第2型糖尿病治疗药的开发产品线(Vol.1）

Abstract

Overview of Therapeutic Clinical Intelligence Report Series

Austin Research Group' s Therapeutic Clinical Intelligence Report Series provides clients within the pharmaceutical and biotechnology industry with detailed information and analysis of competitive products in the development pipeline. Reports contain synthesized information and analysis of clinical development activities for key marketed and pipeline products within multiple therapeutic categories and generally include the following data points:

• Product Overview: Mechanism of Action, Developing Companies, Indications and Phase of Development.
• Clinical Trial Assessments: Detailed evaluations of completed and ongoing competitor studies that capture key elements of the study protocol including:
  • Trial design
  • Start and end dates
  • Study size and patient type
  • Number of participating sites
  • Dosing regimen
  • Endpoints
  • Safety and efficacy results

Clients utilize the report as an resource to support key decisions including:

• Analyzing the overall depth and breadth of the competitive landscape within a therapeutic area
• Assessing target product profiles of key current and future competitors
• Benchmarking competitor clinical trial designs and results
• Developing clinical analogues to support go-no-go decisions
• Identifying clinical hurdles posed by competitors
• Designing clinical trials more effectively to maximize a product' s penetration

Scope of Research & Analysis

• The scope of this research focuses on the research and development pipeline for Type-2 diabetes non-insulin therapeutics.
• Specifically, this report examines the 35 most promising compounds in Phase 2, Phase 3, and Registration stages of development.
• This report provides detailed analysis of the product profiles and clinical trials involving 35 of these novel agents.

Table of Contents

Section 1: Executive Summary

• Scope of Research & Analysis
• Type-2 Diabetes Disease Overview
• Overview of Progression to Type 2 Diabetes
• Global Projections for the Diabetes Epidemic: 2003-2025
• Epidemiology of T2 Diabetes: Current and predicted prevalence
• Currently Available Treatments for T2 Diabetes
• Unmet Need in Type-2 Diabetes Market
• FDA Summary Guidance for Development of T2 Diabetes Therapeutics
• Overview of Competitive Landscape: Late-Stage Products Profiled in Intelligence Report
• Overview of Competitive Landscape: Mid & Early Stage Products Profiled in Intelligence Report
• Competitive Launch Timeline Analysis
• Overview of Clinical Trials Landscape

Section 2: The Current Market Leaders in T2 Diabetes

• Actos Product Overview - Competitor Snapshot
• Avandia Product Overview - Competitor Snapshot
• Byetta Product Overview - Competitor Snapshot
• Januvia Product Overview - Competitor Snapshot
• Symlin Product Overview - Competitor Snapshot
• Galvus Product Overview - Competitor Snapshot

Section 3: Future Competitive Threats Novel Therapeutics in Late-Stage Development

• Alogliptin (SYR-322)
• Alogliptin Product Overview - Competitor Snapshot
• Alogliptin Phase II Study Design & Results
• Alogliptin Phase III Study Design (Ongoing)
• Alogliptin Phase III Study Design (Ongoing)
• Alogliptin Phase III Study Design (Ongoing)
• Alogliptin Phase III Study Design (Ongoing)
• Alogliptin Phase III Study Design & Results
• Alogliptin Phase III Study Design (Ongoing)
• Alogliptin Phase III Study Design (Ongoing)

• Liraglutide
• Liraglutide Product Overview - Competitor Snapshot
• Liraglutide Phase II Study Design & Results
• Liraglutide Phase II Study Design & Results
• Overview of Liraglutide Registrational Program
• Liraglutide Phase III Study Design & Results LEAD 1
• Liraglutide Phase III Study Design (Ongoing) LEAD 2
• Liraglutide Phase III Study Design & Results LEAD 3
• Liraglutide Phase III Study Design (Ongoing) LEAD 4
• Liraglutide Phase III Study Design (Ongoing) LEAD 5
• Liraglutide Phase III Study Design & Results LEAD 6
• Liraglutide Phase III Study Design (Ongoing) Japan NDA-Enabling Trial

