한글목차

약제 요약

IPX203은 파킨슨병 치료제로 개발된 새로운 경구용 칼비도파/레보도파 서방형 캡슐 제제로, 속방성 과립과 서방성 비드를 함유하고 있습니다. 속방성 과립은 카르비도파와 레보도파로 구성되어 있으며, 빠른 용출을 위해 붕괴성 폴리머가 함유되어 있습니다. 서방형 비드는 레보도파로 구성되어 있으며, 서방형 폴리머로 코팅되어 약물이 천천히 방출되도록 하고, 점착성 폴리머로 흡수 부위에 더 오래 부착되도록 하며, 장용성 코팅으로 위 내에서 조기 붕괴를 방지합니다.

단계 3 임상시험의 톱라인 결과에 기반하여 Amneal Pharmaceuticals는 파킨슨병 치료용 IPX203 서방 캡슐의 신약 승인 신청을 시행하고, FDA에 수리되었습니다.

주요 7 시장(미국·독일·프랑스·이탈리아·스페인·영국·일본)의 파킨슨병용 IPX203에 대해 조사분석했으며, 작용기서, 용법과 용량, 연구개발 활동에 관한 인사이트, 매출의 예측 등을 제공하고 있습니다.

목차

제1장 리포트의 서론

제2장 파킨슨병에서의 IPX203 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 IPX203 시장 평가

• 파킨슨병에서 IPX203의 시장 전망
• 주요 7 시장 분석
  • 주요 7 시장 파킨슨병용 IPX203의 시장 규모
• 시장 분석 : 국가별
  • 미국의 파킨슨병용 IPX203의 시장 규모
  • 독일의 파킨슨병용 IPX203의 시장 규모
  • 영국의 파킨슨병용 IPX203의 시장 규모

제6장 SWOT 분석

제7장 애널리스트의 견해

제8장 부록

제9장 DelveInsight의 서비스 내용

제10장 면책사항

제11장 DelveInsight 소개

제12장 리포트 구입 옵션

영문목차

"IPX203 Market Size, Forecast, and Emerging Insight - 2032" report provides comprehensive insights about IPX203 for Parkinson's disease in the seven major markets. A detailed picture of the IPX203 for Parkinson's Disease 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 IPX203 for Parkinson's Disease. 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 IPX203 market forecast analysis for Parkinson's disease in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in Parkinson's disease.

Drug Summary:

IPX203 is a novel, oral formulation of carbidopa/levodopa extended-release capsules designed for the treatment of Parkinson's disease. IPX203 contains immediate-release granules and extended-release beads. The immediate-release granules consist of carbidopa and levodopa, with a disintegrant polymer to allow for rapid dissolution. The extended-release beads consist of levodopa, coated with a sustained release polymer to allow for slow release of the drug, a mucoadhesive polymer to keep the granules adhered to the area of absorption longer, and an enteric coating to prevent the granules from disintegrating prematurely in the stomach.

Based on the topline results from the Phase III clinical trial Amneal Pharmaceuticals submitted an NDA for IPX203 extended-release capsules for the treatment of Parkinson's disease which is accepted by the FDA.

Scope of the Report:

The report provides insights into:

• A comprehensive product overview including the IPX203 description, mechanism of action, dosage and administration, research and development activities in Parkinson's disease.
• Elaborated details on IPX203 regulatory milestones and other development activities have been provided in this report.
• The report also highlights the IPX203 research and development activities in Parkinson's disease across the United States, Europe and Japan.
• The report also covers the patents information with expiry timeline around IPX203.
• The report contains forecasted sales of IPX203 for Parkinson's disease till 2032.
• Comprehensive coverage of the late-stage emerging therapies for Parkinson's disease.
• The report also features the SWOT analysis with analyst views for IPX203 in Parkinson's disease.

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.

IPX203 Analytical Perspective by DelveInsight

• In-depth IPX203 Market Assessment

This report provides a detailed market assessment of IPX203 for Parkinson's disease 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.

• IPX203 Clinical Assessment

The report provides the clinical trials information of IPX203 for Parkinson's disease covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights:

• In the coming years, the market scenario for Parkinson's disease 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 IPX203 dominance.
• Other emerging products for Parkinson's disease are expected to give tough market competition to IPX203 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 IPX203 in Parkinson's disease.
• Our in-depth analysis of the forecasted sales data of IPX203 from 2024 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the IPX203 in Parkinson's disease.

Key Questions:

• What is the product type, route of administration and mechanism of action of IPX203?
• What is the clinical trial status of the study related to IPX203 in Parkinson's disease and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the IPX203 development?
• What are the key designations that have been granted to IPX203 for Parkinson's disease?
• What is the forecasted market scenario of IPX203 for Parkinson's disease?
• What are the forecasted sales of IPX203 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 IPX203 for Parkinson's disease?
• Which are the late-stage emerging therapies under development for the treatment of Parkinson's disease?

Table of Contents

1. Report Introduction

2. IPX203 Overview in Parkinson's disease

• 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. IPX203 Market Assessment

• 5.1. Market Outlook of IPX203 in Parkinson's disease
• 5.2. 7MM Analysis
  • 5.2.1. Market Size of IPX203 in the 7MM for Parkinson's disease
• 5.3. Country-wise Market Analysis
  • 5.3.1. Market Size of IPX203 in the United States for Parkinson's disease
  • 5.3.2. Market Size of IPX203 in Germany for Parkinson's disease
  • 5.3.3. Market Size of IPX203 in France for Parkinson's disease
  • 5.3.4. Market Size of IPX203 in Italy for Parkinson's disease
  • 5.3.5. Market Size of IPX203 in Spain for Parkinson's disease
  • 5.3.6. Market Size of IPX203 in the United Kingdom for Parkinson's disease
  • 5.3.7. Market Size of IPX203 in Japan for Parkinson's disease

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