| Report Code: 40253 | Published: July 2019 | Pages: 193 | Available format: |
| Therapeutic Area(s): | Nephrology | Report Type: Indication Pipeline Reports |
Chapter 1. Research Background
1.1 Research Objectives
1.2 Definition
1.3 Research Scope
1.3.1 Pipeline Analysis by Phase
1.3.2 Pipeline Analysis by Molecule Type
1.3.3 Pipeline Analysis by Route of Administration
1.4 Key Stakeholders
Chapter 2. Research Methodology
2.1 Secondary Research
2.2 Primary Research
2.2.1 Breakdown of Primary Research Respondents
2.2.1.1 By industry participant
2.2.1.2 By geography
2.2.1.3 By designation
2.2.2 Key Opinion Leaders (KOLs) Validation
2.3 Coverage of Epidemiology Analysis
2.4 Forecast Methodology
2.5 Assumptions for the Study
Chapter 3. Executive Summary
3.1 Voice of KOLs
Chapter 4. Introduction
4.1 Disease Overview
4.1.1 Classification of AKI
4.1.1.1 General classification
4.1.1.2 Classification based on daily urine excretion
4.1.1.3 RIFLE classification system for AKI
4.1.1.4 AKI network classification system
4.2 Causes
4.2.1 Reduced Blood Flow to Kidneys
4.2.2 Damage to Kidneys
4.2.3 Obstruction to the Drainage of Kidneys
4.3 Risk Factors
4.4 Symptoms
4.4.1 Complications
4.5 Diagnosis
4.6 Treatment
4.6.1 Treatment of the Underlying Cause of AKI
4.6.2 Treatment of Symptoms/Complications Associated with AKI
4.7 Prevention
4.8 Key Drivers
4.8.1 Research Funding from Various Agencies
4.8.2 Non-Availability of Approved Treatment
4.9 Key Barriers
4.9.1 Discontinuation of Drugs
4.10 Technology Overview
4.10.1 Epigenetic Regulators Platform
4.10.2 Smart Growth Factor Technology Platform
4.10.3 Cellmid's Technology
4.10.4 Cyclophilin Inhibitors
4.10.5 Hibernation Technology
4.11 Drug Designations
Chapter 5. Pipeline Drugs Outlook
5.1 AKI Pipeline Drugs Snapshot
5.1.1 Pipeline Drugs Snapshot by Phase
5.1.2 Pipeline Drugs Snapshot by Molecule Type
5.1.3 Pipeline Drugs Snapshot by Route of Administration
5.1.4 Pipeline Drugs Snapshot by Company
Chapter 6. Hospital- Acquired AKI Epidemiology Forecast for 7MM
6.1 7MM
6.2 U.S.
6.3 Japan
6.4 EU5
6.4.1 By Country
6.4.1.1 Germany
6.4.1.2 France
6.4.1.3 Italy
6.4.1.4 U.K.
6.4.1.5 Spain
Chapter 7. AKI Therapeutics Pipeline Analysis by Phase (2019)
