Acute ischemic stroke (AIS) occurs when a blood clot blocks a vessel supplying blood to the brain, leading to brain cell damage. According to Forshing Lui et al., 2025, ischemic stroke accounts for approximately 87% of all stroke cases. The growing focus on novel thrombolytic agents, neuroprotective therapies, and mechanical thrombectomy has intensified research in the acute ischemic stroke therapeutics landscape. According to the acute ischemic stroke pipeline analysis by Expert Market Research, advancements in drug delivery systems and biologics are expected to fuel growth in the coming years. This reflects a strong pipeline of acute ischemic stroke drugs targeting improved clinical outcomes and faster recovery.
Major companies involved in the acute ischemic stroke pipeline analysis include Shin Poong Pharmaceutical Co. Ltd., Shijiazhuang Yiling Pharmaceutical Co. Ltd., and others.
Leading drugs currently in the pipeline include SP-8203, JX10, BB-031, and others.
The drug pipeline for acute ischemic stroke is expanding due to increased R&D in neuroprotective agents, rising clinical trials for thrombolytics, and growing focus on combination therapies for improved outcomes.
The Acute Ischemic Stroke Pipeline Analysis Report by Expert Market Research gives comprehensive insights into acute ischemic stroke therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for acute ischemic stroke. The acute ischemic stroke report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The acute ischemic stroke pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with acute ischemic stroke treatment guidelines to ensure optimal care practices.
The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to acute ischemic stroke.
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Acute ischemic stroke is a neurological emergency caused by a sudden blockage of blood flow to the brain due to a blood clot, depriving brain tissue of oxygen and nutrients. This leads to rapid brain cell damage and requires immediate medical intervention to minimize lasting neurological impairment.
Acute ischemic stroke treatment typically includes intravenous thrombolytics such as alteplase or tenecteplase to dissolve clots, mechanical thrombectomy, and supportive care to restore cerebral blood flow and prevent complications. For instance, in March 2025, the FDA approved Tenecteplase for acute ischemic stroke, offering faster administration as a 5-second IV bolus. It demonstrated noninferiority to alteplase in the Phase 3 AcT trial.
According to Forshing Lui et al., 2025, ischemic strokes account for approximately 87% of all strokes. In the United States, over 795,000 individuals experience a stroke annually, with around 610,000 being first-time cases. About 185,000 strokes occur in those with prior incidents. Stroke is responsible for one in six cardiovascular deaths. Non-Hispanic Black and Pacific Islander adults face the highest incidence and mortality rates, with stroke-related deaths rising to 41.1 per 100,000 in 2021.
This section of the report covers the analysis of acute ischemic stroke drug candidates based on several segmentations, including:
By Phase
By Drug Class
By Route of Administration
The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase III covers a major share of the total acute ischemic stroke clinical trials. It accounts for around 38% of the acute ischemic stroke drug pipeline, reflecting strong late-stage development activity. Phase II follows with 30%, indicating robust ongoing clinical research. Phase IV holds approximately 18%, showcasing post-marketing progress. This balanced pipeline supports future innovation and growth in the acute ischemic stroke treatment landscape.
The drug molecule categories covered under the acute ischemic stroke pipeline analysis include small molecules, biologics, monoclonal antibodies, and cell-based therapies. The acute ischemic stroke report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for acute ischemic stroke.
Neuroprotective drug therapies are gaining traction in the acute ischemic stroke pipeline to complement mechanical reperfusion. For instance, nelonemdaz, a selective N-methyl-D-aspartate receptor antagonist and free radical scavenger, has undergone phase 3 clinical evaluation. Although it did not achieve its primary efficacy endpoint, it represents an emerging class targeting excitotoxicity and oxidative stress post-stroke.
The EMR report for the acute ischemic stroke pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed acute ischemic stroke therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in acute ischemic stroke clinical trials:
This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for acute ischemic stroke. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of acute ischemic stroke drug candidates.
SP-8203, sponsored by Shin Poong Pharmaceutical Co. Ltd., is undergoing a Phase III trial to evaluate its efficacy and safety in acute ischemic stroke patients receiving thrombolytic therapy. This small molecule neuroprotectant inhibits matrix metalloprotease activity, aiming to reduce infarct volume and hemorrhagic risk. The study is enrolling 852 patients under a double-blind, placebo-controlled design.
JX10 is an investigational drug by Corxel Pharmaceuticals, currently being evaluated in the Phase 2/3 ORION study. The objective is to assess its efficacy and safety in patients with acute ischemic stroke (AIS) presenting within 4.5 to 24 hours. JX10 is believed to have thrombolytic and anti-inflammatory properties, potentially extending the treatment window and improving neurological outcomes.
BB-031, sponsored by Basking Biosciences, Inc., is an RNA aptamer targeting von Willebrand Factor (vWF), currently being evaluated in a Phase 2 trial for acute ischemic stroke. This study is examining the safety, tolerability, pharmacokinetics, and pharmacodynamics of ascending and selected single doses in patients within 24 hours of stroke onset, aiming to rapidly restore cerebral blood flow.
*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*
The Acute Ischemic Stroke Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for acute ischemic stroke. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into acute ischemic stroke collaborations, regulatory environments, and potential growth opportunities.
Ischemic Stroke Market Report and Forecast
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*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*
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