• Saxagliptin
• Saxagliptin Product Overview - Competitor Snapshot
• Saxagliptin Phase I Studies (#1 & #2): Design & Results
• Saxagliptin Phase III Study Design & Results
• Saxagliptin Phase III Study Design
• Saxagliptin Phase III Study Design
• Saxagliptin Phase III Study Design & Results
• Saxagliptin Phase III Study Design (Ongoing)
• Saxagliptin Phase III Study Design (Ongoing)

• AGI-1067
• AGI-1067 Product Overview - Competitor Snapshot
• AGI-1067 Phase III Study Design & Interim Results (Ongoing) ANDES (AGI-1067 as a Novel Antidiabetic Agent Evaluation Study)

• Exanatide LAR (exenatide)
• Exenatide LAR Product Overview - Competitor Snapshot
• Exenatide LAR Phase II Study Design & Results
• Exenatide LAR Phase II Study Design (Ongoing)
• Exenatide LAR Phase III Study Design & Results-DURATION-1
• Exenatide LAR Phase III Study Design (Ongoing)
• Exenatide LAR Phase III Study Design (Ongoing)
• Exenatide LAR Phase III Study Designs (Ongoing)

• Dapagliflozin
• Dapagliflozin Product Overview - Competitor Snapshot
• Dapagliflozin Phase II Study Design & Results
• Overview of Dapagliflozin Registrational Program
• Dapagliflozin Phase III Study Design (Ongoing)
• Dapagliflozin Phase III Study Design (Ongoing)
• Dapagliflozin Phase III Study Design (Ongoing)
• Dapagliflozin Phase III Study Design (Ongoing)

• Balaglitazone
• Balaglitazone Product Overview - Competitor Snapshot
• Balaglitazone Phase II Study Design & Results
• Balaglitazone Phase III Study Design (Ongoing)

• BI-1356
• BI-1356 Product Overview - Competitor Snapshot
• BI-1356 Phase I/II Study Design & Results
• BI-1356 Phase I/II Study Design & Results
• BI-1356 Phase I/II Study Design (ongoing)
• BI-1356 Phase III Study Design (Ongoing)
• BI-1356 Phase III Study Design (Ongoing)
• BI-1356 Phase III Study Design (Ongoing)
• BI-1356 Phase III Study Design (Ongoing)
• BI-1356 Phase III Study Design (Ongoing)

• rivoglitazone (CS-011)
• rivoglitazone Product Overview - Competitor Snapshot
• Rivoglitazone Phase II/III Study Design & Results
• Rivoglitazone Phase III Study Design (Ongoing)

• AVE-0010
• AVE-0010 Product Overview - Competitor Snapshot
• AVE-0010 Phase IIa Study Design & Results
• AVE-0010 Phase IIb Study Design
• AVE-0010 Phase 2b Top-Line Efficacy Results
• AVE-0010 Product Positioning

• R1583
• R1583 Product Overview - Competitor Snapshot
• R1583 Phase II Study Design & Results
• R1583 Phase II Study Design & Results
• R1583 Phase II Study Design & Results
• R1583 Phase II Study Design & Results

• AVE-2268
• AVE-2268 FDC Product Overview - Competitor Snapshot
• AVE-2268 Phase IIb Study Design
• remogliflozin
• Remogliflozin Product Overview - Competitor Snapshot
• Remogliflozin Phase I Study Design (Ongoing)
• Remogliflozin Phase I Study Design (Ongoing)
• Remogliflozin Phase II Study Design (Ongoing)
• Remogliflozin Phase II Study Design (Ongoing)
• Remogliflozin Phase II Study Design (Completed)

• PHX1149
• PHX1149 Product Overview - Competitor Snapshot
• PHX1149 Phase I Study Design & Results
• PHX1149 Phase I Study Design & Results
• PHX1149 Phase IIa Study Design & Results
• PHX1149 Phase IIb Study Design (Ongoing)