7.1 Phase III
7.1.1 Teprasiran
7.1.1.1 Pre-Clinical results
7.1.1.2 Clinical trials
7.1.1.3 Clinical results
7.1.1.4 Technology
7.1.1.5 Strategic development
7.2 Phase II/III
7.2.1 RESCAP
7.2.1.1 Clinical trials
7.2.1.2 Grants
7.2.1.3 Patents
7.3 Phase II
7.3.1 EA-230
7.3.1.1 Clinical trials
7.3.2 ASP1128
7.3.2.1 Pre-Clinical studies
7.3.2.2 Clinical trials
7.3.2.3 Strategic development
7.3.3 ANG-3777
7.3.3.1 Pre-Clinical results
7.3.3.2 Clinical trials
7.3.3.3 Clinical results
7.3.3.4 Designation
7.3.3.5 Collaboration
7.3.4 Recombinant Alkaline Phosphatase Enzyme (reCAP)
7.3.4.1 Pre-Clinical results
7.3.4.2 Clinical trials
7.3.4.3 Pre-clinical results
7.3.4.4 Clinical trial results
7.3.4.5 Financing
7.3.4.6 Designation
7.3.5 Bovine Alkaline Phosphatase
7.3.5.1 Clinical trial and results
7.3.5.2 Strategic development
7.3.6 Reltecimod
7.3.6.1 Pre-clinical studies
7.3.6.2 Clinical trials
7.3.6.3 Financing
7.3.7 DUR 928
7.3.7.1 Pre-clinical trials
7.3.7.2 Clinical trials
7.3.7.3 Clinical trial results
7.3.7.4 Technology
7.4 Phase I/II
7.4.1 SBI-101
7.4.1.1 Clinical trials
7.4.1.2 Grants
7.5 Phase I
7.5.1 ROSgard
7.5.1.1 Pre-Clinical results
7.5.1.2 Clinical trials
7.5.1.3 Collaboration
7.5.1.4 Patent
7.5.2 Cilakin
7.5.2.1 Pre-clinical results
7.5.2.2 Clinical trial
7.5.2.3 Clinical trial results
7.5.3 Iron Sucrose + Sn Protoporphyrin
7.5.3.1 Clinical trials
7.5.4 Metablok
7.5.4.1 Pre-Clinical trials
7.5.4.2 Clinical trial
7.5.4.3 Patents
7.5.4.4 Financing
7.5.4.5 Other
7.6 IND
7.6.1 SGF-1
7.6.1.1 Pre-Clinical results
7.6.1.2 Patent
7.6.1.3 Technology
7.6.1.4 Strategic development
7.6.1.5 Financing
7.6.1.6 Grant
7.7 Pre-Clinical
7.7.1 Recombinant MFG-E8
7.7.1.1 Pre-clinical results
7.7.1.2 Grant
7.7.1.3 Patent
7.7.2 CAB101
7.7.2.1 Pre-clinical results
7.7.2.2 Technology
7.7.3 R 190
7.7.4 CC-4066
7.7.4.1 Patents
7.7.4.2 Technology
7.7.4.3 Strategic developments
7.7.4.4 Spin-off
7.7.5 Erythropoietin Receptor Agonist
7.7.5.1 Pre-Clinical studies
7.7.5.2 Grants
7.7.6 TTX-332
7.7.7 SUL-138
7.7.7.1 Pre-Clinical results
7.7.7.2 Technology
7.7.8 RLS-003
7.7.9 TRC-160334
7.7.9.1 Pre-Clinical results
7.7.10 5-Aminolevulinic Acid (5-ALA) + Fe
7.7.10.1 Pre-Clinical results
7.7.11 Mitsugumin53
7.7.11.1 Pre-Clinical result
7.8 Discovery
7.8.1 Research Program for Kidney Disease
7.8.1.1 Strategic developments
7.8.2 DM 199
7.8.2.1 Patents
7.9 Inactive
7.9.1 Aza-lasmiditan (Inactive)
7.9.1.1 Pre-clinical results
7.9.1.2 Grants
7.9.2 ANG-4102
7.9.3 Elamipretide
7.9.3.1 Strategic development
7.9.3.2 Technology
7.9.4 Pyridoxamine
7.9.4.1 Strategic development
7.9.5 Vasculotide
7.9.5.1 Pre-Clinical Result
7.9.6 Hepatocyte Growth Factor
7.9.6.1 Pre-clinical results
7.9.7 Minocin
7.9.7.1 Clinical trials
7.9.8 CXA-10
7.9.8.1 Clinical trials
