Multiple Sclerosis (MS) is an autoimmune disorder in which the immune system attacks the myelin sheath that surrounds and protects the nerve fibers, causing inflammation eventually affecting the brain, spinal cord and optic nerves which disrupts the flow of information within the brain, and between the brain and body. It can be of four types: Clinically Isolated syndrome, Relapsing-remitting Multiple Sclerosis, Secondary progressive Multiple Sclerosis and Primary progressive Multiple Sclerosis.

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The exact cause of Multiple Sclerosis is still unclear but the risk factors include family history, genetic factors, vitamin D and B12 deficiency, age, obesity, smoking, infections, other autoimmune diseases.

The most common symptoms of Multiple Sclerosis include spasticity/muscle spasms, pain, muscle weakness, numbness, fatigue, tingling, blurred or poor vision, cognitive and mood disturbances, balance and co-ordination issues.

Multiple Sclerosis can be diagnosed by the doctors with a physical and neurological examination, with questions of symptoms and medical history. Diagnostic tests include blood tests, spinal tap (lumbar puncture), MRI scans, spinal fluid analysis, evoked potential tests, optical coherence tomography.

The most common treatments options for Multiple Sclerosis are disease-modifying therapies, interferon beta medications, monoclonal antibodies, stem cell therapy, plasma exchange.

The pipeline of Multiple Sclerosis treatment market consists of a great variable of drugs. Integrin Alpha4-beta1 Antagonists, Bruton’s Tyrosine Kinase (BTK) Inhibitors, Receptor Interacting Protein Kinase 1 (RIPK1) Inhibitors, Interleukin 7 Inhibitors, Muscarinic M1 Receptor Antagonists, and some others are the most highlighted class of this indication. Ongoing research and current trials have the potential to change the market.

More than 120 key players, including pharma giants such as Hoffmann-La Roche, Sanofi, Biogen, Idorsia Pharmaceutical Ltd, Novartis, and others are working to bring novel therapies that overcome the roadblocks of Multiple Sclerosis treatment pipeline.

Report Highlights
Global Insight Service’s, “Multiple Sclerosis – Drug Pipeline Landscape, 2023,” is an overview of the Multiple Sclerosis pipeline drugs. This report covers detailed insights on Multiple Sclerosis drugs under development, assessment by target, mechanism of action, route of administration and molecule type. Product pipeline by companies, stage of development and key regulatory designations, deals and milestones have been presented to gain insights and thus help industry participants for decision making. Multiple Sclerosis pipeline report helps gaining insights on drugs which are under development stage of drug development process across globally. Global Insight Services aims to cover all the drug attributes, deals, regulatory milestones and all the upcoming milestones.

Recent Developments
In December 2022, AB Science received clearance from the U.S. Food and Drug Administration (FDA) to initiate the confirmatory Phase 3 study with masitinib in the treatment of progressive multiple sclerosis.

In July 2022, Polpharma Biologics announced that European Medicines Agency (EMA) has accepted the Marketing Approval Application (MAA) and U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for the Natalizumab Biosimilar-PB006 for the treatment of Multiple Sclerosis.

In April 2022, Imcyse dosed first patient in Adaptive Phase 1/2 study of IMCY-0141 for Multiple Sclerosis.In March 2022, Pipeline Therapeutics reported positive Phase 1 clinical results for PIPE-307 and received clearance from the U.S. Food and Drug Administration to proceed with a Phase 1b/2a study of PIPE-307 in relapsing-remitting multiple sclerosis (RRMS) patients.

In July 2021, Biogen Inc and InnoCare Pharma Limited entered into license and collaboration agreement for orelabrutinib for the potential treatment of multiple sclerosis (MS).

In March 2021, Immunic and 4SC AG sign agreement regarding the settlement of Royalty Obligations for Immunic’s IMU-838.

In September 2019, Polpharma Biologics entered a global commercialization agreement with Sandoz AG for the development, manufacturing and supply of natalizumab biosimilar.

Key Products
Natalizumab Biosimilar-PB006 is a monoclonal antibody and biosimilar of Natalizumab which is under development by Polpharma Biologics for the treatment of Multiple Sclerosis. In July 2022, European Medicines Agency (EMA) has accepted the Marketing Approval Application (MAA) and U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for the Natalizumab Biosimilar-PB006 for the treatment of Multiple Sclerosis. In September 2019, Polpharma Biologics entered a global commercialization agreement with Sandoz AG for the development, manufacturing and supply of natalizumab biosimilar.

Vidofludimus calcium (IMU-838) is under development by Immunic AG for the treatment of Multiple Sclerosis including relapsing multiple sclerosis and progressive multiple sclerosis. In July 2021, drug got U.S. FDA clearance for its Investigational New Drug application for the phase 3 ENSURE program of vidofludimus in patients with RMS. In September 2016, Immunic acquired IMU-838 from 4SC AG through an asset acquisition.

Orelabrutinib (ICP-002) is under global development for the treatment of Multiple Sclerosis. In July 2021, Biogen Inc and InnoCare Pharma Limited entered into license and collaboration agreement for orelabrutinib for the treatment of multiple sclerosis (MS). Biogen will have exclusive rights to orelabrutinib outside of China (including Hong Kong, Macau and Taiwan), while InnoCare will retain exclusive worldwide rights to orelabrutinib in China (including Hong Kong, Macau and Taiwan).