Multiple Sclerosis Pipeline 2025: MOA, ROA, FDA-Approved Drugs, and Clinical Trial Progress Assessment by DelveInsight | Biogen, Immune Response BioPharma, Celgene, Novartis, Sanofi, Actelion, Bayer

(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Multiple Sclerosis pipeline constitutes 75+ key companies continuously working towards developing 80+ Multiple Sclerosis treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

The Multiple Sclerosis 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.

"Multiple Sclerosis Pipeline Insight, 2025 [https://www.delveinsight.com/sample-request/multiple-sclerosis-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Multiple Sclerosis Market.

Some of the key takeaways from the Multiple Sclerosis Pipeline Report:

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Companies across the globe are diligently working toward developing novel Multiple Sclerosis treatment therapies with a considerable amount of success over the years.

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Multiple Sclerosis companies working in the treatment market are Biogen, Immune Response BioPharma, ImCyse, Atara Biotherapeutics, Emerald Health Pharmaceuticals, Sanofi, RemeGen, Gossamer Bio, 4D Pharma, HuniLife Biotechnology, Anokion, GSK plc, GeNeuro, Immunic Therapeutics, Sanofi, Hoffman-La-Roche, and others, are developing therapies for the Multiple Sclerosis treatment

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Emerging Multiple Sclerosis therapies in the different phases of clinical trials are- BIIB091, NeuroVax, IMCY-0141, ATA188, EHP-101, SAR441344, RC18, GB7208, MRx0002, HuL001, ANK-700, GSK3888130, Temelimab, IMU-838, Tolebrutinib, Fenebrutinib, and others are expected to have a significant impact on the Multiple Sclerosis market in the coming years.

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In June 2025, Ashvattha Therapeutics announced at the SNMMI Annual Meeting that its nanomedicines can be tailored to visualize neuroinflammation in patients with Multiple Sclerosis.

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In June 2025, IASO Bio showcased encouraging results of Equecabtagene Autoleucel in Multiple Sclerosis patients from an IIT study during the 11th Congress of the EAN.

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In June 2025, Telomir Pharmaceuticals announced that Telomir-1 resets the body's epigenetic clock, reverses DNA methylation, and restores gene regulation in patients with Werner Syndrome.

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In May 2025, TG Therapeutics announced upcoming data presentations on BRIUMVI for Multiple Sclerosis at the 2025 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting.

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In May 2025, Immunic announced plans to proceed with the development of its multiple sclerosis (MS) candidate, vidofludimus calcium (IMU-838), despite its Phase II trial not meeting the primary endpoint. Preliminary results from the ongoing CALLIPER study (NCT05054140) revealed a modest advantage in an exploratory MRI-based primary endpoint, showing a 5% annualized reduction in brain volume loss compared to placebo.

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In March 2025, The U.S. FDA has granted Priority Review to Sanofi's regulatory submission for tolebrutinib, following positive outcomes from the Phase III HERCULES (NCT04411641), GEMINI 1 (NCT04410978), and GEMINI 2 (NCT04410991) trials. The submission seeks approval for the treatment of non-relapsing secondary progressive multiple sclerosis (nrSPMS) and aims to reduce disability progression unrelated to relapse activity in adults.

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In February 2025, Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) announced today the completion of its trial titled "A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of Lucid-21-302 in Healthy Adult Participants." Following the trial, a final safety review committee (SRC) meeting concluded that Lucid-21-302 (Lucid-MS) was well-tolerated, with no safety concerns and no serious adverse events reported. Lucid-MS is a first-in-class, non-immunomodulatory, neuroprotective compound being developed for the treatment of multiple sclerosis (MS)

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In January 2025, Pheno Therapeutics received clinical trial authorization (CTA) from the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) for its small-molecule therapy, PTD802. This approval paves the way for the first-in-human trial of PTD802, a selective G protein-coupled receptor 17 (GPR17) antagonist, designed to promote remyelination in patients with neurological disorders, particularly multiple sclerosis (MS).

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In January 2025, Contineum Therapeutics, Inc. (NASDAQ: CTNM), a clinical-stage biopharmaceutical company specializing in innovative therapies for neuroscience, inflammation, and immunology (NI&I) conditions, announced the successful completion of targeted enrollment for its Phase 2 PIPE-307 VISTA trial. A total of 168 patients have been enrolled in the study, which is evaluating PIPE-307, a potentially first-in-class M1 receptor antagonist, as a treatment for relapsing-remitting multiple sclerosis (RRMS).

