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# Grace Therapeutics NDA for Hemorrhage Drug Submitted
- URL: https://www.fdaweb.com/grace-therapeutics-nda-for-hemorrhage-drug-submitted/
- Published: 2025-08-27T12:00:00.000Z
- Updated: 2026-09-14T15:20:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159771

FDA has accepted for review a Grace Therapeutics NDA for GTx-104 (nimodipine for injection) for treating patients with aneurysmal subarachnoid hemorrhage (ASH). The company says the submission was supported by a comprehensive data package including positive data obtained from the company’s Phase 3 STRIVE-ON safety trial of GTx-104\. The agency set a user fee review action target date of 4/23/2026.

“Our NDA is supported by a robust data package including positive results from our STRIVE-ON trial, which provide support for improved clinical outcomes in ASH patients and both medical and pharmacoeconomic evidence of the potential benefit of GTx-104 in the treatment of ASH,” the company says. “The standard of care for ASH has not seen meaningful innovation in nearly 40 years, and we believe these results point to a very promising role for GTx-104, if approved, as a potential breakthrough for the care of ASH patients.”

ASH is described as a life-threatening medical emergency caused by bleeding into the space between the brain and its surrounding membranes, resulting from a ruptured saccular brain aneurysm.

FDA previously granted Grace an Orphan Drug Designation for GTx-104.