• INT131
• INT131 Product Overview - Competitor Snapshot
• INT131 Phase I Study Design & Results
• INT131 Phase I Study Design & Results
• INT131 Phase IIa Study Design & Results
• INT131 Phase IIb Study Design (Ongoing)

• albiglutide
• albiglutide Product Overview - Competitor Snapshot
• albiglutide Phase I Study Design
• albiglutide Phase I Study Design
• albiglutide Phase I/II Study Design (Ongoing)
• albiglutide Phase IIb Study Design (Ongoing)

Section 4: Long-Term Potential Competitive Threats Innovative Therapies in Mid-Stage Development

• Aleglitazar
• Aleglitazar Product Overview - Competitor Snapshot
• Aleglitazar Phase IIb Study Design (Ongoing)
• Aleglitazar Phase IIb Study Design (Ongoing)

• PF-00734200
• PF-00734200 Product Overview - Competitor Snapshot
• PF-00734200 Phase IIa Study Design & Results
• PF-00734200 Phase IIa Study Design (Ongoing)
• PF-00734200 Phase II Study Design (Ongoing)

• R1579
• R1579 Product Overview - Competitor Snapshot
• R1579 Phase I Study Design & Results
• R1579 Phase II Study Design (Ongoing)

• TAK-472 (SYR-472)
• TAK-472 Product Overview - Competitor Snapshot
• TAK-472 Phase II Study Design (Ongoing)

• AMG-222 (ALS 2-0426)
• AMG-222 Product Overview - Competitor Snapshot

• INCB13739
• INCB13739 Product Overview - Competitor Snapshot
• INCB13739 Phase I Study Design & Results
• INCB13739 Phase IIa Study Design & Results

• MB07803
• MB07803 Product Overview - Competitor Snapshot
• MB07803 Phase IIa Study Design & Results

• ISIS 113715
• ISIS 113715 Product Overview - Competitor Snapshot
• ISIS 113715 Phase I Study Design & Results
• ISIS 113715 Phase II Study Design & Results
• ISIS 113715 Phase II Study Design (Ongoing)

• AZD2207
• AZD2207 Product Overview - Competitor Snapshot

• DIO-902
• DIO-902 Product Overview - Competitor Snapshot
• DIO-902 Phase IIa Study Design & Results
• DIO-902 Phase II/III Study Design (Ongoing)
• DIO-902 Phase II/III Extension Study Design (Ongoing)

• EMD 387008
• EMD 387008 Product Overview - Competitor Snapshot

• indeglitazar
• indeglitazar Product Overview - Competitor Snapshot
• indeglitazar Phase IIa Study Design & Results

• azilsartan
• azilsartan Product Overview - Competitor Snapshot

• MBX-2044
• MBX-2044 Product Overview - Competitor Snapshot
• MBX-2044 Phase IIa Study Design & Results

• CJC-1134-PC
• CJC-1134-PC Product Overview - Competitor Snapshot
• CJC-1134-PC Phase I/II Study Design & Results
• CJC-1134-PC Phase I/II Study Design & Results
• CJC-1134-PC Phase II Study Design (Ongoing)
• CJC-1134-PC Phase II Study Design (Ongoing)

• CRx-401
• CRx-401 Product Overview - Competitor Snapshot
• CRx-401 Phase II Study Design (Ongoing)

• K-111
• K-111 Product Overview - Competitor Snapshot
• K-111 Phase IIa Study Design & Results
• K-111 Phase IIa Study Design & Results

• MP-513
• MP-513 Product Overview - Competitor Snapshot
• MP-513 Phase II Study Design (Ongoing)

• AKP-020
• AKP-020 Product Overview - Competitor Snapshot
• AKP-020 Phase II Study Design (Discontinued)

• AVE0847
• AVE0847 Product Overview - Competitor Snapshot
• AVE0847 Phase II Study Design (Completed-Results Unpublished)

Section 6: APPENDIX

• Disclaimer
• Report Licensing