Multiple Sclerosis Clinical Trials Assessment 2025: Competitive Landscape, FDA Approvals, Therapies, Emerging Drugs, Mechanism of Action, Route of Administration by DelveInsightMultiple Sclerosis Clin

Multiple sclerosis companies such as Sanofi, Immunic, InnoCare, Tiziana Life Sciences, Biogen, J-Pharma, Bristol-Myers Squibb, Polpharma Biologics, Nervgen, Nucleome Therapeutics, Medsenic, TeraImmun, Autobahn Therapeutics, Guangzhou Lupeng Pharmaceutical, GlaxoSmithKline, ImCyse, Novartis, Biocad, Apimeds, Genentech (Roche), Merck, AB Science, Apurano Pharmaceuticals, Antisense Therapeutics, RemeGen, Atara Biotherapeutics, Stem Cell Medicine, Ever Supreme Bio Technology Co., Ltd., and others.
(Albany, USA) 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.

DelveInsight's 'Multiple Sclerosis Competitive Landscape 2025' report provides comprehensive global coverage of pipeline multiple sclerosis medication 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.

Key Takeaways from the Multiple Sclerosis Pipeline Report

* DelveInsight's multiple sclerosis competitive report depicts a robust space with 75+ active players working to develop 80+ pipeline multiple sclerosis treatments.
* Key multiple sclerosis companies such as Sanofi, Immunic, InnoCare Pharma, Tiziana Life Sciences, Biogen, J-Pharma, Bristol-Myers Squibb, Polpharma Biologics, Repertoire Immune Medicines, Nervgen, Nucleome Therapeutics, Medsenic, TeraImmun, Autobahn Therapeutics, Guangzhou Lupeng Pharmaceutical, GlaxoSmithKline, ImCyse, Novartis, Biocad, Apimeds, Genentech (Roche), Merck, AB Science, Apurano Pharmaceuticals, Worg Pharmaceuticals, Antisense Therapeutics, RemeGen, Atara Biotherapeutics, Contineum Therapeutics, Stem Cell Medicine Ltd., Ever Supreme Bio Technology Co., Ltd., and others are evaluating new multiple sclerosis medications to improve the treatment landscape.
* Promising pipeline multiple sclerosis treatment drugs, such as SAR 441344, IMU-838, Orelabrutinib, Foralumab, BIIB091, JPH 034, CC-97540, PB018, Autoimmune disorder vaccines, NVG300, NT-0002, Arscimed, TI-235, LL-341070, LP-168, GSK 3888130B, IMCY-0141, and others are under different phases of multiple sclerosis clinical trials.

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Multiple Sclerosis Overview

Multiple sclerosis (MS) is the most common neurological disease in young adults, typically beginning between ages 20-40 and affecting about 400,000 people in the U.S. and 2.5 million globally. It is an immune-mediated demyelinating disorder of the central nervous system, three times more prevalent in women.

The relapsing-remitting form (RRMS) accounts for ~85% of cases, marked by flare-ups followed by remission. Symptoms include vision problems, muscle weakness, stiffness, spasms, tingling, numbness, and pain. Less common forms, such as primary progressive MS, typically appear later (ages 39-41).

MS development involves genetic, environmental, and infectious factors, with inflammation being the primary driver. EAE animal models have advanced understanding of immune mechanisms, particularly innate responses through Toll-like receptors (TLRs).

Diagnosis relies on a combination of clinical exams, MRI, CSF analysis, and evoked potential tests, as no single definitive test exists.

Treatment includes disease-modifying therapies (DMTs) to regulate the immune response and symptomatic therapies to manage clinical effects. Since 2013, 12 DMTs have been approved by the FDA/EMA, including dimethyl fumarate (TECFIDERA), alemtuzumab (LEMTRADA), pegylated interferon- (PLEGRIDY), and glatiramer acetate (COPAXONE).

