약제 요약
FDY-5301은 요오드화나트륨을 함유한 원소 환원제이며, 패러데이는 세계 주요 시장에서 FDY-5301의 사용방법에 대한 특허를 보유하고 있으며, FDY-5301의 전임상시험에서 심근 및 골격근 손상을 감소시키는 능력을 입증했습니다. FDY-5301의 STEMI 후 재관류 장애 치료에 대한 임상 2상 시험에서 FDY-5301은 양호한 내약성을 보였으며, 심장 손상을 최소화할 수 있는 잠재적 효능에 대한 유망한 징후를 보여주었습니다.
지난 5월 패러데이 파마슈티컬스는 1차 경피적 관상동맥중재술(PCI)을 받기 전 STEMI 환자의 CV 사망 및 심부전 감소에 대한 FDY-5301의 유효성과 안전성을 평가하기 위한 3상 임상시험인 Iocyte AMI-III 임상 3상 시험에 첫 번째 환자를 등록했습니다. 이 임상은 북미, 유럽, 이스라엘의 150개 기관에서 약 2,300명의 전 STEMI 환자 등록을 목표로 하고 있습니다. 이 임상시험은 미국 FDA와의 특별 프로토콜 계약에 따라 진행됩니다. 이 시험이 성공하면 시판 허가 신청에 도움이 될 수 있습니다.
주요 7 시장(미국·독일·프랑스·이탈리아·스페인·영국·일본)의 심근경색용 FDY-5301에 대해 조사분석했으며, 작용기서, 용법과 용량, 연구개발 활동에 관한 인사이트, 매출의 예측 등을 제공하고 있습니다.
목차
제1장 리포트의 서론
제2장 심근경색에서의 FDY-5301 개요
- 제품의 상세
- 임상 개발
- 기타 개발 활동
- 제품 개요
제3장 경쟁 구도(출시 치료법)
제4장 경쟁 구도(후기 신치료법)
제5장 FDY-5301 시장 평가
- 심근경색에서 FDY-5301의 시장 전망
- 주요 7 시장 분석
- 주요 7 시장 심근경색용 FDY-5301의 시장 규모
- 시장 분석 : 국가별
- 미국의 심근경색용 FDY-5301의 시장 규모
- 독일의 심근경색용 FDY-5301의 시장 규모
- 영국의 심근경색용 FDY-5301의 시장 규모
제6장 SWOT 분석
제7장 애널리스트의 견해
제8장 부록
제9장 DelveInsight의 서비스 내용
제10장 면책사항
제11장 DelveInsight 소개
제12장 리포트 구입 옵션
KSA
"FDY-5301 Market Size, Forecast, and Emerging Insight - 2032" report provides comprehensive insights about FDY-5301 for myocardial infarction in the seven major markets. A detailed picture of the FDY-5301 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 FDY-5301 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 FDY-5301 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:
FDY-5301 is an elemental reducing agent containing sodium iodide for which Faraday has obtained a method of use patent protection in major markets worldwide. Preclinical studies of FDY-5301 have demonstrated its ability to reduce cardiac and skeletal muscle injury. Phase I data have demonstrated no signs of toxicity in healthy subjects. A Phase II trial of FDY-5301 in treating reperfusion injury following a STEMI demonstrated the treatment was well-tolerated and provided encouraging signals of potential efficacy in minimizing cardiac damage.
In May 2022, Faraday Pharmaceuticals enrolled the first patient in its Iocyte AMI-III study - a Phase III clinical trial assessing the efficacy and safety of FDY-5301 in reducing CV death and heart failure in anterior STEMI patients undergoing primary percutaneous intervention (PCI). The study aims to enroll approximately 2,300 anterior STEMI patients across 150 centers in North America, Europe, and Israel. The trial is being conducted under a special protocol agreement with the US FDA. The study, if successful, would support a regulatory submission for marketing approval.
Scope of the Report:
The report provides insights into:
- A comprehensive product overview including the FDY-5301 description, mechanism of action, dosage and administration, research and development activities in myocardial infarction.
- Elaborated details on FDY-5301 regulatory milestones and other development activities have been provided in this report.
- The report also highlights the FDY-5301 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 FDY-5301.
- The report contains forecasted sales of FDY-5301 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 FDY-5301 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.
FDY-5301 Analytical Perspective by DelveInsight
- In-depth FDY-5301 Market Assessment
This report provides a detailed market assessment of FDY-5301 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 2025 to 2032.
- FDY-5301 Clinical Assessment
The report provides the clinical trials information of FDY-5301 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 FDY-5301 dominance.
- Other emerging products for myocardial infarction are expected to give tough market competition to FDY-5301 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 FDY-5301 in myocardial infarction.
- Our in-depth analysis of the forecasted sales data of FDY-5301 from 2025 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the FDY-5301 in myocardial infarction.
Key Questions:
- What is the product type, route of administration and mechanism of action of FDY-5301?
- What is the clinical trial status of the study related to FDY-5301 in myocardial infarction and study completion date?
- What are the key collaborations, mergers and acquisitions, licensing and other activities related to the FDY-5301 development?
- What are the key designations that have been granted to FDY-5301 for myocardial infarction?
- What is the forecasted market scenario of FDY-5301 for myocardial infarction?
- What are the forecasted sales of FDY-5301 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 FDY-5301 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. FDY-5301 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. FDY-5301 Market Assessment
- 5.1. Market Outlook of FDY-5301 in myocardial infarction
- 5.2. 7MM Analysis
- 5.2.1. Market Size of FDY-5301 in the 7MM for myocardial infarction
- 5.3. Country-wise Market Analysis
- 5.3.1. Market Size of FDY-5301 in the United States for myocardial infarction
- 5.3.2. Market Size of FDY-5301 in Germany for myocardial infarction
- 5.3.3. Market Size of FDY-5301 in France for myocardial infarction
- 5.3.4. Market Size of FDY-5301 in Italy for myocardial infarction
- 5.3.5. Market Size of FDY-5301 in Spain for myocardial infarction
- 5.3.6. Market Size of FDY-5301 in the United Kingdom for myocardial infarction
- 5.3.7. Market Size of FDY-5301 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
