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Multiple Sclerosis Drug Pipeline Analysis Report 2025

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    Drug Pipelines

  • 200 Pages
  • June 2025
  • Region: Global
  • Expert Market Research
  • ID: 6102746
Multiple sclerosis is a chronic autoimmune disease that affects the central nervous system, leading to progressive neurological impairment. It accounts for approximately 1.8 million cases worldwide. There is a significant unmet clinical need for better therapies to treat the disease, as current treatment options, such as immunomodulators and monoclonal antibodies, have limitations in efficacy and safety. Furthermore, the growing focus on novel multiple sclerosis therapeutics, including remyelination agents and neuroprotective drugs, is likely to drive pipeline growth in the coming years. Advancements in biologics, gene therapy, and cell-based approaches are also shaping the future of multiple sclerosis drug development.

Report Coverage

The Multiple Sclerosis Drug Pipeline Insight Report by the publisher gives comprehensive insights into multiple sclerosis therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for multiple sclerosis. The multiple sclerosis report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The multiple sclerosis pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with multiple sclerosis treatment guidelines to ensure optimal care practices.

The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to multiple sclerosis.

Multiple Sclerosis Drug Pipeline Outlook

Multiple sclerosis is a chronic disease in which the immune system mistakenly attacks the protective covering of nerve fibers in the central nervous system, causing inflammation and damage. It can lead to symptoms like muscle weakness, fatigue, and vision problems. The disease occurs in episodes of flare-ups, with progressive worsening over time.

Multiple sclerosis treatment aims to reduce disease activity and manage symptoms. Current therapies include disease-modifying drugs (DMDs) that slow progression, corticosteroids to manage relapses and symptomatic treatments. Emerging treatments focus on remyelination and neuroprotection, offering hope for improved outcomes.

Multiple Sclerosis Epidemiology

The global multiple sclerosis drug pipeline is evolving rapidly, driven by the rising incidence of the disease. Over 1.8 million people are affected worldwide, with nearly 1 million cases in the United States. The United Kingdom reports over 150,000 individuals living with multiple sclerosis, while India has approximately 145,800 multiple sclerosis patients, with a prevalence rate of 11 per 100,000. These statistics highlight the increasing demand for innovative multiple sclerosis therapeutics.

Multiple Sclerosis - Drug Pipeline Therapeutic Assessment

This section of the report covers the analysis of multiple sclerosis drug candidates based on several segmentations, including:

By Phase

  • Late-Stage Products (Phase 3 and Phase 4)
  • Mid-Stage Products (Phase 2)
  • Early-Stage Products (Phase I)
  • Preclinical and Discovery Stage Products

By Drug Class

  • Small Molecules
  • Monoclonal Antibodies
  • Gene Therapies
  • Peptides
  • Cell Therapies

By Route of Administration

  • Oral
  • Parenteral
  • Others

Multiple Sclerosis - Pipeline Assessment Segmentation, By Phases

The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to analysis, phase II covers a major share of the total multiple sclerosis clinical trials.

Multiple Sclerosis - Pipeline Assessment Segmentation, By Drug Classes

The drug molecule categories covered under the multiple sclerosis pipeline analysis include small molecules, monoclonal antibodies, gene therapies, peptides, and cell therapies. The multiple sclerosis report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for multiple sclerosis.

Multiple Sclerosis Clinical Trials Therapeutic Assessment - Competitive Dynamics

The report for the multiple sclerosis drug pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed multiple sclerosis therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in multiple sclerosis clinical trials:
  • Novartis Pharmaceuticals
  • Eli Lilly and Company
  • Hoffmann-La Roche
  • ModernaTX, Inc.
  • Celgene
  • Sanofi
  • Biogen
  • Ever Supreme Bio Technology Co., Ltd.
  • ImStem Biotechnology
  • Kyverna Therapeutics
  • Abata Therapeutics
  • Zenas BioPharma, LLC
  • Genentech, Inc.
  • Contineum Therapeutics
  • Indapta Therapeutics, Inc.

Multiple Sclerosis Emerging Drugs Profile

This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for multiple sclerosis. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of multiple sclerosis drug candidates.

Drug: Frexalimab

The Phase 3 study, sponsored by Sanofi, aims to evaluate the efficacy and safety of Frexalimab in adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS). The objective is to assess the drug's ability to delay disability progression compared to a placebo. The study is anticipated to be completed by March 2028, with an estimated 858 participants.

Drug: LY3541860

The drug LY3541860, sponsored by Eli Lilly and Company, is currently undergoing a Phase 2 study to assess its safety and efficacy in adult participants with relapsing multiple sclerosis. The primary objective is to evaluate its effect on slowing the occurrence of new T1 gadolinium-enhancing lesions. The study, expected to enroll approximately 200 participants, will be completed by August 2028.

Drug: RO7121932

Hoffmann-La Roche is a Phase 1 study, that aims to investigate the safety, tolerability, and pharmacokinetics of intravenous (IV) and subcutaneous (SC) RO7121932 in participants with multiple sclerosis. The study, which includes single and multiple ascending doses, is expected to be completed by December 2026, with an enrollment of around 129 participants.

