Gemcabene - Emerging Insight and Market Forecast - 2030

Overview

Gemcabene - Emerging Insight and Market Forecast - 2030 report by the publisher outlays comprehensive insights of the product indicated for the treatment of its approved condition. A detailed picture of the Gemcabene in Seven Major Markets, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan, for the study period 2017-2030 is provided in this report along with a detailed description of the product. The product details cover mechanism of action, dosage and administration, route of synthesis, and pharmacological studies, including product marketed details, regulatory milestones, and other development activities. Further, it also consists of market assessments inclusive of the market forecast, SWOT analysis, and detailed analyst views. It further highlights the market competitors, late-stage emerging therapies, and patent details in the global space.

Gemcabene is a peroxisome proliferation-activated receptor (PPARα) agonist, under development as a once-daily, oral therapy for the treatment of dyslipidemia. In May 2020, NeuroBo Pharmaceuticals announced that it received written communication from the US Food and Drug Administration (FDA) that the clinical development program for Gemcabene remains on partial clinical hold. In January 2016, the Gemcabene phase II clinical study was placed on partial clinical hold as the FDA requested 2-year rat and mouse carcinogenicity studies to be completed and submitted. In May 2018, the company submitted the requested data to the FDA, which the Agency determined was insufficient to lift the partial clinical hold at that time. On April 20, 2020, the company filed an amendment to the FDA's partial clinical hold letter received in June 2018.

Scope of the report

The report provides insights into:

• A comprehensive product overview including the product description, mechanism of action, dosage and administration, route of synthesis, pharmacological studies (pharmacodynamics and pharmacokinetics) and adverse reactions.
• Elaborated details on regulatory milestones and other development activities have been provided in this report.
• The report also highlights the drug marketed details across the United States, Europe and Japan.
• The report also covers the patent's information with expiry timeline around Gemcabene.
• The report contains historical and forecasted sales for Gemcabene till 2030.
• Comprehensive coverage of the late-stage emerging therapies (Phase III) in the space with a brief snapshot of the details.
• The report also features the SWOT analysis with analyst insights and key findings of Gemcabene.

Methodology

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

Gemcabene Analytical Perspective

In-depth Gemcabene Market Assessment

This report provides a detailed market assessment of Gemcabene 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 historical and forecasted sales data from 2017 to 2030.

Gemcabene Clinical Assessment

The report provides the clinical trials information of Gemcabene covering trial interventions, trial conditions, trial status, start and completion dates.

Report highlights

• In the coming years, the market scenario for Gemcabene is set to change due to the extensive research in the treatment of the indicated condition 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 and academics are working to assess challenges and seek opportunities that could influence Gemcabene dominance. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Other approved products for the disease are giving market competition to Gemcabene and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, development activities, and some key findings provide the current market scenario of Gemcabene.
• Our in-depth analysis of the sales data of Gemcabene from 2017 to 2030 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the Gemcabene in the market.

Key Questions Answered

• What is the prescribed dosage and strengths of Gemcabene are available in the market?
• What are the common adverse reactions or side effects of Gemcabene?
• What is the product type, route of administration and mechanism of action of Gemcabene?
• What are the chemical specifications of Gemcabene?
• How are the clinical trials diversified on the basis of the trial status?
• What is the history of Gemcabene, and what is its future?
• What are the marketed details of Gemcabene in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain, and the United Kingdom), and Japan?
• How many patents have been granted to Gemcabene and when these patents will get expire?
• What are the pros (benefits) and cons (disadvantages) of Gemcabene?
• In which countries Gemcabene got approval and when it gets launched?
• What are the clinical trials are currently ongoing for Gemcabene?
• How the safety and efficacy results determined the approval of Gemcabene?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the Gemcabene development?
• What are the key designations that have been granted to Gemcabene?
• What is the historical and forecasted market scenario of Gemcabene?
• How is the market trend of Gemcabene is different in the Seven Major Markets (the United States, EU5 [Germany, France, Italy, Spain, and the United Kingdom], and Japan)?
• What are the other approved products available and how these are giving competition to Gemcabene?
• Which are the late-stage emerging therapies under development for the treatment of the indicated condition?