Non Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH) Drug Development Pipeline Review, 2018

This report provides an overview of the non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) pipeline landscape. The report provides comprehensive information on the therapeutics under development and key players active in this space, and also features data for dormant and discontinued projects.

NAFLD and NASH represent considerable burdens for healthcare systems, particularly in developed countries where NAFLD is the most common liver disorder.

NAFLD is strongly related to insulin resistance and is therefore often treated by therapeutics originally intended for use in diabetes mellitus. Up to 80% of obese people have NAFLD, which is usually asymptomatic or mildly symptomatic.

NASH is a severe form of NAFLD. It presents as a swelled or inflamed liver and may result in cirrhosis and consequent liver failure. As populations age the incidence of NASH is likely to rise and become a major healthcare concern for western systems.

Scope

– Which companies are the most active within the pipeline for NAFLD and NASH therapeutics?

– Which pharmaceutical approaches are 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 within this field?

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

Companies mentioned

AdAlta Ltd

Akcea Therapeutics Inc

Albireo Pharma Inc

Allergan Plc

Amunix Operating Inc

Aquinox Pharmaceuticals Inc

Arcturus Therapeutics Ltd

Ardelyx Inc

Arisaph Pharmaceuticals Inc

Assembly Biosciences Inc

AstraZeneca Plc

BASF SE

Betagenon AB

Bird Rock Bio Inc

BLR Bio LLC

Boehringer Ingelheim GmbH

Bristol-Myers Squibb Co

Cadila Healthcare Ltd

Can-Fite BioPharma Ltd

Cardax Inc

Carmot Therapeutics Inc

Catabasis Pharmaceuticals Inc

Cerenis Therapeutics Holding SA

ChemoCentryx Inc

CJ HealthCare Corp

CohBar Inc

Connexios Life Sciences Pvt Ltd

ConSynance Therapeutics Inc

Corcept Therapeutics Inc

CymaBay Therapeutics Inc

Daewoong Pharmaceutical Co Ltd

Daiichi Sankyo Co Ltd

Debiopharm International SA

Dicerna Pharmaceuticals Inc

Dimerix Bioscience Pty Ltd

Dong-A Socio Holdings Co Ltd

Dr. Falk Pharma GmbH

DURECT Corp

Eli Lilly and Co

Enanta Pharmaceuticals Inc

Enyo Pharma SA

Eternygen GmbH

Evgen Pharma Plc

Exicure Inc

Forma Therapeutics Inc

Galectin Therapeutics Inc

Galecto Biotech AB

Galmed Pharmaceuticals Ltd

Gemphire Therapeutics Inc

Genfit SA

GenKyoTex SA

Gilead Sciences Inc

GlaxoSmithKline Plc

GRI Bio Inc

Guangdong Zhongsheng Pharmaceutical Co Ltd

Hanmi Pharmaceuticals Co Ltd

HemoShear Therapeutics, LLC

Huons Global Co Ltd

iCo Therapeutics Inc.

Immuron Ltd

Intercept Pharmaceuticals Inc

Inventiva

Ionis Pharmaceuticals Inc

Kissei Pharmaceutical Co Ltd

Kowa Co Ltd

Kyorin Pharmaceutical Co Ltd

Madrigal Pharmaceuticals Inc.

