Multiple Sclerosis Clinical Trial Pipeline

Major pharmaceutical companies are working to advance the pipeline space and unlock the future growth potential of the Multiple Sclerosis treatment landscape.

LAS VEGAS , NV, UNITED STATES, February 13, 2025 /EINPresswire.com/ -- DelveInsight’s 'Multiple Sclerosis Pipeline Insight 2024' report provides comprehensive global coverage of pipeline Multiple Sclerosis therapies in various stages of clinical development. Major pharmaceutical companies are working to advance the pipeline space and future growth potential of the Multiple Sclerosis pipeline domain.

For Multiple Sclerosis emerging drugs, the Multiple Sclerosis pipeline analysis report provides a 360° view of the therapeutics landscape by development point, product type, route of administration, molecule type, and MOA. The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.

Key Takeaways from the Multiple Sclerosis Pipeline Report
• DelveInsight’s Multiple Sclerosis Pipeline analysis depicts a robust space with 75+ active players working to develop 80+ pipeline drugs for Multiple Sclerosis treatment.
• The leading Multiple Sclerosis companies include Immune Response BioPharma, Inc., Clene Nanomedicine, Sanofi, Merck Healthcare KGaA, TG Therapeutics, Inc., Apimeds Inc., Bayer HealthCare, Novartis, Biogen, Alkermes, Genentech, and others are evaluating their lead assets to improve the Multiple Sclerosis treatment landscape.
• Key Multiple Sclerosis pipeline therapies in various stages of development include IMU-838, BIIB091, NeuroVax, IMCY-0141, CNM-Au8, IMS001, Fenebrutinib (GDC-0853, RG7845), and others.
• In December 2024, Sanofi announced that the U.S. FDA granted Breakthrough Therapy designation to tolebrutinib for the treatment of non-relapsing secondary progressive multiple sclerosis (nrSPMS), following positive results from the HERCULES phase 3 study, showing potential in delaying disability progression.
• In October 2024, SetPoint Medical received Investigational Device Exemption (IDE) approval from the FDA to study its proprietary neuroimmune modulation platform in individuals with relapsing-remitting multiple sclerosis (RRMS).
• In September 2024, Roche announced FDA approval for OCREVUS ZUNOVO™ (ocrelizumab & hyaluronidase-ocsq) for relapsing and primary progressive multiple sclerosis (MS). This first subcutaneous injection for both forms of MS is administered by a healthcare professional twice a year in about 10 minutes, offering expanded treatment options.

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Multiple Sclerosis Overview
Multiple sclerosis (MS) is the most common neurological disorder in young adults, typically presenting between the ages of 20 and 40. MS targets the axons in the central nervous system, which are protected by myelin (white matter). The most common form of MS is relapsing-remitting MS, affecting about 85% of those diagnosed. This form is characterized by flare-ups (relapses or exacerbations) of symptoms, followed by periods of remission where symptoms improve or disappear. Some individuals with relapsing-remitting MS experience frequent symptoms triggered by specific factors. Exacerbations, which last at least 24 hours, are sudden intensifications or new appearances of MS symptoms, often linked to the development of new damage in the brain.

Early MS symptoms include vision issues (blurred or double vision, optic neuritis causing eye pain and rapid vision loss), muscle weakness (often in the hands and legs), muscle stiffness, painful spasms, tingling, numbness, or pain in the arms, legs, trunk, or face, clumsiness and balance problems, bladder control issues, and dizziness.

The main cause of MS damage is inflammation in the central nervous system. The exact cause of this inflammation remains unknown, but studies suggest that genetic, environmental, and infectious factors may contribute to the development of MS. Immunological studies using animal models of MS (experimental autoimmune encephalomyelitis or EAE) have provided insights into the condition. The innate immune response, triggered by microbial products activating specific receptors (such as Toll-like receptors), and regulatory T cells (Tregs), play a role in MS. Environmental factors, including exposure to infections and sunlight/vitamin D, can influence MS risk, particularly when individuals move between risk areas before age 15.

Diagnosing MS involves evaluating medical history, physical exams, MRI scans, evoked potentials, and CSF/blood tests, while excluding other possible causes for the symptoms. MRI scans of the brain and spinal cord are used to detect characteristic MS lesions, and a lumbar puncture (spinal tap) may be performed to analyze cerebrospinal fluid for proteins and inflammatory cells associated with MS.

MS treatment focuses on two areas: disease-modifying therapies (DMT) to address the immune dysfunction and therapies to manage symptoms. The European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) have approved 12 medications for MS treatment.

Find out more about Multiple Sclerosis medication @ https://www.delveinsight.com/report-store/multiple-sclerosis-pipeline-insight?utm_source=einpresswire&utm_medium=pressrelease&utm_campaign=jpr

Multiple Sclerosis Treatment Analysis: Drug 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.

Key Multiple Sclerosis Therapies and Companies
• CNM-Au8: Clene Nanomedicine
• IMS001: ImStem Biotechnology
• Fenebrutinib (GDC-0853, RG7845): Hoffmann-La Roche
• IMU-838: Immunic Therapeutics
• BIIB091: Biogen
• IMCY-0141: ImCyse
• NeuroVax: Immune Response BioPharma

Learn more about the novel and emerging Multiple Sclerosis pipeline therapies @ https://www.delveinsight.com/report-store/multiple-sclerosis-pipeline-insight?utm_source=einpresswire&utm_medium=pressrelease&utm_campaign=jpr

Multiple Sclerosis 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
• Parenteral
• Intravitreal
• Subretinal
• Topical.

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

Scope of the Multiple Sclerosis Pipeline Report
• Coverage: Global
• Key Multiple Sclerosis Companies: Immune Response BioPharma, Inc., Clene Nanomedicine, Sanofi, Merck Healthcare KGaA, TG Therapeutics, Inc., Apimeds Inc., Bayer HealthCare, Novartis, Biogen, Alkermes, Genentech, and others.
• Key Multiple Sclerosis Pipeline Therapies: IMU-838, BIIB091, NeuroVax, IMCY-0141, CNM-Au8, IMS001, Fenebrutinib (GDC-0853, RG7845), and others.

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Table of Contents
1. Introduction
2. Executive Summary
3. Multiple Sclerosis Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Multiple Sclerosis Pipeline Therapeutics
6. Multiple Sclerosis Pipeline: Late-Stage Products (Phase III)
7. Multiple Sclerosis Pipeline: Late-Stage Products (Phase III)
8. Multiple Sclerosis Pipeline: Mid-Stage Products (Phase II)
9. Multiple Sclerosis 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

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. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.

Jatin Vimal
DelveInsight Business Research LLP
+1 469-945-7679
info@delveinsight.com

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