PXL065の市場規模、予測、新薬の考察（2032年）

薬剤のサマリー

PXL065は、ピオグリタゾンのR立体異性体（重水素修飾された単一のR異性体）であり、合理化されたフェーズII試験（DESTINY-1）で主要エンドポイントを達成しました。親分子のピオグリタゾン（ACTOS）は、2型糖尿病治療薬として1999年より販売されています。ピオグリタゾンは、生体内で相互変換する2つのミラー分子（RとSの立体異性体）の等比混合物です。その他のチアゾリジンジオン（TZD）分子と同様に、ピオグリタゾンはPPARYの活性化を標的とし、ミトコンドリアのピルビン酸輸送体（MPC）を調節する経路で非ゲノム的な活動を媒介します。しかし、ピオグリタゾンのNASHに対する適応外使用は、体重増加、骨折、体液貯留などのPPARY関連の副作用のために制限されています。American Association for the Study of Liver Diseases（AASLD）とEuropean Association for the Study of the Liver（EASL）が発表した診療ガイドラインでは、生検で証明されたNASH患者に推奨されている唯一の薬剤です。

重水素修飾されたR立体異性体であるPXL065は、ピオグリタゾンのS立体異性体に関連するPPARY活性や関連するAEはほとんど観測されません。前臨床モデルにおいて、PXL065は、非ゲノム経路作用によりピオグリタゾンのNASH有効性を保持し、体重増加や体液貯留をほとんど生じないことが観測されました。PXL065は、NASH治療に新たなアプローチを提供する、組成物IPを持つ新規化学物質（NCE）です。

当レポートでは、主要7市場（米国、ドイツ、フランス、イタリア、スペイン、英国、日本）における非アルコール性脂肪性肝炎（NASH）向けPXL065について調査分析し、市場規模の予測や、作用機序、用法と用量、研究開発活動などの情報を提供しています。

目次

第1章 レポートのイントロダクション

第2章 非アルコール性脂肪肝炎（NASH）におけるPXL065の概要

• 製品詳細
• 臨床開発
  • 臨床研究
  • 臨床試験情報
  • 安全性と有効性
• その他の開発活動
• 製品のプロファイル

第3章 競合情勢（上市済みの治療法）

第4章 競合情勢（後期段階の新治療法）

第5章 PXL065市場の評価

• 非アルコール性脂肪肝炎（NASH）におけるPXL065の市場見通し
• 主要7市場の分析
  • 主要7市場の非アルコール性脂肪肝炎（NASH）向けPXL065の市場規模
• 市場の分析：国別
  • 米国の非アルコール性脂肪肝炎（NASH）向けPXL065の市場規模
  • ドイツの非アルコール性脂肪肝炎（NASH）向けPXL065の市場規模
  • 英国の非アルコール性脂肪肝炎（NASH）向けPXL065の市場規模

第6章 SWOT分析

第7章 アナリストの見解

第8章 付録

第9章 DelveInsightのサービス内容

第10章 免責事項

第11章 DelveInsightについて

第12章 レポート購入オプション

List of Tables

• Table 1: PXL065, Clinical Trial Description, 2023
• Table 2: PXL065, General Description
• Table 3: Competitive Landscape (Marketed Therapies)
• Table 4: Competitive Landscape (Emerging Therapies)
• Table 5: PXL065 Market Size in the 7MM, in USD million (2019-2032)
• Table 6: PXL065 Market Size in the US, in USD million (2019-2032)
• Table 7: PXL065 Market Size in Germany, in USD million (2019-2032)
• Table 8: PXL065 Market Size in France, in USD million (2019-2032)
• Table 9: PXL065 Market Size in Italy, in USD million (2019-2032)
• Table 10: PXL065 Market Size in Spain, in USD million (2019-2032)
• Table 11: PXL065 Market Size in the UK, in USD million (2019-2032)
• Table 12: PXL065 Market Size in Japan, in USD million (2019-2032)

List of Figures

• Figure 1: PXL065 Market Size in the 7MM, USD million (2019-2032)
• Figure 2: PXL065 Market Size in the United States, USD million (2019-2032)
• Figure 3: PXL065 Market Size in Germany, USD million (2019-2032)
• Figure 4: PXL065 Market Size in France, USD million (2019-2032)
• Figure 5: PXL065 Market Size in Italy, USD million (2019-2032)
• Figure 6: PXL065 Market Size in Spain, USD million (2019-2032)
• Figure 7: PXL065 Market Size in the United Kingdom, USD million (2019-2032)
• Figure 8: PXL065 Market Size in Japan, USD million (2019-2032)

"PXL065 Market Size, Forecast, and Emerging Insight - 2032" report provides comprehensive insights about PXL065 for Non-alcoholic Steatohepatitis (NASH) in the seven major markets. A detailed picture of the PXL065 for NASH 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 PXL065 for NASH. 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 PXL065 market forecast analysis for NASH in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in NASH.

