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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: 02 Dec 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

  • 11 Nov 2025 According to a Grace Therapeutics media release, company announced that an abstract of the Pivotal Phase 3 STRIVE-ON Safety Trial has been accepted for presentation as a late breaking trial at the Society of Vascular and Interventional Neurology (SVIN) annual meeting, to be held11/21/2025 10:30:00 AM - 12:00 PM in Orlando, FL.
  • 23 Oct 2025 According to a Grace Therapeutics media release, the U.S FDA established a Prescription Drug User Fee Act (PDUFA) target date of April 23, 2026 for the review of the GTx-104 NDA submission based on the data from the trial.
  • 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.

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