Key Developments in the Multiple Sclerosis Treatment Space

* In August 2025, Hope Biosciences received FDA RMAT designation for its HB-adMSCs stem cell therapy for treating relapsing-remitting multiple sclerosis (RRMS).
* In June 2025, newly reported data from the Phase III OPTIMUM-LT open-label extension trial (NCT03232073) showed that treatment with Ponesimod (Vanda Pharmaceuticals) was safe and led to sustained reduction in relapses, MRI lesions, and low disability accumulation among patients with relapsing multiple sclerosis over a long-term period. At time points of up to 8.2 years, more than half of the patients included were still relapse-free.
* In May 2025, Neuralink announced that it has received the FDA's "breakthrough" designation for its device aimed at restoring communication for individuals with severe speech impairment. The device, designed to assist patients with conditions like amyotrophic lateral sclerosis (ALS), stroke, spinal cord injury, cerebral palsy, and multiple sclerosis, represents a significant step forward in neurotechnology.
* In February 2025, Quantum BioPharma Ltd. announced that it had completed its trial entitled "A Phase I, Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of Lucid-21-302 in Healthy Adult Participants." A final safety review committee ("SRC") meeting was held after completion of the trial. The SRC found that Lucid-21-302 "(Lucid-MS") was well-tolerated with no safety concerns, and no serious adverse events were reported during the trial.
* In January 2025, Contineum Therapeutics, Inc., a clinical-stage biopharmaceutical company pioneering differentiated therapies for the treatment of neuroscience, inflammation, and immunology (NI&I) indications, announced that it has completed the targeted enrollment of 168 patients in its Phase II PIPE-307 VISTA trial.
* In January 2025, Century Health and Nira Medical announced a partnership to curate data from more than 3,000 patients with multiple sclerosis to advance the understanding of the disease and treatment outcomes. Based on data from Nira Medical's network of clinics, Century Health's AI platform will create structured datasets that will be analyzed in partnership with life sciences companies to accelerate research into MS treatment and improve patient outcomes.
* In January 2025, Pheno Therapeutics Limited announced that it had received Clinical Trial Authorization (CTA) from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for its lead candidate, PTD802.
* In December 2024, the FDA granted Breakthrough Therapy Designation to Sanofi's BTK inhibitor candidate Tolebrutinib for the treatment of adults with Nonrelapsing Secondary Progressive Multiple Sclerosis (SPMS).
* In October 2024, Immunic announced a positive outcome from the non-binding, interim futility analysis of its Phase III ENSURE program, which investigated the lead asset, nuclear receptor-related 1 (Nurr1) activator vidofludimus calcium (IMU-838), for the treatment of relapsing multiple sclerosis (RMS). Based on the outcome of the interim futility analysis, an unblinded Independent Data Monitoring Committee (IDMC) has recommended that the trials are not futile and should continue as planned.
* In October 2024, Hope Biosciences Research Foundation (HBRF) announced positive top-line results of a Phase II clinical trial to evaluate Hope Biosciences' adiposederived autologous mesenchymal stem cell therapy (HB-adMSCs) for patients with mild to moderate relapsing-remitting multiple sclerosis (MS).
* In March 2024, Immunic, Inc., announced that it had received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application 16/981,122, entitled, "Calcium salt polymorphs as anti-inflammatory, immunomodulatory and anti-proliferative agents," covering the composition-of-matter of a specific polymorph of vidofludimus calcium (IMU-838) and a related method of production of the material. The claims are expected to protect 2039, unless extended further. The patent was previously granted to the company in Australia, Canada, Indonesia, Japan, and Mexico.
* In January 2024, TG Therapeutics, Inc. announced that it has agreed with Precision BioSciences, Inc. to acquire a worldwide license to Precision's Azercabtagene Zapreleucel (azer-cel), an allogeneic CD19 CAR T cell therapy program for autoimmune diseases and all other non-oncology indications.

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Multiple Sclerosis Market Dynamics

The multiple sclerosis market is shaped by a complex interplay of scientific innovation, unmet medical needs, competitive drug development, and evolving healthcare policies. The multiple sclerosis market has experienced steady growth over the past decade, largely driven by an expanding patient population, earlier diagnosis, and a robust pipeline of disease-modifying therapies (DMTs). However, the market remains dynamic due to intense competition among established drugs and increasing pressure on pricing and reimbursement.

The disease-modifying therapy segment dominates the multiple sclerosis market and includes both first-line and high-efficacy treatments. Historically, injectable interferons and glatiramer acetate were the standard of care, but oral therapies such as fingolimod, dimethyl fumarate, and teriflunomide have gained substantial market share due to their convenience and efficacy. In recent years, monoclonal antibodies like natalizumab, ocrelizumab, and alemtuzumab have offered superior disease control for patients with highly active multiple sclerosis. Ocrelizumab, in particular, has reshaped the landscape by becoming the first approved treatment for primary progressive multiple sclerosis (PPMS), a previously underserved segment of the patient population.

Pipeline development is another critical factor influencing multiple sclerosis market dynamics. Numerous investigational therapies are targeting novel mechanisms, including Bruton's tyrosine kinase (BTK) inhibitors, remyelination agents, and cell-based therapies. These candidates aim to not only halt disease progression but also promote neural repair, a major unmet need in multiple sclerosis treatment. The entry of BTK inhibitors, which offer a potentially safer and more targeted alternative to B-cell depletion therapies, could significantly alter treatment algorithms if clinical trials prove successful.

Market access and pricing pressures are increasingly shaping commercial strategies. As biosimilars of established drugs enter the market, pricing competition is intensifying, particularly in Europe and other cost-sensitive regions. Payers are demanding greater value from high-cost therapies, prompting pharmaceutical companies to invest in real-world evidence, long-term safety data, and patient-reported outcomes. Furthermore, as healthcare systems emphasize cost-effectiveness and value-based care, manufacturers must navigate complex reimbursement frameworks to maintain market share.

In summary, the multiple sclerosis market is highly dynamic and competitive, characterized by rapid innovation, shifting treatment paradigms, and evolving stakeholder expectations. Future growth will depend not only on therapeutic advancements but also on the ability of companies to demonstrate value, address unmet needs, and adapt to changing policy environments. With promising new mechanisms in development and growing attention to neurorepair and personalized medicine, the multiple sclerosis treatment landscape is poised for further transformation in the coming decade.

