Renal Cluster Drug Development Pipeline Review, 2017

This report provides an overview of the renal cluster pipeline landscape. The report provides comprehensive information on the therapeutics under development and key players involved in therapeutic development for Kidney Fibrosis, Chronic Kidney Disease (Chronic Renal Failure), Acute Renal Failure (ARF), Kidney Transplant Rejection, and also features dormant and discontinued projects.

Accumulation of extracellular matrix in the kidney causes kidney fibrosis. It is a progressive disorder characterized by glomerulosclerosis and tubulointerstitial fibrosis and may lead to detrimental effects on the kidney functioning. Chronic kidney disease is the slow loss of kidney function over time. Signs and symptoms of kidney disease include nausea, vomiting, loss of appetite, fatigue and weakness, sleep problems, hiccups and swelling of feet and ankles.

Acute kidney failure occurs when kidneys suddenly become unable to filter waste products from blood. Symptoms include drowsiness, shortness of breath, fatigue, seizures or coma in severe cases and chest pain. Finally, kidney transplantation is a therapy performed to replace a diseased kidney with a healthy kidney from another person. Due to differences between the two patients, an autoimmune reaction against the donor kidney may occur in the recipient.

The size of these pipelines ranges from 59 in chronic kidney disease to 36 in acute kidney failure, and 39 in the final two. While kidney transplant rejection treatments are largely focused on immune system molecular targets such as tumor necrosis factor alpha and complement factors, a range of cellular signaling components are being pursued in the other three key indications, including the activin receptors, cyclin dependent kinases, and growth factor receptors.

Scope

– Which companies are the most active within the pipeline for renal cluster therapeutics?

– Which pharmaceutical approaches are the most prominent at each stage of the pipeline and within each indication?

– To what extent do universities and institutions play a role within this pipeline, compared to pharmaceutical companies?

– What are the most important R&D milestones and data publications to have happened in the field of renal cluster therapeutics?

Reasons to buy

- Understand the overall pipeline, with an at-a-glance overview of all products in therapeutic development for each indication

- Assess the products in development in granular detail, with an up-to-date overview of each individual pipeline program in each indication, and a comprehensive picture of recent updates and milestones for each

- Analyze the companies, institutions and universities currently operating in the pipeline, and the products being fielded by each of these

- Understand the composition of the pipeline in terms of molecule type, molecular target, mechanism of action and route of administration

Table of Contents

Table of Contents

GBI Research Report Guidance 2

Executive Summary 3

Table of Contents 4

List of Tables 6

List of Figures 10

Introduction 11

GBI Research Report Coverage 11

Kidney Fibrosis – Overview 11

Chronic Kidney Disease (Chronic Renal Failure) – Overview 11

Acute Renal Failure (ARF) (Acute Kidney Injury) – Overview 11

Kidney Transplant Rejection – Overview 11

Therapeutics Development 12

Kidney Fibrosis 12

Chronic Kidney Disease (Chronic Renal Failure) 18

Acute Renal Failure (ARF) (Acute Kidney Injury) 27

Kidney Transplant Rejection 34

Therapeutics Assessment 41

Kidney Fibrosis 41

Chronic Kidney Disease (Chronic Renal Failure) 51

Acute Renal Failure (ARF) (Acute Kidney Injury) 61

Kidney Transplant Rejection 69

Companies Involved in Therapeutics Development 77

Kidney Fibrosis 77

Chronic Kidney Disease (Chronic Renal Failure) 87

Acute Renal Failure (ARF) (Acute Kidney Injury) 106

Kidney Transplant Rejection 120

Dormant Projects 132

Kidney Fibrosis 132

Chronic Kidney Disease (Chronic Renal Failure) 133

Acute Renal Failure (ARF) (Acute Kidney Injury) 135

Kidney Transplant Rejection 136

Discontinued Products 138

Chronic Kidney Disease (Chronic Renal Failure) 138

Acute Renal Failure (ARF) (Acute Kidney Injury) 139

Kidney Transplant Rejection 139

Product Development Milestones 140

Kidney Fibrosis 140

Chronic Kidney Disease (Chronic Renal Failure) 148

Acute Renal Failure (ARF) (Acute Kidney Injury) 161

Kidney Transplant Rejection 170

Appendix 180

Methodology 180

Coverage 180

Secondary Research 180

Primary Research 180

Expert Panel Validation 180

Contact Us 181

Disclaimer 181

List of Tables

List of Tables

Number of Products under Development for Kidney Fibrosis 12

Number of Products under Development by Companies, Kidney Fibrosis 14

Number of Products under Development by Universities/Institutes, Kidney Fibrosis 15

