Graves' Disease Clinical Trials Outlook 2026: Market Competition, Regulatory Progress, Emerging Therapies, Mechanisms, And Delivery Approaches By Delveinsight

Key Highlights from the Graves' Disease Market Analysis

• According to DelveInsight's assessments, Graves' disease accounts for approximately 60–80% of hyperthyroidism cases. Although it is the leading cause, its overall prevalence remains relatively low, affecting nearly 1.2% of the US population.
• The American Thyroid Association (2024) reports that over 12% of Americans will experience a thyroid disorder during their lifetime, with nearly 20 million individuals currently living with thyroid disease. Women are five to eight times more likely than men to develop thyroid-related conditions.
• Data from the National Institute of Diabetes and Digestive and Kidney Diseases (2021) indicates that Graves' disease impacts roughly 1 in 100 Americans.
• Research by Shang et al. (2024) estimates that 2.7–3.0% of China's adult population -representing over 31 million people-suffers from autoimmune disorders, with autoimmune thyroid diseases and rheumatoid arthritis being the most prevalent contributors.
• Key companies active in the Graves' Disease pipeline include Apitope International NV, Immunovant Sciences GmbH, Novartis Pharmaceuticals, Pfizer, Hoffmann-La Roche, and others.
• Prominent therapies under development include linsitinib, batoclimab, teprotumumab, VRDN-001 (10 mg/kg), satralizumab, IBI311, among others.

Recent Progress in the Graves' Disease Pipeline

Over the past year, the Graves' Disease and thyroid eye disease (TED) landscape has seen multiple significant milestones:

• February 2026 – Immunovant Sciences GmbH reported findings from its Phase 2b randomized, double-blind, placebo-controlled study evaluating IMVT-1402 in adults with Graves' Disease.
• January 2026 – Merida Biosciences announced Phase 1 results assessing safety, pharmacokinetics, pharmacodynamics, and immunogenicity of MER511 administered intravenously and subcutaneously in GD patients.
• December 2025 – Sanofi disclosed outcomes from a Phase 2 open-label study investigating rilzabrutinib in adult GD patients.
• September 2025 – Immunovant, Inc. presented six-month off-treatment data on batoclimab at the Annual Meeting of the American Thyroid Association (ATA).
• May 2025 – Amgen secured UK MHRA approval for TEPEZZA® (teprotumumab) for moderate-to-severe TED, marking the first authorized therapy in the UK for adult TED patients.
• May 2025 – Viridian Therapeutics Inc. obtained FDA Breakthrough Therapy Designation for veligrotug (veli), targeting IGF-1R in TED.
• January 2025 – Sling Therapeutics shared Phase 2b/3 LIDS trial topline results for linsitinib, an oral IGF-1R inhibitor.
• December 2024 – Viridian Therapeutics Inc. reported favorable Phase 3 THRIVE-2 trial data for veligrotug in chronic TED.

These advancements underscore the intensifying research focus on thyroid-associated ophthalmopathy and demonstrate the pipeline's expansion beyond conventional GD treatments.