多発性硬化症の臨床試験分析 2025：パイプライン治療、FDA/EMA承認、作用機序、主要医薬品開発

DelveInsight's Multiple Sclerosis Competitive Landscape 2025 report offers an in-depth global view of multiple sclerosis (MS) medications currently advancing through various stages of clinical development. It highlights the efforts of leading pharmaceutical companies and evaluates the future growth potential within the MS pipeline domain.

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Key Highlights from the Report

The multiple sclerosis pipeline reflects a highly active and competitive space, with more than 60 companies actively working to bring over 75 investigational therapies to market. Major players including 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, and ImCyse are among those pushing new treatment options forward.

Notable pipeline candidates currently under evaluation across various clinical trial phases include 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, and IMCY-0141, among others.

Understanding Multiple Sclerosis

Multiple sclerosis is the leading neurological disorder among young adults, most commonly emerging between the ages of 20 and 40. The disease targets myelin-protected axons within the central nervous system (CNS), disrupting normal nerve signal transmission. The most prevalent form, relapsing-remitting multiple sclerosis (RRMS), accounts for roughly 85% of all diagnoses and is marked by alternating episodes of symptom flares and partial or complete remission.

Early symptoms typically include visual disturbances, muscle weakness or stiffness in the limbs, involuntary spasms, and sensations of tingling, numbness, or pain across the face, trunk, arms, or legs.

Globally, MS affects approximately 2.5 million individuals, with around 400,000 cases in the United States alone. The condition is nearly three times more common in women than men, with the average age of onset ranging from 25 to 29 years for RRMS. Approximately 10% of MS diagnoses occur before the age of 18, and the condition is found in roughly 1 in every 1,000 individuals of European descent.

The underlying driver of MS-related damage is chronic CNS inflammation, though the precise immune triggers remain under investigation. Current research points to a combination of genetic predisposition, environmental exposure, and infectious agents as contributing factors. Studies utilizing experimental autoimmune encephalomyelitis (EAE) — an animal model designed to mimic human MS — have been instrumental in uncovering the roles of both innate and adaptive immune responses, particularly the involvement of Toll-like receptors (TLRs).

Because no single diagnostic test exists for MS, diagnosis relies on a combination of clinical history, neurological examination, MRI imaging, evoked potential testing, and cerebrospinal fluid (CSF) analysis, while systematically ruling out other conditions. MRI scans remain particularly valuable in detecting the characteristic brain and spinal cord lesions associated with the disease.

Treatment strategies center around two approaches: disease-modifying therapies (DMTs) that address the underlying immune dysfunction, and symptomatic treatments that target specific clinical manifestations. As of now, 12 therapies have received approval from both the FDA and EMA, including 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 MS market has grown steadily over the past decade, fueled by a rising patient population, earlier and more accurate diagnoses, and an expanding pipeline of disease-modifying therapies. Despite this growth, the market remains intensely competitive, with increasing pressure on drug pricing and reimbursement structures.

The DMT segment continues to dominate the MS treatment landscape. While injectable interferons and glatiramer acetate were once considered the standard of care, oral therapies such as fingolimod, dimethyl fumarate, and teriflunomide have captured significant market share due to their ease of administration. High-efficacy monoclonal antibodies — including natalizumab, ocrelizumab, and alemtuzumab — have further reshaped the treatment paradigm, particularly for patients with highly active MS. Ocrelizumab has been especially transformative, becoming the first approved therapy for primary progressive multiple sclerosis (PPMS), a population that had historically lacked targeted treatment options.

The pipeline remains a major driver of market evolution. Emerging drug classes such as Bruton's tyrosine kinase (BTK) inhibitors, remyelination agents, and cell-based therapies are being investigated with the dual goal of halting disease progression and promoting neural repair — a significant unmet need that existing therapies do not address. BTK inhibitors, in particular, may offer a more targeted alternative to broad B-cell depletion strategies, potentially redefining treatment decision-making if ongoing trials yield positive results.

