Acute Ischemic Stroke Pipeline 2025: Latest FDA Approvals, Clinical Trials, and Emerging Therapies Assessment by DelveInsight | Genentech, NoNO, Biogen, Avilex Pharma, SanBio, ZZ Biotech, Revalesio

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Acute Ischemic Stroke Pipeline 2025: Latest FDA Approvals, Clinical Trials, and Emerging Therapies Assessment by DelveInsight | Genentech, NoNO, Biogen, Avilex Pharma, SanBio, ZZ Biotech, Revalesio
(Las Vegas, Nevada, United States) As per DelveInsight’s assessment, globally, Acute Ischemic Stroke pipeline constitutes 20+ key companies continuously working towards developing 25+ Acute Ischemic Stroke treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

 

The Acute Ischemic Stroke Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

 

“Acute Ischemic Stroke Pipeline Insight, 2025“ report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Acute Ischemic Stroke Market.

 

Some of the key takeaways from the Acute Ischemic Stroke Pipeline Report:

  • Companies across the globe are diligently working toward developing novel Acute Ischemic Stroke treatment therapies with a considerable amount of success over the years.

  • Acute Ischemic Stroke companies working in the treatment market are Acticor Biotech, Athersys/Healios K.K., Bristol-Myers Squibb, Lumosa Therapeutics, Abbvie, and others, are developing therapies for the Acute Ischemic Stroke treatment

  • Emerging Acute Ischemic Stroke therapies in the different phases of clinical trials are- ST-01, AVLX 144, NTS-104, PP-007, UMSC01, NCS-01, LT3001, RNS60, BIIB131 (TMS007), 3K3A-APC, Nerinetide, Nelonemdaz, and others are expected to have a significant impact on the Acute Ischemic Stroke market in the coming years.

  • In May 2025, Results from the randomized ASSET-IT trial suggest that adding intravenous (IV) tirofiban to standard systemic thrombolysis within 4.5 hours of acute ischemic stroke onset enhances functional outcomes. An excellent recovery—defined as a modified Rankin Scale (mRS) score of 0–1—was seen in 65.9% of patients receiving tirofiban, compared to 54.9% in the placebo group (adjusted risk ratio 1.18; 95% CI: 1.06–1.31). Although there were more cases of symptomatic intracranial hemorrhage in the tirofiban group (seven vs. none), the overall incidence remained low at 1.7%.

  • In February 2025, Prolong Pharmaceuticals, LLC, a clinical-stage biopharmaceutical company, announced plans to present new clinical findings from its ongoing HEMERA-1 Phase 1 trial focused on acute ischemic stroke (AIS). The poster presentation will feature updates on the company’s lead candidate, PP-007, a PEGylated carboxyhemoglobin bovine therapy. Prolong recently concluded enrollment for Part 3 of the trial, representing a significant milestone in the development of the AIS program.

  • In February 2025, DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel therapies for severe ischemic conditions, has announced the peer-reviewed publication of a study titled “Recombinant human tissue kallikrein-1 for treating acute ischemic stroke and preventing recurrence” by Kasner et al. The study is currently available online and will be featured in the February 2025 edition of the journal Stroke.

  • In October 2024, Prolong Pharmaceuticals, LLC, a clinical-stage biopharmaceutical company, has announced that the FDA has granted Fast Track designation to its experimental treatment, PP-007 (PEGylated carboxyhemoglobin, bovine), for acute ischemic stroke (AIS). The therapy is currently being evaluated for safety and effectiveness in the ongoing U.S.-based clinical study, HEMERA-1.

  • In October 2024, Remedy Pharmaceuticals, a prominent company in stroke drug development, announced that the FDA’s Office of Orphan Products Division (OOPD) has awarded Orphan Drug Designation to CIRARA for the treatment of large territory acute ischemic stroke, including large hemispheric infarctions (LHI).

 

Acute Ischemic Stroke Overview

Acute ischemic stroke occurs when blood flow to a part of the brain is abruptly interrupted or significantly reduced, leading to a lack of oxygen and nutrients necessary for brain cells to function. This blockage is usually caused by a blood clot that has formed in an artery supplying the brain or has traveled from another part of the body.

 

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Emerging Acute Ischemic Stroke Drugs Under Different Phases of Clinical Development Include:

  • Glenzocimab (ACT017): Acticor Biotech

  • Nerinetide: NoNO

  • Invimestrocel (HLCM051): Athersys/Healios K.K.

  • BMS986177: Bristol-Myers Squibb

  • LT-3001: Lumosa Therapeutics

  • Elezanumab: Abbvie

  • MultiStem: Athersys/Healios K.K.