Reasons To Buy This Report

The Multiple Sclerosis Drug Pipeline Insight Report provides a strategic overview of the latest and future landscape of treatments for multiple sclerosis. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into multiple sclerosis collaborations, regulatory environments, and potential growth opportunities.

Key Questions Answered in the Multiple Sclerosis - Pipeline Insight Report

  • Which companies/institutions are leading the multiple sclerosis drug development?
  • What is the efficacy and safety profile of multiple sclerosis pipeline drugs?
  • Which company is leading the multiple sclerosis pipeline development activities?
  • What is the current multiple sclerosis commercial assessment?
  • What are the opportunities and challenges present in the multiple sclerosis drug pipeline landscape?
  • What is the efficacy and safety profile of multiple sclerosis pipeline drugs?
  • Which company is conducting major trials for multiple sclerosis drugs?
  • Which companies/institutions are involved in multiple sclerosis collaborations aimed at providing enhanced therapeutic alternatives for patients?
  • What are the geographies covered for clinical trials in multiple sclerosis?

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Table of Contents

1 Preface
1.1 Introduction
1.2 Objectives of the Study
1.3 Research Methodology & Assumptions
2 Executive Summary
3 Overview of Multiple Sclerosis
3.1 Signs and Symptoms
3.2 Causes
3.3 Risk Factors
3.4 Diagnosis
3.5 Treatment
4 Patient Profile: Multiple Sclerosis
4.1 Patient Profile Overview
4.2 Patient Psychology and Emotional Impact Factors
4.3 Risk Assessment and Treatment Success Rate
5 Multiple Sclerosis: Epidemiology Snapshot
5.1 Multiple Sclerosis Incidence by Key Markets
5.2 Multiple Sclerosis - Patients Seeking Treatment in Key Markets
6 Multiple Sclerosis: Market Dynamics
6.1 Market Drivers and Constraints
6.2 SWOT Analysis
7 Multiple Sclerosis: Key Facts Covered
7.1 Top Countries Contributing to Clinical Trials in Asia-Pacific
7.2 Top Countries Contributing to Clinical Trials in Europe
7.3 Top Countries Contributing to Clinical Trials in North America
7.4 Top Countries Contributing to Clinical Trials in Other Regions
8 Multiple Sclerosis, Drug Pipeline Assessment
8.1 Assessment by Treatment Type
8.2 Assessment by Route of Administration
8.3 Assessment by Drug Class
9 Drug Pipeline Comparative Analysis
9.1 List of Multiple Sclerosis Pipeline Drugs
9.1.1 By Company
9.1.2 By Phase
9.1.3 By Indication
9.1.4 By Trial Status
9.1.5 By Funder Type
9.2 Attribute Scoring Analysis of Pipeline Drugs (Top Drugs)
10 Multiple Sclerosis Drug Pipeline - Late-Stage Products (Phase III and IV) (Top Drugs)
10.1 Comparative Analysis for Late-Stage Drugs
10.1.1 Study Type
10.1.2 Recruitment Status
10.1.3 Company
10.1.4 Funder Type
10.2 Product Level Analysis*
10.2.1 Drug: Frexalimab
10.2.1.1 Product Description
10.2.1.2 Trial ID
10.2.1.3 Sponsor Name
10.2.1.4 Study Type
10.2.1.5 Drug Class
10.2.1.6 Eligibility Criteria
10.2.1.7 Study Record Dates
10.2.1.7.1 First Submitted
10.2.1.7.2 First Posted
10.2.1.7.3 Last Update Posted
10.2.1.7.4 Last Verified
10.2.1.8 Indication
10.2.1.9 Study Design
10.2.1.10 Recruitment Status
10.2.1.11 Enrollment (Estimated)
10.2.1.12 Location Countries
10.2.1.13 Recent Results
10.2.2 Drug: IMU-838
10.2.3 Drug: Tolebrutinib
10.2.4 Other Drugs
11 Multiple Sclerosis Drug Pipeline - Mid-Stage Products (Phase II) (Top Drugs)
11.1 Comparative Analysis for Mid-Stage Drugs
11.1.1 Study Type
11.1.2 Recruitment Status
11.1.3 Company
11.1.4 Funder Type
11.2 Product Level Analysis*
11.2.1 Drug: LY3541860
11.2.1.1 Product Description
11.2.1.2 Trial ID
11.2.1.3 Sponsor Name
11.2.1.4 Study Type
11.2.1.5 Drug Class
11.2.1.6 Eligibility Criteria
11.2.1.7 Study Record Dates
11.2.1.7.1 First Submitted
11.2.1.7.2 First Posted
11.2.1.7.3 Last Update Posted
11.2.1.7.4 Last Verified
11.2.1.8 Indication
