한글목차

약제 요약

PXL065는 피오글리타존의 R 입체 이성질체(중수소로 변형된 단일 R 이성질체)로, 간소화된 임상 2상 시험(DESTINY-1)에서 주요 평가변수를 달성했습니다. 모체인 피오글리타존(ACTOS)은 1999-2형 당뇨병 치료제로 판매되고 있습니다. 피오글리타존은 생체 내에서 상호 전환되는 두 개의 거울 분자(R과 S의 입체 이성질체)의 등비 혼합물입니다. 다른 티아졸리딘디온(TZD) 분자와 마찬가지로 피오글리타존은 PPARY의 활성화를 표적으로 삼고 미토콘드리아 피루브산 운송체(MPC)를 조절하는 경로를 통해 비유전체적 활동을 매개합니다. 그러나 피오글리타존의 NASH에 대한 적응증 외 사용은 체중 증가, 골절, 체액 저류와 같은 PPARY 관련 부작용으로 인해 제한적으로 사용되고 있으며, American Association for the Study of Liver Diseases(AASLD)와 European Association for the Study of the Liver(EASL)에서 발표한 진료지침에서 생검으로 입증된 NASH 환자에게 권장되는 유일한 약물입니다.

PXL065는 중수소로 변형된 R 입체 이성질체인 PXL065는 피오글리타존의 S 입체 이성질체에서 관찰되는 PPARY 활성 및 관련 부작용이 거의 관찰되지 않습니다. 전임상 모델에서 PXL065는 비유전체 경로 작용을 통해 피오글리타존의 NASH 효능을 유지하면서 체중 증가와 체액 저류를 거의 일으키지 않는 것으로 관찰되었으며, PXL065는 NASH 치료에 대한 새로운 접근법을 제공하는 신규 화학물질(NCE) IP를 보유한 신약입니다.

주요 7 시장(미국, 독일, 프랑스, 이탈리아, 스페인, 영국, 일본)의 비알코올성 지방성 간염(NASH)용 PXL065에 대해 조사분석했으며, 시장 규모 예측 및 작용기서, 용법과 용량, 연구개발 활동 등의 정보를 제공하고 있습니다.

목차

제1장 리포트 서론

제2장 비알코올성 지방간염(NASH)에서 PXL065의 개요

• 제품 상세
• 임상 개발
  • 임상 연구
  • 임상시험 정보
  • 안전성과 유효성
• 기타 개발 활동
• 제품의 개요

제3장 경쟁 구도(출시 치료법)

제4장 경쟁 구도(후기 단계의 새로운 치료법)

제5장 PXL065 시장 평가

• 비알코올성 지방간염(NASH)에서 PXL065 시장 전망
• 주요 7 시장의 분석
  • 주요 7 시장의 비알코올성 지방간염(NASH)용 PXL065 시장 규모
• 시장의 분석 : 국가별
  • 미국의 비알코올성 지방간염(NASH)용 PXL065 시장 규모
  • 독일의 비알코올성 지방간염(NASH)용 PXL065 시장 규모
  • 영국의 비알코올성 지방간염(NASH)용 PXL065 시장 규모

제6장 SWOT 분석

제7장 애널리스트의 견해

제8장 부록

제9장 DelveInsight 서비스 내용

제10장 면책사항

제11장 DelveInsight 소개

제12장 리포트 구입 옵션

영문목차

"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