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DelveInsight's "Ischemic Stroke Pipeline Analysis, 2025" delivers extensive intelligence on over 50 pharmaceutical firms and more than 55 investigational medications within the Ischemic Stroke development arena. The analysis encompasses profiles of Ischemic Stroke pipeline therapeutic candidates, spanning both clinical and preclinical phases. Additionally, it includes evaluation of Ischemic Stroke pipeline therapeutics by product category, developmental phase, administration method, and molecular classification. The report also spotlights dormant pipeline products in this therapeutic area.
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Primary Highlights from the Ischemic Stroke Pipeline Analysis
Primary Highlights from the Ischemic Stroke Pipeline Analysis
Berlin, November 23, 2025, Bayer has reported encouraging topline findings from its global Phase III OCEANIC-STROKE trial evaluating the once-daily, oral FXIa inhibitor asundexian. The investigational therapy achieved both its primary efficacy and safety endpoints, marking a significant milestone in stroke prevention research. According to the results, asundexian 50 mg once daily delivered a meaningful reduction in the risk of ischemic stroke compared with placebo when used alongside antiplatelet therapy in patients who had experienced a non-cardioembolic ischemic stroke or a high-risk ischemic attack. Importantly, the treatment did not lead to an increased rate of ISTH major bleeding, demonstrating a favorable safety profile in comparison to placebo under the same treatment conditions.
On November 21, 2025, SK Chemicals Co. Ltd revealed a Phase IV exploratory Investigation to Evaluate the Efficacy and Safety of Renexin CR in Patients With Acute Non-cardioembolic Ischemic Stroke.
On November 20, 2025, Fujian Shengdi Pharmaceutical Co. Ltd initiated a phase II clinical trial to Evaluate the Safety and Efficacy of HRS-7450 Injection in Patients With Acute Ischemic Stroke. A study plans to enroll a total of 208 patients with Acute Ischemic Stroke (AIS) who present within 4.5 to 24 hours of symptom onset and meet the specified imaging criteria.
On November 12, 2025, Basking Biosciences Inc. initiated an investigation to evaluate the safety and tolerability of ascending doses (Part A) and selected doses (Part B) of BB-031 in acute ischemic stroke patients presenting within 24 hours of stroke onset. Participants will be randomized to receive one dose of either the investigational drug or placebo and will be followed for 90 days. A total of 228 patients are planned in this study.
DelveInsight's Ischemic Stroke pipeline analysis reveals a dynamic field featuring more than 50 engaged entities advancing over 55 investigational treatments for Ischemic Stroke management.
Major Ischemic Stroke pharmaceutical firms include Genentech, Supergene, Tasly Pharmaceutical, Pharmazz, GNT Pharma, NoNO, Angde Biotech Pharmaceutical, ZZ Biotech, Bristol-Myers Squibb, Athersys, Bayer Healthcare, NuvOx Pharma, Healios, Acticor Biotech, DiaMedica Therapeutics, Moleac, Biogen, Revalesio Corporation, and Shijiazhuang Yiling Pharmaceutical Co, among additional organizations.
Notable Ischemic Stroke Pipeline investigational medications include Afamelanotide, Neflamapimod, Recombinant human urokinase, Alteplase, Aspirin, Ticagrelor, AX200 (G-CSF), Acetylsalicylic acid (ASA), Sovateltide, NXY-059, among others.
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The Ischemic Stroke Pipeline Analysis delivers a condition synopsis, pipeline landscape, and therapeutic evaluation of principal investigational therapies within this domain. The analysis also emphasizes unaddressed medical requirements concerning the development of Ischemic Stroke.
Ischemic Stroke Background
Ischemic Stroke Background
Stroke is a leading cause of death and disability worldwide and can be broadly classified into ischaemic stroke and haemorrhagic stroke, the latter of which includes intracerebral haemorrhage and subarachnoid haemorrhage. Ischaemic stroke is defined as infarction of the brain, spinal cord or retina and represents approximately 71% of all strokes globally. Advances in brain imaging have shifted the definition of ischaemic stroke from a largely clinical determination to a tissue-based classification. Many transient events with full clinical recovery are now classed as stroke based on the identification of permanent tissue injury on MRI. A transient ischemic attack (TIA or mini-stroke) is the same as a stroke but the symptoms only last for a short amount of time. It is a major warning sign of a stroke and should always be taken seriously.
Ischemic Stroke Investigational Drug Profiles
Ischemic Stroke Investigational Drug Profiles
BMS-986177: Bristol-Myers Squibb/ Johnson & Johnson Innovative Medicine
Milvexian (BMS-986177) (Factor XIa) is an investigational anticoagulant compound. Factor XIa (FXIa) plays a key role in the activation and amplification of the coagulation cascade via the intrinsic pathway. A small study of Hemophilia C patients showed a lower risk of stroke. The medication is under development by Bristol-Myers Squibb in collaboration with Johnson & Johnson. Presently the product is undergoing Phase III developmental stage for managing Ischemic Stroke.
XY03 EA: Shijiazhuang Yiling Pharmaceutical Co. Ltd.
XY03 EA, is an investigational medication under development by Shijiazhuang Yiling Pharmaceutical Co. Ltd. XY03-EA decreased the cerebral injuries and NDS by increasing cerebral blood flow, improving brain energy metabolism, accelerating ROS clearance, suppressing inflammatory responses, and inhibiting autophagy in the MCAO/R model rats. In the nonhuman primate MCAO/R model, the treatment of XY03-EA for 3 weeks could significantly inhibit the NDS progression rate and indicate a positive trend to reduce the infarct volume in a dose-dependent way. Mechanistically, XY03-EA inhibited ROS-dependent autophagy activation and thereby protected the PC-12 cells from the autophagic cell death induced by OGD/R. Presently the medication is undergoing Phase II/III Clinical trial assessment for managing Acute Ischemic Stroke.