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In September 2024, Roche presented additional data from a Phase II study of its Bruton's tyrosine kinase (BTK) inhibitor, revealing nearly complete disease suppression in patients with relapsing multiple sclerosis (RMS) based on long-term findings. The company shared 48-week data for fenebrutinib from the FENopta open-label extension (OLE) study (NCT05119569), which followed a 12-week double-blind Phase II trial. This update comes shortly after Sanofi reported mixed results for its BTK inhibitor, tolebrutinib, where the HERCULES trial met its primary endpoint, but the two GEMINI trials did not.

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In September 2024, Sanofi has revealed the results of its Phase III clinical trials for the investigational oral brain-penetrant BTK inhibitor, tolebrutinib, which is being developed for the treatment of multiple sclerosis (MS). The trials, known as HERCULES, GEMINI 1, and GEMINI 2, yielded mixed outcomes; while the HERCULES trial achieved its primary endpoint, the GEMINI trials did not. The HERCULES study specifically evaluated the efficacy and safety of tolebrutinib in patients with non-relapsing secondary progressive MS (nrSPMS) compared to a placebo.

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In August 2024, TG Therapeutics, a partner of Precision Biosciences, has received approval from the US Food and Drug Administration (FDA) for an investigational new drug (IND) application to initiate a Phase I clinical trial of Azercabtagene Zapreleucel (azer-cel) for progressive forms of multiple sclerosis (MS). Azer-cel is an innovative allogeneic CAR T therapy developed by Precision BioSciences. Earlier this year, in January, Precision entered into a licensing agreement with TG Therapeutics, granting them global rights to azer-cel for autoimmune diseases, excluding cancer indications.

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In August 2024, Indapta Therapeutics has received approval from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application, paving the way for a future Phase I clinical trial of IDP-023 aimed at treating progressive multiple sclerosis (MS). IDP-023 is a g-natural killer (g-NK) cell therapy. The trial will be conducted by Stanford University and the University of California, San Francisco (UCSF) in the US.

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In April 2024, Roche has released data from the Phase III OCARINA II study evaluating a subcutaneous (SC) injection of OCREVUS (ocrelizumab) in patients with relapsing or primary progressive multiple sclerosis (RMS or PPMS). OCREVUS is a humanized monoclonal antibody specifically designed to target CD20-positive B cells and is administered biannually through a ten-minute subcutaneous injection. This multicenter, global, randomized trial compared the pharmacokinetics, safety, and both radiological and clinical effects of OCREVUS delivered via SC injection to those of intravenous (IV) infusion.

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In March 2024, NeuroGenesis Bio has announced favorable results from an interim analysis conducted during the open-label extension of a Phase II clinical trial for NG-01, aimed at treating progressive multiple sclerosis (MS). NG-01, the company's leading candidate, is an autologous bone marrow-derived stem cell therapy designed to secrete higher levels of remyelinating and neurotrophic factors at the injury site within the central nervous system.

Multiple Sclerosis Overview

Multiple Sclerosis (MS) is a chronic autoimmune disease that affects the central nervous system, leading to nerve damage and impaired communication between the brain and body. Symptoms vary but may include fatigue, muscle weakness, vision problems, and difficulty with coordination. While there is no cure, treatments help manage symptoms and slow disease progression.

Get a Free Sample PDF Report to know more about Multiple Sclerosis Pipeline Therapeutic Assessment:

https://www.delveinsight.com/report-store/multiple-sclerosis-pipeline-insight [https://www.delveinsight.com/report-store/multiple-sclerosis-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Emerging Multiple Sclerosis Drugs Under Different Phases of Clinical Development Include:

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BIIB091: Biogen

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NeuroVax: Immune Response BioPharma

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IMCY-0141: ImCyse

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ATA188: Atara Biotherapeutics

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EHP-101: Emerald Health Pharmaceuticals

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SAR441344: Sanofi

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RC18: RemeGen

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GB7208: Gossamer Bio

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MRx0002: 4D Pharma

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HuL001: HuniLife Biotechnology

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ANK-700: Anokion

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GSK3888130: GSK plc

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Temelimab: GeNeuro

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IMU-838: Immunic Therapeutics

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Tolebrutinib: Sanofi

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Fenebrutinib: Hoffman-La-Roche

Multiple Sclerosis Route of Administration

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

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Oral

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Parenteral

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Intravenous

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Subcutaneous

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Topical.

