Soticlestat Emerging Drug Insight

“Soticlestat Market Size, Forecast, and Emerging Insight – 2032” report provides comprehensive insights about Soticlestat for Developmental and Epileptic Encephalopathy in the 7MM. A detailed picture of the Soticlestat for Developmental and Epileptic Encephalopathy in the 7MM, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan, for the study period 2019–2032 is provided in this report along with a detailed description of the Soticlestat for Developmental and Epileptic Encephalopathy. The report provides insight about mechanism of action, dosage and administration, as well as research and development activity including regulatory milestones, along with other developmental activities. Further, it also consists of future market assessments inclusive of the Soticlestat market forecast, analysis for Developmental and Epileptic Encephalopathy in the 7MM, descriptive analysis such as SWOT, analyst views, comprehensive overview of market competitors, and brief about emerging therapies in Developmental and Epileptic Encephalopathy.

Drug Summary

Soticlestat (OV935/TAK-935), a potent, highly-selective, first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase (CH24H), with the potential to reduce seizure susceptibility and improve seizure control. CH24H is predominantly expressed in the brain, where it plays a central role in cholesterol homeostasis. CH24H converts cholesterol to 24-hydroxycholesterol (24HC), exiting the brain into the blood plasma circulation. Glutamate is one of the main neurotransmitters in the brain and can play a role in initiating and spreading seizure activity. Recent literature indicates CH24H is involved in the over-activation of the glutamatergic pathway through modulation of the NMDA channel, implying its potential role in central nervous system diseases such as epilepsy.

Ovid and Takeda believe that OV935’s novel mechanism of action may potentially treat rare epilepsies by inhibiting CH24H from decreasing 24HC levels, effectively decreasing glutamate hyperactivity.

Takeda was conducting Phase II trials of the drug to treat CDKL5 deficiency disorder and Dup15q syndrome, but the Phase II result did not support further development in these indications. The Phase II ELEKTRA study in individuals with Lennox-Gastaut Syndrome (LGS) and Dravet Syndrome (DS) has been completed, and positive topline results have been reported.

The company is currently conducting multiple Phase III clinical development trials of Soticlestat as adjunctive therapy in pediatric and adult patients suffering from LGS and Dravet Syndrome and anticipates potential approval of Soticlestat for these indications in 2023.

Scope of the Report

The report provides insights into:

•  A comprehensive product overview including the Soticlestat description, mechanism of action, dosage and administration, research and development activities in Developmental and Epileptic Encephalopathy.
•  Elaborated details on Soticlestat regulatory milestones and other development activities have been provided in this report.
•  The report also highlights the Soticlestat research and development activity in Developmental and Epileptic Encephalopathy details across the United States, Europe and Japan.
•  The report also covers the patents information with expiry timeline around Soticlestat.
•  The report contains forecasted sales of Soticlestat for Developmental and Epileptic Encephalopathy till 2032.
•  Comprehensive coverage of the late-stage emerging therapies for Developmental and Epileptic Encephalopathy.
•  The report also features the SWOT analysis with analyst views for Soticlestat in Developmental and Epileptic Encephalopathy.

Methodology

The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight’s team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

Soticlestat Analytical Perspective by DelveInsight

• In-depth Soticlestat Market Assessment

This report provides a detailed market assessment of Soticlestat in Developmental and Epileptic Encephalopathy in the 7MM, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. This segment of the report provides forecasted sales data from 2023 to 2032.

• Soticlestat Clinical Assessment

The report provides the clinical trials information of Soticlestat for Developmental and Epileptic Encephalopathy covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights 

•  In the coming years, the market scenario for Developmental and Epileptic Encephalopathy is set to change due to the extensive research and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.  
•  The companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence Soticlestat dominance.
•  Other emerging products for Developmental and Epileptic Encephalopathy are expected to give tough market competition to Soticlestat and launch of late-stage emerging therapies in the near future will significantly impact the market.
•  A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of Soticlestat in Developmental and Epileptic Encephalopathy.
•  Our in-depth analysis of the forecasted sales data of Soticlestat from 2023 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the Soticlestat in Developmental and Epileptic Encephalopathy.

Key Questions

•  What is the product type, route of administration and mechanism of action of Soticlestat?
•  What is the clinical trial status of the study related to Soticlestat in Developmental and Epileptic Encephalopathy and study completion date?
•  What are the key collaborations, mergers and acquisitions, licensing and other activities related to the Soticlestat development?
•  What are the key designations that have been granted to Soticlestat for Developmental and Epileptic Encephalopathy?
•  What is the forecasted market scenario of Soticlestat for Developmental and Epileptic Encephalopathy?
•  What are the forecasted sales of Soticlestat in the 7MM, including the United States, Europe (Germany, France, Italy, Spain, and the United Kingdom), and Japan? 
•  What are the other emerging products available in Developmental and Epileptic Encephalopathy and how are they giving competition to Soticlestat for Developmental and Epileptic Encephalopathy?
•  Which are the late-stage emerging therapies under development for the treatment of Developmental and Epileptic Encephalopathy?