市場調査レポート
商品コード
1462295
FDY-5301の市場規模、予測、新薬の考察(2032年)FDY-5301 Market Size, Forecast, and Emerging Insight - 2032 |
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FDY-5301の市場規模、予測、新薬の考察(2032年) |
出版日: 2024年04月01日
発行: DelveInsight
ページ情報: 英文 30 Pages
納期: 2~10営業日
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FDY-5301はヨウ化ナトリウムを含む元素還元剤であり、Faradayは世界の主要市場において使用方法の特許を取得しています。FDY-5301の前臨床試験では、心筋と骨格筋の傷害を軽減する能力が実証されています。フェーズI試験では、健常者に毒性は認められませんでした。STEMI後の再灌流障害の治療におけるFDY-5301のフェーズII試験では、この治療が良好な忍容性を示し、心臓障害を最小化する潜在的な有効性の有望な兆候が示されました。
2022年5月、Faraday PharmaceuticalsはIocyte AMI-III試験(一次経皮的インターベンション(PCI)を受ける前STEMI患者のCV死と心不全の減少におけるFDY-5301の有効性と安全性を評価するフェーズ3臨床試験)の最初の患者を登録しました。本試験は北米、欧州、イスラエルの150施設全体で約2,300人の前STEMI患者の登録を目指しています。この試験は米国FDAとの特別プロトコル契約に基づき実施されます。本試験が成功すれば、上市承認申請の支えとなる可能性があります。
当レポートでは、主要7市場(米国・ドイツ・フランス・イタリア・スペイン・英国・日本)における心筋梗塞向けFDY-5301について調査分析し、作用機序、用法と用量、研究開発活動についての考察、収益の予測などを提供しています。
"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.
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.
The report provides insights into:
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
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.
The report provides the clinical trials information of FDY-5301 for myocardial infarction covering trial interventions, trial conditions, trial status, start and completion dates.