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Report Overview
Myasthenia gravis (MG) is a chronic autoimmune neuromuscular disorder characterized by fluctuating skeletal muscle weakness caused by impaired neuromuscular transmission. According to Fan Jiang et al., 2023, MG is a low-incidence disease, with an estimated global incidence of 0.3–2.8 per 100,000 person-years worldwide. According to the myasthenia gravis pipeline analysis by Expert Market Research, the therapeutic landscape is evolving rapidly, driven by targeted biologics, complement inhibitors, FcRn antagonists, and next-generation immunotherapies. The growing disease awareness, improved diagnostic rates, and unmet needs in refractory MG are increasing R&D focus. These factors are expected to support steady pipeline expansion and treatment innovation in the coming years.
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Major companies involved in the myasthenia gravis pipeline analysis include Immunovant Sciences GmbH, ImmunAbs Inc., and others.
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Leading drugs currently in the pipeline include IMVT-1402, IM-101, CNP-106, and others.
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The pipeline is expanding rapidly, driven by innovative antibody therapies, targeted immunomodulators, and novel gene-based approaches. The increasing prevalence, advanced clinical trials, and rising investment are fueling significant growth in the coming years.
Report Coverage
The Myasthenia Gravis Pipeline Analysis Report by Expert Market Research gives comprehensive insights into myasthenia gravis therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for myasthenia gravis. The myasthenia gravis report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The myasthenia gravis 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 myasthenia gravis 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 myasthenia gravis.
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Myasthenia Gravis Pipeline Outlook
Myasthenia gravis is a rare, chronic autoimmune disorder that disrupts neuromuscular communication, causing fluctuating muscle weakness. It occurs when autoantibodies, particularly anti-acetylcholine receptor (AChR) and anti-muscle-specific tyrosine kinase (MuSK), impair signal transmission between nerves and muscles, affecting activities like breathing, speaking, and eye movement.
Myasthenia gravis treatments focus on symptom management and immune modulation, including acetylcholinesterase inhibitors, corticosteroids, immunosuppressants, plasma exchange, and novel targeted therapies that reduce autoantibody production. In December 2025, the FDA approved UPLIZNA® (inebilizumab-cdon) for adults with generalized Myasthenia Gravis who are positive for AChR or MuSK antibodies. The twice-yearly CD19-targeted B cell therapy demonstrated durable efficacy in the Phase 3 MINT trial, reducing steroid dependence and improving daily functioning, marking a significant advancement in the pipeline.
Myasthenia Gravis Epidemiology
The epidemiology of myasthenia gravis highlights a growing patient base that is increasingly shaping therapeutic development. According to Fan Jiang et al., 2023, myasthenia gravis (MG) has a global incidence of 0.3–2.8 per 100,000 person-years. As per Amgen, approximately 85% of patients have the generalized form (gMG), with global prevalence of 2–36 cases per 100,000. Around 85% have antibodies against acetylcholine receptor (AChR), and 7% against MuSK. MG is more common in women aged 20–30 and men over 50. The growing patient population is driving pipeline development.
Myasthenia Gravis – Pipeline Therapeutic Assessment
This section of the report covers the analysis of myasthenia gravis drug candidates based on several segmentations, including:
By Phase
The pipeline assessment report covers 50+ drug analyses based on 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
The myasthenia gravis pipeline analysis report covers 50+ drug analyses based on drug classes:
- Small Molecules
- Monoclonal Antibodies
- Gene Therapies
- Peptides
- Polymers
By Route of Administration
The pipeline assessment report covers 50+ drug analyses based on the route of administration:
- Oral
- Parenteral
- Others
Myasthenia Gravis 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 EMR analysis, phase III, with 40%, covers a major share of the total myasthenia gravis clinical trials, reflecting strong late-stage development and high potential for near-term market impact. Phase II accounts for 27%, indicating promising mid-stage candidates. This balanced pipeline suggests continued innovation and growth opportunities in the myasthenia gravis market.
