Graves’ Disease- Pipeline Insight, 2022


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Graves’ Disease- Pipeline Insight, 2022

DelveInsight’s, “Graves’ Disease- Pipeline Insight, 2022” report provides comprehensive insights about 10+ 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. Geography Covered • Global coverage Graves’ disease: Understanding Graves’ disease: Overview Graves’ disease is a disease affecting the thyroid and often the skin and eyes. The thyroid is a gland and is part of the endocrine system, the network of glands that secrete hormones that regulate the chemical processes (metabolism) that influence the body’s activities as well as regulating the heart rate, body temperature, and blood pressure. Hormones are secreted directly into the bloodstream where they travel to various areas of the body. Graves’ disease is characterized by abnormal enlargement of the thyroid (goiter) and increased secretion of thyroid hormone (hyperthyroidism). Thyroid hormones are involved with many different systems of the body and, consequently, the specific symptoms and signs of Graves’ disease can vary widely from one person to another. Common symptoms include unintended weight loss, an abnormal intolerance of heat, muscle weakness, fatigue and protrusion or bulging of the eyeballs from their sockets. Graves’ disease is an autoimmune disease. Onset of the symptoms associated with Graves’ disease is usually gradual, often taking several weeks or months to develop. Symptoms may include behavioral changes such as nervousness, irritability, anxiousness, restlessness and difficulty sleeping (insomnia). Additional symptoms include unintended weight loss, muscle weakness, an abnormal intolerance to heat, increased sweating, a rapid, irregular heartbeat (tachycardia) and fatigue. Graves’ disease is often associated with abnormalities affecting the eyes often referred to as Graves’ ophthalmopathy. Subdivisions of Graves’ disease: Graves' dermopathy, Graves’ orbitopathy and Graves' ophthalmopathy. Graves’ disease is considered to be an autoimmune disorder, but other factors may contribute to its development, including genetic, environmental, and/or other factors. A diagnosis of Graves’ disease is made based upon a detailed patient and family history, a thorough clinical evaluation, identification of characteristic findings, and specialized tests such as blood tests that measure the levels of thyroid hormone and thyroid-stimulating hormone. Blood tests to detect the presence of specific antibodies that cause Graves’ disease can be performed to confirm a diagnosis, but are usually not necessary. Treatment of Graves’ disease usually involves one of three methods, antithyroid drugs (thionamides), use of radioactive iodine, or surgery. The specific form of treatment recommended may be based upon the age of an affected individual and the degree of the illness. “Graves’ Disease- Pipeline Insight, 2022" report by DelveInsight 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 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’ disease Emerging Drugs • Secukinumab: Novartis Secukinumab is a recombinant high-affinity fully human monoclonal anti-IL-17A antibody currently approved for the treatment of 3 inflammatory/ autoimmune diseases: moderate to severe plaque psoriasis (PsO), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) (ankylosing spondylitis (AS) and non-radiographic axSpA). • 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’ 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, such as: • Major Players in Graves’ Disease There are approx. 10+ 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, Novartis. • Phases DelveInsight’s 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 • 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’ disease: Pipeline Development 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. Pipeline 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 • Novartis • Astellas • Jiangsu Hengrui Medicine • Viridian Therapeutics • ImmunoGen • AV7 • HanAll Biopharma • Harbour BioMed • Immunovant Key Products • Secukinumab • Linsitinib • SHR 1314 • VRDN 001 • CFZ533 • K1 70 • RVT-1401

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Introduction
Executive Summary
Graves’ Disease: Overview
Causes
Mechanism of Action
Signs and Symptoms
Diagnosis
Disease Management
Pipeline Therapeutics
Comparative Analysis
Therapeutic Assessment
Assessment by Product Type
Assessment by Stage and Product Type
Assessment by Route of Administration
Assessment by Stage and Route of Administration
Assessment by Molecule Type
Assessment by Stage and Molecule Type
Graves’ Disease– DelveInsight’s Analytical Perspective
Late Stage Products (Phase III)
Comparative Analysis
Secukinumab: Novartis
Product Description
Research and Development
Product Development Activities
Drug profiles in the detailed report…..
Mid Stage Products (Phase II)
Comparative Analysis
SHR 1314: Jiangsu Hengrui Medicine
Product Description
Research and Development
Product Development Activities
Drug profiles in the detailed report…..
Early Stage Products (Phase I)
Comparative Analysis
Drug Name: Company Name
Product Description
Research and Development
Product Development Activities
Drug profiles in the detailed report…..
Preclinical and Discovery Stage Products
Comparative Analysis
Drug Name : Company Name
Product Description
Research and Development
Product Development Activities
Drug profiles in the detailed report…..
Inactive Products
Comparative Analysis
Graves’ Disease Key Companies
Graves’ Disease Key Products
Graves’ Disease - Unmet Needs
Graves’ Disease - Market Drivers and Barriers
Graves’ Disease - Future Perspectives and Conclusion
Graves’ Disease Analyst Views
Graves’ Disease Key Companies
Appendix

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