Pricing pressures are also reshaping commercial strategies. As biosimilars of established MS drugs gain regulatory approval and enter the market — especially across Europe — competition is intensifying. Payers and healthcare systems are demanding stronger evidence of real-world value, pushing manufacturers to invest in long-term safety data, patient-reported outcomes, and value-based care models.

Looking ahead, the MS market's trajectory will be shaped not only by scientific breakthroughs but also by the ability of companies to demonstrate clear clinical and economic value, navigate complex reimbursement environments, and respond to growing interest in personalized medicine and neurorepair strategies.

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Approved MS Drug Highlights

BRIUMVI – TG Therapeutics BRIUMVI is a next-generation monoclonal antibody engineered to bind a unique epitope on CD20-positive B-cells. Through a specialized glycoengineering process that removes specific sugar molecules from the antibody structure, BRIUMVI achieves efficient B-cell depletion at relatively low doses. It is currently approved for adult patients with relapsing forms of MS, including clinically isolated syndrome (CIS), RRMS, and active secondary progressive multiple sclerosis (SPMS).

Tyruko – Sandoz Tyruko is a biosimilar closely modeled after a well-established anti-α4 integrin monoclonal antibody. In the United States, it carries FDA approval as a standalone treatment for relapsing forms of MS — including CIS, RRMS, and active SPMS — as well as for Crohn's disease in adult patients. It holds the distinction of being the first and only FDA-approved biosimilar indicated for relapsing MS.

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Notable Recent Developments in the MS Treatment Space

• June 2025: Long-term data from the Phase III OPTIMUM-LT open-label extension trial (NCT03232073) demonstrated that Ponesimod (Vanda Pharmaceuticals) sustained meaningful reductions in relapse rates, MRI lesion activity, and disability accumulation over a follow-up period of up to 8.2 years, with more than half of enrolled patients remaining relapse-free.
• February 2025: Quantum BioPharma Ltd. successfully completed its Phase I multiple ascending dose study evaluating Lucid-21-302 (Lucid-MS). The Safety Review Committee confirmed the compound was well-tolerated, with no serious adverse events observed throughout the trial.
• January 2025: Contineum Therapeutics completed targeted enrollment of 168 patients in its Phase II PIPE-307 VISTA trial for its investigational NI&I candidate.
• January 2025: Century Health and Nira Medical announced a strategic partnership to build and analyze a structured dataset from over 3,000 MS patients using AI-driven tools, with the goal of accelerating research and improving treatment outcomes.
• January 2025: Pheno Therapeutics Limited received Clinical Trial Authorization from the UK's MHRA for its lead candidate, PTD802.
• December 2024: The FDA granted Breakthrough Therapy Designation to Sanofi's BTK inhibitor Tolebrutinib for the treatment of adults with nonrelapsing secondary progressive MS.
• October 2024: Immunic received a positive non-binding interim futility analysis outcome from its Phase III ENSURE program evaluating IMU-838 (vidofludimus calcium) for relapsing MS. The Independent Data Monitoring Committee recommended continuation of the trials.
• October 2024: Hope Biosciences Research Foundation reported positive top-line Phase II results for HB-adMSCs, its adipose-derived autologous mesenchymal stem cell therapy, in patients with mild-to-moderate RRMS.
• March 2024: Immunic, Inc. received a Notice of Allowance from the USPTO for patent application 16/981,122, covering the composition of a specific polymorph of IMU-838 (vidofludimus calcium), with claims expected to provide protection through 2039.
• January 2024: TG Therapeutics secured a worldwide license from Precision BioSciences for Azercabtagene Zapreleucel (azer-cel), an allogeneic CD19 CAR T cell therapy being explored across autoimmune and other non-oncology indications.

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Key Contributor to the Global Multiple Sclerosis Pipeline

The Asia-Pacific region is rapidly establishing itself as an important contributor to the global multiple sclerosis clinical development landscape, with companies from Japan, South Korea, and Taiwan now sponsoring or co-sponsoring clinical programs spanning Phase 1 through Phase 3. What distinguishes many of these programs is their mechanistic orientation toward CNS-compartmentalized neuroinflammation — the biological driver of disease progression that most approved peripheral immunosuppressants are unable to adequately address. Taken together, these emerging Asia-Pacific pipelines represent a meaningful and increasingly recognized addition to the global MS drug development ecosystem.

