Multiple Sclerosis - Competitive landscape, 2025

DelveInsight's, "Multiple Sclerosis - Competitive landscape, 2025" report provides comprehensive insights about 60+ companies and 75+ drugs in Multiple Sclerosis Competitive landscape. It covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered:

• Global coverage

Multiple Sclerosis: Understanding

Multiple Sclerosis: Overview

Multiple sclerosis (MS) is the most common neurological disorder in young adults, with symptoms usually occurring between the ages of 20 and 40 years. MS attacks the axons of the central nervous system, which are protected by myelin, commonly known as white matter. Relapsing-remitting MS: the most common form, affecting about 85% of MS patients. It is marked by flare-ups (relapses or exacerbations) of symptoms followed by periods of remission, when symptoms improve or disappear.

There are several rare and unusual types of MS. Some people with relapsing-remitting MS deal with a number of frequent symptoms, which sometimes seem to be connected to certain triggers. Exacerbations (also known as recurrences, relapses, or seizures) are the sudden exacerbations of MS symptoms or the appearance of new symptoms that last for at least 24 h. Early MS symptoms often include: Vision problems such as blurred or double vision or optic neuritis, which causes pain with eye movement and a rapid loss of vision, Muscle weakness, often in the hands and legs, and muscle stiffness accompanied by painful muscle spasms, Tingling, numbness, or pain in the arms, legs, trunk, or face.

Multiple sclerosis (MS) is the most common immune-mediated inflammatory demyelinating disease of the CNS, affecting around 400,000 people in the US and 2.5 million worldwide.

It is three times more common in females and typically onset occurs between ages 20 and 40. The mean age of onset is 25-29 for relapsing-remitting MS and 39-41 for primary progressive MS.

Approximately 10% of cases occur before age 18, with a prevalence of 1 in 1000 among populations of European ancestry.

Inflammation of the central nervous system is the leading cause of MS damage. The specific factors that cause this inflammation are still unknown. Studies show that hereditary, environmental, and infectious pathogens are one of the factors that influence the development of multiple sclerosis. Many immunological studies have been conducted on animal models of human MS known as experimental autoimmune encephalomyelitis (EAE). These are the innate and adaptive immune responses. The innate immune response is initiated by a microbial product that non-antigenically activates specific receptors, primarily Toll-like receptors (TLRs).

No single pathognomonic test exists for the diagnosis of MS. Diagnosis is made by weighing the history and physical, MRI, evoked potentials, and CSF/blood studies and excluded other causes of the patient's symptoms. Doctors use different tests to rule out or confirm the diagnosis. In addition to complete medical history, physical examination, and a detailed neurological examination, a doctor may recommend: MRI scans of the brain and spinal cord to look for the characteristic lesions of MS and Lumbar puncture (sometimes called a spinal tap) to obtain a sample of cerebrospinal fluid and examine it for proteins and inflammatory cells associated with the disease.

Treatment of MS has two aspects: disease-modifying therapy (DMT) for the underlying immune disorder, and therapies to relieve or modify symptoms. There are actually 12 products licensed by The European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA). Among them dimethyl fumarate (Tecfidera), alemtuzumab (Lemtrada), pegylated interferon-B (Plegridy) and glatiramer acetate (Copaxone) 40 mg have been produced and licensed since 2013.

Report Highlights:

• 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 has received Clinical Trial Authorization (CTA) from the UK's MHRA (Medicines and Healthcare products Regulatory Agency) for its lead candidate, PTD802.
• In December 2024, The U.S. Food and Drug Administration (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 22, 2024, Immunic announced a positive outcome of the non-binding, interim futility analysis of its Phase III ENSURE program, investigating 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 provide protection into 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 entered into an agreement 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.

Multiple Sclerosis: Company and Product Profiles (Marketed Therapies)

1. Company Overview: TG Therapeutics

TG Therapeutics is a biopharmaceutical company dedicated to developing and commercializing innovative treatments for B-cell diseases, including autoimmune conditions like multiple sclerosis and B-cell malignancies such as non-Hodgkin's lymphoma. Founded in 2011, the company is headquartered in New York and focuses on leveraging advances in B-cell biology to improve patient outcomes. Key products include ublituximab, a glycoengineered monoclonal antibody targeting CD20-expressing B-cells, and umbralisib. Notably, TG Therapeutics has received approval for BRIUMVI, a treatment for relapsing forms of multiple sclerosis. The company conducts extensive clinical trials and collaborates with a global network of clinical sites to support patient access to its medicines. Through its research and development efforts, TG Therapeutics aims to provide effective and convenient treatments for patients with B-cell mediated diseases.

Product Description: BRIUMVI

BRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses. BRIUMVI is indicated for the treatment of adults with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

2. Company Overview: Sandoz

Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilar. The purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical needs. The vision is to be the world's leading and most valued generics company. The broad portfolio of high-quality medicines covers major therapeutic areas.

Product Description: Tyruko

Tyruko has been developed to be highly similar to the reference medicine, an established, highly effective anti-a4 integrin monoclonal antibody disease modifying treatment in relapsing forms of multiple sclerosis (MS). Tyruko is indicated in the US as a monotherapy for relapsing forms of MS, including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS) and active secondary progressive disease, as well as Crohn's disease in adults. It is the first and only FDA-approved biosimilar for relapsing forms of MS.

