Thyroid Eye Disease - Pipeline Insight, 2025

This “Thyroid Eye Disease - Pipeline Insight, 2025” report provides comprehensive insights about 20+ companies and 25+ pipeline drugs in Thyroid Eye 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.

Thyroid Eye Disease: Understanding

Thyroid Eye Disease: Overview

Thyroid eye disease (TED), also known as Graves' orbitopathy, is a chronic autoimmune inflammatory condition affecting the tissues around the eyes, often associated with Graves' disease. It leads to symptoms such as proptosis (eye bulging), eyelid retraction, and impaired eye movement due to inflammation and swelling of the extraocular muscles and orbital fat. First described centuries ago, TED remains the most common cause of adult proptosis, affecting approximately 25 to 50% of individuals with Graves’ disease. Its understanding has advanced significantly, emphasizing its immune-mediated nature and complex pathophysiology.

Thyroid eye disease (TED) commonly presents with symptoms such as bulging of the eyes (proptosis or exophthalmos), a gritty or dry sensation, redness, irritation, and puffiness of the eyelids. Patients may also experience double vision, blurred vision, eyelid retraction, and a deep, sometimes painful pressure in the eye socket, especially during eye movement. These symptoms can vary in severity and may significantly impact vision and quality of life. In more severe cases, inflammation and swelling can lead to compression of the optic nerve, potentially causing vision loss if not treated promptly. Light sensitivity and excessive tearing are also common complaints among patients. The severity of symptoms often fluctuates, with periods of active inflammation followed by stable phases. Difficulty closing the eyes completely can lead to corneal dryness and damage. Early diagnosis and proper management are essential to prevent complications and preserve visual function.

Thyroid Eye Disease (TED) follows a self-limiting course due to the absence of orbital lymphoid tissue, as described by Rundle's natural history model. The disease progresses through an initial phase of rapidly increasing severity, lasting from six months to five years, followed by an inflammatory (active) phase and eventually stabilizing into an inactive phase beyond 18 months. Even after stabilization, fibrotic changes persist, preventing a complete return to baseline, with surgical intervention often required in the inactive stage. Early aggressive immunosuppressive therapy during the active phase can help reduce permanent tissue damage. The "Cone model" further illustrates disease progression through circumferential cone expansion displacing extraconal fat, axial elongation causing proptosis and muscle strain, and eventual cone hypertension leading to impaired venous drainage and increased muscle stiffness.

The treatment of thyroid eye disease (TED) is tailored to disease severity and activity, beginning with smoking cessation and restoration of normal thyroid function, followed by lubrication for mild cases and immunosuppressive therapies - such as corticosteroids, immunomodulators, and biologics like teprotumumab - for moderate to severe active disease. Surgical interventions, including orbital decompression and corrective procedures for proptosis, strabismus, and lid retraction, are reserved for inactive or sight-threatening cases, with the overall approach aiming to control inflammation, prevent complications, and restore both visual function and appearance.

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

Thyroid Eye Disease Emerging Drugs Chapters

This segment of the Thyroid Eye Disease report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, II, 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.

Thyroid Eye Disease Emerging Drugs

VRDN-003: Viridian Therapeutics, Inc.

VRDN-003 is a potential best-in-class subcutaneous monoclonal antibody targeting IGF-1R. VRDN-003 has the same binding domain as its parent molecule, veligrotug (VRDN-001), and was engineered to have a longer half-life. VRDN-003 is designed to maintain the clinical response of veligrotug (VRDN-001) IV while significantly increasing patient convenience and potentially improving safety. VRDN-003 is subcutaneously administered anti-IGF-1R antibody in development for TED. VRDN-003 has the same binding domain as VRDN-001, was engineered to have a longer half-life, and acts as a full antagonist of IGF-1R. IGF-1R inhibition is the only approved mechanism of action that has been clinically and commercially validated for TED and has shown to be highly effective in treating the disease. Currently, the drug is in Phase III stage of its development for the treatment of Thyroid Eye Disease.

Linsitinib: Sling Therapeutics, Inc.

Linsitinib is a convenient oral small molecule, taken twice-daily and with a short half-life, in clinical development for thyroid eye disease (TED). Linsitinib works by inhibiting the IGF-1R target, which is the only validated clinical target in TED and the only target for current FDA-approved therapies. Activation of the IGF-1R target leads to inflammation and proptosis seen in TED. Linsitinib has an established safety profile through treatment of more than 900 patients in fifteen clinical trials in multiple diseases. Currently, the drug is in Phase II/III stage of its development for the treatment of Thyroid Eye Disease.

TOUR006: Tourmaline Bio, Inc.

Pacibekitug is a long-acting, fully-human, anti-IL-6 monoclonal antibody with best-in-class potential and differentiated properties including a naturally long half-life, low immunogenicity, and high binding affinity to IL-6. Tourmaline is currently developing pacibekitug in atherosclerotic cardiovascular disease (ASCVD) and thyroid eye disease (TED) as its first two indications, with plans to expand into abdominal aortic aneurysm (AAA) and additional diseases in the future. Pacibekitug has been studied in hundreds of autoimmune patients demonstrating deep inhibition of the IL-6 signaling pathway with relatively low amounts of drug exposure and delivery in an infrequently administered, low-volume, subcutaneous administration. Currently, the drug is in Phase II stage of its development for the treatment of Thyroid Eye Disease.

Lonigutamab: ACELYRIN Inc.

Lonigutamab is a humanized IgG1 monoclonal antibody targeting the insulin-like growth factor 1 (IGF-1) receptor and is delivered subcutaneously. Relative to standard of care, lonigutamab binds to a distinct epitope, which results in internalization of the receptor within minutes. The characteristics of lonigutamab that enable subcutaneous delivery also enable the potential for longer-term, convenient dosing, which can potentially improve depth and durability of clinical response. Currently, the drug is in Phase I/II stage of its development for the treatment of Thyroid Eye Disease.

Thyroid Eye Disease: Therapeutic Assessment

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

Major Players in Thyroid Eye Disease

• There are approx. 20+ key companies which are developing the therapies for Thyroid Eye Disease. The companies which have their Thyroid Eye Disease drug candidates in the most advanced stage, i.e. Phase III include, Viridian Therapeutics, Inc.

Phases
The report covers around 25+ 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
Thyroid Eye 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:

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

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

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

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

Thyroid Eye Disease: Pipeline Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Thyroid Eye 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 Thyroid Eye Disease drugs.

Thyroid Eye Disease Report Insights

• Thyroid Eye Disease Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• Viridian Therapeutics, Inc.
• Tourmaline Bio, Inc.
• Sinocelltech Ltd.
• Hoffmann-La Roche
• Sanofi
• H. Lundbeck A/S
• ACELYRIN Inc.
• Sling Therapeutics, Inc.
• Changchun GeneScience Pharmaceutical Co., Ltd.
• argenx

Key Products

• VRDN-003
• TOUR006
• SCTT11o
• Satralizumab
• Rilzabrutinib
• Lu AG22515
• lonigutamab
• linsitinib
• GenSci098
• Efgartigimod

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