Myositis - Pipeline Insight, 2025

DelveInsight’s, “Myositis - Pipeline Insight, 2025,” report provides comprehensive insights about 18+ companies and 20+ pipeline drugs in Myositis 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

• Global coverage

Myositis Understanding

Myositis: Overview

Myositis is a group of rare inflammatory muscle diseases characterized by muscle inflammation and weakness. It can affect various parts of the body, including skeletal muscles, the skin, and internal organs, depending on the type. The primary symptom is muscle weakness, which typically develops gradually over weeks to months, but other symptoms can include muscle pain, difficulty swallowing, and fatigue. Myositis is often autoimmune in nature, where the immune system mistakenly attacks healthy muscle tissues. It can be challenging to diagnose due to its rarity and the overlap of symptoms with other muscle or autoimmune disorders.

There are several types of myositis, including polymyositis, dermatomyositis, inclusion body myositis (IBM), and juvenile myositis. Polymyositis involves inflammation primarily of the skeletal muscles, while dermatomyositis affects both muscles and the skin, causing rashes in addition to muscle weakness. Inclusion body myositis is distinct as it progresses more slowly and affects older adults, leading to significant muscle atrophy and loss of mobility. Juvenile myositis, which occurs in children, primarily affects the skin and muscles and can be associated with other systemic symptoms like vasculitis.

The exact cause of myositis is not fully understood, but genetic factors, infections, medications, and environmental triggers are believed to play a role. In many cases, the immune system becomes dysregulated, attacking the body’s own tissues, which leads to inflammation in the muscles. Viral infections, such as the flu or HIV, can sometimes trigger myositis, and certain drugs, including statins and some cancer therapies, may also contribute to its onset.

Diagnosis of myositis typically involves a combination of clinical evaluation, blood tests (to check for elevated muscle enzymes and specific autoantibodies), muscle biopsy, and imaging techniques like MRI. Treatment is focused on managing symptoms and slowing the progression of the disease, and it often includes immunosuppressive medications such as corticosteroids and disease-modifying antirheumatic drugs (DMARDs). In some cases, physical therapy is essential for maintaining muscle strength and mobility.

Though there is no cure for myositis, many patients can achieve symptom control and an improved quality of life with proper treatment. However, the long-term prognosis varies depending on the specific type of myositis, the severity of the disease, and how early treatment is initiated. Research is ongoing to better understand the underlying mechanisms and to develop more targeted therapies for this rare and complex group of diseases.

""Myositis - Pipeline Insight, 2025"" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Myositis pipeline landscape is provided which includes the disease overview and Myositis treatment guidelines. The assessment part of the report embraces, in depth Myositis 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, Myositis 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 Myositis R&D. The therapies under development are focused on novel approaches to treat/improve Myositis.

Myositis Emerging Drugs Chapters

This segment of the Myositis report encloses its detailed analysis of various drugs in different stages of clinical development, including phase 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.

Myositis Emerging Drugs

• PF-06823859: Pfizer

PF-06823859 is a potent, selective, humanised immunoglobulin 1-neutralising monoclonal antibody (mAb) that is administered through intravenous injection and acts by targeting interferon beta 1 (IFNB1). In the Phase II study, the drug was generally safe and well tolerated, and significantly decreased muscle enzyme levels (CK) in patients with muscle-predominant refractory moderate-to-severe Dermatomyositis (DM). Currently, the drug is in the Phase III stage of its development for the treatment of Myositis.

• M5049: Merck KGaA

M5049, also known as Enpatoran, is a small molecule drug currently being investigated for its potential to treat various inflammatory conditions, including myositis. This drug acts as an antagonist to Toll-like receptors 7 and 8 (TLR7/8), which are involved in the immune response, particularly in conditions characterized by excessive inflammation. The drug is undergoing Phase II clinical trials specifically targeting dermatomyositis and polymyositis, both forms of inflammatory myopathies. These trials are designed to evaluate the drug's efficacy and safety in patients suffering from these conditions.

• RAY121: Chugai Pharmaceutical

RAY121 is an investigational therapeutic antibody that targets the classical complement pathway, specifically inhibiting complement C1s, which plays a role in inflammatory and autoimmune responses. RAY121 utilizes a novel recycling antibody technology developed by Chugai Pharmaceutical. This technology is designed to enhance the half-life of the drug in the bloodstream, potentially allowing for less frequent dosing while maintaining therapeutic efficacy. Currently, RAY121 is being evaluated in a Phase Ib clinical trial known as the RAINBOW Trial. This trial aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of RAY121 in patients with various autoimmune conditions, including Dermatomyositis and other disease.

Further product details are provided in the report……..

Myositis: Therapeutic Assessment

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

• Major Players in Myositis

There are approx. 18+ key companies which are developing the therapies for Myositis. The companies which have their Myositis drug candidates in the most advanced stage, i.e. Phase III include, Pfizer.

• Phases

DelveInsight’s report covers around 20+ 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 candidates
• Route of Administration

Myositis 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
• Parenteral
• intravenous
• Subcutaneous
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy
• Product Type

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

Myositis: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Myositis 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 Myositis drugs.

Myositis Report Insights

• Myositis Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Myositis 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 Myositis drugs?
• How many Myositis drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Myositis?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Myositis 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 Myositis and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• GlaxoSmithKline
• Merck KGaA
• Abcuro, Inc.
• Orphazyme
• Bristol-Myers Squibb
• Kezar Life Sciences, Inc.
• Viela Bio
• Paean Biotechnology Inc.
• Alexion Pharmaceuticals
• Janssen Biotech
• CSL Behring
• Pfizer
• Restem, LLC.
• Roche

Key Products

• Belimumab
• M5049
• ABC008
• Abatacept
• KZR-616
• MEDI7734
• PN-101
• Ravulizumab
• tocilizumab
• PF-06823859
• Ustekinumab