Matinas BioPharma Holdings Inc

MedImmune LLC

Merck & Co Inc

Metacrine Inc

Mitsubishi Tanabe Pharma Corp

Miyarisan Pharmaceutical Company Ltd

Naia Ltd

NeuroVive Pharmaceutical AB

NGM Biopharmaceuticals Inc

Nippon Chemiphar Co Ltd

Novartis AG

NovaTarg Therapeutics Inc

Novo Nordisk AS

Nuevolution AB

Ocera Therapeutics Inc

Oramed Pharmaceuticals Inc

Pfizer Inc

Pharmaxis Ltd

Phenex Pharmaceuticals AG

Promethera Biosciences SA

ProMetic Life Sciences Inc

Protalix BioTherapeutics Inc

Redx Pharma Plc

Regulus Therapeutics Inc

reMYND NV

Renova Therapeutics Inc

Ritter Pharmaceuticals Inc

Saje Pharma LLC

Sancilio & Company Inc

Sanofi

Second Genome Inc

Seres Therapeutics Inc

Shenzhen HighTide Biopharmaceutical Ltd

Shire Plc

Sprint Bioscience AB

Synlogic Inc

TaiwanJ Pharmaceuticals Co Ltd

TCM Biotech International Corp

Theratechnologies Inc

Tiziana Life Sciences Plc

TRACON Pharmaceuticals Inc

Translate Bio Inc

Vascular Biogenics Ltd

Verlyx Pharma Inc

Viking Therapeutics Inc

Zebra Discovery Ltd

Table of Contents

1 Table of Contents

1 Table of Contents 4

1.1 List of Tables 5

1.2 List of Figures 8

2 Introduction 9

2.1 Gastrointestinal Report Coverage 9

2.2 Non-Alcoholic Steatohepatitis (NASH) - Overview 9

2.3 Non Alcoholic Fatty Liver Disease (NAFLD) - Overview 9

3 Therapeutics Development 10

3.1 Non-Alcoholic Steatohepatitis (NASH) 10

3.2 Non Alcoholic Fatty Liver Disease (NAFLD) 29

4 Therapeutics Assessment 37

4.1 Non-Alcoholic Steatohepatitis (NASH) 37

4.2 Non Alcoholic Fatty Liver Disease (NAFLD) 48

5 Companies Involved in Therapeutics Development 58

5.1 Non-Alcoholic Steatohepatitis (NASH) 58

5.2 Non Alcoholic Fatty Liver Disease (NAFLD) 103

6 Dormant Projects 124

6.1 Non-Alcoholic Steatohepatitis (NASH) 124

6.2 Non Alcoholic Fatty Liver Disease (NAFLD) 127

7 Discontinued Products 129

7.1 Non-Alcoholic Steatohepatitis (NASH) 129

7.2 Non Alcoholic Fatty Liver Disease (NAFLD) 130

8 Product Development Milestones 131

8.1 Non-Alcoholic Steatohepatitis (NASH) 131

8.2 Non Alcoholic Fatty Liver Disease (NAFLD) 143

9 Appendix 158

9.1 Methodology 158

9.2 Coverage 158

9.3 Secondary Research 158

9.4 Primary Research 158

9.5 Expert Panel Validation 158

9.6 Contact Us 159

9.7 Disclaimer 159

List of Tables

1.1 List of Tables

Table 1: Number of Products under Development for Non-Alcoholic Steatohepatitis (NASH) 10

Table 2: Number of Products under Development by Companies, Non-Alcoholic Steatohepatitis (NASH) 12

Table 3: Number of Products under Development by Universities/Institutes, Non-Alcoholic Steatohepatitis (NASH) 16

Table 4: Products under Development by Companies, Non-Alcoholic Steatohepatitis (NASH) 17

Table 5: Products under Development by Universities/Institutes, Non-Alcoholic Steatohepatitis (NASH) 29

Table 6: Number of Products under Development for Non Alcoholic Fatty Liver Disease (NAFLD) 30

Table 7: Number of Products under Development by Companies, Non Alcoholic Fatty Liver Disease (NAFLD). 31

Table 8: Number of Products under Development by Universities/Institutes, Non Alcoholic Fatty Liver Disease (NAFLD). 33

Table 9: Products under Development by Companies, Non Alcoholic Fatty Liver Disease (NAFLD). 33

Table 10: Products under Development by Universities/Institutes, Non Alcoholic Fatty Liver Disease (NAFLD). 36

