Multiple sclerosis - Pipeline Insight, 2025

This “Multiple sclerosis - Pipeline Insight, 2025” report provides comprehensive insights about 75+ companies and 80+ pipeline drugs in Multiple sclerosis pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also 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

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. The recurrence of MS is thought to be associated with the development of new damaged areas of the brain. 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, Clumsiness, particularly difficulty staying balanced when walking, Bladder control problems, Intermittent or more constant dizziness.

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). Regulatory T cells (T reg) are another CD4+ T cell type involved in the pathogenesis of MS. Environmental factors, such as exposure to infectious agents as well as sunlight exposure/vitamin D, are felt to account for changing the risk of MS when a person migrates from one risk area to another before age 15.

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).

"Multiple sclerosis- Pipeline Insight, 2025" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Multiple sclerosis pipeline landscape is provided which includes the disease overview and Multiple sclerosis treatment guidelines. The assessment part of the report embraces, in depth Multiple sclerosis commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Multiple sclerosis collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Multiple sclerosis R&D. The therapies under development are focused on novel approaches to treat/improve Multiple sclerosis.

Multiple sclerosis Emerging Drugs Chapters

This segment of the Multiple sclerosis report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, II, I, Preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Multiple sclerosis Emerging Drugs

IMU-838: Immunic Therapeutics

Vidofludimus calcium (IMU-838) is a small molecule investigational drug under development as an oral tablet formulation for the treatment of relapsing-remitting multiple sclerosis, or RRMS, inflammatory bowel disease, or IBD, and other chronic inflammatory and autoimmune diseases. Bolstered by excellent clinical data from the phase II EMPhASIS trial, Immunic believed that vidofludimus calcium has the potential to demonstrate medically important advantages compared with other treatments, particularly for the early treatment of RMS patients, due to its placebo like safety profile and its robust anti-inflammatory and neuroprotective properties.

BIIB091: Biogen

BIIB091 selectively inhibits Burton’s tyrosine kinase (BTK), a non-receptor tyrosine kinase that regulates the development and signaling of B cells and myeloid cells hypothesized to contribute to MS pathogenesis. In addition, BTK has been demonstrated to play a key role in the activation of another cell of the immune system, the myeloid cells via another receptor of this cell (Fcγ receptor signaling (FcγRs)). Preclinical studies demonstrated BIB091 to be a high potency molecule with good drug-like properties and a safety/tolerability profile suitable for clinical development as a highly selective, reversible BTKi for treating autoimmune diseases such as MS. Currently, the drug is in the Phase II stage of its development for the treatment of Multiple sclerosis.

IMCY-0141: ImCyse

IMCY-0141 is the Company’s second clinical-stage compound. This Imotope is designed based on MOG (Myelin Oligodendrocyte Glycoprotein) with the aim to halt the progression of multiple sclerosis (MS) by stopping the body’s immune system from attacking the central nervous system and disrupting undesirable autoimmune responses that drive the destruction of the myelin sheath protecting the nerves. IMCY-0141 has shown promising results in several MS preclinical models, demonstrating an immune response that supports the proposed mode of action and inducing a memory response so that the treatment effect is long-lasting and requires less frequent dosing regimens. Also, if treatment is begun early enough, it has the potential to allow patients to live with minimal impact from the disease. Currently, the drug is in Phase I/II stage of its clinical trial for the treatment of multiple sclerosis.

NeuroVax: Immune Response BioPharma

NeuroVax contains a combination of three protein fragments (peptides) which appear on the surface of T-cells involved in the immune response in MS. Studies suggested that treatment with NeuroVax stimulates production of certain regulatory T-cells, which in turn decrease the levels of other T-cells which attack myelin. NeuroVax is a Once a Month Dosing injection, safe, tolerable, enhances FOXP3+ Tregs & Regulates Pathogenic T Cells in MS Patients, a first in class disease modifying Multiple Sclerosis Vaccine. NeuroVax IR has been shown to stimulate strong, disease-specific cell-mediated immunity in nearly all treated patients. NeuroVax appears to work in part by enhancing levels of Foxp3+ Tregs, which may help regulate expression of pathogenic T cells in MS patients. The three TCR peptides combined in it correspond to one or more TCR gene families which are over expressed in 90% of MS patients.

Multiple sclerosis: Therapeutic Assessment

This segment of the report provides insights about the different Multiple sclerosis drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Multiple sclerosis

• There are approx. 75+ key companies which are developing the therapies for Multiple sclerosis. The companies which have their Multiple sclerosis drug candidates in the most advanced stage, i.e. Phase III include, Immunic Therapeutics.

Phases

The report covers around 80+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive

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

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Multiple sclerosis: Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Multiple sclerosis therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Multiple sclerosis drugs.

Multiple sclerosis Report Insights

• Multiple sclerosis Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Multiple sclerosis Report Assessment

• Pipeline Product Profiles
• 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 drugs?

Key Players

• Novartis
• Sanofi
• Immunic
• Biocad
• Apimeds
• Genentech (Roche)
• Merck
• AB Science
• Apurano Pharmaceuticals
• Biogen
• Tiziana Life Sciences
• Worg Pharmaceuticals
• Antisense Therapeutics
• RemeGen
• Atara Biotherapeutics
• Contineum Therapeutics
• Stem Cell Medicine Ltd.
• Ever Supreme Bio Technology Co., Ltd.
• ImCyse

Key Products

• Remibrutinib
• Tolebrutinib
• IMU 838
• BCD-132
• Apitox
• Fenebrutinib
• Evobrutinib
• Masitinib
• Adezunap
• BIIB091
• Foralumab
• WP1303
• ATL1102
• RC18
• ATA188
• PIPE-307
• SCM-010
• UMSC01
• IMCY-0141

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