Relapsing-Remitting Multiple Sclerosis Pipeline: 25+ Leading Innovators Paving the Way for Breakthrough Therapies and Treatments | DelveInsight

The relapsing-remitting multiple sclerosis (RRMS) therapeutics market is experiencing a significant transformation, driven by key innovators like Immunic AG, Sanofi, Anokion, RemeGen, HuniLife Biotechnology, Biogen, and Clene Nanomedicine. With the development of novel oral therapies, disease-modifying drugs, and targeted biologics, these companies are reshaping the treatment landscape. The pipeline is particularly focused on enhancing efficacy, reducing relapse rates, and improving long-term outcomes for patients, while also addressing treatment resistance and safety concerns. Advanced therapeutic platforms are offering promising solutions for managing RRMS and improving patients' quality of life.

DelveInsight's "Relapsing-Remitting Multiple Sclerosis Pipeline Insight, 2025" comprehensively analyzes the current clinical landscape and growth prospects in the relapsing-remitting multiple sclerosis market. The report covers disease insights, treatment guidelines, and a detailed pipeline assessment from preclinical to marketed stages. It includes drug mechanisms, clinical studies, regulatory progress, and key developments such as collaborations, mergers, funding, and designations.

For emerging relapsing-remitting multiple sclerosis drugs, the relapsing-remitting multiple sclerosis pipeline analysis report provides a 360° view of the therapeutic landscape by development stage, product type, route of administration, molecule type, and mechanism of action (MOA). The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.

Key Takeaways from the Relapsing-Remitting Multiple Sclerosis Pipeline Report
• DelveInsight's relapsing-remitting multiple sclerosis pipeline analysis depicts a strong space with 25+ active players working to develop 28+ pipeline drugs for relapsing-remitting multiple sclerosis treatment.
• The leading relapsing-remitting multiple sclerosis companies include Immunic AG, Sanofi, Anokion, RemeGen, HuniLife Biotechnology, Biogen, Clene Nanomedicine, Novartis, Celltrion, Imcyse SA, Takeda, and others are evaluating their lead assets to improve the relapsing-remitting multiple sclerosis treatment landscape.
• Key relapsing-remitting multiple sclerosis pipeline therapies in various stages of development include IMU-838, Tolebrutinib, ANK700, CNM Au 8, Telitacicept, HuL001, BIIB-061, Remibrutinib, CT-P53, IMCY-0141, Ixazomib, and others.
• In March 2025, the FDA began priority review of the regulatory submission for tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS) and slow disability accumulation in adult patients, independent of relapse activity.
• In March 2025, the FDA began priority review of the regulatory submission for tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS) and slow disability accumulation in adult patients. The FDA's target decision date is September 28, 2025. A regulatory submission is also under review in the EU.
• In October 2024, SetPoint Medical announced receiving FDA Investigational Device Exemption (IDE) approval to study its neuroimmune modulation platform in patients with relapsing-remitting multiple sclerosis (RRMS).
• In September 2024, Roche announced that the FDA approved OCREVUS ZUNOVO (ocrelizumab & hyaluronidase-ocsq) for treating relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). This is the first and only twice-a-year, healthcare professional-administered subcutaneous injection for both MS forms, providing more treatment options for MS patients.

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Relapsing-Remitting Multiple Sclerosis Overview
Multiple sclerosis is characterized by scar tissue (plaques) in the central nervous system (CNS), resulting from immune system attacks on myelin. These plaques, visible on MRI, can vary in size. In Relapsing-Remitting Multiple Sclerosis (RRMS), inflammatory attacks cause symptoms like visual impairments, fatigue, numbness, and cognitive issues. Over time, around 65% of RRMS patients progress to Secondary Progressive MS (SPMS), where symptoms worsen, including increased weakness, fatigue, and psychological impairments. MS rarely leads to death, and most individuals have a normal life expectancy.

The disease's pathology includes focal inflammation and neurodegeneration. Inflammation creates plaques and disrupts the blood-brain barrier (BBB), leading to further CNS injury. This inflammation triggers immune cell activity, which damages the BBB and contributes to disease progression.

MS treatment is challenging and tailored to the specific form of the disease. While there is no proven therapy for primary progressive MS, disease-modifying therapies (DMTs) help manage relapsing forms by reducing relapses and slowing progression. DMTs are mainly approved for RRMS, with oral treatments offering slightly better persistence than injectable ones. Interferon beta, the first FDA-approved MS treatment, reduces relapse rates and slows progression, particularly in RRMS. New treatments aim to reduce long-term disability in RRMS patients.

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Relapsing-Remitting Multiple Sclerosis Treatment Analysis: Drug Profile
IMU-838: Immunic AG
Vidofludimus calcium (IMU-838) is an investigational small molecule drug being developed as an oral tablet for the treatment of relapsing-remitting multiple sclerosis (RRMS), inflammatory bowel disease (IBD), and other chronic inflammatory and autoimmune conditions. Supported by promising results from the Phase II EMPhASIS trial, Immunic believes IMU-838 offers significant benefits over other treatments, especially for early RRMS treatment, due to its favorable safety profile and strong anti-inflammatory and neuroprotective effects. The drug is currently in Phase III trials for RRMS.

Tolebrutinib: Sanofi
Tolebrutinib is an investigational Bruton's tyrosine kinase (BTK) inhibitor with brain-penetrant properties, designed to target B lymphocytes and microglial cells in the central nervous system (CNS). It is being assessed in Phase III clinical trials for relapsing forms of multiple sclerosis (RMS), non-relapsing secondary progressive MS (nrSPMS), and primary progressive MS (PPMS). Its safety and efficacy have not yet been reviewed by regulatory authorities.

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Relapsing-Remitting Multiple Sclerosis Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• 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 candidates

By Route of Administration
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

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

Scope of the Relapsing-Remitting Multiple Sclerosis Pipeline Report
• Coverage: Global
• Key Relapsing-Remitting Multiple Sclerosis Companies: Immunic AG, Sanofi, Anokion, RemeGen, HuniLife Biotechnology, Biogen, Clene Nanomedicine, Novartis, Celltrion, Imcyse SA, Takeda, and others.
• Key Relapsing-Remitting Multiple Sclerosis Pipeline Therapies: IMU-838, Tolebrutinib, ANK700, CNM Au 8, Telitacicept, HuL001, BIIB-061, Remibrutinib, CT-P53, IMCY-0141, Ixazomib, and others.

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Table of Contents
1. Introduction
2. Executive Summary
3. Relapsing-Remitting Multiple Sclerosis Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Relapsing-Remitting Multiple Sclerosis Pipeline Therapeutics
6. Relapsing-Remitting Multiple Sclerosis Pipeline: Late-Stage Products (Phase III)
7. Relapsing-Remitting Multiple Sclerosis Pipeline: Mid-Stage Products (Phase II)
8. Relapsing-Remitting Multiple Sclerosis Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

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This release was published on openPR.