J-Pharma Co., Ltd. is advancing JPH034, an orally administered allosteric inhibitor of LAT1 (L-type amino acid transporter 1) engineered with high blood–brain barrier penetration, into Phase 1 clinical development for nonrelapsing secondary progressive MS (nrSPMS). In a significant regulatory milestone, the FDA completed its IND safety review in February 2025 and authorized the company to initiate Phase 1 clinical trials in the United States. Unlike most approved MS therapies that modulate peripheral immune populations, JPH034 targets activated microglia within the CNS directly — addressing the compartmentalized neuroinflammation responsible for irreversible disability accumulation in progressive disease. The candidate was originally discovered through collaborative research with Professor Yoshikatsu Kanai at Osaka University Graduate School of Medicine, was awarded a competitive Fast Forward Research and Commercialization Grant from the National Multiple Sclerosis Society (NMSS) in June 2023, and in June 2024 became the subject of an exclusive worldwide licensing agreement with Georgetown University covering patents related to amino acid transporter inhibition in CNS inflammatory diseases. J-Pharma has additionally been selected for Japan's AMED Drug Discovery Venture Ecosystem Enhancement Project, securing subsidies of up to ¥2.0 billion to support ongoing development. Companion investigator-initiated studies at European academic institutions are currently underway to confirm colocalization of microglial LAT1 expression at demyelinating lesion sites, with the aim of defining the patient population most likely to benefit from JPH034 ahead of the pivotal trial stage.

MediciNova, Inc. , the Japanese biopharmaceutical company also listed on Nasdaq, is the developer of MN-166 (ibudilast), a brain-penetrant oral therapy that acts simultaneously as a phosphodiesterase (PDE4/PDE10) inhibitor, a macrophage migration inhibitory factor (MIF) inhibitor, and a TLR4 antagonist — producing both anti-inflammatory and direct neuroprotective effects within the CNS. MN-166 has completed Phase 2b development in the SPRINT-MS trial (NCT01982942), which enrolled 255 patients with primary or secondary progressive MS and demonstrated a statistically significant 48% reduction in whole-brain atrophy at 96 weeks versus placebo (p = 0.04), one of the most compelling neuroprotective signals reported in progressive MS clinical research to date. The FDA granted MN-166 Fast Track designation for progressive MS in 2016, and following SPRINT-MS, MediciNova has characterized the asset as Phase 3-ready for nrSPMS, with a confirmatory Phase 3 trial planned subject to securing a development partner. Ibudilast was originally licensed from Kyorin Pharmaceutical (Japan) and carries more than 30 years of post-marketing safety data, having been approved in Japan and South Korea under the brand name Ketas for post-stroke complications and asthma since 1989 — a track record that substantially de-risks the compound's safety profile in future MS trials.

Apimeds Korea is developing Apitox, a purified, lyophilized bee venom formulation delivered via intradermal injection, as add-on therapy in relapsing forms of MS. Apitox's therapeutic effects are mediated by its principal bioactive peptides — melittin and apamin — which modulate the NF-κB signaling pathway and suppress pro-inflammatory cytokines including TNF-alpha and IL-6, with both anti-inflammatory and potential neuroprotective activity observed in preclinical and early human studies. Apimeds has submitted IND 122804 to the FDA for a Phase III multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate Apitox as an add-on treatment aimed at improving disability outcomes and quality of life in MS patients, building on early-phase data from the Castro Trial, which enrolled nine bee venom non-allergic patients with progressive MS. In May 2025, Apimeds Pharmaceuticals US completed its NYSE American IPO, raising $13.5 million with proceeds designated to support the active Phase III osteoarthritis program and initiate at least one company-sponsored MS study under the active FDA IND. Apitox has been approved by South Korea's Ministry of Food and Drug Safety for osteoarthritis since 2003, providing a post-marketing safety record across more than 3,000 patients that provides an established regulatory foundation for its MS development path.