NONO-42: NoNO Inc.
NoNO-42 is a nerinetide analog intended for use in individuals experiencing an acute ischemic stroke with or without thrombolytics. Of the 650,000 individuals experiencing an acute ischemic stroke treated annually in US hospitals, approximately 10% receive a thrombolytic, which may reduce the applicability of nerinetide. Compatibility of NoNO-42 with thrombolytics broadens the availability of neuroprotection and neurorestoration to all hospital treated strokes. Presently, the medication is undergoing Phase II developmental stage for managing acute ischemic stroke.
hNPC01: Hopstem Biotechnology
hNPC01 refers to a novel cell therapy utilizing human induced pluripotent stem cell (iPSC)-derived human forebrain neural progenitor cells aimed at managing ischemic stroke. This therapy is particularly significant as it represents the first iPSC-derived product to receive FDA Investigational New Drug (IND) clearance for stroke treatment. Presently, the medication is undergoing Phase I developmental stage for managing acute ischemic stroke.
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The Ischemic Stroke Pipeline Analysis Offers Insights Into
The Ischemic Stroke Pipeline Analysis Offers Insights Into
The analysis delivers detailed intelligence regarding pharmaceutical companies developing therapeutics for Ischemic Stroke management, including cumulative therapies created by each organization for this indication.
It evaluates various therapeutic candidates categorized into early-phase, mid-phase, and late-phase development for Ischemic Stroke Treatment.
Ischemic Stroke pharmaceutical firms engaged in targeted therapeutic development with corresponding active and inactive (dormant or terminated) initiatives.
Ischemic Stroke investigational medications classified by developmental phase, administration method, target receptor, monotherapy or combination therapy, distinct mechanism of action, and molecular classification.
Comprehensive analysis of partnerships (company-to-company collaborations and company-to-academia partnerships), licensing arrangements, and funding particulars for future progression of the Ischemic Stroke market.
Ischemic Stroke Pharmaceutical Firms
Ischemic Stroke Pharmaceutical Firms
Genentech, Supergene, Tasly Pharmaceutical, Pharmazz, GNT Pharma, NoNO, Angde Biotech Pharmaceutical, ZZ Biotech, Bristol-Myers Squibb, Athersys, Bayer Healthcare, NuvOx Pharma, Healios, Acticor Biotech, DiaMedica Therapeutics, Moleac, Biogen, Revalesio Corporation, and Shijiazhuang Yiling Pharmaceutical Co, among additional organizations.
The Ischemic Stroke pipeline analysis presents therapeutic evaluation of investigational medications by Administration Method. Products are classified under multiple administration routes including:
Oral Intravenous Subcutaneous Parenteral Topical
Ischemic Stroke products are classified under various molecular categories including:
Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy
Unveil the future of Ischemic Stroke Treatment. Learn about new drugs, pipeline developments, and key companies with DelveInsight's expert analysis - Ischemic Stroke Market Drivers and Barriers
Scope of the Ischemic Stroke Pipeline Analysis
Scope of the Ischemic Stroke Pipeline Analysis
Coverage: Global
Ischemic Stroke Pharmaceutical Firms: Genentech, Supergene, Tasly Pharmaceutical, Pharmazz, GNT Pharma, NoNO, Angde Biotech Pharmaceutical, ZZ Biotech, Bristol-Myers Squibb, Athersys, Bayer Healthcare, NuvOx Pharma, Healios, Acticor Biotech, DiaMedica Therapeutics, Moleac, Biogen, Revalesio Corporation, and Shijiazhuang Yiling Pharmaceutical Co, among additional organizations.
Ischemic Stroke Pipeline Investigational Treatments: Afamelanotide, Neflamapimod, Recombinant human urokinase, Alteplase, Aspirin, Ticagrelor, AX200 (G-CSF), Acetylsalicylic acid (ASA), Sovateltide, NXY-059, among others.
Ischemic Stroke Therapeutic Evaluation by Product Category: Monotherapy, Combination, Mono/Combination
Ischemic Stroke Therapeutic Evaluation by Clinical Phases: Discovery, Preclinical, Phase I, Phase II, Phase III
Get the latest on Ischemic Stroke Therapies and clinical trials. Download DelveInsight's in-depth pipeline report today! - Ischemic Stroke Companies, Key Products and Unmet Needs
Table of Contents
Table of Contents
Introduction
Executive Summary
Ischemic Stroke: Overview
Pipeline Therapeutics
Therapeutic Assessment
Ischemic Stroke– DelveInsight’s Analytical Perspective
Late Stage Products (Phase III)
BMS-986177: Bristol-Myers Squibb/ Johnson & Johnson Innovative Medicine
Drug profiles in the detailed report…..
Mid Stage Products (Phase II)
XY03 EA: Shijiazhuang Yiling Pharmaceutical Co. Ltd.
Drug profiles in the detailed report…..
Early Stage Products (Phase I)
hNPC01: Hopstem Biotechnology
Drug profiles in the detailed report…..
Preclinical and Discovery Stage Products
Drug name: Company name
Drug profiles in the detailed report…..
Inactive Products
Ischemic Stroke Key Companies
Ischemic Stroke Key Products
Ischemic Stroke- Unmet Needs
Ischemic Stroke- Market Drivers and Barriers
Ischemic Stroke- Future Perspectives and Conclusion
Ischemic Stroke Analyst Views
Ischemic Stroke Key Companies
Appendix
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