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Safety and Tolerability of GTX-104 (Nimodipine Injection for IV Infusion) Compared with Oral Nimodipine in Patients Hospitalized for Aneurysmal Subarachnoid Hemorrhage (aSAH): a Prospective, Randomized Trial

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Trial Profile

Safety and Tolerability of GTX-104 (Nimodipine Injection for IV Infusion) Compared with Oral Nimodipine in Patients Hospitalized for Aneurysmal Subarachnoid Hemorrhage (aSAH): a Prospective, Randomized Trial

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2025

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At a glance

  • Drugs Nimodipine (Primary) ; Nimodipine
  • Indications Subarachnoid haemorrhage
  • Focus Adverse reactions; Registrational
  • Acronyms STRIVE-ON
  • Sponsors Acasti Pharma; Grace Therapeutics

Most Recent Events

  • 22 Sep 2025 According to a Grace Therapeutics media release, results from this Pivotal Phase 3 STRIVE-ON Safety Trial of GTx-104 in aSAH were presented at the 2025 Neurocritical Care Society annual meeting, held in Montreal, Quebec, Canada September 18-21, 2025.
  • 27 Aug 2025 According to a Grace Therapeutics media release, on August 22, 2025 the USFDA accepted the Company's NDA for formal review and established April 23, 2026 as PDUFA Target Date, based on the comprehensive data package supported by positive results from this study
  • 25 Jun 2025 According to a Grace Therapeutics media release, based on positive data from this trial, the company submitted NDA to the U.S. Food and Drug Administration (FDA) for GTx-104.

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