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Molecule Type

Multiple Sclerosis Molecule Type

Multiple Sclerosis Products have been categorized under various Molecule types, such as

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Monoclonal Antibody

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Peptides

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Polymer

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Small molecule

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Gene therapy

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Product Type

Multiple Sclerosis Pipeline Therapeutics Assessment

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Multiple Sclerosis Assessment by Product Type

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Multiple Sclerosis By Stage and Product Type

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Multiple Sclerosis Assessment by Route of Administration

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Multiple Sclerosis By Stage and Route of Administration

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Multiple Sclerosis Assessment by Molecule Type

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Multiple Sclerosis by Stage and Molecule Type

DelveInsight's Multiple Sclerosis Report covers around 80+ products under different phases of clinical development like

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Late-stage products (Phase III)

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Mid-stage products (Phase II)

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Early-stage product (Phase I)

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Pre-clinical and Discovery stage candidates

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Discontinued & Inactive candidates

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Route of Administration

Further Multiple Sclerosis product details are provided in the report. Download the Multiple Sclerosis pipeline report to learn more about the emerging Multiple Sclerosis therapies [https://www.delveinsight.com/sample-request/multiple-sclerosis-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Some of the key companies in the Multiple Sclerosis Therapeutics Market include:

Key companies developing therapies for Multiple Sclerosis are - Celgene, Actelion (now Janssen Pulmonary Hypertension), EMD Serono, Inc., Bayer, Acorda Therapeutics, Inc., Biogen, Teva Pharmaceuticals, Novartis, Sanofi, F. Hoffmann-La Roche Ltd, and others.

Multiple Sclerosis Pipeline Analysis:

The Multiple Sclerosis pipeline report provides insights into

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The report provides detailed insights about companies that are developing therapies for the treatment of Multiple Sclerosis with aggregate therapies developed by each company for the same.

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It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Multiple Sclerosis Treatment.

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Multiple Sclerosis key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.

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Multiple Sclerosis 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.

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Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Multiple Sclerosis 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 Multiple Sclerosis drugs and therapies [https://www.delveinsight.com/sample-request/multiple-sclerosis-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Multiple Sclerosis Pipeline Market Drivers

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Increasing Population with Multiple Sclerosis, extensive Approved therapies, wide range of R&D Pipeline, increasing Awareness are some of the important factors that are fueling the Multiple Sclerosis Market.

Multiple Sclerosis Pipeline Market Barriers

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However, high cost of drugs, high Incidence of adverse events and other factors are creating obstacles in the Multiple Sclerosis Market growth.

Scope of Multiple Sclerosis Pipeline Drug Insight

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Coverage: Global

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Key Multiple Sclerosis Companies: Biogen, Immune Response BioPharma, ImCyse, Atara Biotherapeutics, Emerald Health Pharmaceuticals, Sanofi, RemeGen, Gossamer Bio, 4D Pharma, HuniLife Biotechnology, Anokion, GSK plc, GeNeuro, Immunic Therapeutics, Sanofi, Hoffman-La-Roche, and others

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Key Multiple Sclerosis Therapies: BIIB091, NeuroVax, IMCY-0141, ATA188, EHP-101, SAR441344, RC18, GB7208, MRx0002, HuL001, ANK-700, GSK3888130, Temelimab, IMU-838, Tolebrutinib, Fenebrutinib, and others

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Multiple Sclerosis Therapeutic Assessment: Multiple Sclerosis current marketed and Multiple Sclerosis emerging therapies

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Multiple Sclerosis Market Dynamics: Multiple Sclerosis market drivers and Multiple Sclerosis market barriers

Request for Sample PDF Report for Multiple Sclerosis Pipeline Assessment and clinical trials [https://www.delveinsight.com/sample-request/multiple-sclerosis-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Table of Contents

1. Multiple Sclerosis Report Introduction

2. Multiple Sclerosis Executive Summary

3. Multiple Sclerosis Overview

4. Multiple Sclerosis- Analytical Perspective In-depth Commercial Assessment

5. Multiple Sclerosis Pipeline Therapeutics

6. Multiple Sclerosis Late Stage Products (Phase II/III)

7. Multiple Sclerosis Mid Stage Products (Phase II)

8. Multiple Sclerosis Early Stage Products (Phase I)

9. Multiple Sclerosis Preclinical Stage Products

10. Multiple Sclerosis Therapeutics Assessment

11. Multiple Sclerosis Inactive Products

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

13. Multiple Sclerosis Key Companies

14. Multiple Sclerosis Key Products

15. Multiple Sclerosis Unmet Needs

16 . Multiple Sclerosis Market Drivers and Barriers

17. Multiple Sclerosis Future Perspectives and Conclusion

18. Multiple Sclerosis 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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