Myasthenia Gravis Pipeline Assessment Segmentation, By Drug Classes
The drug molecule categories covered under the myasthenia gravis pipeline analysis include small molecules, monoclonal antibodies, gene therapies, peptides, and polymers. The myasthenia gravis report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for myasthenia gravis. Complement-targeted therapies are emerging as promising treatment options for generalized myasthenia gravis. For instance, cemdisiran, an investigational small interfering RNA (siRNA) that inhibits complement factor 5 (C5), is under evaluation as a monotherapy with quarterly subcutaneous dosing. Additionally, the combination therapy cemdi-poze, pairing cemdisiran with the C5 antibody pozelimab, is being investigated to enhance complement inhibition and improve patient outcomes in daily functioning.
Myasthenia Gravis Clinical Trials – Key Players
The EMR report for the myasthenia gravis pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed myasthenia gravis therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in myasthenia gravis clinical trials:
- Immunovant Sciences GmbH
- ImmunAbs Inc.
- COUR Pharmaceutical Development Company, Inc.
- Shanghai Jiaolian Drug Research and Development Co., Ltd.
- NMD Pharma A/S
- Novartis Pharmaceuticals
- Dianthus Therapeutics
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Juno Therapeutics, Inc.
- Kyverna Therapeutics
- Janssen Research & Development, LLC
- UCB Biopharma SRL
- RemeGen Co., Ltd.
Myasthenia Gravis – 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 myasthenia gravis. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of myasthenia gravis drug candidates.
Drug: IMVT-1402
IMVT-1402 is being developed by Immunovant Sciences GmbH as a potentially best-in-class anti-FcRn monoclonal antibody for treating mild to severe generalized myasthenia gravis. This Phase 3, multicenter, randomized, placebo-controlled, double-blind study is assessing the efficacy, safety, and tolerability of IMVT-1402 in adult participants. The drug is designed to inhibit the neonatal Fc receptor (FcRn), thereby reducing pathogenic autoantibodies that cause muscle weakness in myasthenia gravis. Administered via subcutaneous injection, IMVT-1402 aims to provide deeper and more durable clinical responses. The study is recruiting 231 participants and is expected to be completed by December 2028.
Drug: IM-101
IM-101 is a humanized monoclonal antibody targeting complement C5, designed to inhibit complement-mediated damage in patients with myasthenia gravis. Sponsored by ImmunAbs Inc., this Phase 1b/2 study aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of IM-101 in adult participants with generalized (gMG) and ocular Myasthenia Gravis (oMG). The trial is examining multiple ascending doses administered intravenously to determine the optimal dose regimen for both AChR antibody-positive and -negative participants. IM-101 works by reducing serum-free C5 concentrations, thereby preventing complement activation and improving neuromuscular transmission. The study is expected to be completed by June 2028.
Drug: CNP-106
CNP-106, sponsored by COUR Pharmaceutical Development Company, Inc., is currently undergoing a Phase 1b/2a first-in-human clinical trial to evaluate its safety, tolerability, pharmacodynamics, and efficacy in subjects with generalized myasthenia gravis (gMG). This biodegradable nanoparticle encapsulates acetylcholine receptors (AChR) and is designed to reduce pathogenic AChR antibodies and T cell populations, thereby improving muscle function. The study is examining multiple ascending doses over 222 days, with participants aged 18–75. Administered via intravenous infusion, CNP-106 targets both AChR and MuSK-mediated gMG to address autoimmune-driven muscle weakness.
*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*
Key Questions Answered in the Myasthenia Gravis Pipeline Insight Report
- Which companies/institutions are leading the myasthenia gravis drug development?
- Which company is leading the myasthenia gravis pipeline development activities?
- What is the current myasthenia gravis commercial assessment?
- What are the opportunities and challenges present in the myasthenia gravis pipeline landscape?
- What is the efficacy and safety profile of myasthenia gravis pipeline drugs?
- Which company is conducting major trials for myasthenia gravis drugs?
- Which companies/institutions are involved in myasthenia gravis collaborations aimed at providing enhanced therapeutic alternatives for patients?
- What are the geographies covered for clinical trials in myasthenia gravis?
Reasons To Buy This Report
The Myasthenia Gravis Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for myasthenia gravis. 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 myasthenia gravis collaborations, regulatory environments, and potential growth opportunities.
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Report Summary
Explore our key highlights of the report and gain a concise overview of key findings, trends, and actionable insights that will empower your strategic decisions.
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