Products under Development by Companies, Kidney Fibrosis 16

Products under Development by Universities/Institutes, Kidney Fibrosis 17

Number of Products under Development for Chronic Kidney Disease (Chronic Renal Failure) 18

Number of Products under Development by Companies, Chronic Kidney Disease (Chronic Renal Failure) 20

Number of Products under Development by Universities/Institutes, Chronic Kidney Disease (Chronic Renal Failure) 22

Products under Development by Companies, Chronic Kidney Disease (Chronic Renal Failure) 23

Products under Development by Universities/Institutes, Chronic Kidney Disease (Chronic Renal Failure) 26

Number of Products under Development for Acute Renal Failure (ARF) (Acute Kidney Injury) 27

Number of Products under Development by Companies, Acute Renal Failure (ARF) (Acute Kidney Injury) 29

Number of Products under Development by Universities/Institutes, Acute Renal Failure (ARF) (Acute Kidney Injury) 30

Products under Development by Companies, Acute Renal Failure (ARF) (Acute Kidney Injury) 31

Products under Development by Universities/Institutes, Acute Renal Failure (ARF) (Acute Kidney Injury) 33

Number of Products under Development for Kidney Transplant Rejection 34

Number of Products under Development by Companies, Kidney Transplant Rejection 36

Number of Products under Development by Universities/Institutes, Kidney Transplant Rejection 37

Products under Development by Companies, Kidney Transplant Rejection 38

Products under Development by Universities/Institutes, Kidney Transplant Rejection 40

Number of Products by Stage and Target, Kidney Fibrosis 42

Number of Products by Stage and Mechanism of Action, Kidney Fibrosis 45

Number of Products by Stage and Route of Administration, Kidney Fibrosis 48

Number of Products by Stage and Molecule Type, Kidney Fibrosis 50

Number of Products by Stage and Target, Chronic Kidney Disease (Chronic Renal Failure) 52

Number of Products by Stage and Mechanism of Action, Chronic Kidney Disease (Chronic Renal Failure) 55

Number of Products by Stage and Route of Administration, Chronic Kidney Disease (Chronic Renal Failure) 58

Number of Products by Stage and Molecule Type, Chronic Kidney Disease (Chronic Renal Failure) 60

Number of Products by Stage and Target, Acute Renal Failure (ARF) (Acute Kidney Injury) 62

Number of Products by Stage and Mechanism of Action, Acute Renal Failure (ARF) (Acute Kidney Injury) 64

Number of Products by Stage and Route of Administration, Acute Renal Failure (ARF) (Acute Kidney Injury) 66

Number of Products by Stage and Molecule Type, Acute Renal Failure (ARF) (Acute Kidney Injury) 68

Number of Products by Stage and Target, Kidney Transplant Rejection 70

Number of Products by Stage and Mechanism of Action, Kidney Transplant Rejection 72

Number of Products by Stage and Route of Administration, Kidney Transplant Rejection 74

