Myositis Clinical Trial Pipeline Analysis: 40+ Key Companies Shaping the Future of Myositis Therapeutics | DelveInsight

DelveInsight's Myositis Pipeline Insight 2026 report provides comprehensive global coverage of available, marketed, and pipeline Myositis therapies in various stages of clinical development. The report provides insights into 40+ companies and 45+ pipeline drugs in the Myositis pipeline landscape, covering clinical and nonclinical stage products, therapeutic assessments, and inactive pipeline products.

Key takeaways from the Myositis Clinical Trial Landscape Report

• DelveInsight's Myositis pipeline report depicts a robust space with 40+ companies working to develop 45+ pipeline therapies for Myositis treatment.
• Key Myositis companies such as Pfizer, Galapagos NV, Fate Therapeutics, Artiva Biotherapeutics, Inc., Aavogen, CRISPR Therapeutics, Century Therapeutics, Inc., Cabaletta Bio, Miltenyi Biotec GmbH, Nkarta, Inc., Kyverna Therapeutics, Gilead Sciences, Bristol-Myers Squibb, Allogene Therapeutics, and Adicet Therapeutics.
• Promising Myositis pipeline therapies in various stages of development include PF-06823859, GLPG3667, FT819, AlloNK, AVGN7, CTX112, CNTY-101, CABA-201, MB-CART19.1, NKX019, KYV-101, KITE-363, BMS-986515, ALLO-329, and ADI-001.

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What is Myositis?

Myositis, or idiopathic inflammatory myopathies (IIMs), represents a group of rare autoimmune disorders characterized by chronic inflammation and progressive weakness of skeletal muscles, with potential involvement of extramuscular organs such as the lungs, heart, and esophagus.
Major subtypes include dermatomyositis (DM), polymyositis (PM), juvenile dermatomyositis (JDM), inclusion body myositis (IBM), immune-mediated necrotizing myopathy (IMNM), as well as overlap and antisynthetase syndromes, each with distinct clinical and immunological features.
Systemic features may include fever, weight loss, interstitial lung disease, Raynaud's phenomenon, and dysphagia. The clinical presentation varies by subtype, with dermatomyositis showing characteristic skin rashes, polymyositis presenting with isolated muscle involvement, and inclusion body or necrotizing myopathy displaying distinct progression patterns.
Diagnosis requires a comprehensive, multimodal approach integrating clinical evaluation, laboratory testing, imaging, electromyography (EMG), and muscle biopsy. Management generally begins with high-dose glucocorticoids, followed by steroid-sparing immunosuppressants. Physiotherapy and multidisciplinary support are also important for preserving muscle function, improving mobility, and optimizing quality of life.

Emerging Myositis Drug Profiles

PF-06823859: Pfizer
PF-06823859 is a humanized monoclonal antibody developed by Pfizer that targets interferon-beta, aiming to inhibit key inflammatory signaling pathways involved in idiopathic inflammatory myopathies. By reducing immune-mediated inflammation in muscle and skin tissues, it is designed to improve muscle strength and decrease disease activity in conditions such as dermatomyositis and polymyositis. Currently, PF-06823859 is under evaluation in Phase III clinical trials for the treatment of Myositis.

GLPG3667: Galapagos NV
GLPG3667 is an investigational, oral small-molecule TYK2 inhibitor developed by Galapagos, designed to selectively modulate key cytokine signaling pathways involved in autoimmune diseases. By inhibiting TYK2, it blocks downstream signaling of cytokines such as type I interferons, IL-12, and IL-23, thereby reducing immune-mediated inflammation in idiopathic inflammatory myopathies.
In Myositis, including dermatomyositis and polymyositis, this mechanism may help improve muscle strength, control skin manifestations, and decrease overall disease activity. Currently, the drug is in Phase II development for the treatment of Myositis.

FT819: Fate Therapeutics
FT819 is an investigational, off-the-shelf allogeneic CAR T-cell therapy engineered to target CD19-positive B cells and developed using induced pluripotent stem cell (iPSC) technology. By selectively depleting pathogenic B cells, it aims to reduce autoantibody production and modulate aberrant immune responses involved in idiopathic inflammatory myopathies.
In Myositis, particularly autoantibody-driven subtypes, this approach may help decrease disease activity and improve muscle function. Currently, FT819 is in Phase I development for the treatment of Myositis.

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Scope of the Myositis Pipeline Report

• Coverage: Global
• Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination
• Therapeutic Assessment By Clinical Stages: Phase III, Phase II, Phase I, Preclinical, Discovery
• Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical
• Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy
• Key Myositis Companies: Pfizer, Galapagos NV, Fate Therapeutics, Artiva Biotherapeutics, Inc., Aavogen, CRISPR Therapeutics, Century Therapeutics, Inc., Cabaletta Bio, Miltenyi Biotec GmbH, Nkarta, Inc., Kyverna Therapeutics, Gilead Sciences, Bristol-Myers Squibb, Allogene Therapeutics, Adicet Therapeutics
• Key Myositis Pipeline Therapies: PF-06823859, GLPG3667, FT819, AlloNK, AVGN7, CTX112, CNTY-101, CABA-201, MB-CART19.1, NKX019, KYV-101, KITE-363, BMS-986515, ALLO-329, ADI-001

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Table of Contents

1. Myositis Pipeline Report Introduction
2. Myositis Pipeline Report Executive Summary
3. Myositis Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Myositis Pipeline Therapeutics
6. Myositis Pipeline: Late Stage Products (Phase III)
7. Myositis Pipeline: Mid Stage Products (Phase II)
8. Myositis Pipeline: Early Stage Products (Phase I)
9. Myositis Pipeline: Preclinical and Discovery Stage Products
10. Myositis Pipeline Therapeutics Assessment
11. Inactive Products in the Myositis Pipeline
12. Key Companies
13. Key Products in the Myositis Pipeline
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

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