Drug Summary:

PXL065 is the R stereoisomer (deuterium-modified single R-isomer) of pioglitazone, which met its primary endpoint in a streamlined Phase II trial (DESTINY-1). Its parent molecule, pioglitazone (ACTOS), has been marketed since 1999 for treating type 2 diabetes. Pioglitazone is a mixture, in equal proportions, of two mirror molecules (R and S stereoisomers) that interconvert in vivo. Like other thiazolidinedione (TZD) molecules, pioglitazone targets the activation of PPARY and mediates non-genomic actions with pathways that modulate the mitochondrial pyruvate carrier (MPC). However, pioglitazone's off-label use for NASH has been limited due to the PPARY-related side effects, including weight gain, bone fractures, and fluid retention. It is the only drug recommended for biopsy-proven NASH patients by the Practice Guidelines published by the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL).

PXL065, the deuterium-modified R stereoisomer, has little or no observed PPARY activity or associated AEs that are related to the S stereoisomer of pioglitazone. In preclinical models, PXL065 retained the NASH efficacy of pioglitazone via non-genomic pathway actions and was observed to produce little or no weight gain or fluid retention. PXL065 is a new chemical entity (NCE) with the composition of matter IP, which offers a new approach to treating NASH.

Scope of the Report:

The report provides insights into:

• A comprehensive product overview including the PXL065 description, mechanism of action, dosage and administration, research and development activities in Non-alcoholic Steatohepatitis (NASH).
• Elaborated details on PXL065 regulatory milestones and other development activities have been provided in this report.
• The report also highlights the PXL065 research and development activities in NASH across the United States, Europe, and Japan.
• The report also covers the patents information with expiry timeline around PXL065.
• The report contains forecasted sales of PXL065 for NASH till 2032.
• Comprehensive coverage of the late-stage emerging therapies for NASH.
• The report also features the SWOT analysis with analyst views for PXL065 in NASH.

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.

PXL065 Analytical Perspective by DelveInsight

• In-depth PXL065 Market Assessment

This report provides a detailed market assessment of PXL065 for Non-alcoholic Steatohepatitis (NASH) 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 2026 to 2032.

• PXL065 Clinical Assessment

The report provides the clinical trials information of PXL065 for Non-alcoholic Steatohepatitis (NASH) covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights:

• In the coming years, the market scenario for Non-alcoholic Steatohepatitis (NASH) 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 PXL065 dominance.
• Other emerging products for NASH are expected to give tough market competition to PXL065 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 PXL065 in NASH.
• Our in-depth analysis of the forecasted sales data of PXL065 from 2026 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the PXL065 in NASH.

Key Questions:

• What is the product type, route of administration and mechanism of action of PXL065?
• What is the clinical trial status of the study related to PXL065 in Non-alcoholic Steatohepatitis (NASH) and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the PXL065 development?
• What are the key designations that have been granted to PXL065 for NASH?
• What is the forecasted market scenario of PXL065 for NASH?
• What are the forecasted sales of PXL065 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 PXL065 for NASH?
• Which are the late-stage emerging therapies under development for the treatment of NASH?

Table of Contents

1. Report Introduction

2. PXL065 Overview in Non-alcoholic Steatohepatitis (NASH)

• 2.1. Product Detail
• 2.2. Clinical Development
  • 2.2.1. Clinical studies
  • 2.2.2. Clinical trials information
  • 2.2.3. Safety and efficacy
• 2.3. Other Developmental Activities
• 2.4. Product Profile

3. Competitive Landscape (Marketed Therapies)

4. Competitive Landscape (Late-stage Emerging Therapies)

5. PXL065 Market Assessment

• 5.1. Market Outlook of PXL065 in Non-alcoholic Steatohepatitis (NASH)
• 5.2. 7MM Analysis
  • 5.2.1. Market Size of PXL065 in the 7MM for Non-alcoholic Steatohepatitis (NASH)
• 5.3. Country-wise Market Analysis
  • 5.3.1. Market Size of PXL065 in the United States for Non-alcoholic Steatohepatitis (NASH)
  • 5.3.2. Market Size of PXL065 in Germany for Non-alcoholic Steatohepatitis (NASH)
  • 5.3.3. Market Size of PXL065 in France for Non-alcoholic Steatohepatitis (NASH)
  • 5.3.4. Market Size of PXL065 in Italy for Non-alcoholic Steatohepatitis (NASH)
  • 5.3.5. Market Size of PXL065 in Spain for Non-alcoholic Steatohepatitis (NASH)
  • 5.3.6. Market Size of PXL065 in the United Kingdom for Non-alcoholic Steatohepatitis (NASH)
  • 5.3.7. Market Size of PXL065 in Japan for Non-alcoholic Steatohepatitis (NASH)

6. SWOT Analysis

7. Analysts' Views

8. Appendix

• 8.1. Bibliography
• 8.2. Report Methodology

9. DelveInsight Capabilities

10. Disclaimer

11. About DelveInsight

12. Report Purchase Options