Number of Products by Stage and Molecule Type, Kidney Transplant Rejection 76

Kidney Fibrosis – Pipeline by AbbVie Inc 77

Kidney Fibrosis – Pipeline by Allergan Plc 77

Kidney Fibrosis – Pipeline by Angion Biomedica Corp 78

Kidney Fibrosis – Pipeline by Apollo Endosurgery Inc 78

Kidney Fibrosis – Pipeline by BiOrion Technologies BV 79

Kidney Fibrosis – Pipeline by Cellmid Ltd 79

Kidney Fibrosis – Pipeline by Epigen Biosciences Inc 80

Kidney Fibrosis – Pipeline by Evotec AG 80

Kidney Fibrosis – Pipeline by Galectin Therapeutics Inc 81

Kidney Fibrosis – Pipeline by GenKyoTex SA 81

Kidney Fibrosis – Pipeline by Horizon Pharma Plc 82

Kidney Fibrosis – Pipeline by Intercept Pharmaceuticals Inc 82

Kidney Fibrosis – Pipeline by Isarna Therapeutics GmbH 83

Kidney Fibrosis – Pipeline by MorphoSys AG 83

Kidney Fibrosis – Pipeline by Pharmaxis Ltd 84

Kidney Fibrosis – Pipeline by ProMetic Life Sciences Inc 84

Kidney Fibrosis – Pipeline by Regulus Therapeutics Inc 85

Kidney Fibrosis – Pipeline by Sirnaomics Inc 85

Kidney Fibrosis – Pipeline by Symic Biomedical Inc 86

Kidney Fibrosis – Pipeline by Vascular Biogenics Ltd 86

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Angion Biomedica Corp 87

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by apceth Biopharma GmbH 87

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Astellas Pharma Inc 88

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by AstraZeneca Plc 88

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Bayer AG 89

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by BLR Bio LLC 89

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Boehringer Ingelheim GmbH 90

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Boryung Pharmaceutical Co Ltd 90

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Cellmid Ltd 91

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Chugai Pharmaceutical Co Ltd 91

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Complexa Inc 92

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Corvidia Corp 92

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by CTI BioPharma Corp 93

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Evotec AG 93

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by F. Hoffmann-La Roche Ltd 94

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Gilead Sciences Inc 94

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by GNI Group Ltd 95

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Lupin Ltd 95

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Navya Biologicals Pvt Ltd 96

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Nippon Zoki Pharmaceutical Co Ltd 96

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Novartis AG 97

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Otsuka Holdings Co Ltd 97

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Prismic Pharmaceuticals Inc 98

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Prolong Pharmaceuticals LLC 98

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by ProMetic Life Sciences Inc 99

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Reata Pharmaceuticals Inc 99

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Regulus Therapeutics Inc 100

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Relypsa Inc 100

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Resverlogix Corp 101

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Spotlight Innovation Inc 101

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Taisho Pharmaceutical Co Ltd 102

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Toray Industries Inc 102

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Tricida Inc 103

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Unity Biotechnology Inc 103

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Vascular BioSciences 104

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by VESSL Therapeutics Ltd 104

Chronic Kidney Disease (Chronic Renal Failure) – Pipeline by Vicore Pharma AB 105

Acute Renal Failure (ARF) (Acute Kidney Injury) – Pipeline by A1M Pharma AB 106

Acute Renal Failure (ARF) (Acute Kidney Injury) – Pipeline by Alloksys Life Sciences BV 106

Acute Renal Failure (ARF) (Acute Kidney Injury) – Pipeline by Am-Pharma BV 107

Acute Renal Failure (ARF) (Acute Kidney Injury) – Pipeline by Angion Biomedica Corp 107

Acute Renal Failure (ARF) (Acute Kidney Injury) – Pipeline by Atox Bio Ltd 108

Acute Renal Failure (ARF) (Acute Kidney Injury) – Pipeline by Cellmid Ltd 108

Acute Renal Failure (ARF) (Acute Kidney Injury) – Pipeline by Complexa Inc 109

Acute Renal Failure (ARF) (Acute Kidney Injury) – Pipeline by DiaMedica Therapeutics Inc 109

Acute Renal Failure (ARF) (Acute Kidney Injury) – Pipeline by DURECT Corp 110

Acute Renal Failure (ARF) (Acute Kidney Injury) – Pipeline by Evotec AG 110

Acute Renal Failure (ARF) (Acute Kidney Injury) – Pipeline by Exponential Biotherapies Inc 111

Acute Renal Failure (ARF) (Acute Kidney Injury) – Pipeline by F. Hoffmann-La Roche Ltd 111

Acute Renal Failure (ARF) (Acute Kidney Injury) – Pipeline by G1 Therapeutics Inc 112

Acute Renal Failure (ARF) (Acute Kidney Injury) – Pipeline by Kringle Pharma Inc 112