7.9.8.2 Funding
7.9.9 Prismocitrate
7.9.9.1 Clinical trials
7.9.10 Levosimendan
7.9.10.1 Clinical trials
7.9.11 Gemigliptin
7.9.11.1 Clinical trials
Chapter 8. Clinical Trials Review
8.1 Clinical Trials by Geography
8.2 Clinical Trials by Trial Status
Chapter 9. Regulatory Framework for Drug Approval
9.1 U.S.
9.2 Europe
9.2.1 Centralized Procedure
9.2.2 Mutual Recognition Procedure
9.2.3 Decentralized Procedure
9.2.4 Nationalized Procedure
9.3 Japan
Chapter 10. Competitive Landscape
10.1 Summary of Strategic Development Activities
10.2 Attribute Analysis
10.2.1 Safety
10.2.2 Efficacy
10.2.3 USP
10.3 Expected Launch Time of Phase III and Phase II Clinical Stage Products
10.4 Key Winning Strategies
10.4.1 Technological Advancements
10.4.2 Collaborations and Partnerships
10.4.3 Development Through Subsidiaries
10.4.4 Acquisition of Additional Pipeline Products
10.5 Pharma Proff’s View
Chapter 11. Company Profiles
11.1 Angion Biomedica Corp.
11.1.1 Business Overview
11.1.2 Product & Service Offerings
11.2 Sentien Biotechnologies Inc.
11.2.1 Business Overview
11.2.2 Product & Service Offerings
11.3 Exponential Biotherapies Inc.
11.3.1 Business Overview
11.3.2 Product & Service Offerings
11.4 Silver Creek Pharmaceuticals Inc.
11.4.1 Business Overview
11.4.2 Product & Service Offerings
11.5 Durect Corporation
11.5.1 Business Overview
11.5.2 Product & Service Offerings
11.6 Quark Pharmaceuticals Inc.
11.6.1 Business Overview
11.6.2 Product & Service Offerings
11.7 DiaMedica Therapeutics Inc.
11.7.1 Business Overview
11.7.2 Product & Service Offerings
11.8 AM-Pharma N.V.
11.8.1 Business Overview
11.8.2 Product & Service Offerings
11.9 TheraSource LLC
11.9.1 Business Overview
11.9.2 Product & Service Offerings
11.10 Astellas Pharma Inc.
11.10.1 Business Overview
11.10.2 Product and Service Offerings
11.10.2.1 Marketed products
11.10.2.2 Pipeline products
11.11 Atox Bio
11.11.1 Business Overview
11.11.2 Product and Service Offerings
Chapter 12. Appendix
12.1 Recently Organized/Held Seminars and Conferences
12.2 Upcoming Conferences
12.3 Sources & References
12.4 Abbreviations
12.5 Related Reports
List of Tables
TABLE 1 GENERAL CLASSIFICATION OF AKI
TABLE 2 CLASSIFICATION OF AKI BASED ON DAILY URINE EXCRETION
TABLE 3 STAGES OF AKI UNDER RIFLE CLASSIFICATION SYSTEM
TABLE 4 STAGES OF AKI UNDER AKIN CLASSIFICATION SYSTEM
TABLE 5 COMPANY BENCHMARKING BASED ON DRUG CANDIDATES
TABLE 6 HOSPITAL- ACQUIRED AKI EPIDEMIOLOGY IN 7MM (2016-2021)
TABLE 7 HOSPITAL- ACQUIRED AKI EPIDEMIOLOGY IN 7MM (2022-2028)
TABLE 8 HOSPITAL-ACQUIRED AKI EPIDEMIOLOGY IN THE U.S. (2016-2021)
TABLE 9 HOSPITAL-ACQUIRED AKI EPIDEMIOLOGY IN THE U.S. (2022-2028)
TABLE 10 HOSPITAL-ACQUIRED AKI EPIDEMIOLOGY IN JAPAN (2016-2021)
TABLE 11 HOSPITAL-ACQUIRED AKI EPIDEMIOLOGY IN JAPAN (2022-2028)
