Graves' Disease - Pipeline Insight, 2025

This “Graves’ Disease - Pipeline Insight, 2025” report provides comprehensive insights about 8+ companies and 10+ pipeline drugs in Graves’ Disease 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.

Graves’ Disease: Understanding

Graves’ Disease: Overview

Graves’ disease is an autoimmune disorder and the most common cause of hyperthyroidism in the U.S., occurring 7-8 times more often in women. It is triggered when the immune system produces antibodies (TRAb or TSI) that mistakenly stimulate the thyroid gland, causing it to overproduce thyroid hormones. Unlike typical immune responses that destroy harmful invaders, these antibodies bind to thyroid receptors and lead to gland overactivity. The disease is named after Robert Graves, who first described it over 150 years ago.

Graves’ disease is an autoimmune disorder in which the immune system produces thyroid-stimulating immunoglobulins (TSI) or TSH receptor antibodies (TRAb) that bind to and activate TSH receptors on thyroid cells. This leads to unregulated overproduction of thyroid hormones (T3 and T4), resulting in hyperthyroidism. The chronic stimulation causes thyroid gland hypertrophy (goiter). In some patients, immune-mediated inflammation also affects orbital tissues, leading to Graves’ ophthalmopathy. Graves’ disease is an autoimmune disorder in which the immune system produces thyroid-stimulating immunoglobulins (TSI) or TSH receptor antibodies (TRAb) that bind to and activate TSH receptors on thyroid cells. This leads to unregulated overproduction of thyroid hormones (T3 and T4), resulting in hyperthyroidism. The chronic stimulation causes thyroid gland hypertrophy (goiter). In some patients, immune-mediated inflammation also affects orbital tissues, leading to Graves’ ophthalmopathy.

Certain factors may increase your risk of developing Graves’ Disease. These include:

Family History - A genetic predisposition to autoimmune disorders increases the risk.

Gender - Women are 7-8 times more likely to develop Graves’ disease than men.

Age - Most commonly occurs in people under 40, especially between 20-40 years old.

Other Autoimmune Diseases - Conditions like type 1 diabetes, rheumatoid arthritis, or lupus raise susceptibility.

Stress or Emotional Trauma - Severe stress can act as a trigger in genetically predisposed individuals.

Smoking - Increases both the risk of developing Graves’ disease and the severity of associated eye disease (Graves’ orbitopathy).

Graves’ disease is diagnosed through a combination of clinical evaluation and laboratory tests. Blood tests typically show elevated thyroid hormones (T3 and T4) and suppressed TSH levels, along with the presence of thyroid-stimulating immunoglobulins (TSI) or TSH receptor antibodies (TRAb). A radioactive iodine uptake (RAIU) scan can confirm diffuse increased uptake characteristic of Graves’ disease. Thyroid ultrasound may also be used to assess gland size and blood flow. Graves’ disease treatment aims to control hyperthyroidism and manage symptoms. First-line options include antithyroid medications such as methimazole or propylthiouracil, which inhibit thyroid hormone production. Radioactive iodine therapy (RAI) is a common definitive treatment that destroys overactive thyroid tissue. In some cases, a thyroidectomy (surgical removal) may be recommended, especially if other treatments fail or are contraindicated. Beta-blockers are often prescribed to manage symptoms like palpitations and tremors. Graves’ ophthalmopathy may require separate treatment with steroids, orbital radiation, or surgery.

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

Graves Disease Emerging Drugs Chapters

This segment of the Graves’ Disease report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II, II/III 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.

Graves’ Disease Emerging Drugs

Batoclimab: Immunovant Sciences GmbH

Batoclimab (IMVT-1401), is a novel, fully human monoclonal antibody targeting the neonatal Fc receptor (FcRn). In nonclinical studies and in clinical trials conducted to date, batoclimab has been observed to reduce IgG antibody levels. High levels of pathogenic IgG antibodies drive a variety of autoimmune diseases and, as a result, we believe that this product candidate has the potential to address a variety of IgG-mediated autoimmune diseases as a self-administered subcutaneous injection. The FcRn receptor facilitates IgG recycling. Batoclimab enhances the degradation of IgG by targeting FcRn and preventing endogenous IgG from binding. This increased catabolism of IgG may curtail the harmful immune response exhibited by auto-antibodies. Currently, the drug is in the Phase III stage of its development for the treatment of Graves Disease.

BHV-1300: Biohaven Therapeutics Ltd.

Rilzabrutinib, developed BHV-1300, developed by Biohaven Therapeutics, is a pioneering IgG-selective degrader built on their MoDE™ (Molecular Degrader of Extracellular Proteins) platform. It is designed to selectively target and remove IgG₁, IgG₂, and IgG₄ antibodies via the liver while sparing IgG₃, thereby preserving key immune defenses. In a Phase I study involving weekly subcutaneous injections, BHV-1300 achieved rapid and sustained reductions of total IgG - up to 84%, with an 80% median decrease - within hours of dosing over a four-week period, all without significant side effects or impact on liver enzymes, albumin, cholesterol, or other immunoglobulin classes. With broad applicability anticipated in autoimmune conditions such as Graves' disease, rheumatoid arthritis, and myasthenia gravis, BHV-1300 is being advanced via a user-friendly subcutaneous autoinjector, with Phase II trials targeting Graves' disease planned for mid-2025. Currently, the drug is in the Phase I stage of its development for the treatment of Graves Disease.

Graves’ Disease: Therapeutic Assessment

This segment of the report provides insights about the different Graves’ Disease drugs segregated based on following parameters that define the scope of the report.

Major Players in Graves’ Disease
There are approx. 8+ key companies which are developing the therapies for Graves’ Disease. The companies which have their Graves Disease drug candidates in the most advanced stage, i.e. Phase III include, Immunovant Sciences GmbH.

Phases
The report covers around 10+ 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
Graves’ Disease pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as:

• Intravenous
• Subcutaneous
• Oral
• Intramuscular

Molecule Type
Products have been categorized under various Molecule types, such as:

• Monoclonal antibody
• Small molecule
• Peptide

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

Graves’ Disease: Pipeline Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Graves’ Disease therapeutic drugs key players involved in developing key drugs.

Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Graves’ Disease drugs.

Graves’ Disease Report Insights

• Graves’ Disease Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• Immunovant Sciences GmbH
• Sanofi
• Biohaven Therapeutics Ltd.
• Septerna Corporation

Key Products

• Batoclimab
• Rilzabrutinib
• BHV-1300
• TSHR Program

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