 

Acute Ischemic Stroke Route of Administration

Acute 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

 

Acute Ischemic Stroke Molecule Type

Acute Ischemic Stroke Products have been categorized under various Molecule types, such as

  • Recombinant fusion proteins

  • Small molecule

  • Monoclonal antibody

  • Peptide

  • Polymer

  • Gene therapy

 

Acute Ischemic Stroke Pipeline Therapeutics Assessment

  • Acute Ischemic Stroke Assessment by Product Type

  • Acute Ischemic Stroke By Stage and Product Type

  • Acute Ischemic Stroke Assessment by Route of Administration

  • Acute Ischemic Stroke By Stage and Route of Administration

  • Acute Ischemic Stroke Assessment by Molecule Type

  • Acute Ischemic Stroke by Stage and Molecule Type

 

DelveInsight’s Acute Ischemic Stroke Report covers around 25+ products under different phases of clinical development like

  • Late-stage products (Phase III)

  • Mid-stage products (Phase II)

  • Early-stage product (Phase I)

  • Pre-clinical and Discovery stage candidates

  • Discontinued & Inactive candidates

  • Route of Administration

 

Further Acute Ischemic Stroke product details are provided in the report. Download the Acute Ischemic Stroke pipeline report to learn more about the emerging Acute Ischemic Stroke therapies

 

Some of the key companies in the Acute Ischemic Stroke Therapeutics Market include:

Key companies developing therapies for Acute Ischemic Stroke are – Genentech, Inc., NoNO Inc., Pharming Technologies B.V., Biogen, Avilex Pharma, SanBio, ZZ Biotech, Revalesio, Stemedica Cell Technologies, StemCyte, Ninnion, Athersys, Inc., Tarveda Therapeutics, Lumosa Therapeutics, NC Medial Research Inc, Acticor Biotech, Meridigen Biotech Co., Prolong Pharmaceuticals, Nanjing Yoko Biomedical Co., Ltd., TrueBinding, Inc., GNT Pharma, Roche, DiaMedica Therapeutics Inc, aptaTargets, Bristol-Myers Squibb, NuvOX Pharma, Simcere Pharmaceutical Co., Ltd., Algernon Pharmaceuticals, Primary Peptides, TMS, Tasly Pharmaceutical, Pharmazz and others.

 

Acute Ischemic Stroke Pipeline Analysis:

The Acute Ischemic Stroke pipeline report provides insights into

  • The report provides detailed insights about companies that are developing therapies for the treatment of Acute Ischemic Stroke with aggregate therapies developed by each company for the same.

  • It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Acute Ischemic Stroke Treatment.

  • Acute Ischemic Stroke key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.

  • Acute Ischemic Stroke Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.

  • Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Acute Ischemic Stroke market.

The report is built using data and information traced from the researcher’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

 

Download Sample PDF Report to know more about Acute Ischemic Stroke drugs and therapies

 

Acute Ischemic Stroke Pipeline Market Drivers

  • Rising incidence of Acute Ischemic Stroke, increasing prevalence of lifestyle associated disorders such as diabetes and hypertension, rising geriatric population are some of the important factors that are fueling the Acute Ischemic Stroke Market.

 

Acute Ischemic Stroke Pipeline Market Barriers

  • However, challenges associated with the clinical research, challenges associated with the diagnosis of Acute Ischemic Stroke and other factors are creating obstacles in the Acute Ischemic Stroke Market growth.

 

Scope of Acute Ischemic Stroke Pipeline Drug Insight

  • Coverage: Global

  • Key Acute Ischemic Stroke Companies: Acticor Biotech, Athersys/Healios K.K., Bristol-Myers Squibb, Lumosa Therapeutics, Abbvie, and others

  • Key Acute Ischemic Stroke Therapies: ST-01, Glenzocimab (ACT017), Nerinetide, Invimestrocel (HLCM051), MultiStem, BMS986177, LT-3001, Elezanumab and others

  • Acute Ischemic Stroke Therapeutic Assessment: Acute Ischemic Stroke current marketed and Acute Ischemic Stroke emerging therapies

  • Acute Ischemic Stroke Market Dynamics: Acute Ischemic Stroke market drivers and Acute Ischemic Stroke market barriers

 

Request for Sample PDF Report for Acute Ischemic Stroke Pipeline Assessment and clinical trials

 

Table of Contents

1. Acute Ischemic Stroke Report Introduction

2. Acute Ischemic Stroke Executive Summary

3. Acute Ischemic Stroke Overview

4. Acute Ischemic Stroke- Analytical Perspective In-depth Commercial Assessment

5. Acute Ischemic Stroke Pipeline Therapeutics

6. Acute Ischemic Stroke Late Stage Products (Phase II/III)

7. Acute Ischemic Stroke Mid Stage Products (Phase II)

8. Acute Ischemic Stroke Early Stage Products (Phase I)

9. Acute Ischemic Stroke Preclinical Stage Products

10. Acute Ischemic Stroke Therapeutics Assessment

11. Acute Ischemic Stroke Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Acute Ischemic Stroke Key Companies

14. Acute Ischemic Stroke Key Products

15. Acute Ischemic Stroke Unmet Needs

16 . Acute Ischemic Stroke Market Drivers and Barriers

17. Acute Ischemic Stroke Future Perspectives and Conclusion

18. Acute Ischemic Stroke Analyst Views

19. Appendix

20. About DelveInsight

 

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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