11.2.1.9 Study Design
11.2.1.10 Recruitment Status
11.2.1.11 Enrollment (Estimated)
11.2.1.12 Location Countries
11.2.1.13 Recent Results
11.2.2 Drug: SAR441344
11.2.3 Drug: BIIB091
11.2.4 Other Drugs
12 Multiple Sclerosis Drug Pipeline - Early-Stage Products (Phase I) (Top Drugs)
12.1 Comparative Analysis for Early-Stage Drugs
12.1.1 Study Type
12.1.2 Recruitment Status
12.1.3 Company
12.1.4 Funder Type
12.2 Product Level Analysis*
12.2.1 Drug: RO7121932
12.2.1.1 Product Description
12.2.1.2 Trial ID
12.2.1.3 Sponsor Name
12.2.1.4 Study Type
12.2.1.5 Drug Class
12.2.1.6 Eligibility Criteria
12.2.1.7 Study Record Dates
12.2.1.7.1 First Submitted
12.2.1.7.2 First Posted
12.2.1.7.3 Last Update Posted
12.2.1.7.4 Last Verified
12.2.1.8 Indication
12.2.1.9 Study Design
12.2.1.10 Recruitment Status
12.2.1.11 Enrollment (Estimated)
12.2.1.12 Location Countries
12.2.2 Biological: ABA-101
12.2.3 Other Drugs
13 Multiple Sclerosis Drug Pipeline - Preclinical and Discovery Stage Products (Top Drugs)
13.1 Comparative Analysis for Preclinical and Discovery Stage Drugs
13.1.1 Study Type
13.1.2 Recruitment Status
13.1.3 Company
13.1.4 Funder Type
13.2 Product Level Analysis*
13.2.1 Drug 1
13.2.1.1 Product Description
13.2.1.2 Trial ID
13.2.1.3 Sponsor Name
13.2.1.4 Study Type
13.2.1.5 Drug Class
13.2.1.6 Eligibility Criteria
13.2.1.7 Study Record Dates
13.2.1.7.1 First Submitted
13.2.1.7.2 First Posted
13.2.1.7.3 Last Update Posted
13.2.1.7.4 Last Verified
13.2.1.8 Indication
13.2.1.9 Study Design
13.2.1.10 Recruitment Status
13.2.1.11 Enrollment (Estimated)
13.2.1.12 Location Countries
13.2.2 Other Drugs
14 Multiple Sclerosis, Key Drug Pipeline Companies
14.1 Novartis Pharmaceuticals
14.1.1 Company Snapshot
14.1.2 Pipeline Product Portfolio
14.1.3 Financial Analysis
14.1.4 Recent News and Developments
14.2 Eli Lilly and Company
14.2.1 Company Snapshot
14.2.2 Pipeline Product Portfolio
14.2.3 Financial Analysis
14.2.4 Recent News and Developments
14.3 Hoffmann-La Roche
14.3.1 Company Snapshot
14.3.2 Pipeline Product Portfolio
14.3.3 Financial Analysis
14.3.4 Recent News and Developments
14.4 ModernaTX, Inc.
14.4.1 Company Snapshot
14.4.2 Pipeline Product Portfolio
14.4.3 Financial Analysis
14.4.4 Recent News and Developments
14.5 Celgene
14.5.1 Company Snapshot
14.5.2 Pipeline Product Portfolio
14.5.3 Financial Analysis
14.5.4 Recent News and Developments
14.6 Sanofi
14.6.1 Company Snapshot
14.6.2 Pipeline Product Portfolio
14.6.3 Financial Analysis
14.6.4 Recent News and Developments
14.7 Biogen
14.7.1 Company Snapshot
14.7.2 Pipeline Product Portfolio
14.7.3 Financial Analysis
14.7.4 Recent News and Developments
14.8 Ever Supreme Bio Technology Co., Ltd.
14.8.1 Company Snapshot
14.8.2 Pipeline Product Portfolio
14.8.3 Financial Analysis
14.8.4 Recent News and Developments
14.9 ImStem Biotechnology
14.9.1 Company Snapshot
14.9.2 Pipeline Product Portfolio
14.9.3 Financial Analysis
14.9.4 Recent News and Developments
14.10 Kyverna Therapeutics
14.10.1 Company Snapshot
14.10.2 Pipeline Product Portfolio
14.10.3 Financial Analysis
14.10.4 Recent News and Developments
14.11 Abata Therapeutics
14.11.1 Company Snapshot
14.11.2 Pipeline Product Portfolio
14.11.3 Financial Analysis
14.11.4 Recent News and Developments
14.12 Zenas BioPharma, LLC
14.12.1 Company Snapshot
14.12.2 Pipeline Product Portfolio
14.12.3 Financial Analysis
14.12.4 Recent News and Developments
14.13 Genentech, Inc.
14.13.1 Company Snapshot
14.13.2 Pipeline Product Portfolio
14.13.3 Financial Analysis
14.13.4 Recent News and Developments
14.14 Contineum Therapeutics
14.14.1 Company Snapshot
14.14.2 Pipeline Product Portfolio
14.14.3 Financial Analysis
14.14.4 Recent News and Developments
14.15 Indapta Therapeutics, Inc.
14.15.1 Company Snapshot
14.15.2 Pipeline Product Portfolio
14.15.3 Financial Analysis
14.15.4 Recent News and Developments
15 Regulatory Framework for Drug Approval, By Region16 Terminated or Suspended Pipeline Products