stroke Prevention After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 15 Feb 2026

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At a glance

  • Drugs Milvexian (Primary)
  • Indications Ischaemic stroke
  • Focus Registrational; Therapeutic Use
  • Acronyms LIBREXI ASTROKE
  • Sponsors Janssen Research & Development

Most Recent Events

  • 14 Nov 2025 According to a Bristol Myers Squibb media release, company announced The Librexia clinical trial program includes two other Phase 3 trials, Librexia AF for patients with atrial fibrillation (AF) and Librexia STROKE for secondary stroke prevention (SSP). The IDMC recommended these trials continue as planned, with topline data expected in 2026.
  • 28 Jun 2023 Planned End Date changed from 31 Dec 2026 to 9 Dec 2026.
  • 25 May 2023 According to a Janssen Pharmaceutica media release, patient dosing is ongoing.

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