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Nimodipine

Generic Name
Nimodipine
Brand Names
Nimotop, Nymalize
Drug Type
Small Molecule
Chemical Formula
C21H26N2O7
CAS Number
66085-59-4
Unique Ingredient Identifier
57WA9QZ5WH
Background

Nimodipine is a 1,4-dihydropyridine calcium channel blocker. It acts primarily on vascular smooth muscle cells by stabilizing voltage-gated L-type calcium channels in their inactive conformation. By inhibiting the influx of calcium in smooth muscle cells, nimodipine prevents calcium-dependent smooth muscle contraction and subsequent vasoconstriction. Compared to other calcium channel blocking agents, nimodipine exhibits greater effects on cerebral circulation than on peripheral circulation. Nimodipine is used to as an adjunct to improve the neurologic outcome following subarachnoid hemorrhage from ruptured intracranial aneurysm.

Indication

For use as an adjunct to improve neurologic outcome following subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms by reducing the incidence and severity of ischemic deficits.

Associated Conditions
Delayed Ischemic Neurological Deficit
Clinical Trials
Related News

Phase 3 Trial Success: GTx-104 Shows Promise in Treating Brain Hemorrhage with Reduced Hypotension Risk

• Grace Therapeutics' Phase 3 STRIVE-ON trial of GTx-104, an injectable nimodipine formulation, met its primary endpoint with 19% reduction in clinically significant hypotension compared to oral nimodipine in aSAH patients. • The novel IV formulation demonstrated superior drug delivery, with 54% of GTx-104 patients achieving ≥95% relative dose intensity compared to only 8% with oral nimodipine, alongside reduced ICU stays and ventilator days. • Grace Therapeutics plans to submit New Drug Application (NDA) in first half of 2025, potentially offering the first major innovation in aSAH treatment in nearly 40 years.

FDA Approves Azurity's Danziten (Nilotinib) for CML Without Mealtime Restrictions

• The FDA has approved Azurity Pharmaceuticals' Danziten (nilotinib) as the first nilotinib formulation for chronic myeloid leukemia (CML) without mealtime restrictions. • Danziten is indicated for adults with newly diagnosed Philadelphia chromosome-positive (Ph+) CML in the chronic phase and those resistant or intolerant to prior imatinib therapies. • The reengineered formulation of Danziten offers equivalent efficacy to Tasigna but with enhanced bioavailability, enabling a lower dosage and potentially improving patient adherence. • Danziten is expected to be available soon through Biologics by McKesson and Limited Specialty Distribution, offering a more convenient treatment option for CML patients.

Acasti Pharma's GTX-104 Trial for aSAH Completes Enrollment Early, Eyes 2026 Launch

• Acasti Pharma's STRIVE-ON trial, evaluating GTX-104 for aneurysmal subarachnoid hemorrhage (aSAH), has completed enrollment ahead of schedule with approximately 100 participants. • Top-line data from the pivotal safety trial is expected by February, potentially leading to a New Drug Application (NDA) filing by June 2025. • H.C. Wainwright maintains a Buy rating for Acasti Pharma, projecting peak sales for GTX-104 to exceed $130 million, with potential FDA approval by April 2026. • GTX-104 is poised to become the new standard of care for aSAH in the ICU, given its product profile and previous data.

Acasti Completes Enrollment in Phase 3 STRIVE-ON Trial of GTX-104 for aSAH

• Acasti Pharma has completed patient enrollment in its Phase 3 STRIVE-ON trial evaluating GTX-104 for aneurysmal subarachnoid hemorrhage (aSAH). • The STRIVE-ON trial is comparing intravenous GTX-104 to oral nimodipine in 100 patients hospitalized with aSAH across 25 U.S. hospitals. • GTX-104, an injectable formulation of nimodipine, aims to address challenges associated with oral administration and improve patient outcomes. • Acasti anticipates STRIVE-ON data readout in early 2025 and plans to submit an NDA to the FDA in the first half of 2025.

FDA Approves Nymalize in Prefilled ENFit Syringes for Subarachnoid Hemorrhage

• The FDA has approved Nymalize (nimodipine) oral solution in prefilled ENFit syringes, offering a potentially more secure drug administration method. • Nymalize is indicated for improving neurological outcomes by reducing ischemic deficits in adults with subarachnoid hemorrhage from ruptured intracranial aneurysms. • The ENFit syringes aim to reduce the risk of misconnections with enteral devices, addressing concerns highlighted by the FDA. • Azurity Pharmaceuticals plans to make the Nymalize prefilled ENFit syringes available through pharmaceutical wholesalers in the coming weeks.
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