Acute Renal Failure (ARF) (Acute Kidney Injury) – Pipeline by Mitotech SA 113

Acute Renal Failure (ARF) (Acute Kidney Injury) – Pipeline by NephroGenex Inc 113

Acute Renal Failure (ARF) (Acute Kidney Injury) – Pipeline by NeuroVive Pharmaceutical AB 114

Acute Renal Failure (ARF) (Acute Kidney Injury) – Pipeline by Nyken BV 114

Acute Renal Failure (ARF) (Acute Kidney Injury) – Pipeline by ProMetic Life Sciences Inc 115

Acute Renal Failure (ARF) (Acute Kidney Injury) – Pipeline by Quark Pharmaceuticals Inc 115

Acute Renal Failure (ARF) (Acute Kidney Injury) – Pipeline by Rediscovery Life Sciences 115

Acute Renal Failure (ARF) (Acute Kidney Injury) – Pipeline by Regulus Therapeutics Inc 116

Acute Renal Failure (ARF) (Acute Kidney Injury) – Pipeline by SBI Pharmaceuticals Co Ltd 116

Acute Renal Failure (ARF) (Acute Kidney Injury) – Pipeline by Spherium Biomed SL 117

Acute Renal Failure (ARF) (Acute Kidney Injury) – Pipeline by STATegics Inc 117

Acute Renal Failure (ARF) (Acute Kidney Injury) – Pipeline by Stealth BioTherapeutics Inc 118

Acute Renal Failure (ARF) (Acute Kidney Injury) – Pipeline by Thrasos Therapeutics Inc 118

Acute Renal Failure (ARF) (Acute Kidney Injury) – Pipeline by Torrent Pharmaceuticals Ltd 119

Acute Renal Failure (ARF) (Acute Kidney Injury) – Pipeline by Xigen SA 119

Kidney Transplant Rejection – Pipeline by Amgen Inc 120

Kidney Transplant Rejection – Pipeline by Angion Biomedica Corp 120

Kidney Transplant Rejection – Pipeline by Apellis Pharmaceuticals Inc 121

Kidney Transplant Rejection – Pipeline by Astellas Pharma Inc 121

Kidney Transplant Rejection – Pipeline by Biogen Inc 122

Kidney Transplant Rejection – Pipeline by Catalyst Biosciences Inc 122

Kidney Transplant Rejection – Pipeline by Corline Biomedical AB 123

Kidney Transplant Rejection – Pipeline by CSL Ltd 123

Kidney Transplant Rejection – Pipeline by GlaxoSmithKline Plc 124

Kidney Transplant Rejection – Pipeline by Grifols SA 124

Kidney Transplant Rejection – Pipeline by Hansa Medical AB 125

Kidney Transplant Rejection – Pipeline by Kyowa Hakko Kirin Co Ltd 125

Kidney Transplant Rejection – Pipeline by Magnus Life Ltd 126

Kidney Transplant Rejection – Pipeline by Noorik Biopharmaceuticals AG 126

Kidney Transplant Rejection – Pipeline by Novartis AG 127

Kidney Transplant Rejection – Pipeline by Opsona Therapeutics Ltd 127

Kidney Transplant Rejection – Pipeline by OSE Immunotherapeutics 128

Kidney Transplant Rejection – Pipeline by Pharmicell Co Ltd 128

Kidney Transplant Rejection – Pipeline by Pharming Group NV 129

Kidney Transplant Rejection – Pipeline by Prolong Pharmaceuticals LLC 129

Kidney Transplant Rejection – Pipeline by Quark Pharmaceuticals Inc 130

Kidney Transplant Rejection – Pipeline by Shire Plc 130

Kidney Transplant Rejection – Pipeline by Tiziana Life Sciences Plc 131

Kidney Fibrosis – Dormant Projects 132

Chronic Kidney Disease (Chronic Renal Failure) – Dormant Projects 133

Acute Renal Failure (ARF) (Acute Kidney Injury) – Dormant Projects 135

Kidney Transplant Rejection – Dormant Projects 136

Chronic Kidney Disease (Chronic Renal Failure) – Discontinued Products 138

Acute Renal Failure (ARF) (Acute Kidney Injury) – Discontinued Products 139

Kidney Transplant Rejection – Discontinued Products 139

List of Figures

List of Figures

Number of Products under Development for Kidney Fibrosis 12

Number of Products under Development by Companies, Kidney Fibrosis 13

Number of Products under Development for Chronic Kidney Disease (Chronic Renal Failure) 18

