Drug Profile

Nimodipine - Grace Therapeutics

Alternative Names: GTX 104; Nimodipine intravenous - Grace Therapeutics

Latest Information Update: 04 Sep 2025

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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

27 Aug 2025 FDA assigns PDUFA action date of (23/04/2026) for Nimodipine for Subarachnoid haemorrhage
22 Aug 2025 USFDA accepts NDA for Nimodipine for Subarachnoid haemorrhage for review
25 Jun 2025 Preregistration for Subarachnoid haemorrhage in USA (IV)

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