Table 11: Number of Products by Stage and Target, Non-Alcoholic Steatohepatitis (NASH) 38

Table 12: Number of Products by Stage and Mechanism of Action, Non-Alcoholic Steatohepatitis (NASH) 42

Table 13: Number of Products by Stage and Route of Administration, Non-Alcoholic Steatohepatitis (NASH) 46

Table 14: Number of Products by Stage and Molecule Type, Non-Alcoholic Steatohepatitis (NASH) 48

Table 15: Number of Products by Stage and Target, Non Alcoholic Fatty Liver Disease (NAFLD) 50

Table 16: Number of Products by Stage and Mechanism of Action, Non Alcoholic Fatty Liver Disease (NAFLD) 53

Table 17: Number of Products by Stage and Route of Administration, Non Alcoholic Fatty Liver Disease (NAFLD) 56

Table 18: Number of Products by Stage and Molecule Type, Non Alcoholic Fatty Liver Disease (NAFLD) 57

Table 19: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by AdAlta Ltd 58

Table 20: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Albireo Pharma Inc 58

Table 21: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Allergan Plc 59

Table 22: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Amunix Operating Inc 59

Table 23: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Aquinox Pharmaceuticals Inc 60

Table 24: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Arcturus Therapeutics Ltd 60

Table 25: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Ardelyx Inc 61

Table 26: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Arisaph Pharmaceuticals Inc 61

Table 27: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Assembly Biosciences Inc 61

Table 28: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by AstraZeneca Plc 62

Table 29: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by BASF SE 63

Table 30: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Betagenon AB 63

Table 31: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Bird Rock Bio Inc 63

Table 32: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by BLR Bio LLC 64

Table 33: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Boehringer Ingelheim GmbH 64

Table 34: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Bristol-Myers Squibb Co 65

Table 35: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Cadila Healthcare Ltd 65

Table 36: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Can-Fite BioPharma Ltd 66

Table 37: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Cardax Inc 66

Table 38: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Carmot Therapeutics Inc 67

Table 39: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Catabasis Pharmaceuticals Inc 67

Table 40: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Cerenis Therapeutics Holding SA 68

Table 41: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by ChemoCentryx Inc 68

Table 42: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by CohBar Inc 69

Table 43: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Connexios Life Sciences Pvt Ltd 69

Table 44: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by ConSynance Therapeutics Inc 69

Table 45: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by CymaBay Therapeutics Inc 70

Table 46: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Daiichi Sankyo Co Ltd 70

Table 47: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Debiopharm International SA 71

Table 48: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Dicerna Pharmaceuticals Inc 71

Table 49: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Dimerix Bioscience Pty Ltd 72

Table 50: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Dong-A Socio Holdings Co Ltd 72

Table 51: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by DURECT Corp 73

Table 52: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Eli Lilly and Co 73

Table 53: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Enanta Pharmaceuticals Inc 74

Table 54: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Enyo Pharma SA 74

Table 55: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Exicure Inc 75

Table 56: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Forma Therapeutics Inc 75

Table 57: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Galectin Therapeutics Inc 75

Table 58: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Galecto Biotech AB 76

Table 59: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Galmed Pharmaceuticals Ltd 76

Table 60: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Gemphire Therapeutics Inc 77

Table 61: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Genfit SA 77

Table 62: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by GenKyoTex SA 78

Table 63: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Gilead Sciences Inc 78

Table 64: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by GlaxoSmithKline Plc 79

Table 65: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by GRI Bio Inc 79

Table 66: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Guangdong Zhongsheng Pharmaceutical Co Ltd 79

Table 67: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Hanmi Pharmaceuticals Co Ltd 80

Table 68: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by HemoShear Therapeutics, LLC 80

Table 69: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by iCo Therapeutics Inc. 81

Table 70: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Immuron Ltd 81

Table 71: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Intercept Pharmaceuticals Inc 82

