The ischemic stroke therapeutic landscape is evolving, with over 55 drugs in the pipeline aimed at improving outcomes for patients affected by this debilitating condition. These emerging therapies encompass a range of mechanisms, from neuroprotection to thrombolysis and neurorestoration, offering hope for more effective treatments. Several companies and academic institutions are actively engaged in research and development to address the challenges and unmet needs in ischemic stroke management.
Late-Stage Clinical Developments
Among the most advanced candidates are Nelonemdaz, developed by GNT Pharma, and 3K3A-APC, by ZZ Biotech, both currently in Phase III clinical trials. Nelonemdaz, a multitarget neuroprotectant, selectively blocks N-methyl-D-aspartate (NMDA) receptors and scavenges free radicals. Preclinical studies have demonstrated its efficacy in ischemia-reperfusion models. 3K3A-APC is a modified recombinant activated protein C (APC) designed to treat acute ischemic stroke, differing in amino acid sequence from the wild-type human APC.
Mid-Stage Innovations
JX10, an investigational drug by JIXING Pharmaceuticals (formerly BIIB131 by Biogen), is in Phase II development. It is designed with both thrombolytic and anti-inflammatory activities, aiming to restore blood flow and improve clinical outcomes post-stroke. Elezanumab (ABT-555), a monoclonal antibody RGMa inhibitor being developed by AbbVie, is also in Phase II. Elezanumab targets RGMa, a modulator of axonal growth and myelination, with the goal of neurorestoration and functional recovery in CNS diseases.
Early-Stage Therapeutics
Meridigen Biotech Co., Ltd. is developing UMC119-06, an umbilical cord-derived MSCs (hUC-MSCs) drug, currently in Phase I trials. This therapy leverages the anti-oxidation, immunomodulation, and cell protection properties of MSCs to treat ischemic stroke.
The pipeline also includes other notable products such as ST-01 (Saillant Therapeutics), Microlyse (TargED Biopharmaceuticals), Glenzocimab (Acticor Biotech), RNS60 (Revalesio Corporation), TXA127 (Constant Therapeutics LLC), NTS-104 (NeuroTrauma Sciences, LLC), and BB-031 (Basking Bioscience), each with unique mechanisms of action and at various stages of development.
