한글목차

DB102(Enzastaurin)는 PKCβ, PI3K, AKT 경로를 억제하는 최초의 경구용 저분자 세린-스레오닌 키나아제 억제제이며, Eli Lilly가 개발하고 Denovo가 전 세계 판권을 획득했습니다.

Denovo는 DLBCL 및 GBM 환자에서 기대되는 치료 효과와 유의미한 상관관계가 있는 바이오마커를 확인하여 국제 특허를 출원했으며, 2018년에 매우 중요한 국제 공동 DLBCL 3상 임상시험을 시작했습니다. 스탠포드 대학으로부터 폐동맥 고혈압(PAH)에 대한 DB102의 사용권을 획득했습니다.

현재 바이오마커 DGM1(Denovo Genomic Marker 1)을 가진 신규 진단 고위험군(IPI >=3) DLBCL 환자를 대상으로 DB102와 R-CHOP 병용요법 및 R-CHOP 단독요법의 유효성을 평가하기 위한 임상 3상을 진행 중입니다. 또한, 회사는 2022년까지 이 임상 3상 시험의 탑라인 데이터를 발표할 예정입니다. 그러나 현재로서는 이에 대한 최신 정보가 없습니다.

이 보고서는 주요 7개국 DB102 시장에 대해 조사했으며, 시장 개요와 함께 2024-2032년까지의 매출 예측 데이터, 경쟁 상황, 국가별 동향 등의 정보를 전해드립니다.

목차

제1장 보고서 서론

제2장 DLBCL의 DB102 개요

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

제3장 경쟁 상황(출시된 치료법)

제4장 경쟁 상황(후기 단계 새로운 치료법)

제5장 DB102 시장 평가

• DLBCL의 DB102 시장 전망
• 주요 7개국 분석
  • DLBCL용 주요 7개국의 DB102 시장 규모
• 국가별 시장 분석
  • 미국
  • 독일
  • 영국

제6장 SWOT 분석

제7장 애널리스트의 견해

제8장 부록

• 참고문헌
• 보고서 조사 방법

제9장 DelveInsight의 서비스 내용

제10장 면책사항

제11장 DelveInsight 소개

제12장 보고서 구입 옵션

영문목차

"DB102 Emerging Drug Insight and Market Forecast - 2032" report provides comprehensive insights about DB102 for Diffuse Large B-cell lymphoma (DLBCL) in the seven major markets. A detailed picture of the DB102 for DLBCL 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 DB102 for DLBCL. 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 DB102 market forecast analysis for DLBCL in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in DLBCL.

Drug Summary:

DB102 (Enzastaurin) is an orally available investigational first-in-class small molecule, serine/threonine kinase inhibitor of the PKC beta, PI3K, and AKT pathways that have been studied in more than 3,000 patients across a range of solid and hematological tumor types. Eli Lilly originally developed DB102 and for which Denovo has acquired worldwide rights.

Denovo has completed the biomarker identification, significantly correlated with the expected therapeutic effects on DLBCL and GBM patients, and has filed international patent applications. Denovo initiated a pivotal Phase III global DLBCL clinical trial in 2018. In 2018, Denovo licensed the rights to use DB102 for pulmonary arterial hypertension (PAH) from Stanford University.

Currently, the drug is in a Phase III trial evaluating the efficacy of DB102 in combination with R-CHOP vs. R-CHOP alone in newly diagnosed high-risk (IPI >=3) DLBCL patients with the biomarker DGM1 (Denovo Genomic Marker 1) (Denovo Biopharma, 2021a). Moreover, the company has also anticipated announcing the topline data of this Phase III trial by 2022. However, so far, there is no update regarding this.

Scope of the Report:

The report provides insights into:

• A comprehensive product overview including the DB102 description, mechanism of action, dosage and administration, research and development activities in Diffuse Large B-cell lymphoma (DLBCL).
• Elaborated details on DB102 regulatory milestones and other development activities have been provided in this report.
• The report also highlights the DB102 research and development activities in DLBCL across the United States, Europe and Japan.
• The report also covers the patents information with expiry timeline around DB102.
• The report contains forecasted sales of DB102 for DLBCL till 2032.
• Comprehensive coverage of the late-stage emerging therapies for DLBCL.
• The report also features the SWOT analysis with analyst views for DB102 in DLBCL.

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.

DB102 Analytical Perspective by DelveInsight

In-depth DB102 Market Assessment

This report provides a detailed market assessment of DB102 for Diffuse Large B-cell lymphoma (DLBCL) 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.

DB102 Clinical Assessment

The report provides the clinical trials information of DB102 for DLBCL covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights:

• In the coming years, the market scenario for Diffuse Large B-cell lymphoma (DLBCL) 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 DB102 dominance.
• Other emerging products for DLBCL are expected to give tough market competition to DB102 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 DB102 in DLBCL.
• Our in-depth analysis of the forecasted sales data of DB102 from 2024 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the DB102 in DLBCL.

Key Questions:

• What is the product type, route of administration and mechanism of action of DB102?
• What is the clinical trial status of the study related to DB102 in Diffuse Large B-cell lymphoma (DLBCL) and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the DB102 development?
• What are the key designations that have been granted to DB102 for DLBCL?
• What is the forecasted market scenario of DB102 for DLBCL?
• What are the forecasted sales of DB102 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 DB102 for DLBCL?
• Which are the late-stage emerging therapies under development for the treatment of DLBCL?

Table of Contents

1. Report Introduction

2. DB102 Overview in DLBCL

• 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. DB102 Market Assessment

• 5.1. Market Outlook of DB102 in DLBCL
• 5.2. 7MM Analysis
  • 5.2.1. Market Size of DB102 in the 7MM for DLBCL
• 5.3. Country-wise Market Analysis
  • 5.3.1. Market Size of DB102 in the United States for DLBCL
  • 5.3.2. Market Size of DB102 in Germany for DLBCL
  • 5.3.3. Market Size of DB102 in France for DLBCL
  • 5.3.4. Market Size of DB102 in Italy for DLBCL
  • 5.3.5. Market Size of DB102 in Spain for DLBCL
  • 5.3.6. Market Size of DB102 in the United Kingdom for DLBCL
  • 5.3.7. Market Size of DB102 in Japan for DLBCL

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