LPCN 1144 Emerging Drug Insight

“LPCN 1144 Market Size, Forecast, and Emerging Insight – 2032” report provides comprehensive insights about LPCN 1144 for Liver fibrosis in the 7MM. A detailed picture of the LPCN 1144 for Liver fibrosis in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the UK, and Japan, for the study period 2019–2032 is provided in this report along with a detailed description of the LPCN 1144 for Liver fibrosis. 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 LPCN 1144 market forecast, analysis for Liver fibrosis in the 7MM, descriptive analysis such as SWOT, analyst views, comprehensive overview of market competitors, and brief about other emerging therapies in Liver fibrosis.

Drug Summary

LPCN 1144, an oral prodrug of bioidentical testosterone, is being developed as a treatment for pre-cirrhotic non-alcoholic steatohepatitis (""NASH"") and recently completed a Phase II paired biopsy NASH confirmed clinical study. Lipocine Inc., is exploring the possibility of licensing LPCN 1144 to a third party, although no licensing agreement has been entered into by the company.

In March 2022, Lipocine Inc. provided an update from the Type C guidance meeting with the US FDA regarding the development path for LPCN 1144. At 12 weeks, treatments with LPCN 1144 resulted in statistically significant liver fat reduction, assessed by MRI-PDFF, meeting the pre-specific primary endpoint of the LiFT clinical study. Statistically significant reduction in liver fat was observed compared to placebo: up to a mean of 9.2% absolute reduction and a 46.8% relative reduction in liver fat. The LPCN 1144 treatment arms have met the pre-specified accelerated approval regulatory endpoint of NASH resolution with no worsening of fibrosis based on NASH CRN scoring with statistical significance.

Scope of the Report

The report provides insights into:

• A comprehensive product overview including the LPCN 1144 description, mechanism of action, dosage and administration, research and development activities in Liver fibrosis.
• Elaborated details on LPCN 1144 regulatory milestones and other development activities have been provided in this report.
• The report also highlights the LPCN 1144 research and development activity in Liver fibrosis in detail across the United States, Europe and Japan.
• The report also covers the patents information with expiry timeline around LPCN 1144.
• The report contains forecasted sales of LPCN 1144 for Liver fibrosis till 2032.
• Comprehensive coverage of the late-stage emerging therapies for Liver fibrosis.
• The report also features the SWOT analysis with analyst views for LPCN 1144 in Liver fibrosis.

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.

LPCN 1144 Analytical Perspective by DelveInsight

In-depth LPCN 1144 Market Assessment

This report provides a detailed market assessment of LPCN 1144 in Liver fibrosis in the 7MM, 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.

LPCN 1144 Clinical Assessment

The report provides the clinical trials information of LPCN 1144 in Liver fibrosis covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights

• In the coming years, the market scenario for Liver fibrosis 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 LPCN 1144 dominance.
• Other emerging products for Liver fibrosis are expected to give tough market competition to LPCN 1144 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 LPCN 1144 in Liver fibrosis.
• Our in-depth analysis of the forecasted sales data from 2025 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the LPCN 1144 in Liver fibrosis.

Key Questions

• What is the product type, route of administration and mechanism of action of LPCN 1144?
• What is the clinical trial status of the study related to LPCN 1144 in Liver fibrosis and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the LPCN 1144 development?
• What are the key designations that have been granted to LPCN 1144 for Liver fibrosis?
• What is the forecasted market scenario of LPCN 1144 for Liver fibrosis?
• What are the forecasted sales of LPCN 1144 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 in Liver fibrosis and how are they giving competition to LPCN 1144 for Liver fibrosis?
• Which are the late-stage emerging therapies under development for the treatment of Liver fibrosis?