TABLE 12 HOSPITAL-ACQUIRED AKI EPIDEMIOLOGY IN EU5 (2016-2021)
TABLE 13 HOSPITAL-ACQUIRED AKI EPIDEMIOLOGY IN EU5 (2022-2028)
TABLE 14 HOSPITAL-ACQUIRED AKI EPIDEMIOLOGY IN GERMANY (2016-2021)
TABLE 15 HOSPITAL-ACQUIRED AKI EPIDEMIOLOGY IN GERMANY (2022-2028)
TABLE 16 HOSPITAL-ACQUIRED AKI EPIDEMIOLOGY IN FRANCE (2016-2021)
TABLE 17 HOSPITAL-ACQUIRED AKI EPIDEMIOLOGY IN FRANCE (2022-2028)
TABLE 18 HOSPITAL-ACQUIRED AKI EPIDEMIOLOGY IN ITALY (2016-2021)
TABLE 19 HOSPITAL-ACQUIRED AKI EPIDEMIOLOGY IN ITALY (2022-2028)
TABLE 20 HOSPITAL-ACQUIRED AKI EPIDEMIOLOGY IN THE U.K. (2016-2021)
TABLE 21 HOSPITAL-ACQUIRED AKI EPIDEMIOLOGY IN THE U.K. (2022-2028)
TABLE 22 HOSPITAL-ACQUIRED AKI EPIDEMIOLOGY IN SPAIN (2016-2021)
TABLE 23 HOSPITAL-ACQUIRED AKI EPIDEMIOLOGY IN SPAIN (2022-2028)
TABLE 24 DESCRIPTION OF TEPRASIRAN
TABLE 25 CLINICAL TRIALS OF TEPRASIRAN
TABLE 26 DESCRIPTION OF RESCAP
TABLE 27 CLINICAL TRIALS OF RESCAP
TABLE 28 DESCRIPTION OF EA-230
TABLE 29 CLINICAL TRIALS OF EA-230
TABLE 30 DESCRIPTION OF ASP1128
TABLE 31 CLINICAL TRIALS OF ASP1128
TABLE 32 DESCRIPTION OF ANG-3777
TABLE 33 CLINICAL TRIALS OF ANG-3777
TABLE 34 DESCRIPTION OF RECAP
TABLE 35 CLINICAL TRIALS OF RECAP
TABLE 36 DESCRIPTION OF BOVINE ALKALINE PHOSPHATASE
TABLE 37 DESCRIPTION OF RELTECIMOD
TABLE 38 CLINICAL TRIALS OF RELTECIMOD
TABLE 39 DESCRIPTION OF DUR 928
TABLE 40 CLINICAL TRIALS OF DUR 928
TABLE 41 DESCRIPTION OF SBI- 101
TABLE 42 CLINICAL TRIALS OF SBI-101
TABLE 43 DESCRIPTION OF ROSGARD
TABLE 44 DESCRIPTION OF CILAKIN
TABLE 45 CLINICAL TRIALS OF CILAKIN
TABLE 46 DESCRIPTION OF IRON SUCROSE + SN PROTOPORPHYRIN
TABLE 47 CLINICAL TRIALS OF IRON SUCROSE + SN PROTOPORPHYRIN
TABLE 48 DESCRIPTION OF METABLOK
TABLE 49 CLINICAL TRIALS OF METABLOK
TABLE 50 DESCRIPTION OF SGF - 1
TABLE 51 DESCRIPTION OF RECOMBINANT MFG-E8
TABLE 52 DESCRIPTION OF CAB101
TABLE 53 DESCRIPTION OF R 190
TABLE 54 DESCRIPTION OF CC -4066
TABLE 55 DESCRIPTION OF ERYTHROPOIETIN RECEPTOR AGONIST
TABLE 56 DESCRIPTION OF TTX - 332
TABLE 57 DESCRIPTION OF SUL - 138
TABLE 58 DESCRIPTION OF RLS-003
TABLE 59 DESCRIPTION OF TRC - 160334
TABLE 60 DESCRIPTION OF 5-ALA + FE
TABLE 61 DESCRIPTION OF MITSUGUMIN53
TABLE 62 DESCRIPTION OF RESEARCH PROGRAM FOR KIDNEY DISEASE
TABLE 63 DESCRIPTION OF DM 199
TABLE 64 DESCRIPTION OF AZA-LASMIDITAN
TABLE 65 DESCRIPTION OF ANG-4102
TABLE 66 DESCRIPTION OF ELAMIPRETIDE
TABLE 67 DESCRIPTION OF PYRIDOXAMINE
TABLE 68 DESCRIPTION OF VASCULOTIDE
TABLE 69 DESCRIPTION OF HEPATOCYTE GROWTH FACTOR
TABLE 70 DESCRIPTION OF MINOCIN
TABLE 71 CLINICAL TRIALS OF MINOCIN
TABLE 72 DESCRIPTION OF CXA-10
TABLE 73 CLINICAL TRIALS OF CXA-10
TABLE 74 DESCRIPTION OF PRISMOCITRATE
TABLE 75 CLINICAL TRIALS OF PRISMOCITRATE
TABLE 76 DESCRIPTION OF LEVOSIMENDAN
