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"Graves' Disease- Pipeline Insight"DelveInsight's comprehensive report offers an in-depth analysis of the current and emerging clinical pipeline for Graves' disease. With more than eight companies and ten pipeline candidates under evaluation globally, this report equips senior pharmaceutical executives with the strategic intelligence needed to navigate a rapidly evolving therapeutic landscape and accelerate product development.

DelveInsight's comprehensive Graves' Disease- Pipeline Insight, 2025 report offers an in-depth analysis of the current and emerging clinical pipeline for Graves' disease. With more than eight companies and ten pipeline candidates under evaluation globally, this report equips senior pharmaceutical executives with the strategic intelligence needed to navigate a rapidly evolving therapeutic landscape and accelerate product development.

Key Takeaways:

• 10 pipeline drugs across 8 biopharma companies are advancing novel mechanisms of action for Graves' disease treatment.

• Immunovant's FcRn-blocking antibody batoclimab (IMVT-1401) has entered Phase III development, demonstrating sustained six-month off-treatment remission in 80% of uncontrolled patients-a potential paradigm shift toward disease modification.

• Biohaven Therapeutics' rilzabrutinib (BHV-1300), a selective IgG degrader, is progressing into Phase II trials by mid-2025, targeting rapid antibody clearance via a subcutaneous autoinjector.

• FDA approval of teprotumumab for thyroid eye disease underscores the unmet needs in Graves' orbitopathy, catalyzing interest in IGF-1R and FcRn blockade strategies.

• Veligrotug, an anti-IGF-1R candidate for thyroid eye disease, received Breakthrough Therapy Designation in August 2025, reinforcing the momentum for targeted biologics in extrathyroidal manifestations.

For more key insights on Graves' disease, download Graves' disease Market Insights Report.

Robust Pipeline Reflecting Unmet Needs and Innovative Mechanisms

Graves' disease remains the predominant cause of hyperthyroidism, affecting women 7–8 times more often than men and most commonly presenting between ages 20 and 40. Standard therapies, antithyroid drugs (methimazole, propylthiouracil), radioactive iodine ablation, and thyroidectomy, address hormone overproduction but fail to achieve durable remission and do not prevent extrathyroidal complications such as ophthalmopathy.

DelveInsight's report identifies several developmental candidates spanning monoclonal antibodies, small molecules, and peptide approaches. Leading late-stage assets include:

• Batoclimab (IMVT-1401) – A fully human anti-FcRn antibody designed to accelerate IgG degradation. Phase III registrational trials are now enrolling globally, with topline readouts anticipated in 2027. Proof-of-concept data showcased 17/21 patients maintaining normalized T3/T4 six months post-treatment, with half achieving anti-thyroid-drug-free remission, signaling potent disease-modifying potential.

• Rilzabrutinib (BHV-1300) – An oral, reversible BTK inhibitor repurposed as an IgG degrader via Biohaven's MODE platform. Phase I studies confirmed up to 84% total IgG reduction without safety signals. A randomized Phase II Graves' disease trial launched in September 2025 will evaluate two dosing regimens in 30 adult participants, measuring thyroid function and ophthalmopathy outcomes.

• Veligrotug – Novasights' anti-IGF-1R biologic granted Breakthrough Therapy Designation by FDA for thyroid eye disease. Early clinical data indicate rapid improvement in proptosis and quality-of-life metrics, addressing a critical gap in orbital inflammation management.

Recent Regulatory and Clinical Advances Accelerate Innovation

• In July 2025, the FDA granted teprotumumab early approval for thyroid eye disease, validating targeted IGF-1R blockade as a transformative approach for Graves' orbitopathy and driving pipeline momentum for extrathyroidal therapies.

• Immunovant presented six-month off-treatment remission data for batoclimab at the 2025 American Thyroid Association Annual Meeting. Lead PI George Kahaly, M.D., Ph.D., highlighted,“These remission data demonstrate strong durability of response and potential disease modification in previously uncontrolled patients”.

• Biohaven Therapeutics continues to advance rilzabrutinib across multiple autoimmune indications. Recent orphan designations in related IgG-mediated disorders bolster confidence in its broad immunomodulatory profile.

Find more recent advancements in this landscape @ Graves' Disease Recent Therapeutic Advancements.

Strategic Insights for Pharma Executives

DelveInsight's report provides a granular assessment of:

• Clinical and commercial landscapes – Competitive positioning of Phase III candidates, market exclusivity forecasts, and peak sales projections.

• Therapeutic gaps and unmet needs – Quantitative epidemiology and patient segmentation to guide target product profiles.

• Licensing, M&A, and collaboration trends – Key partnerships, funding rounds, and licensing deals shaping the Graves' disease ecosystem.

• Regulatory pathways and designations – Fast track, breakthrough, and orphan designations informing development strategies.

• Route of administration and formulation – Subcutaneous, intravenous, and oral modalities shaping patient convenience and adherence.

• Molecule and product type analyses – Comparison of monoclonal antibodies, small molecules, and peptide therapeutics across mechanism classes.

To explore comprehensive insights on Graves' disease and other therapeutic areas, download the Graves' Disease Pipeline Insight report today.

Table of Contents

1. Key Insights

2. Executive Summary of Graves' Disease

3. Competitive Intelligence Analysis for Graves' Disease

4. Graves' Disease Market Overview at a Glance

5. Graves' Disease Background and Overview

6. Graves' Disease Patient Journey

7. Graves' Disease Epidemiology and Patient Population

8. Treatment Algorithm, Current Treatment, and Medical Practices

9. Graves' Disease Unmet Needs

10. Key Endpoints of Graves' Disease Treatment

11. Graves' Disease Marketed Products

12. Graves' Disease Emerging Therapies

13. Graves' Disease: Seven Major Market Analysis

14. Attribute analysis

15. 7MM: Market Outlook

16. Access and Reimbursement Overview of Graves' Disease

17. KOL Views

18. Graves' Disease Market Drivers

19. Graves' Disease Market Barriers

20. Appendix

21. DelveInsight Capabilities

22. Disclaimer

23. About DelveInsight

About DelveInsight

DelveInsight Business Research LLP is a specialized market research and consulting firm focused exclusively on the life sciences. Leveraging deep expertise in clinical development, regulatory affairs, and market dynamics, DelveInsight delivers actionable intelligence to accelerate decision-making for pharma and biotech leaders.

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