AMX0035 Emerging Drug Insight and Market Forecast - 2032

“AMX0035 Emerging Drug Insight and Market Forecast - 2032” report provides comprehensive insights about AMX0035 for Amyotrophic Lateral Sclerosis in seven major markets. A detailed picture of the AMX0035 for Amyotrophic Lateral Sclerosis in 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 AMX0035 for Amyotrophic Lateral Sclerosis. 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 AMX0035 market forecast analysis for Amyotrophic Lateral Sclerosis in 7MM, SWOT, analyst views, comprehensive overview of market competitors, and brief about other emerging therapies in Amyotrophic Lateral Sclerosis.

Drug Summary

AMX0035 is an investigational neuroprotective therapy being developed to minimize neuronal death and dysfunction. In Amyotrophic Lateral Sclerosis and other neurodegenerative disorders, the drug targets endoplasmic reticulum and mitochondrial-dependent neuronal degeneration pathways and blocks stress to maintain a balance between them.

AMX0035 is a fixed-dose co-formulation of two active compounds, namely, sodium phenylbutyrate (PB) and Taurursodiol (tauroursodeoxycholic acid [TUDCA]). Out of these, PB is prescribed under the brand name Buphenyl and acts as a scavenger to facilitate the excretion of excess nitrogen, while TUDCA is a naturally occurring bile acid with anti-apoptotic and neuroprotective effects. These active compounds are optimized to treat both the energy crisis in the mitochondria and the toxic, unfolded proteins in the endoplasmic reticulum, ultimately disrupting the neurological chain of events that leads to patient suffering.

In December 2021, the company announced that the FDA had accepted its NDA for AMX0035 for Amyotrophic Lateral Sclerosis treatment. The FDA has granted Priority Review and assigned a prescription drug user fee act date for AMX0035 of June 29, 2022. The NDA submission is based on data from the CENTAUR trial, a randomized, double-blind, placebo-controlled Phase II clinical trial conducted at 25 centers of the Northeast Amyotrophic Lateral Sclerosis Consortium (NEAmyotrophic Lateral Sclerosis), evaluating 137 people with Amyotrophic Lateral Sclerosis.

In Europe, European Commission and Humanitas Mirasole SpA, with other collaborators, has started a Phase III trial (NCT03800524) to evaluate the safety and efficacy of tauroursodeoxycholic (TUDCA) as an add-on treatment to riluzole in patients affected by Amyotrophic Lateral Sclerosis.

Scope of the Report

The report provides insights into:

• A comprehensive product overview including the AMX0035 description, mechanism of action, dosage and administration, research and development activities in Amyotrophic Lateral Sclerosis.
• Elaborated details on AMX0035 regulatory milestones and other development activities have been provided in this report.
• The report also highlights the AMX0035 research and development activities in Amyotrophic Lateral Sclerosis across the United States, Europe and Japan.
• The report also covers the patents information with expiry timeline around AMX0035.
• The report contains forecasted sales of AMX0035 for Amyotrophic lateral sclerosis till 2032.
• Comprehensive coverage of the late-stage emerging therapies for Amyotrophic Lateral Sclerosis.
• The report also features the SWOT analysis with analyst views for AMX0035 in Amyotrophic Lateral Sclerosis.

Methodology

The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by a 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.

AMX0035 Analytical Perspective

In-depth AMX0035 Market Assessment

This report provides a detailed market assessment of AMX0035 for Amyotrophic lateral sclerosis in seven major markets, 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 2022 to 2032.

AMX0035 Clinical Assessment

The report provides the clinical trials information of AMX0035 for Amyotrophic Lateral Sclerosis covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights

• In the coming years, the market scenario for Amyotrophic lateral sclerosis 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 AMX0035 dominance.
• Other emerging products for Amyotrophic Lateral Sclerosis are expected to give tough market competition to AMX0035 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 AMX0035 in Amyotrophic Lateral Sclerosis.
• Our in-depth analysis of the forecasted sales data of AMX0035 from 2022 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the AMX0035 in Amyotrophic Lateral Sclerosis.

Key Questions Answered

• What is the product type, route of administration and mechanism of action of AMX0035?
• What is the clinical trial status of the study related to AMX0035 in Amyotrophic lateral sclerosis and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the AMX0035 development?
• What are the key designations that have been granted to AMX0035 for Amyotrophic Lateral Sclerosis?
• What is the forecasted market scenario of AMX0035 for Amyotrophic Lateral Sclerosis?
• What are the forecasted sales of AMX0035 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 AMX0035 for Amyotrophic Lateral Sclerosis?
• Which are the late-stage emerging therapies under development for the treatment of Amyotrophic Lateral Sclerosis?