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

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Date: 22-Mar-2018
No. of pages: 159

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

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

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

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

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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