STRIVE-ON: IV GTx-104 May Offer New Standard of Care for Aneurysmal Subarachnoid Hemorrhage

Grace Therapeutics has announced results from its phase 3 STRIVE-ON Safety Trial demonstrating the safety and tolerability of GTx-104 for the treatment of aneurysmal subarachnoid hemorrhage (aSAH) were presented at the 2025 Neurocritical Care Society annual meeting.1

Trial results were presented in an oral presentation titled “Safety and Tolerability of GTx-104 (Nimodipine Injection for I.V. Infusion) Compared with Oral Nimodipine in Patients with Aneurysmal Subarachnoid Hemorrhage: a Prospective, Randomized Trial” by H. Alex Choi, MD, a professor of neurosurgery and neurology at UT Health Houston McGovern Medical School and member of the Grace Scientific Advisory Board.1

“Results from the STRIVE-ON trial showed that intravenous GTx-104 has the potential to deliver its potent neuroprotective effects while reducing hypotensive events compared to orally administered nimodipine. Additionally, subjects treated with GTx-104 had improvements in ICU length of stay and reduction in the need for mechanical ventilation,” Choi said in a statement.1 “These data provide a compelling case for GTx-104 as an alternative for oral nimodipine in hospital pharmacies should it be approved by the FDA.”

GTx-104 is a clinical stage, novel, injectable formulation of nimodipine being developed for IV infusion in aSAH patients. As described by Grace Therapeutics, the unique nanoparticle technology of GTx-104 facilitates aqueous formulation of insoluble nimodipine for a standard peripheral IV infusion, and GTx-104 provides a convenient IV delivery of nimodipine in the Intensive Care Unit, potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients.1

Additionally, intravenous delivery of GTx-104 has the potential to lower food effects, drug-to-drug interactions, and eliminate potential dosing errors. GTx-104 also has the potential to better manage hypotension in this patient population. It has been administered in > 200 patients and healthy volunteers and was well tolerated with significantly lower inter- and intra-subject pharmacokinetic variability compared to oral nimodipine.1

On August 22, 2025, the US Food and Drug Administration accepted the Company’s New Drug Application (NDA) for GTx-104 for formal review. The application seeks approval for GTx-104 for the treatment of patients with aSAH and is supported by positive data obtained from the phase 3 STRIVE-ON safety trial. With the acceptance, the FDA established a Prescription Drug User Fee Act (PDUFA) target date of April 23, 2026.2

STRIVE-ON was a prospective, randomized open-label trial of GTx-104 compared with oral nimodipine in patients hospitalized with aSAH. A total of 50 patients were administered GTx-104 and 52 patients received oral nimodipine. The primary endpoint was the number of patients with ≥ 1 episode of clinically significant hypotension reasonably considered to be caused by the drug, and additional secondary endpoints included safety, clinical, and pharmacoeconomic outcomes.1,2

As described at the time of the NDA acceptance, the trial met its primary endpoint, with patients receiving GTx-104 experiencing a 19% reduction in ≥ 1 incidence of clinically significant hypotension compared to oral nimodipine (28% vs 35%). Other measures also favored or were comparable to GTx-104, including:

• 54% patients receiving GTx-104 had relative dose intensity (RDI) of 95% or higher compared to only 8% on oral nimodipine
• 29% more patients receiving GTx-104 had favorable functional outcomes at 90 days compared to oral nimodipine
• Fewer intensive care unit (ICU) readmissions, ICU days, and ventilator days for patients receiving GTx-104 versus oral nimodipine

Results showed adverse events were comparable between the 2 arms and no new safety issues were identified with patients receiving GTx-104. There were 8 deaths on the GTx-104 arm compared to 4 deaths on the oral nimodipine arm, all of which were due to severity of the patient’s underlying disease. No deaths were determined to be related to GTx-104 or oral nimodipine.2

“The presented data reinforce the potential of GTx-104 as a major innovation in the treatment of aSAH patients. These data were well received by the clinicians and pharmacists attending the conference, who expressed their excitement about the potential of I.V. administered GTx-104 to better manage hypotension and dose compliance,” Prashant Kohli, CEO of Grace Therapeutics, said in a statement.1 “The standard of care for aSAH has not seen meaningful innovation in nearly 40 years, and we believe our STRIVE-ON trial results point to a very promising role for GTx-104 in the treatment of these patients, if approved. We look forward to continuing to engage with the FDA during their review as they work toward their PDUFA target date of April 23, 2026.”

References

1. Grace Therapeutics. Grace Therapeutics Pivotal Phase 3 STRIVE-ON Safety Trial Presented at 2025 Neurocritical Care Annual Meeting. September 22, 2025. Accessed September 22, 2025. https://www.gracetx.com/investors/news-events/press-releases/detail/294/grace-therapeutics-pivotal-phase-3-strive-on-safety-trial-presented-at-2025-neurocritical-care-annual-meeting

2. Grace Therapeutics. Grace Therapeutics Announces U.S. Food and Drug Administration Acceptance for Review of New Drug Application for GTx-104. August 27, 2025. Accessed September 22, 2025. https://www.gracetx.com/investors/news-events/press-releases/detail/291/grace-therapeutics-announces-u-s-food-and-drug-administration-acceptance-for-review-of-new-drug-application-for-gtx-104