Graves’ Orbitopathy- Pipeline Insight, 2025

DelveInsight’s, “Graves’ Orbitopathy- Pipeline Insight, 2025” report provides comprehensive insights about 8+ companies and 8+ pipeline drugs in Graves’ Orbitopathy 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.

Geography Covered

• Global coverage

Graves’ Orbitopathy: Understanding

Graves’ Orbitopathy: Overview

Graves orbitopathy (Graves eye disease or Graves ophthalmopathy) is a constellation of signs and symptoms related to the orbit and surrounding tissues in patients with Graves disease. It can also sporadically occur in patients who are euthyroid or even hypothyroid as a result of chronic thyroiditis. It is an autoimmune process affecting retro-ocular tissues. In its severe form, it can be sight-threatening; thus, prompt evaluation and timely referral and management become of utmost importance. Graves orbitopathy occurs in patients with Graves disease and is an autoimmune disease of retro-ocular tissue. Complications can be serious and sight-threatening. It is important to know how to evaluate patients with Graves' orbitopathy and treat them according to the severity of the disease. Graves’ orbitopathy has been said to occur in as many as 25 to 50% of patients diagnosed with Graves' disease. History and physical examination are paramount to assess Graves orbitopathy. In patient history, it is necessary to elicit if the patient is experiencing any symptoms. Not all those with proptosis will be symptomatic. Symptoms that may be present include a foreign-body sensation in the eyes with resultant tearing, pain or pressure in or behind the eye, and pain on moving the eye in any direction. Visual alterations may also be present in the form of diplopia, blurring, desaturation of color vision, or rarely complete loss of vision. Some patients may notice swelling around their eyes or redness, and others may report that they are unable to close their eyes completely. On physical examination, the first step is to inspect the eyes for proptosis and comment on whether it is symmetrical or asymmetrical and, if an exophthalmometer should make available, objective measures of the degree of proptosis. Also, evaluate for conjunctival injection, chemosis, and periorbital edema. Upper eyelid retraction (although not specific to Graves orbitopathy) is often present. Teprotumumab is an insulin-like growth factor-1 (IGF-1) receptor antagonist. It was approved by the US Food and Drug Administration (FDA) in 2020 for the use in active moderate-to-severe Graves orbitopathy. The management of Graves orbitopathy in children is largely similar to that of adults. Firstly one needs to render the child euthyroid, with antithyroid drugs being the first-line treatment. For the orbitopathy, clinical monitoring is often acceptable. Steroids can be used in select cases when no improvement or worsening of eye manifestations occurs despite being euthyroid. Surgery is rarely indicated, and orbital radiation has no role in juvenile Graves orbitopathy, given the potential risk for inducing tumor formation.

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

Graves’ Orbitopathy Emerging Drugs Chapters

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

Graves’ Orbitopathy Emerging Drugs

• Linsitinib: Astellas

Linsitinib, which was in-licensed from Astellas Pharma to Sling Therapeutics, is designed to inhibit the insulin-like growth factor I receptor (IGF-1R). Dysfunction in the IGF-1R signaling pathway leads to a prevalence of thyroid-stimulating hormone receptor autoantibodies (TSHR-Abs) that drive excess fibrous tissue growth in TED. Independent data from a model of TED in patient fibroblast cells suggest that linsitinib is at least as potent as currently available treatment. The U.S. Food and Drug Administration (FDA) cleared an Investigational New Drug (IND) application for linsitinib for the treatment of TED.Currently, the drug is in Phase II/III stage of Clinical trial evaluation for the treatment of Graves Orbitopathy.

• SHR 1314: Jiangsu Hengrui Medicine

Vunakizumab (SHR 1314) is being developed by Jiangsu Hengrui Medicine, for the treatment of psoriasis and other autoimmune diseases. Currently, the drug is in Phase II stage of Clinical trial evaluation for the treatment of Active Moderate to Severe Graves' Orbitopathy.

Further product details are provided in the report……..

Graves’ Orbitopathy: Therapeutic Assessment

This segment of the report provides insights about the different Graves’ Orbitopathy drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Graves’ Orbitopathy

There are approx. 8+ key companies which are developing the therapies for Graves’ Orbitopathy. The companies which have their Graves’ Orbitopathy drug candidates in the most advanced stage, i.e. phase II /III include, Astellas.

• Phases

DelveInsight’s report covers around 8+ 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’ Orbitopathy pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Ophthalmic
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal
• Molecule Type

Products have been categorized under various Molecule types such as

• Oligonucleotide
• Peptide
• Small molecule
• Product Type

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

Graves’ Orbitopathy: Pipeline Development Activities

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

Pipeline Development Activities

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

Graves’ Orbitopathy Report Insights

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

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

Key Players

• Astellas
• Jiangsu Hengrui Medicine
• Novartis

Key Products

• Linsitinib
• SHR 1314
• Secukinumab