Multiple Sclerosis: Company and Product Profiles (Pipeline Therapies)

1. Company Overview: Immunic

Immunic, Inc.is a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in Phase III and Phase II clinical trials for the treatment of relapsing and progressive multiple sclerosis, respectively, and has shown therapeutic activity in Phase II clinical trials in patients suffering from relapsing-remitting multiple sclerosis, progressive multiple sclerosis and moderate-to-severe ulcerative colitis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease, for which it is currently in preparations for a Phase II clinical trial. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases

Product Description: IMU-838

IMU-838 (Vidofludimus calcium) is a small molecule investigational drug in development as an oral next-generation treatment option for patients with multiple sclerosis and other chronic inflammatory and autoimmune diseases. The selective immune modulator activates the neuroprotective transcription factor nuclear receptor related 1 (Nurr1), which is associated with direct neuroprotective properties. Additionally, vidofludimus calcium is a known inhibitor of the enzyme dihydroorotate dehydrogenase (DHODH). This mechanism is associated with the anti-inflammatory and anti-viral effects of vidofludimus calcium. Vidofludimus calcium has been observed to selectively act on hyperactive T and B cells while leaving other immune cells largely unaffected and enabling normal immune system function, e.g., in fighting infections. Currently the drug is in Phase III of its clinical trial for the treatment of Multiple Sclerosis.

2. Company Overview: Tiziana Life Sciences

Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana's innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana's lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana's technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.

Product Description: Foralumab

Foralumab is a fully human anti-CD3 monoclonal antibody, designed to modulate the immune system by targeting the CD3 Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 10 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program with either an improvement or stability of disease seen within 6 months in all patients. The FDA has recently allowed an additional 20 patients to be enrolled in this EA program. In addition, intranasal foralumab is currently being studied in a Phase IIa, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis.

Activated T cells play an important role in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development, binds to the T cell receptor and dampens inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets. This effect has been observed in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects. The non-active SPMS intranasal foralumab Phase II trial began screening patients in November of 2023. Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treatment of neuroinflammatory and neurodegenerative human diseases.

3. Company Overview: J-Pharma Co., Ltd.

J-Pharma Co., Ltd. is a clinical-stage biopharmaceutical company based in Yokohama, Japan, founded in 2005 by Dr. Hitoshi Endou. The company specializes in developing novel therapeutics targeting solute carrier (SLC) transporters, particularly LAT1 (L-type amino acid transporter 1), which is overexpressed in various cancers and autoimmune diseases. Its lead candidates include nanvuranlat (JPH203), a LAT1 inhibitor for advanced biliary tract cancer, and JPH034, aimed at treating multiple sclerosis and brain tumors. J-Pharma collaborates with global institutions and has established a U.S. subsidiary to advance its drug development and regulatory strategies.

Product Description: JPH034

JPH034 is a small-molecule compound developed by J-Pharma, a Japanese biotech company. It targets LAT1 (L-type amino acid transporter 1), which is overexpressed in various cancers, including glioblastoma and biliary tract cancers. The compound is designed to inhibit tumor growth by blocking amino acid uptake essential for cancer cell survival. Currently, JPH034 is in clinical trials, with promising results in solid tumors. J-Pharma focuses on LAT1-targeted therapeutics as a novel cancer treatment strategy.

4. Company Overview: Polpharma Biologics

Polpharma Biologics is an international biotechnology company specializing in the development and manufacturing of biosimilar and novel biologic medicines. Established in 2013 as a spin-off from Poland's Polpharma Group, it operates state-of-the-art facilities in Gdansk and Warsaw, Poland, and Utrecht, Netherlands. The company offers fully integrated services across the biopharmaceutical value chain, from cell line development to commercial-scale production, catering to both its proprietary pipeline and industry partners. Polpharma Biologics has formed strategic collaborations, including joint ventures like Bioeq, and has entered global commercialization agreements for biosimilar products such as natalizumab and ranibizumab. With a workforce of over 800 specialists, the company is committed to expanding access to high-quality, affordable biologic therapies worldwide.

Product Description: PB018

PB018 is an investigational biosimilar of ocrelizumab, developed by Polpharma Biologics, targeting CD20 to deplete B-cells implicated in multiple sclerosis (MS). Designed to mirror the reference biologic's efficacy and safety, PB018 is currently in the preclinical stage of development. This initiative underscores Polpharma Biologics' commitment to expanding affordable treatment options for autoimmune diseases like MS. The company is actively seeking licensing partners to advance PB018 through clinical development and commercialization.

Multiple Sclerosis Analytical Perspective by DelveInsight

• In-depth Commercial Assessment: Multiple Sclerosis Collaboration Analysis by Companies

The Report provides in-depth commercial assessment of drugs that have been included, which comprises collaboration, agreement, licensing and acquisition - deals values trends. The sub-segmentation is described in the report which provide company-company collaboration (licensing/partnering), company academic collaboration and acquisition analysis in tabulated form.

• Multiple Sclerosis Competitive Landscape

The report comprises of comparative assessment of Companies (by therapy, development stage, and technology).

Multiple Sclerosis Report Assessment

• Company Analysis
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions:

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Multiple Sclerosis drugs?
• How many Multiple Sclerosis drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Multiple Sclerosis?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Multiple Sclerosis therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Multiple Sclerosis and their status?
• What are the key designations that have been granted to the emerging and approved drugs?

Key Players

• Sanofi
• Immunic
• InnoCare Pharma
• Tiziana Life Sciences
• Biogen
• J-Pharma
• Bristol-Myers Squibb
• Polpharma Biologics
• Repertoire Immune Medicines

Key Products

• SAR 441344
• IMU-838
• Orelabrutinib
• Foralumab
• BIIB091
• JPH 034
• CC-97540
• PB018
• Autoimmune disorder vaccines