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Relapsing Multiple Sclerosis Pipeline Analysis Report 2025

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    Report

  • 200 Pages
  • June 2025
  • Region: Global
  • Expert Market Research
  • ID: 6102699
Relapsing multiple sclerosis (RMS) is the most common form of multiple sclerosis, characterized by episodes of new or worsening neurological symptoms. According to the World Health Organization, over 1.8 million people are affected by MS globally. Relapsing multiple sclerosis pipeline analysis by the publisher highlights significant advancements in small molecules, biologics, and gene therapies. The growing focus on targeted therapies, immunomodulators, and monoclonal antibodies is driving innovation in the relapsing multiple sclerosis pipeline. Moreover, with increased R&D investments, the clinical pipeline for relapsing multiple sclerosis is expected to grow steadily in the coming years.

Report Coverage

The Relapsing Multiple Sclerosis Pipeline Analysis Report by the publisher gives comprehensive insights into relapsing multiple sclerosis therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for relapsing multiple sclerosis. The relapsing multiple sclerosis report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The relapsing 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 relapsing 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 relapsing multiple sclerosis.

Relapsing Multiple Sclerosis Pipeline Outlook

Relapsing multiple sclerosis (RMS) is a chronic autoimmune disorder where the immune system attacks the protective myelin sheath covering nerve fibers in the central nervous system. This leads to inflammation and nerve damage, causing symptoms such as vision problems, muscle weakness, and cognitive impairment. RMS is characterized by flare-ups (relapses) followed by periods of partial or complete recovery (remissions).

Relapsing multiple sclerosis treatments aim to reduce relapses, delay disability progression, and control inflammation. These include disease-modifying therapies, monoclonal antibodies, oral agents, and injectable medications. In September 2024, the U.S. FDA approved Ocrevus Zunovo, the first and only twice-yearly, 10-minute subcutaneous injection for RMS. It offers flexible access without IV infrastructure, supported by ten years of efficacy data.

Relapsing Multiple Sclerosis Epidemiology

Relapsing forms of multiple sclerosis (MS), especially relapsing-remitting MS (RRMS), involve recurrent episodes of neurological symptoms followed by recovery. According to a study published in 2025, an estimated 1.89 million people were living with MS globally in 2021, with a prevalence of 23.9 cases per 100,000 population. It is estimated that over 16,000 deaths are due to MS annually, with the highest burden in North America and Western Europe. The incidences are projected to increase by 2050.

Relapsing Multiple Sclerosis - Pipeline Therapeutic Assessment

This section of the report covers the analysis of relapsing 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

  • Monoclonal Antibodies
  • Small Molecules
  • Recombinant Fusion Proteins
  • Peptides
  • Gene Therapies
  • Others

By Route of Administration

  • Oral
  • Parenteral
  • Others

Relapsing 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 III, with 59.26%, covers a major share of the total relapsing multiple sclerosis clinical trials. Phase II follows at 40.74%, and Phase IV holds at 25.93%. Phase I contributes 22.22%, and Early Phase I represents 4.88%. This ensures steady growth and therapeutic advancement in the relapsing multiple sclerosis pipeline.

Relapsing Multiple Sclerosis Pipeline Assessment Segmentation, By Drug Classes

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

Bruton’s tyrosine kinase (BTK) inhibitors are emerging as a novel class in the relapsing multiple sclerosis drug pipeline. For instance, Roche’s investigational therapy, fenebrutinib, showed near-complete suppression of disease activity and no disability progression over 48 weeks in Phase II trial. It also demonstrated significant MRI lesion reduction, with a favorable safety profile consistent across multiple indications.

Relapsing Multiple Sclerosis Clinical Trials - Key Players

The report for the relapsing multiple sclerosis pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed relapsing multiple sclerosis therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in relapsing multiple sclerosis clinical trials:
  • Novartis Pharmaceuticals
  • Bristol-Myers Squibb
  • Hoffmann-La Roche
  • Sandoz Group AG
  • Zenas BioPharma
  • Genentech, Inc.
  • TG Therapeutics, Inc.
  • Sanofi
  • Immunic AG
  • Genentech, Inc.

Relapsing 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 relapsing multiple sclerosis. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of relapsing multiple sclerosis drug candidates.

Drug: BMS-986374

BMS-986374 (ozanimod), sponsored by Bristol-Myers Squibb, is currently being evaluated in a Phase IV study to determine its effectiveness and safety in Chinese adults with relapsing multiple sclerosis. This study is assessing the therapeutic impact of Zeposia, an oral S1P receptor modulator that selectively binds to S1P1 and S1P5, preventing lymphocyte migration from lymph nodes and potentially reducing inflammatory damage in the central nervous system.

Drug: Fenebrutinib

Fenebrutinib is being evaluated in a Phase III study sponsored by Hoffmann-La Roche to compare its efficacy and safety against teriflunomide in adults with relapsing multiple sclerosis. The study aims to assess disability progression and relapse rates. Fenebrutinib is a highly selective, reversible oral BTK inhibitor, designed to modulate B-cell activity and innate immune responses with minimal off-target effects.

Key Questions Answered in the Relapsing Multiple Sclerosis Pipeline Analysis Report

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

Reasons To Buy This Report

The Relapsing Multiple Sclerosis Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for relapsing 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 relapsing multiple sclerosis collaborations, regulatory environments, and potential growth opportunities.

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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 Relapsing Multiple Sclerosis
3.1 Signs and Symptoms
3.2 Causes
3.3 Risk Factors
3.4 Diagnosis
3.5 Treatment
4 Patient Profile: Relapsing Multiple Sclerosis
4.1 Patient Profile Overview
4.2 Patient Psychology and Emotional Impact Factors
4.3 Risk Assessment and Treatment Success Rate
5 Relapsing Multiple Sclerosis: Epidemiology Snapshot
5.1 Relapsing Multiple Sclerosis Incidence by Key Markets
5.2 Relapsing Multiple Sclerosis - Patients Seeking Treatment in Key Markets
6 Relapsing Multiple Sclerosis: Market Dynamics
6.1 Market Drivers and Constraints
6.2 SWOT Analysis
7 Relapsing 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 Relapsing 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 Relapsing 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 Relapsing 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: BMS-986374
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 Biological: CYB704
10.2.3 Drug: Fenebrutinib
10.2.4 Other Drugs
11 Relapsing 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 Biological: YTB323
11.2.4 Other Drugs
12 Relapsing 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: CC-97540
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 Other Drugs
13 Relapsing 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 Relapsing 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 Bristol-Myers Squibb
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 Sandoz Group AG
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 Zenas BioPharma
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 Genentech, Inc.
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 TG Therapeutics, Inc.
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 Sanofi
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 Immunic AG
14.9.1 Company Snapshot
14.9.2 Pipeline Product Portfolio
14.9.3 Financial Analysis
14.9.4 Recent News and Developments
15 Regulatory Framework for Drug Approval, By Region16 Terminated or Suspended Pipeline Products