This “ONC201 Emerging Drug Insight and Market Forecast - 2032” report provides comprehensive insights about ONC201 for glioblastoma multiforme (GBM) in the seven major markets. A detailed picture of the ONC201 for GBM in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and 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 ONC201 for GBM. The report provides insights about mechanism of action, dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of future market assessments inclusive of the ONC201 market forecast analysis for GBM in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in GBM.
The drug targets multiple brain cancer indications, such as GBM and diffuse intrinsic pontine gliomas or diffuse midline glioma altogether. It has been found in early results that this drug can kill cancer cells but not normal cells and may be effective in patients with a specific genetic mutation in their tumor: the H3 K27M mutation. Primarily, this mutation occurs in tumors that occur in the midline region of the brain (thalamus, pons, spinal cord).
Chimerix planned to meet with the FDA in the first half of 2022 to review the design for the ONC201 first-line randomized placebo-controlled, Phase III trial in combination with radiation therapy that is planned to initiate in the second half of 2022 in patients who harbor the H3 K27M mutation.
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Drug Summary
A novel therapeutic intervention of imipridone class is in development by Oncoceutics (acquired by Chimerix), i.e., ONC201, a highly selective antagonist of dopamine receptor D2 (DRD2) and ClpP agonist that can penetrate the blood-brain barrier effectively. ONC201 engages proven anticancer pathways that lead to apoptosis in cancer cells. It is a small molecule originally identified as a TNF-related apoptosis-inducing ligand (TRAIL)-inducing compound. It has a unique ability to induce the expression of both pro-death ligand TRAIL and its receptor DR5 through the engagement of the cellular integrated stress response (ISR) pathway. ONC201 has demonstrated single-agent efficacy in eliminating cancer stem cells CSCs in glioblastoma multiforme (GBM), colorectal, and prostate cancer models.The drug targets multiple brain cancer indications, such as GBM and diffuse intrinsic pontine gliomas or diffuse midline glioma altogether. It has been found in early results that this drug can kill cancer cells but not normal cells and may be effective in patients with a specific genetic mutation in their tumor: the H3 K27M mutation. Primarily, this mutation occurs in tumors that occur in the midline region of the brain (thalamus, pons, spinal cord).
Chimerix planned to meet with the FDA in the first half of 2022 to review the design for the ONC201 first-line randomized placebo-controlled, Phase III trial in combination with radiation therapy that is planned to initiate in the second half of 2022 in patients who harbor the H3 K27M mutation.
Scope of the Report
The report provides insights into:
- A comprehensive product overview including the ONC201 description, mechanism of action, dosage and administration, research and development activities in glioblastoma multiforme (GBM).
- Elaborated details on ONC201 regulatory milestones and other development activities have been provided in this report.
- The report also highlights the ONC201 research and development activities in GBM across the United States, Europe and Japan.
- The report also covers the patents information with expiry timeline around ONC201.
- The report contains forecasted sales of ONC201 for GBM till 2032.
- Comprehensive coverage of the late-stage emerging therapies for GBM.
- The report also features the SWOT analysis with analyst views for ONC201 in GBM.
Methodology
The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by the 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.ONC201 Analytical Perspective
In-depth ONC201 Market Assessment
This report provides a detailed market assessment of ONC201 for glioblastoma multiforme (GBM) in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides forecasted sales data from 2025 to 2032.ONC201 Clinical Assessment
The report provides the clinical trials information of ONC201 for GBM covering trial interventions, trial conditions, trial status, start and completion dates.Report Highlights
- In the coming years, the market scenario for glioblastoma multiforme (GBM) 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 ONC201 dominance.
- Other emerging products for GBM are expected to give tough market competition to ONC201 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 ONC201 in GBM.
- This in-depth analysis of the forecasted sales data of ONC201 from 2025 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the ONC201 in GBM.
Key Questions
- What is the product type, route of administration and mechanism of action of ONC201?
- What is the clinical trial status of the study related to ONC201 in glioblastoma multiforme (GBM) and study completion date?
- What are the key collaborations, mergers and acquisitions, licensing and other activities related to the ONC201 development?
- What are the key designations that have been granted to ONC201 for GBM?
- What is the forecasted market scenario of ONC201 for GBM?
- What are the forecasted sales of ONC201 in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain, and the United Kingdom), and Japan?
- What are the other emerging products available and how are these giving competition to ONC201 for GBM?
- Which are the late-stage emerging therapies under development for the treatment of GBM?
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Table of Contents
1. Report Introduction3. Competitive Landscape (Marketed Therapies)4. Competitive Landscape (Late-stage Emerging Therapies)6. SWOT Analysis7. Analysts’ Views9. Publisher Capabilities10. Disclaimer11. About the Publisher12. Report Purchase Options
2. ONC201 Overview in GBM
5. ONC201 Market Assessment
8. Appendix
List of Tables
List of Figures