한글목차

약제 요약

셀라토그렐은 강력하고, 선택성이 높고, 즉각적이고, 가역적인 P2Y12 수용체 길항제로 심근경색 재발 위험이 높은 환자의 심근경색 치료제로 개발되고 있습니다. 이 약은 AMI를 시사하는 증상이 나타날 때 약물전달 디바이스(자가주사기)를 통해 피하로 자가투여하는 방식입니다.

만성관상동맥증후군 환자와 AMI 환자를 대상으로 한 2건의 임상 2상 시험이 발표되어 혈소판 응집을 신속하고 가역적으로 억제하는 것으로 나타났으며, 셀라토그렐 16mg의 SC 투여는 15분 이내에 빠른 작용을 보였고, 약 8시간까지 효과가 지속되는 것으로 나타났습니다. Selatogrel의 안전성과 내약성은 모든 시험에서 양호하게 나타났습니다.

2021년 6월, Idorsia는 AMI가 의심되는 환자를 대상으로 셀라토그렐 자가주사제의 유효성과 안전성을 평가하기 위한 3상 등록 임상인 SOS-AMI를 시작한다고 발표했습니다.

특별 프로토콜 평가가 FDA와 합의되었습니다. 이는 FDA가 향후 판매 신청을 지원하기 위한 시험에서 전체 프로토콜 설계의 특정 중요 요소(예: 진입 기준, 용량 선택, 평가변수, 계획된 분석 등)가 적절하고 수용 가능하다는 데 동의했음을 의미합니다.

셀라토그렐을 이용한 3상 임상시험은 AMI 재발 위험이 높은 환자 약 14,000명 등록을 목표로 환자를 모집하고 있습니다. 환자 모집은 더 많은 기관이 참여함에 따라 활성화되고 있으며, 약 45개국, 500개 이상의 기관을 목표로 하고 있습니다.

주요 7 시장(미국·독일·프랑스·이탈리아·스페인·영국·일본)의 심근경색용 Selatogrel에 대해 조사분석했으며, 작용기서, 용법과 용량, 연구개발 활동에 관한 인사이트, 매출의 예측 등을 제공하고 있습니다.

목차

제1장 리포트의 서론

제2장 심근경색에서 Selatogrel의 개요

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

제3장 경쟁 구도(출시 치료법)

제4장 경쟁 구도(후기 신치료법)

제5장 Selatogrel 시장 평가

• 심근경색에서 Selatogrel의 시장 전망
• 주요 7 시장 분석
  • 주요 7 시장의 심근경색용 Selatogrel의 시장 규모
• 시장 분석 : 국가별
  • 미국의 심근경색용 Selatogrel의 시장 규모
  • 독일의 심근경색용 Selatogrel의 시장 규모
  • 영국의 심근경색용 Selatogrel의 시장 규모

제6장 SWOT 분석

제7장 애널리스트의 견해

제8장 부록

제9장 DelveInsight의 서비스 내용

제10장 면책사항

제11장 DelveInsight 소개

제12장 리포트 구입 옵션

영문목차

"Selatogrel Market Size, Forecast, and Emerging Insight - 2032" report provides comprehensive insights about selatogrel for myocardial infarction in the seven major markets. A detailed picture of the selatogrel for myocardial infarction 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 selatogrel for myocardial infarction. 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 selatogrel market forecast analysis for myocardial infarction in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in myocardial infarction.

Drug Summary:

Selatogrel is a potent, highly selective, fast-acting, and reversible P2Y12 receptor antagonist, being developed for treating AMI in patients at high risk of recurrent AMI. It is self-administered subcutaneously via a drug delivery device (autoinjector) upon the occurrence of symptoms suggestive of an AMI.

Two published Phase II studies, one in patients with chronic coronary syndromes and one in patients with AMI, showed fast and reversible inhibition of platelet aggregation. SC administration of selatogrel 16 mg has demonstrated a rapid onset of action, within 15 min, with the magnitude of the effect extending over approximately 8h. Selatogrel was safe and well-tolerated in both studies.

In June 2021, Idorsia announced the initiation of the Phase III registration study "SOS-AMI" to evaluate the efficacy and safety of self-administered SC selatogrel in suspected AMI.

A special protocol assessment has been agreed upon with the FDA. This indicates the FDA agrees with the adequacy and acceptability of specific critical elements of overall protocol design (e.g., entry criteria, dose selection, endpoints, and planned analyses) for a study intended to support a future marketing application.

The Phase III study with selatogrel is recruiting patients, with a target enrollment of approximately 14,000 patients at high risk of recurrent AMI. Patient recruitment is ramping up as more sites become involved, with a target of more than 500 sites in about 45 countries.

Scope of the Report:

The report provides insights into:

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

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.

Selatogrel Analytical Perspective by DelveInsight

• In-depth Selatogrel Market Assessment

This report provides a detailed market assessment of selatogrel for myocardial infarction 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.

• Selatogrel Clinical Assessment

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

Report Highlights:

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

Key Questions:

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

Table of Contents

1. Report Introduction

2. Selatogrel Overview in myocardial infarction

• 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. Selatogrel Market Assessment

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

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