Ischemic Stroke - Pipeline Insight, 2025

This “Ischemic Stroke- Pipeline Insight, 2025” report provides comprehensive insights about 50+ companies and 55+ pipeline drugs in Ischemic Stroke pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Ischemic Stroke: Understanding

Ischemic Stroke: Overview

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 retina1 and represents ~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.

The etiology of ischemic stroke is due to either a thrombotic or embolic event that causes a decrease in blood flow to the brain. In a thrombotic event, the blood flow to the brain is obstructed within the blood vessel due to dysfunction within the vessel itself, usually secondary to atherosclerotic disease, arterial dissection, fibromuscular dysplasia, or inflammatory condition. In an embolic event, debris from elsewhere in the body blocks blood flow through the affected vessel. The etiology of stroke affects both prognosis and outcomes.

For the diagnosis, blood tests may be used to check your overall health. The blood's ability to clot will also be tested. Blood tests may include a check for diabetes. Diabetes increases the risk for a stroke. CT or MRI pictures may show where the stroke happened and any damage to the brain. Additionally, an arteriography is used to take x-rays of your arteries to look for blood flow blockage.

Current optimal management of patients with ischaemic stroke occurs in geographically defined stroke units with an experienced interdisciplinary team of physicians, nurses and allied health clinicians, using best-evidence stroke guidelines, which includes intravenous thrombolysis and/or endovascular thrombectomy. Intravenous thrombolysis reduces disability when administered within 4.5h of stroke onset (defined as the time from when the patient with a stroke was last known to be healthy)6, although selected patients with favourable brain perfusion imaging benefit up to 9 h or after wake-up-onset stroke (that is, stroke symptoms upon waking that were not present before sleep).

Endovascular thrombectomy (that is, mechanical clot retrieval via catheter angiography) reduces disability in a broad group of patients with large vessel occlusion when performed within 6 h of the time the patient with a stroke was last known to be healthy and, in patients selected using brain perfusion imaging, up to 24h after stroke onset. However, both intravenous thrombolysis and endovascular thrombectomy are time-critical, and health system engineering to accelerate treatment remains one of the key challenges to maximizing the benefits of these therapies.

'Ischemic Stroke- Pipeline Insight, 2025' report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Ischemic Stroke pipeline landscape is provided which includes the disease overview and Ischemic Stroke treatment guidelines. The assessment part of the report embraces, in depth Ischemic Stroke commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Ischemic Stroke collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Ischemic Stroke R&D. The therapies under development are focused on novel approaches to treat/improve Ischemic Stroke.

Ischemic Stroke Emerging Drugs Chapters

This segment of the Ischemic Stroke report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Ischemic Stroke Emerging Drugs

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 drug is being developed by Bristol-Myers Squibb in collaboration with Johnson & Johnson. Currently the product is in Phase III stage of development for treatment of Ischemic Stroke.

XY03 EA: Shijiazhuang Yiling Pharmaceutical Co. Ltd.

XY03 EA, is an investigational drug being developed 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. Currently the drug is in Phase II stage of Clinical trial evaluation for the treatment of Acute Ischemic Stroke.

NONO-42: NoNO Inc.

NoNO-42 is a nerinetide analog intended for use in people experiencing an acute ischemic stroke with or without thrombolytics. Of the 650,000 people 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 neuroprotection and neurorestoration to all hospital treated strokes. Currently, the drug is in Phase II stage of its development for the treatment of 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 treating 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. Currently, the drug is in Phase II stage of its development for the treatment of acute ischemic stroke.

Ischemic Stroke: Therapeutic Assessment

This segment of the report provides insights about the different Ischemic Stroke drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Ischemic Stroke

• There are approx. 50+ key companies which are developing the therapies for Ischemic Stroke. The companies which have their Ischemic Stroke drug candidates in the most advanced stage, i.e. Phase III include, Bristol-Myers Squibb/ Johnson & Johnson Innovative Medicine.

Phases

The report covers around 55+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

Ischemic Stroke pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Ischemic Stroke: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Ischemic Stroke therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Ischemic Stroke drugs.

Ischemic Stroke Report Insights

• Ischemic Stroke Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Ischemic Stroke Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Ischemic Stroke drugs?
• How many Ischemic Stroke drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Ischemic Stroke?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Ischemic Stroke therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Ischemic Stroke and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• 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
• Shijiazhuang Yiling Pharmaceutical Co. Ltd.

Key Products

• Tenecteplase
• Recombinant staphylokinase
• Prourokinase recombinant
• Sovateltide
• Nelonemdaz
• Nerinetide
• Reteplase
• 3K3A-APC
• BMS-986177
• MultiStem
• BAY2433334
• DDFPe
• Invimestrocel
• Glenzocimab
• DM199
• MLC1501
• BIIB 131
• RNS60
• XY03 EA
• NONO-42

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