Grace Therapeutics, Inc. receives U.S. Food and Drug Administration CRL for GTx-104 NDA in aSAH, citing CMC and non-clinical issues; company plans resubmission.
Written By: Sana Khan BPharm
Reviewed By: Pharmacally Editorial Team
Grace Therapeutics, Inc. has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration for its New Drug Application (NDA) for GTx-104, an investigational intravenous formulation of nimodipine for the treatment of aneurysmal subarachnoid hemorrhage (aSAH).
The agency identified deficiencies in the Chemistry, Manufacturing, and Controls (CMC) and non-clinical sections, including issues related to leachables from product packaging, toxicology risk assessments, and manufacturing deficiencies at a contract facility.
The company stated that it believes these issues are addressable and plans to request a Type A meeting with the FDA to clarify requirements for resubmission.
Chief Executive Officer Prashant Kohli said the company remains confident in its clinical data and expects to resolve the identified concerns in a revised filing.
The application is supported by data from the STRIVE-ON trial (NCT05995405), a randomized, open-label study comparing GTx-104 with oral nimodipine in 102 hospitalized aSAH patients.
The trial met its primary endpoint, showing a 19% reduction in clinically significant hypotension in the GTx-104 group compared with oral therapy (28% vs. 35%). Patients receiving GTx-104 also demonstrated higher treatment adherence, with 54% achieving relative dose intensity of at least 95% versus 8% in the oral group, and a 29% higher rate of favorable functional outcomes at 90 days.
Additional findings included fewer ICU readmissions, shorter ICU stays, and fewer ventilator days. Safety outcomes were comparable between groups, with no new safety signals identified; reported deaths were attributed to underlying disease severity rather than treatment.
Aneurysmal subarachnoid hemorrhage is a serious form of stroke caused by rupture of a brain aneurysm and accounts for about 5% of all strokes, with an estimated 42,500 hospital-treated cases annually in the United States.
GTx-104 is a nanoparticle-based intravenous formulation designed for use in intensive care settings, offering more consistent drug delivery and potentially reducing variability, dosing challenges, and complications associated with oral administration in critically ill patients.
The therapy has been evaluated in more than 200 patients and healthy volunteers and has shown favorable tolerability with lower pharmacokinetic variability compared to oral nimodipine.
Grace Therapeutics intends to work with the FDA to address the identified deficiencies and determine the appropriate next steps for resubmission.
Reference:
Grace Therapeutics Provides Regulatory Update on New Drug Application for GTx-104 April 23, 2026. https://www.gracetx.com/investors/news-events/press-releases/detail/303/grace-therapeutics-provides-regulatory-update-on-new-drug-application-for-gtx-104
Safety and Tolerability of GTX-104 Compared with Oral Nimodipine in Patients with ASAH (STRIVE-ON), ClinicalTrials.gov ID NCT05995405. https://clinicaltrials.gov/study/NCT05995405
About the Writer
Sana Jamil Khan is a B. Pharm graduate with a strong interest in medical writing and scientific communication. Her work focuses on interpreting clinical research, exploring developments in pharmaceutical science, and presenting complex medical information in a clear and accessible manner. She is particularly interested in topics related to human clinical studies, drug safety observations, and emerging therapeutic research.