Ischemic Stroke Clinical Trials 2025: Tenecteplase FDA Approval, Thrombectomy Upgrades, and Neuroprotection/Recovery Programs Drive Momentum

DelveInsight's "Ischemic Stroke - Clinical Trials, 2025" captures a rapidly evolving landscape in which improvements in acute reperfusion (thrombolysis and endovascular thrombectomy), adjunctive neuroprotection, and post-stroke recovery technologies are converging to reduce disability. In early 2025 the FDA approved tenecteplase (TNK) for acute ischemic stroke - a single-bolus thrombolytic that simplifies IV thrombolysis and may improve workflow and reperfusion outcomes compared with alteplase.

Endovascular device innovation continues in parallel: updated generation thrombectomy systems (recent 510(k) clearances for devices such as the pRESET Delta family) and refinements in aspiration/guide technologies aim to boost first-pass reperfusion and expand treatment windows.

Beyond reperfusion, active clinical research is intensifying around neuroprotective agents and adjunctive strategies delivered during or after thrombectomy, and on restorative technologies (including neuromodulation) to improve long-term functional recovery. Recent reviews and trial reports through 2024-2025 highlight neuroprotection and optimized microvascular reperfusion as the next frontiers for reducing post-stroke disability.

Interested in learning more about the current treatment landscape and the key drivers shaping the ischemic stroke pipeline? Click here: https://www.delveinsight.com/report-store/ischemic-stroke-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Takeaways from the Ischemic Stroke Pipeline Report
• DelveInsight's ischemic stroke pipeline analysis depicts a robust space with 50+ active players working to develop 55+ pipeline drugs for ischemic stroke treatment.
• The leading ischemic stroke companies 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, Shijiazhuang Yiling Pharmaceutical Co. Ltd., and others are evaluating their lead assets to improve the ischemic stroke treatment landscape.
• Key ischemic stroke pipeline therapies in various stages of development include 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, and others.
• In July 2025, Revalesio announced that the FDA granted Fast Track designation to RNS60, its investigational therapy for acute ischemic stroke. This aims to speed up development and review of RNS60, which may protect brain tissue even after blood flow restoration, addressing a key gap in stroke treatment.
• In July 2025, Revalesio announced that the FDA granted Fast Track designation to RNS60, its investigational therapy for acute ischemic stroke. This status aims to speed development and review of RNS60, which may protect brain tissue even after blood flow is restored, addressing a significant gap in stroke care.
• In July 2025, Imperative Care received FDA 510(k) clearance for its Zoom 7X Catheter, a new tool for aspiration thrombectomy in ischemic stroke. As part of the Zoom Stroke System, the catheter features CenTRXTM Technology with a 96-degree pre-shaped tip designed to center in vessels and improve clot removal by optimizing aspiration in challenging anatomy.
• In March 2025, Perfuze, a leading medical device company dedicated to advancing stroke treatment, announced that it received FDA 510(k) clearance for its ZiplineTM Access Catheters. This regulatory milestone strengthens Perfuze's growing portfolio of innovative neurovascular devices, empowering physicians to treat acute ischemic strokes with greater speed, ease, and precision. In addition, Perfuze has secured €22 million in follow-on funding
• In March 2025, the U.S. Food and Drug Administration approved TNKase (tenecteplase), a thrombolytic agent, for the treatment of acute ischemic stroke in adults.
• In February 2025, Vena Medical announced that the FDA has granted Breakthrough Device designation for its MicroAngioscope, marking a "historic leap forward" in neurovascular care and stroke treatment.

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Ischemic Stroke Overview
Ischemic stroke occurs when a blood clot or other obstruction blocks blood flow to the brain, depriving brain tissue of oxygen and nutrients. It accounts for approximately 85% of all stroke cases. The most common causes include atherosclerosis, cardioembolism (e.g., from atrial fibrillation), and small vessel disease. Symptoms typically appear suddenly and may include weakness on one side of the body, difficulty speaking or understanding speech, vision problems, and loss of coordination. Rapid diagnosis and treatment are critical, as brain cells begin to die within minutes.

Treatment focuses on restoring blood flow, often through clot-dissolving drugs like tPA (tissue plasminogen activator), or mechanical thrombectomy. Long-term management includes antiplatelet or anticoagulant therapy, blood pressure and cholesterol control, rehabilitation, and lifestyle changes to reduce recurrence risk. Emerging therapies are targeting neuroprotection, vascular repair, and inflammation, offering hope for better recovery outcomes.

Find out more about ischemic stroke medication @ https://www.delveinsight.com/report-store/ischemic-stroke-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Ischemic Stroke Treatment Analysis: Drug Profile
BMS-986177 (Milvexian) - Bristol-Myers Squibb / Johnson & Johnson
Milvexian (BMS-986177) is an investigational oral anticoagulant targeting Factor XIa, a key enzyme in the intrinsic coagulation pathway. By inhibiting FXIa, Milvexian aims to reduce stroke risk with a potentially lower bleeding profile. Developed jointly by Bristol-Myers Squibb and Johnson & Johnson, the drug is currently in Phase III clinical trials for the treatment of ischemic stroke.

XY03 EA - Shijiazhuang Yiling Pharmaceutical Co. Ltd.
XY03 EA is an experimental therapy aimed at treating acute ischemic stroke, currently in Phase II/III trials. In preclinical studies, it demonstrated neuroprotective effects by increasing cerebral blood flow, enhancing brain energy metabolism, reducing oxidative stress, suppressing inflammation, and inhibiting autophagy. In both rodent and primate stroke models, XY03 EA showed a dose-dependent reduction in neurological damage and infarct size.

NONO-42 - NoNO Inc.
NONO-42 is a next-generation analog of nerinetide developed for use in acute ischemic stroke, with or without thrombolytic therapy. Unlike its predecessor, NONO-42 is designed to be compatible with thrombolytics, expanding its potential use to a broader stroke patient population. It is currently in Phase II development for providing neuroprotection and supporting brain recovery in acute stroke cases.

Learn more about the novel and emerging ischemic stroke pipeline therapies @ https://www.delveinsight.com/report-store/ischemic-stroke-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Ischemic Stroke Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• 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

By Route of Administration
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

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

Scope of the Ischemic Stroke Pipeline Report
• Coverage: Global
• Key Ischemic Stroke Companies: 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., and others.
• Key Ischemic Stroke Pipeline Therapies: 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, and others.

Dive deep into rich insights for drugs used for ischemic stroke treatment; visit @ https://www.delveinsight.com/report-store/ischemic-stroke-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. Ischemic Stroke Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Ischemic Stroke Pipeline Therapeutics
6. Ischemic Stroke Pipeline: Late-Stage Products (Phase III)
7. Ischemic Stroke Pipeline: Late-Stage Products (Phase III)
8. Ischemic Stroke Pipeline: Mid-Stage Products (Phase II)
9. Ischemic Stroke Pipeline: Early Stage Products (Phase I)
10. Therapeutic Assessment
11. Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Key Companies
14. Key Products
15. Unmet Needs
16. Market Drivers and Barriers
17. Future Perspectives and Conclusion
18. Analyst Views
19. Appendix

Contact Us:
Jatin Vimal
jvimal@delveinsight.com
+14699457679
Healthcare Consulting
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About DelveInsight
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This release was published on openPR.