Number of Products under Development by Companies, Chronic Kidney Disease (Chronic Renal Failure) 19

Number of Products under Development by Universities/Institutes, Chronic Kidney Disease (Chronic Renal Failure) 22

Number of Products under Development for Acute Renal Failure (ARF) (Acute Kidney Injury) 27

Number of Products under Development by Companies, Acute Renal Failure (ARF) (Acute Kidney Injury) 28

Number of Products under Development for Kidney Transplant Rejection 34

Number of Products under Development by Companies, Kidney Transplant Rejection 35

Number of Products under Development by Universities/Institutes, Kidney Transplant Rejection 37

Number of Products by Top 10 Targets, Kidney Fibrosis 41

Number of Products by Stage and Top 10 Targets, Kidney Fibrosis 41

Number of Products by Top 10 Mechanism of Actions, Kidney Fibrosis 44

Number of Products by Stage and Top 10 Mechanism of Actions, Kidney Fibrosis 44

Number of Products by Routes of Administration, Kidney Fibrosis 47

Number of Products by Stage and Routes of Administration, Kidney Fibrosis 47

Number of Products by Molecule Types, Kidney Fibrosis 49

Number of Products by Stage and Molecule Types, Kidney Fibrosis 49

Number of Products by Top 10 Targets, Chronic Kidney Disease (Chronic Renal Failure) 51

Number of Products by Stage and Top 10 Targets, Chronic Kidney Disease (Chronic Renal Failure) 51

Number of Products by Top 10 Mechanism of Actions, Chronic Kidney Disease (Chronic Renal Failure) 54

Number of Products by Stage and Top 10 Mechanism of Actions, Chronic Kidney Disease (Chronic Renal Failure) 54

Number of Products by Top 10 Routes of Administration, Chronic Kidney Disease (Chronic Renal Failure) 57

Number of Products by Stage and Top 10 Routes of Administration, Chronic Kidney Disease (Chronic Renal Failure) 57

Number of Products by Top 10 Molecule Types, Chronic Kidney Disease (Chronic Renal Failure) 59

Number of Products by Stage and Top 10 Molecule Types, Chronic Kidney Disease (Chronic Renal Failure) 59

Number of Products by Top 10 Targets, Acute Renal Failure (ARF) (Acute Kidney Injury) 61

Number of Products by Stage and Top 10 Targets, Acute Renal Failure (ARF) (Acute Kidney Injury) 61

Number of Products by Top 10 Mechanism of Actions, Acute Renal Failure (ARF) (Acute Kidney Injury) 63

Number of Products by Stage and Top 10 Mechanism of Actions, Acute Renal Failure (ARF) (Acute Kidney Injury) 63

Number of Products by Routes of Administration, Acute Renal Failure (ARF) (Acute Kidney Injury) 65

Number of Products by Stage and Routes of Administration, Acute Renal Failure (ARF) (Acute Kidney Injury) 65

Number of Products by Molecule Types, Acute Renal Failure (ARF) (Acute Kidney Injury) 67

Number of Products by Stage and Molecule Types, Acute Renal Failure (ARF) (Acute Kidney Injury) 67

Number of Products by Top 10 Targets, Kidney Transplant Rejection 69

Number of Products by Stage and Top 10 Targets, Kidney Transplant Rejection 69

Number of Products by Top 10 Mechanism of Actions, Kidney Transplant Rejection 71

Number of Products by Stage and Top 10 Mechanism of Actions, Kidney Transplant Rejection 71

Number of Products by Routes of Administration, Kidney Transplant Rejection 73

Number of Products by Stage and Routes of Administration, Kidney Transplant Rejection 73

Number of Products by Top 10 Molecule Types, Kidney Transplant Rejection 75

Number of Products by Stage and Top 10 Molecule Types, Kidney Transplant Rejection 75

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