ABION Inc. is in the early development stage with ABN101, a bio-better formulation of interferon-beta for relapsing MS. Unlike a biosimilar, ABN101 is engineered with glycosylation modifications intended to meaningfully improve upon first-generation IFN-β products such as Avonex and Rebif — targeting enhanced pharmacokinetics, a reduced immunogenicity profile, and a potentially more convenient route of administration for MS patients. The company has disclosed ABN101 as a strategic pipeline asset and indicated plans for clinical initiation; however, no Phase 1 trial registration has been publicly confirmed in the most recently available disclosures. ABION's current active clinical programs are focused primarily on ABN401, a c-MET inhibitor in non-small cell lung cancer, and the progress of ABN101 in MS should be followed through the company's regulatory filings and investor communications as the program develops.

Ever Supreme Bio Technology Co., Ltd. is advancing UMSC01, an allogeneic off-the-shelf cell therapy derived from umbilical cord mesenchymal stem cells (UC-MSCs), through a Phase I/IIa clinical trial in relapsing-remitting MS under a seamless trial design approved by both the US FDA and Taiwan's TFDA. UMSC01 exerts its effects through multiple complementary mechanisms — systemically suppressing autoreactive T and B cells, inducing regulatory T cell populations, delivering neuroprotective paracrine signaling, and providing potential structural support for axonal remyelination. The therapy is administered through a dual-route approach combining intravenous infusion for systemic immune modulation with intrathecal delivery for direct CNS access, simultaneously addressing both peripheral immune dysregulation and compartmentalized neuroinflammation. The Phase I/IIa MS trial has successfully enrolled and dosed its first two participants in Taiwan, with the Safety Monitoring Committee confirming no safety concerns following initial administrations. The broader UMSC01 program across indications including acute myocardial infarction, acute ischemic stroke, and COVID-19 completed Phase I in the AMI indication with no treatment-related adverse events in eight subjects — a meaningful safety precedent for the MS program's continued advancement. Importantly, under Taiwan's newly enacted regenerative medicine legislation, therapies addressing life-threatening or severely disabling conditions may receive a provisional five-year market authorization following Phase II completion, offering Ever Supreme a potentially accelerated regulatory pathway to commercialization compared to conventional clinical development timelines.

Collectively, the MS programs being advanced by these five Asia-Pacific companies reflect a broader and important global shift in how the scientific community is approaching multiple sclerosis — from peripheral immunosuppression toward CNS-penetrant neuroprotection, microglial modulation, and cellular repair strategies. Whether through direct CNS small molecule targeting (JPH034, ibudilast), anti-inflammatory peptide signaling (Apitox), immunomodulatory cytokine bio-betterment (ABN101), or allogeneic stem cell delivery (UMSC01), each program is addressing a dimension of MS pathophysiology that remains substantially underserved by the current standard of care. This emerging cluster of Asia-Pacific innovators represents one of the most mechanistically diverse and scientifically compelling segments of the evolving global multiple sclerosis treatment landscape.

Report Scope

Coverage: Global

Key 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 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. Executive Summary
3. Pipeline Overview
4. Marketed Drugs — BRIUMVI (TG Therapeutics)
5. Clinical Trial Therapeutics
6. Late-Stage Products (Pre-Registration)
7. Late-Stage Products (Phase III) — IMU-838 (Immunic)
8. Mid-Stage Products (Phase II) — Foralumab (Tiziana Life Sciences)
9. Early-Stage Products (Phase I) — JPH034 (J-Pharma Co., Ltd.)
10. Preclinical and Discovery Stage Products — PB018 (Polpharma Biologics)
11. Therapeutics Assessment
12. Inactive Pipeline Products
13. Company-University Collaborations and Licensing Analysis
14. Unmet Needs
15. Market Drivers and Barriers
16. Appendix

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