Phase 3 STRIVE-ON Data Support Clinical Benefit of GTx-104 Over Oral Nimopidine in Subarachnoid Hemorrhage

At the 2025 Neurocritical Care Society annual meeting, held September 18-21 in Montreal, Quebec, Grace Therapeutics presented positive, pivotal data from its phase 3 STRIVE-ON trial (NCT05995405) testing GTx-104, an investigational, injectable, intravenous (IV) formulation of nimopidine as a treatment for aneurysmal subarachnoid hemorrhage (aSAH). All told, the therapeutic met its primary end point, demonstrating a safe and well tolerated profile compared with oral nimodipine, further supporting the drug’s development.¹

STRIVE-ON, a prospective, randomized open-label trial, comprised 102 patients hospitalized with aSAH who were randomly assigned to either GTx-104 (n = 50) or oral nimopidine (n = 52). Led by Alex Choi, MD, professor of neurosurgery and neurology at UT Health Houston McGovern Medical School, the trial’s primary end point was the number of patients with at least 1 episode of clinically significant hypotension reasonably considered to be caused by the drug, with other secondary end points of safety, clinical, and pharmaeconomic outcomes.

All told, the trial met its primary end point, with patients on GTx-104 showing a 19% reduction in at least one incidence of clinically significant hypotension compared with oral nimopidine (28% vs 35%). Between the two groups, the rate of adverse events were comparable and no new safety signals were identified among those on the investigational product.

"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 wrote 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."

Nimopidine, a calcium channel blocker, has been a cornerstone therapy in the management of aSAH for several decades. Its primary role is not to prevent rebleeding or directly repair the aneurysm, but rather to reduce the risk of delayed cerebral ischemia, considered of the most serious complications following aSAH. GTx-104 is still nimopidine, but in a novel IV, aqueous nanoparticle formulation intended for peripheral IV infusion, designed specifically for ICU use in aSAH.

GTx-104, backed by data from STRIVE-ON, is currently under review by the FDA, with a PDUFA date set for April 23, 2026.² If approved, the drug could offer a true ICU-ready route of administration, with more consistent exposure vs oral nimopidine, and potentially fewer drug-related hypotension events.

Additional data from STRIVE-ON showed that 54% of patients receiving GTx-104 had relative dose intensity (RDI) of 95% or higher compared with only 8% of those on oral nimopidine. In addition, 29% more patients on the investigational agent had favorable functional outcomes at 90 days, reflected through modified Rankin scale, compared with oral nimopidine.

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In terms of pharmacoeconomic outcomes, patients on GTx-104 spent –1.5 fewer days in the ICU than those on oral nimodipine, as well as 5 less days on ventilation than the nimodipine cohort. Patients on the investigational agent also had a 48% reduced ICU readmission rate than those on oral nimodipine. Overall, there were 8 deaths in the GTx-104 arms and 4 in the oral nimopidine arm, none of which were related to either treatment.

From day 1 to day 14, investigators recorded a 93% decrease in mechanical ventilation use, 69% decreased used in external ventricular drain, and an 80% lessened use of deep sedation. Notably, all 4 patients who were comatose at day 1 were free of their condition by day 14. Although relatively smaller numbers, the oral nimodipine group experienced changes of –42%, –51%, –38%, and –60%, respectively, on those patient resource utilization drivers of aSAH.

"The presentation of our STRIVE-ON data at the Neurocritical Care Society annual meeting caps a very eventful and productive period for Grace, led by the FDA’s acceptance for review of our New Drug Application (NDA) for GTx-104," Prashant Kohli, chief executive officer at Grace, said in a statement.¹ "The presented data reinforce the potential of GTx-104 as a major innovation in the treatment of aSAH patients."

Kohli added, “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. 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 Pivotal Phase 3 STRIVE-ON Safety Trial Presented at 2025 Neurocritical Care Annual Meeting. News release. Grace Therapeutics. 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 Announces U.S. Food and Drug Administration Acceptance for Review of New Drug Application for GTx-104. News release. August 27, 2025. Accessed September 23, 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