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Approved Multiple Sclerosis Drug Analysis

BRIUMVI: TG Therapeutics

BRIUMVI is an innovative monoclonal antibody that binds to a distinct epitope on CD20-positive B-cells. Targeting CD20 with monoclonal antibodies has become a key strategy in treating autoimmune diseases like relapsing multiple sclerosis (RMS). BRIUMVI is specifically engineered through glycoengineering to lack certain sugar molecules typically found on antibodies. This modification enhances its ability to deplete B-cells effectively at lower doses. BRIUMVI is approved for use in adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting multiple sclerosis, and active secondary progressive multiple sclerosis.

Tyruko: Sandoz

Tyruko has been designed to closely resemble the reference medicine, a well-established and highly effective anti-4 integrin monoclonal antibody used for modifying disease progression in relapsing forms of multiple sclerosis. In the United States, Tyruko is approved as a standalone treatment for relapsing forms of MS, including clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and active secondary progressive multiple sclerosis, as well as for treating Crohn's disease in adults. It is the first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis.

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Multiple Sclerosis Market Drivers

* Rising Prevalence of Multiple Sclerosis - Increasing global cases (~2.5 million worldwide) with higher incidence among women is driving demand for effective treatments.
* Strong Pipeline of Novel Therapies - Advances in disease-modifying therapies (DMTs), biologics, and oral agents (e.g., sphingosine-1-phosphate receptor modulators, monoclonal antibodies).
* Regulatory Approvals & Expanded Indications - Ongoing FDA/EMA approvals of innovative therapies and label expansions boost market growth.
* Advances in Diagnostics - Improved MRI technology, biomarkers, and CSF analysis enable earlier and more accurate detection.
* Increasing Awareness & Diagnosis Rates - Patient advocacy groups and healthcare programs promote better disease recognition and treatment uptake.
* Personalized & Precision Medicine - AI-driven biomarker research and genetic profiling enhance targeted treatment approaches.
* Supportive Reimbursement Policies - Coverage in developed markets encourages patient access to high-cost therapies.

Multiple Sclerosis Market Barriers

* High Treatment Costs - Premium pricing of biologics and DMTs limits accessibility, particularly in low- and middle-income countries.
* Adverse Effects & Safety Concerns - Long-term immunosuppressive therapies pose risks such as infections and malignancies, affecting compliance.
* Complex Diagnosis - Lack of a definitive test and overlapping symptoms with other conditions delay timely intervention.
* Patent Expirations & Biosimilars - Entry of generics/biosimilars threatens revenues of blockbuster drugs.
* Regional Disparities - Limited infrastructure, specialist availability, and healthcare funding in emerging markets restrict adoption.
* Regulatory Hurdles - Stringent approval processes and long trial durations slow market entry for new therapies.
* Unmet Needs in Progressive Multiple Sclerosis - Current therapies are more effective for RRMS, while primary progressive Multiple Sclerosis (PPMS) and secondary progressive Multiple Sclerosis (SPMS) have fewer treatment options.

Scope of the Multiple Sclerosis Pipeline Report

* Coverage: Global
* Key Multiple Sclerosis Companies: Sanofi, Immunic, InnoCare Pharma, Tiziana Life Sciences, Biogen, J-Pharma, Bristol-Myers Squibb, Polpharma Biologics, Repertoire Immune Medicines, Nervgen, Nucleome Therapeutics, Medsenic, TeraImmun, Autobahn Therapeutics, Guangzhou Lupeng Pharmaceutical, GlaxoSmithKline, ImCyse and others.
* Key Multiple Sclerosis Pipeline Therapies: SAR 441344, IMU-838, Orelabrutinib, Foralumab, BIIB091, JPH 034, CC-97540, PB018, Autoimmune disorder vaccines, NVG300, NT-0002, Arscimed, TI-235, LL-341070, LP-168, GSK 3888130B, IMCY-0141 and others.

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Table of Contents

1. Multiple Sclerosis Pipeline Report Introduction

2. Multiple Sclerosis Pipeline Report Executive Summary

3. Multiple Sclerosis Pipeline: Overview

4. Multiple Sclerosis Marketed Drugs

4.1. BRIUMVI: TG Therapeutics

5. Multiple Sclerosis Clinical Trial Therapeutics

6. Multiple Sclerosis Pipeline: Late-Stage Products (Pre-registration)

7. Multiple Sclerosis Pipeline: Late-Stage Products (Phase III)

7.1. IMU-838: Immunic

8. Multiple Sclerosis Pipeline: Mid-Stage Products (Phase II)

8.1. Foralumab: Tiziana Life Sciences

9. Multiple Sclerosis Pipeline: Early-Stage Products (Phase I)

9.1. JPH034: J-Pharma Co., Ltd.

10. Multiple Sclerosis Pipeline: Preclinical and Discovery Stage Products

10.1. PB018: Polpharma Biologics

11. Multiple Sclerosis Pipeline Therapeutics Assessment

12. Inactive Products in the Multiple Sclerosis Pipeline

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

14. Unmet Needs

15. Multiple Sclerosis Market Drivers and Barriers

16. Appendix

About DelveInsight

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