Table 72: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Inventiva 82

Table 73: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Ionis Pharmaceuticals Inc 83

Table 74: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Kissei Pharmaceutical Co Ltd 83

Table 75: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Kyorin Pharmaceutical Co Ltd 84

Table 76: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Madrigal Pharmaceuticals Inc. 84

Table 77: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Matinas BioPharma Holdings Inc 84

Table 78: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by MedImmune LLC 85

Table 79: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Merck & Co Inc 85

Table 80: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Metacrine Inc 86

Table 81: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Mitsubishi Tanabe Pharma Corp 86

Table 82: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Naia Ltd 87

Table 83: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by NeuroVive Pharmaceutical AB 87

Table 84: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by NGM Biopharmaceuticals Inc 88

Table 85: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Nippon Chemiphar Co Ltd 88

Table 86: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Novartis AG 89

Table 87: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by NovaTarg Therapeutics Inc 89

Table 88: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Novo Nordisk AS 90

Table 89: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Nuevolution AB 90

Table 90: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Ocera Therapeutics Inc 90

Table 91: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Oramed Pharmaceuticals Inc 91

Table 92: Non-Alcoholic Steatohepatitis (NASH) – Pipeline by Pfizer Inc 92

List of Figures

1.2 List of Figures

Figure 1: Number of Products under Development for Non-Alcoholic Steatohepatitis (NASH) 10

Figure 2: Number of Products under Development by Companies, Non-Alcoholic Steatohepatitis (NASH) 11

Figure 3: Number of Products under Development by Universities/Institutes, Non-Alcoholic Steatohepatitis (NASH) 16

Figure 4: Number of Products under Development for Non Alcoholic Fatty Liver Disease (NAFLD) 29

Figure 5: Number of Products under Development by Companies, Non Alcoholic Fatty Liver Disease (NAFLD). 30

Figure 6: Number of Products by Top 10 Targets, Non-Alcoholic Steatohepatitis (NASH) 37

Figure 7: Number of Products by Stage and Top 10 Targets, Non-Alcoholic Steatohepatitis (NASH) 37

Figure 8: Number of Products by Top 10 Mechanism of Actions, Non-Alcoholic Steatohepatitis (NASH) 41

Figure 9: Number of Products by Stage and Top 10 Mechanism of Actions, Non-Alcoholic Steatohepatitis (NASH) 41

Figure 10: Number of Products by Routes of Administration, Non-Alcoholic Steatohepatitis (NASH) 45

Figure 11: Number of Products by Stage and Routes of Administration, Non-Alcoholic Steatohepatitis (NASH) 46

Figure 12: Number of Products by Top 10 Molecule Types, Non-Alcoholic Steatohepatitis (NASH) 47

Figure 13: Number of Products by Stage and Top 10 Molecule Types, Non-Alcoholic Steatohepatitis (NASH) 47

Figure 14: Number of Products by Top 10 Targets, Non Alcoholic Fatty Liver Disease (NAFLD) 48

Figure 15: Number of Products by Stage and Top 10 Targets, Non Alcoholic Fatty Liver Disease (NAFLD) 49

Figure 16: Number of Products by Top 10 Mechanism of Actions, Non Alcoholic Fatty Liver Disease (NAFLD) 51

Figure 17: Number of Products by Stage and Top 10 Mechanism of Actions, Non Alcoholic Fatty Liver Disease (NAFLD) 52

Figure 18: Number of Products by Routes of Administration, Non Alcoholic Fatty Liver Disease (NAFLD) 55

Figure 19: Number of Products by Stage and Routes of Administration, Non Alcoholic Fatty Liver Disease (NAFLD) 55

Figure 20: Number of Products by Top 10 Molecule Types, Non Alcoholic Fatty Liver Disease (NAFLD) 56

Figure 21: Number of Products by Stage and Top 10 Molecule Types, Non Alcoholic Fatty Liver Disease (NAFLD) 57

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