TABLE 77 CLINICAL TRIALS OF LEVOSIMENDAN
TABLE 78 DESCRIPTION OF GEMIGLIPTIN
TABLE 79 CLINICAL TRIALS OF GEMIGLIPTIN
TABLE 80 COLLABORATIONS AND LICENSING AGREEMENTS
TABLE 81 ACQUISITIONS
TABLE 82 ATTRIBUTE ANALYSIS
TABLE 83 EXPECTED LAUNCH TIME OF PHASE III AND PHASE II CLINICAL STAGE PRODUCTS
TABLE 84 ANGION BIOMEDICA CORP. – AT A GLANCE
TABLE 85 SENTIEN BIOTECHNOLOGIES INC. – AT A GLANCE
TABLE 86 EXPONENTIAL BIOTHERAPIES INC. – AT A GLANCE
TABLE 87 SILVER CREEK PHARMACEUTICALS INC. – AT A GLANCE
TABLE 88 DURECT CORPORATION – AT A GLANCE
TABLE 89 QUARK PHARMACEUTICALS INC. - AT A GLANCE
TABLE 90 DIAMEDICA THERAPEUTICS INC. - AT A GLANCE
TABLE 91 AM-PHARMA N.V. - AT A GLANCE
TABLE 92 THERASOURCE LLC - AT A GLANCE
TABLE 93 ASTELLAS PHARMA INC.– AT A GLANCE
TABLE 94 MARKETED PRODUCTS
TABLE 95 PIPELINE PRODUCTS
TABLE 96 ATOX BIO – AT A GLANCE
TABLE 97 RECENTLY ORGANIZED NPC SEMINARS AND CONFERENCES
TABLE 98 UPCOMING SEMINARS AND CONFERENCES
TABLE 99 SOURCES & REFERENCES
List of Figures
FIG 1 RESEARCH METHODOLOGY
FIG 2 BREAKDOWN OF PRIMARY RESEARCH RESPONDENTS, BY INDUSTRY PARTICIPANT
FIG 3 BREAKDOWN OF PRIMARY RESEARCH, BY GEOGRAPHY
FIG 4 BREAKDOWN OF PRIMARY RESEARCH, BY DESIGNATION
FIG 5 GENERAL CLASSIICATION OF AKI
FIG 6 CLINICAL DIAGNOSIS OF AKI
FIG 7 TREATMENT ALGORITHM FOR AKI
FIG 8 AKI THERAPEUTICS PIPELINE DRUGS SNAPSHOT, BY PHASE (2019)
FIG 9 AKI THERAPEUTICS PIPELINE DRUGS SNAPSHOT, BY MOLECULE TYPE (2019)
FIG 10 AKI PIPELINE DRUGS SNAPSHOT, BY ROUTE OF ADMINISTRATION (2019)
FIG 11 TOTAL NUMBER OF INCIDENT CASES OF HOSPITAL- ACQUIRED AKI IN 7MM (2016 & 2028)
FIG 12 HOSPITAL- ACQUIRED AKI INCIDENT CASES IN 7MM (2016-2028)
FIG 13 HOSPITAL-ACQUIRED AKI EPIDEMIOLOGY IN THE U.S. (2016-2028)
FIG 14 HOSPITAL-ACQUIRED AKI EPIDEMIOLOGY IN JAPAN (2016-2028)
FIG 15 HOSPITAL-ACQUIRED AKI EPIDEMIOLOGY IN EU5 (2016-2028)
FIG 16 HOSPITAL-ACQUIRED AKI EPIDEMIOLOGY IN GERMANY (2016-2028)
FIG 17 HOSPITAL-ACQUIRED AKI EPIDEMIOLOGY IN FRANCE (2016-2028)
FIG 18 HOSPITAL-ACQUIRED AKI EPIDEMIOLOGY IN ITALY (2016-2028)
FIG 19 HOSPITAL-ACQUIRED AKI EPIDEMIOLOGY IN THE U.K. (2016-2028)
FIG 20 AKI EPIDEMIOLOGY IN SPAIN (2016-2028)
FIG 21 BREAKDOWN OF CLINICAL TRIALS, BY GEOGRAPHY
FIG 22 BREAKDOWN OF CLINICAL TRIALS, BY TRIAL STATUS
FIG 23 DRUG DISCOVERY AND APPROVAL PROCESS (PRE-CLINICAL AND CLINICAL TRIALS STAGES)
FIG 24 DRUG APPROVAL PROCESS (NDA REVIEW AND POST-MARKETING STAGES)
FIG 25 NEW DRUG DEVELOPMENT AND APPROVAL PROCESS IN EU
FIG 26 MARKETING AUTHORIZATION PROCEDURES IN EU
FIG 27 CENTRALIZED PROCEDURE FOR DRUG APPROVAL
FIG 28 MUTUAL RECOGNITION PROCEDURE FOR DRUG APPROVAL
FIG 29 DECENTRALIZED PROCEDURE FOR DRUG APPROVAL
FIG 30 NEW DRUG DEVELOPMENT AND APPROVAL PROCESS IN JAPAN
FIG 31 EXPECTED LAUNCH TIMELINE