Remedy Pharmaceuticals announced that the Food and Drug Administration (FDA) has granted Fast Track designation to Cirara for the treatment of large hemispheric infarctions (LHI). is a type of ischemic stroke associated with a high likelihood of developing life-threatening cerebral edema caused by the opening of Sur1-Trpm4 channels in the capillary endothelium. This leads to compromised arterial inflow to surrounding tissues, causing further ischemic damage and infarct enlargement frequently resulting in brain herniation and death. 

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The FDA recently accepted the investigational new drug (IND) application for Cirara. Remedy expects to initiate the Phase 3 study, CHARM (Cirara in large Hemispheric infarction Analyzing modified Rankin & Mortality), in patients with LHI by the end of this year.

Cirara is an investigational, injectable, high affinity inhibitor of Sur1-Trpm4 channels utilizing Remedy’s proprietary MPD technology.

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