Multiple sclerosis Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies | Novartis, Sanofi, Immunic, Biocad, Apimeds, Genentech (Roche), Merck, AB Science, Apurano Pharmaceuticals, Biogen, Tiziana L

DelveInsight's, "Multiple sclerosis Pipeline Insight 2025" report provides comprehensive insights about 75+ companies and 80+ pipeline drugs in Multiple sclerosis 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.

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Key Takeaways from the Multiple Sclerosis Pipeline Report
• In March 2025, Novartis Pharmaceuticals announced a study is divided into a Core Part and Extension Part. The Core Part is a 24-month, double-blind, triple, randomized, 3-arm active-controlled in children/adolescent patients aged 10-17 years old with Multiple Sclerosis (MS). The Extension Part is 60-month (5 year) open label (except for first 12 weeks transition which will remain double-blind) treatment for patients who complete the Core Part of the study and meet all inclusion/exclusion criteria.
• In March 2025, Hoffmann-La Roche announced a study Evaluating the Patient Perspective of the Physical Impact of Multiple Sclerosis and Providing Continued Access to Ocrelizumab in Patients With Multiple Sclerosis Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Study and Without Access to a Post-Trial Access Program
• In January 2025:- Novartis Pharmaceuticals:- The study is divided into a Core Part and Extension Part. The Core Part is a 24-month, double-blind, triple, randomized, 3-arm active-controlled in children/adolescent patients aged 10-17 years old with Multiple Sclerosis (MS). The Extension Part is 60-month (5 year) open label (except for first 12 weeks transition which will remain double-blind) treatment for patients who complete the Core Part of the study and meet all inclusion/exclusion criteria.
• In January 2025:- Sanofi:- The purpose of this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy of frexalimab in delaying the disability progression and the safety up to approximately 51 months administration of study intervention compared to placebo in male and female participants with nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with nrSPMS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include:
• In January 2025:- Hoffmann-La Roche:- An Open-Label, Multicenter Extension Study Evaluating the Patient Perspective of the Physical Impact of Multiple Sclerosis and Providing Continued Access to Ocrelizumab in Patients With Multiple Sclerosis Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Study and Without Access to a Post-Trial Access Program.
• DelveInsight's Multiple Sclerosis pipeline report depicts a robust space with 75+ active players working to develop 80+ pipeline therapies for Multiple Sclerosis treatment.
• The leading Multiple Sclerosis Companies such as Novartis, Sanofi, Immunic, Biocad, Apimeds, Genentech (Roche), Merck, AB Science, Apurano Pharmaceuticals, Biogen, Tiziana Life Sciences, Worg Pharmaceuticals, Antisense Therapeutics, RemeGen, Atara Biotherapeutics, Contineum Therapeutics, Stem Cell Medicine Ltd., Ever Supreme Bio Technology Co., Ltd., and ImCyse and others.
• Promising Multiple Sclerosis Therapies such as 11C-BMS-986196, ofatumumab, Fingolimod, Siponimod, elezanumab, Alemtuzumab, Tecfidera, and others.

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Multiple sclerosis Emerging Drugs Profile

• IMU-838: Immunic Therapeutics
Vidofludimus calcium (IMU-838) is a small molecule investigational drug under development as an oral tablet formulation for the treatment of relapsing-remitting multiple sclerosis, or RRMS, inflammatory bowel disease, or IBD, and other chronic inflammatory and autoimmune diseases. Bolstered by excellent clinical data from the phase II EMPhASIS trial, Immunic believed that vidofludimus calcium has the potential to demonstrate medically important advantages compared with other treatments, particularly for the early treatment of RMS patients, due to its placebo like safety profile and its robust anti-inflammatory and neuroprotective properties.

• BIIB091: Biogen
BIIB091 selectively inhibits Burton's tyrosine kinase (BTK), a non-receptor tyrosine kinase that regulates the development and signaling of B cells and myeloid cells hypothesized to contribute to MS pathogenesis. In addition, BTK has been demonstrated to play a key role in the activation of another cell of the immune system, the myeloid cells via another receptor of this cell (Fcγ receptor signaling (FcγRs)). Preclinical studies demonstrated BIB091 to be a high potency molecule with good drug-like properties and a safety/tolerability profile suitable for clinical development as a highly selective, reversible BTKi for treating autoimmune diseases such as MS. Currently, the drug is in the Phase II stage of its development for the treatment of Multiple sclerosis.

