nimodipine (GTX-104) / Grace Therapeutics - LARVOL DELTA

Phase 1, randomized, crossover study comparing intravenous GTX-104 to oral nimodipine in healthy human subjects. (PubMed, PLoS One) - "The average oral bioavailability for nimodipine capsules was 7%. These results enabled a Phase 3 safety study of GTX-104 in humans with aneurysmal subarachnoid hemorrhage."

Clinical • Journal • P1 data • Cardiovascular • Hematological Disorders • Subarachnoid Hemorrhage

Grace Therapeutics Announces U.S. Food and Drug Administration Acceptance for Review of New Drug Application for GTx-104 (GlobeNewswire) - "The application seeks approval for GTx-104 for the treatment of patients with aSAH, and is supported by a comprehensive data package including positive data obtained from the Company’s Phase 3 STRIVE-ON safety trial of GTx-104. The FDA established a Prescription Drug User Fee Act (PDUFA) target date of April 23, 2026 for its review of the Company’s NDA submission."

FDA filing • PDUFA • Subarachnoid Hemorrhage

Grace Therapeutics Announces Submission of New Drug Application to U.S. Food and Drug Administration for GTx-104 (GlobeNewswire) - "Grace Therapeutics...announced the submission to the U.S. Food and Drug Administration (FDA) of the Company’s New Drug Application (NDA) for GTx-104. The application includes a comprehensive data package, including positive data obtained from the Company’s Phase 3 STRIVE-ON safety trial of GTx-104, whereby it met its primary endpoint and provided evidence of clinical benefit when compared to orally administered nimodipine."

FDA filing • Subarachnoid Hemorrhage

Grace Therapeutics Announces Alignment with the FDA Supporting the Planned NDA Submission for GTx-104 (GlobeNewswire) - "Grace Therapeutics, Inc...announced details of the Company’s Type C meeting with the U.S. Food and Drug Administration (FDA). The purpose of this meeting was to obtain FDA feedback on the completed Phase 3 STRIVE-ON safety trial of GTx-104 and its planned New Drug Application (NDA) submission including clinical, non-clinical, and chemistry, manufacturing, and control (CMC) requirements. Based on feedback from the FDA, the Company believes that the data and regulatory packages as currently structured will be sufficient for submission of an NDA....The Company anticipates filing its NDA for GTx-104 in the second quarter of 2025. Acceptance of the NDA will be subject to the FDA’s review of the complete filing."

FDA event • FDA filing • CNS Disorders • Subarachnoid Hemorrhage

Grace Therapeutics Announces Third Fiscal Quarter 2025 Financial Results, Provides Business Update (GlobeNewswire) - "Announced Phase 3 STRIVE-ON Safety Trial Met Primary Endpoint and Provided Clinical Benefit Compared to Orally Administered Nimodipine; New Drug Application (NDA) Submission Anticipated First Half of Calendar 2025."

FDA filing • CNS Disorders • Subarachnoid Hemorrhage

Grace Therapeutics Announces Results From Pivotal Phase 3 STRIVE-ON Safety Trial of GTx-104 in aSAH (GlobeNewswire) - P3 | N=100 | STRIVE-ON (NCT05995405) | Sponsor: Grace Therapeutics, Inc. | "The trial met its primary endpoint, with patients receiving GTx-104 observed to have a 19% reduction in at least one incidence of clinically significant hypotension compared to oral nimodipine (28% versus 35%). Other measures also favored or were comparable to GTx-104, including: i) 54% of patients who received GTx-104 had a relative dose intensity (RDI) of 95% or higher of the prescribed dose compared to only 8% on oral nimodipine. ii) 29% relative increase in the number of patients receiving GTx-104 compared to oral nimodipine with favorable outcomes at 90 days follow up on the modified Rankin scale. Quality of life as measured by EQ-5D-3L also favored patients receiving GTx-104 versus oral nimodipine. iii) Fewer intensive care unit (ICU) readmissions, ICU days, and ventilator days for patients receiving GTx-104 versus oral nimodipine."

P3 data • CNS Disorders • Subarachnoid Hemorrhage

STRIVE-ON: Safety and Tolerability of GTX-104 Compared with Oral Nimodipine in Patients with ASAH (clinicaltrials.gov) - P3 | N=100 | Active, not recruiting | Sponsor: Acasti Pharma Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Hematological Disorders • Subarachnoid Hemorrhage

STRIVE-ON: Safety and Tolerability of GTX-104 Compared With Oral Nimodipine in Patients With aSAH (clinicaltrials.gov) - P3 | N=100 | Recruiting | Sponsor: Acasti Pharma Inc.

Trial completion date • Trial primary completion date • Cardiovascular • Hematological Disorders • Subarachnoid Hemorrhage

STRIVE-ON: Safety and Tolerability of GTX-104 Compared With Oral Nimodipine in Patients With aSAH (clinicaltrials.gov) - P3 | N=100 | Recruiting | Sponsor: Acasti Pharma Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Hematological Disorders • Subarachnoid Hemorrhage

Relative Bioavailability of Intravenous GTX-104 Compared to Oral Nimodipine Capsules in Healthy Subjects (clinicaltrials.gov) - P1 | N=58 | Completed | Sponsor: Acasti Pharma Inc. | N=253 ➔ 58

Enrollment change • Cardiovascular • Hematological Disorders • Subarachnoid Hemorrhage

GTX-104, Novel IV Formulation of Nimodipine to Treat Subarachnoid Hemorrhage: a Pharmacokinetic Comparison with Oral Nimodipine (NCS 2023) - No abstract available

PK/PD data • Hematological Disorders • Subarachnoid Hemorrhage

GTX-104, Novel IV Formulation of Nimodipine to Treat Subarachnoid Hemorrhage: a Pharmacokinetic Comparison with Oral Nimodipine (NCS 2023) - No abstract available

PK/PD data • Hematological Disorders • Subarachnoid Hemorrhage

STRIVE-ON: Safety and Tolerability of GTX-104 Compared With Oral Nimodipine in Patients With aSAH (clinicaltrials.gov) - P3 | N=100 | Not yet recruiting | Sponsor: Acasti Pharma Inc.

New P3 trial • Cardiovascular • Hematological Disorders • Subarachnoid Hemorrhage

Relative Bioavailability of Intravenous GTX-104 Compared to Oral Nimodipine Capsules in Healthy Subjects (clinicaltrials.gov) - P1 | N=253 | Completed | Sponsor: Acasti Pharma Inc.

New P1 trial • Cardiovascular • Hematological Disorders • Subarachnoid Hemorrhage