> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Agency Rejects Grace Therapeutics’ GTx-104 NDA
- URL: https://www.fdaweb.com/agency-rejects-grace-therapeutics-gtx-104-nda/
- Published: 2026-04-23T12:00:00.000Z
- Updated: 2026-09-14T13:37:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161035

FDA has issued Grace Therapeutics a complete response letter rejecting approval for its experimental treatment GTx-104 (nimodipine), citing outstanding manufacturing and non-clinical issues rather than problems with clinical efficacy. The drug is being developed for intravenous infusion to address significant unmet medical needs in aneurysmal subarachnoid hemorrhage patients.

The company says the agency action focused on deficiencies in chemistry, manufacturing and controls, as well as certain non-clinical data requirements. Importantly, the agency did not request any additional clinical trials, a signal that the drug’s efficacy and safety data in patients may be sufficient pending resolution of the technical concerns.

Grace Therapeutics says it plans to resubmit its NDA after addressing the issues identified by regulators, which include questions related to packaging “leachables,” toxicology risk assessments, and manufacturing deficiencies at a contract production facility. The company also intends to request a formal Type A meeting with FDA to clarify next steps.

GTx-104 is a novel intravenous formulation of nimodipine, a drug commonly used to prevent complications following aneurysmal subarachnoid hemorrhage, a rare but life-threatening type of stroke caused by bleeding in the space surrounding the brain. The therapy is designed to improve drug delivery in critically ill patients, particularly those unable to take oral medications, according to the company.

Clinical data from the company’s mid-stage STRIVE-ON trial showed that GTx-104 met its primary endpoint, reducing the incidence of clinically significant low blood pressure compared with standard oral nimodipine, the company says. The study also suggested improvements in dosing consistency and functional outcomes, along with reductions in intensive care utilization.

However, mortality outcomes were mixed: eight deaths were reported in the GTx-104 arm compared with four in the oral treatment group, though the company said none were attributed to the drug itself and were instead linked to the severity of patients’ underlying condition.

Aneurysmal subarachnoid hemorrhage accounts for roughly 5% of all strokes and affects an estimated 42,000 patients treated in U.S. hospitals each year, Grace says. The condition often requires intensive care management and carries a high risk of complications and death.