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Acute Kidney Injury (AKI) Therapeutics

Acute Kidney Injury (AKI) Therapeutics, 2019 - Pipeline Analysis, Clinical Trials and Results, Patents, Designations, Collaborations, and Other Developments

Report Code: PP10253 Published: July 2019 Pages: 193 Available format: 
Therapeutic Area(s): Nephrology Report Type: Indication Pipeline Reports
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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