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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: 05 Aug 2026

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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

  • 28 Jul 2026 According to Grace Therapeutics media release, the company announced receipt of the U.S. FDA meeting minutes from a Type A Meeting held with the FDA to discuss the CRL. FDA Did Not Identify any clinical safety or efficacy deficiencies and did not request additional clinical data. The items cited by the FDA relate to the current good manufacturing practice compliance status of the CDMO. together with additional leachables data time point and excipient toxicology risk assessment.
  • 18 Jun 2026 According to Grace Therapeutics media release, results from this trial were presented at 2026 American Academy of Neurology,(April 18-22, 2026, Chicago, IL),Society of Critical Care Medicines Critical Care Congress (March 22-24, 2026, Chicago, IL) and American Association of Neuroscience Nurses (March 21-24, 2026, Dallas, TX).
  • 23 Apr 2026 According to Grace Therapeutics media release, the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Company's New Drug Application (NDA) for GTx-104 for the treatment of patients with aSAH.

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