Press release
Multiple Sclerosis Clinical Trials Analysis 2025: EMA, PDMA, FDA Approvals, Clinical Trials, Therapies, Medication, NDA Approval, IND, Mechanism of Action, Route of Administration by DelveInsight
Multiple Sclerosis Clinical Trials
Key Takeaways from the Multiple Sclerosis Pipeline Report
• DelveInsight's multiple sclerosis competitive report depicts a robust space with 60+ active players working to develop 75+ 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, 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.
Request a sample and discover the recent advances in multiple sclerosis treatment drugs @ Multiple Sclerosis Competitive Report - https://www.delveinsight.com/sample-request/multiple-sclerosis-competitive-landscape?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
Multiple Sclerosis Overview
Multiple sclerosis is the most prevalent neurological condition affecting young adults, typically beginning between the ages of 20 and 40. It targets the axons in the central nervous system, which are protected by myelin, often referred to as white matter. The relapsing-remitting form of multiple sclerosis is the most common, accounting for about 85% of cases. It is characterized by periods of symptom flare-ups, followed by phases of remission during which symptoms partially or fully subside.
Although rarer forms of multiple sclerosis exist, individuals with relapsing-remitting multiple sclerosis may experience recurring symptoms, sometimes seemingly triggered by specific factors. Exacerbations involve a sudden worsening of symptoms or the emergence of new ones that persist for at least 24 hours. Early signs of multiple sclerosis may include visual disturbances, muscle weakness or stiffness, particularly in the limbs, accompanied by spasms, as well as tingling, numbness, or pain in various parts of the body, including the face, trunk, arms, and legs.
Multiple sclerosis is the most common immune-mediated inflammatory demyelinating disease of the central nervous system, affecting around 400,000 people in the U.S. and approximately 2.5 million globally. It is three times more prevalent in women, with the average age of onset being 25-29 years for relapsing-remitting multiple sclerosis and 39-41 years for primary progressive multiple sclerosis. Around 10% of cases begin before age 18, and prevalence is about 1 in 1,000 among those of European descent.
The core cause of multiple sclerosis-related damage is inflammation within the CNS, though the exact triggers of this immune response remain unclear. Research indicates that genetic, environmental, and infectious factors contribute to multiple sclerosis development. Animal studies using experimental autoimmune encephalomyelitis (EAE), a model mimicking human multiple sclerosis, have been crucial in understanding the innate and adaptive immune responses involved. The innate immune system is activated by microbial elements that interact with pattern recognition receptors, particularly Toll-like receptors (TLRs).
Currently, there is no single definitive test for diagnosing multiple sclerosis. Diagnosis is based on a combination of clinical history, physical and neurological exams, MRI imaging, evoked potential tests, and cerebrospinal fluid (CSF) analysis, while ruling out other possible conditions. MRI scans help detect characteristic brain and spinal cord lesions, and a lumbar puncture may reveal inflammatory markers associated with MS.
Multiple sclerosis treatment involves two main strategies: disease-modifying therapies (DMTs) to manage the underlying immune response and symptomatic treatments to alleviate specific clinical manifestations. As of now, 12 treatments have been approved by both the EMA and the FDA. Notable among these are dimethyl fumarate (TECFIDERA), alemtuzumab (LEMTRADA), pegylated interferon-β (PLEGRIDY), and glatiramer acetate (COPAXONE), all approved since 2013.
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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.
To know more about multiple sclerosis treatment options, visit @ Multiple Sclerosis Therapeutics Market - https://www.delveinsight.com/sample-request/multiple-sclerosis-competitive-landscape?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
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-α4 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.
Find out more about FDA-approved multiple sclerosis drugs @ Multiple Sclerosis Treatment Market- https://www.delveinsight.com/sample-request/multiple-sclerosis-competitive-landscape?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
Key Developments in the Multiple Sclerosis Treatment Space
• 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 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' adipose derived 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.
Learn more about the new multiple sclerosis drug @ Multiple Sclerosis Clinical Trials - https://www.delveinsight.com/sample-request/multiple-sclerosis-competitive-landscape?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
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.
Dive deep into rich insights for drugs for multiple sclerosis, visit @ Multiple Sclerosis Drugs Market - https://www.delveinsight.com/sample-request/multiple-sclerosis-competitive-landscape?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
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
For further information on the newest multiple sclerosis treatments, reach out @ Drugs for Multiple Sclerosis - https://www.delveinsight.com/sample-request/multiple-sclerosis-competitive-landscape?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
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