• IMCY-0141: ImCyse
IMCY-0141 is the Company's second clinical-stage compound. This Imotope is designed based on MOG (Myelin Oligodendrocyte Glycoprotein) with the aim to halt the progression of multiple sclerosis (MS) by stopping the body's immune system from attacking the central nervous system and disrupting undesirable autoimmune responses that drive the destruction of the myelin sheath protecting the nerves. IMCY-0141 has shown promising results in several MS preclinical models, demonstrating an immune response that supports the proposed mode of action and inducing a memory response so that the treatment effect is long-lasting and requires less frequent dosing regimens. Also, if treatment is begun early enough, it has the potential to allow patients to live with minimal impact from the disease. Currently, the drug is in Phase I/II stage of its clinical trial for the treatment of multiple sclerosis.

• NeuroVax: Immune Response BioPharma
NeuroVax contains a combination of three protein fragments (peptides) which appear on the surface of T-cells involved in the immune response in MS. Studies suggested that treatment with NeuroVax stimulates production of certain regulatory T-cells, which in turn decrease the levels of other T-cells which attack myelin. NeuroVax is a Once a Month Dosing injection, safe, tolerable, enhances FOXP3+ Tregs & Regulates Pathogenic T Cells in MS Patients, a first in class disease modifying Multiple Sclerosis Vaccine. NeuroVax IR has been shown to stimulate strong, disease-specific cell-mediated immunity in nearly all treated patients. NeuroVax appears to work in part by enhancing levels of Foxp3+ Tregs, which may help regulate expression of pathogenic T cells in MS patients. The three TCR peptides combined in it correspond to one or more TCR gene families which are over expressed in 90% of MS patients.

Learn more about Multiple Sclerosis Drugs opportunities in our groundbreaking Multiple Sclerosis research and development projects @ Multiple Sclerosis Unmet Needs- https://www.delveinsight.com/sample-request/multiple-sclerosis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Multiple Sclerosis Companies
Novartis, Sanofi, Immunic, Biocad, Apimeds, Genentech (Roche), Merck, AB Science, Apurano Pharmaceuticals, Biogen, Tiziana Life Sciences, Worg Pharmaceuticals, Antisense Therapeutics, RemeGen, Atara Biotherapeutics, Contineum Therapeutics, Stem Cell Medicine Ltd., Ever Supreme Bio Technology Co., Ltd., and ImCyse and others.

Multiple sclerosis 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

Multiple Sclerosis Products have been categorized under various Molecule types such as
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Discover the latest advancements in Multiple Sclerosis treatment by visiting our website. Stay informed about how we're transforming the future of neurology @ Multiple Sclerosis Market Drivers and Barriers, and Future Perspectives- https://www.delveinsight.com/sample-request/multiple-sclerosis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Scope of the Multiple Sclerosis Pipeline Report
• Coverage- Global
• Multiple Sclerosis Companies- Novartis, Sanofi, Immunic, Biocad, Apimeds, Genentech (Roche), Merck, AB Science, Apurano Pharmaceuticals, Biogen, Tiziana Life Sciences, Worg Pharmaceuticals, Antisense Therapeutics, RemeGen, Atara Biotherapeutics, Contineum Therapeutics, Stem Cell Medicine Ltd., Ever Supreme Bio Technology Co., Ltd., and ImCyse and others.
• Multiple Sclerosis Therapies- 11C-BMS-986196, ofatumumab, Fingolimod, Siponimod, elezanumab, Alemtuzumab, Tecfidera, and others.
• Multiple Sclerosis Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
• Multiple Sclerosis Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

For a detailed overview of our latest research findings and future plans, read the full details of Multiple Sclerosis Pipeline on our website @ Multiple Sclerosis Emerging Drugs and Companies- https://www.delveinsight.com/sample-request/multiple-sclerosis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Table of Content
1. Introduction
2. Executive Summary
3. Multiple sclerosis: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. Multiple sclerosis - DelveInsight's Analytical Perspective
7. Late Stage Products (Phase III)
8. IMU-838: Immunic Therapeutics
9. Drug profiles in the detailed report.....
10. Mid Stage Products (Phase II)
11. BIIB091: Biogen
12. Drug profiles in the detailed report.....
13. Early Stage Products (Phase I)
14. NeuroVax: Immune Response BioPharma
15. Drug profiles in the detailed report.....
16. Preclinical and Discovery Stage Products
17. Drug name: Company name
18. Drug profiles in the detailed report.....
19. Inactive Products
20. Multiple sclerosis Key Companies
21. Multiple sclerosis Key Products
22. Multiple sclerosis- Unmet Needs
23. Multiple sclerosis- Market Drivers and Barriers
24. Multiple sclerosis- Future Perspectives and Conclusion
25. Multiple sclerosis Analyst Views
26. Multiple sclerosis Key Companies
27. Appendix

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