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Nimodipine - Grace Therapeutics

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Drug Profile

Nimodipine - Grace Therapeutics

Alternative Names: GTX 104; Nimodipine intravenous - Grace Therapeutics

Latest Information Update: 08 May 2026

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At a glance

  • Originator Grace Therapeutics
  • Class Antihaemorrhagics; Antihypertensives; Dihydropyridines; Esters; Small molecules
  • Mechanism of Action Calcium channel antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Subarachnoid haemorrhage
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Preregistration Subarachnoid haemorrhage

Most Recent Events

  • 08 May 2026 Grace Therapeutics intends to resubmit the New Drug Application t the US FDA for nimodipine for Subarachnoid haemorrhage
  • 23 Apr 2026 Grace Therapeutics intends to request a Type A meeting with the US FDA to clarify the path forward and determine the appropriate next steps on the CRL for the New Drug Application (NDA) for nimodipine for Subarachnoid haemorrhage
  • 23 Apr 2026 The US FDA issues a Complete Response Letter (CRL) for the New Drug Application (NDA) for nimodipine for Subarachnoid haemorrhage

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