한글목차

Rilzabrutinib(PRN-1008)은 경구용 브루톤 티로신 키나아제(BTK) 가역적 공유결합 억제제이며, BTK는 B세포 수용체(BCR), Fc 감마 수용체 및 Fc 엡실론 수용체 경로의 하류에 위치하는 필수적인 신호 전달 요소입니다. BTK의 활성화는 B세포의 활성화와 성숙에 필수적이며, BTK는 Fc 수용체 신호를 통해 대식세포, 호중구, 비만세포와 같은 다른 면역세포의 항체 매개 활성화도 조절합니다. 이 후보물질은 B세포를 고갈시키지 않으면서 효과적이고 안전하게 B세포의 기능을 조절할 수 있는 속효성 경구용 치료제로서 자가면역질환 및 염증성 질환 치료에 큰 진전이 있을 것으로 기대됩니다.

전 임상에서 PRN1008은 항 CD41로 유도된 ITP 모델 마우스에서 용량 의존적으로 유의한 혈소판 감소 억제 효과를 보였으며, PRN1008은 항체 구동형 쥐 관절염 모델과 자연발생적 자가항체 매개개 천포창에서 신속하고 유의한 항염증 효과를 보였습니다. 보여주었습니다. 전임상 데이터는 PRN1008이 비장 대식세포에서 자가항체/Fc 감마수용체 신호전달 억제를 통해 혈소판 파괴를 감소시키고, B세포 활성화에서 자가항체 생성 효과에 영향을 미치며, ITP에서 혈소판 손실을 감소시킬 수 있음을 시사합니다.

주요 7개국의 PRN-1008 시장에 대해 조사했으며, 시장의 개요와 2024-2032년 판매 예측 데이터, 경쟁 구도 및 국가별 동향 등을 제공하고 있습니다.

목차

제1장 리포트의 서론

제2장 면역성 혈소판 감소증(ITP)에 대한 PRN-1008의 개요

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

제3장 경쟁 구도(출시 치료법)

제4장 경쟁 구도(후기 단계 신규 치료법)

제5장 PRN-1008 시장 평가

• ITP에 대한 PRN-1008의 시장 전망
• 주요 7개국 시장 분석
  • 주요 7개국에서 ITP에 대한 PRN-1008의 시장 규모
• 국가별 시장 분석
  • 미국
  • 독일
  • 영국

제6장 SWOT 분석

제7장 애널리스트의 견해

제8장 부록

제9장 DelveInsight의 서비스 내용

제10장 면책사항

제11장 DelveInsight 소개

제12장 리포트 구입 옵션

영문목차

“"PRN-1008 Emerging Drug Insight and Market Forecast - 2032" ” report provides comprehensive insights about PRN-1008 for immune thrombocytopenic purpura (ITP) in the seven major markets. A detailed picture of the PRN-1008 for ITP 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 PRN-1008 for ITP. 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 PRN-1008 market forecast analysis for ITP in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in ITP.

Drug Summary:

Rilzabrutinib (PRN-1008) is an orally administered reversible covalent inhibitor of bruton tyrosine kinase (BTK). BTK is an essential signaling element downstream of the B-cell receptor (BCR), Fc-gamma receptor, and Fc-epsilon receptor pathways. BTK activation is critical for B-cell activation and maturation. BTK also regulates antibody-mediated activation of other immune cells, such as macrophages, neutrophils, and mast cells, through Fc receptor signaling. The drug candidate is a fast-acting, orally available therapy that could effectively and safely modulate B-cell function without depleting the B-cell and is expected to be a major advancement in treating autoimmune and inflammatory diseases.

In preclinical studies, PRN1008 demonstrated a significant dose-dependent platelet loss reduction in an anti-CD41-induced mouse model of ITP. PRN1008 showed rapid and significant anti-inflammatory effects in an antibody-driven rat arthus model and spontaneous autoantibody-mediated canine pemphigus foliaceus. The preclinical data suggest that PRN1008 could reduce platelet destruction via inhibition of autoantibody/Fc-gamma receptor signaling in splenic macrophages and affect autoantibody generation effects on B-cell activation to diminish platelet loss in ITP.

Scope of the Report:

The report provides insights into:

• A comprehensive product overview including the PRN-1008 description, mechanism of action, dosage and administration, research and development activities in immune thrombocytopenic purpura (ITP).
• Elaborated details on PRN-1008 regulatory milestones and other development activities have been provided in this report.
• The report also highlights the PRN-1008 research and development activities in ITP across the United States, Europe and Japan.
• The report also covers the patents information with expiry timeline around PRN-1008.
• The report contains forecasted sales of PRN-1008 for ITP till 2032.
• Comprehensive coverage of the late-stage emerging therapies for ITP.
• The report also features the SWOT analysis with analyst views for PRN-1008 in ITP.

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.

PRN-1008 Analytical Perspective by DelveInsight

In-depth PRN-1008 Market Assessment

This report provides a detailed market assessment of PRN-1008 for immune thrombocytopenic purpura (ITP) 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 2024 to 2032.

PRN-1008 Clinical Assessment

The report provides the clinical trials information of PRN-1008 for ITP covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights:

• In the coming years, the market scenario for immune thrombocytopenic purpura (ITP) 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 PRN-1008 dominance.
• Other emerging products for ITP are expected to give tough market competition to PRN-1008 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 PRN-1008 in ITP.
• Our in-depth analysis of the forecasted sales data of PRN-1008 from 2024 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the PRN-1008 in ITP.

Key Questions:

• What is the product type, route of administration and mechanism of action of PRN-1008?
• What is the clinical trial status of the study related to PRN-1008 in immune thrombocytopenic purpura (ITP) and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the PRN-1008 development?
• What are the key designations that have been granted to PRN-1008 for ITP?
• What is the forecasted market scenario of PRN-1008 for ITP?
• What are the forecasted sales of PRN-1008 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 PRN-1008 for ITP?
• Which are the late-stage emerging therapies under development for the treatment of ITP?

Table of Contents

1. Report Introduction

2. PRN-1008 Overview in ITP

• 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. PRN-1008 Market Assessment

• 5.1. Market Outlook of PRN-1008 in ITP
• 5.2. 7MM Analysis
  • 5.2.1. Market Size of PRN-1008 in the 7MM for ITP
• 5.3. Country-wise Market Analysis
  • 5.3.1. Market Size of PRN-1008 in the United States for ITP
  • 5.3.2. Market Size of PRN-1008 in Germany for ITP
  • 5.3.3. Market Size of PRN-1008 in France for ITP
  • 5.3.4. Market Size of PRN-1008 in Italy for ITP
  • 5.3.5. Market Size of PRN-1008 in Spain for ITP
  • 5.3.6. Market Size of PRN-1008 in the United Kingdom for ITP
  • 5.3.7. Market Size of PRN-1008 in Japan for ITP

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