Diarrhea and Constipation Drug Development Pipeline Review, 2018

This report provides an overview of the pipeline landscape for diarrhea and constipation. It provides comprehensive information on the therapeutics under development and key players involved in therapeutic development for diarrhea and constipation, and features dormant and discontinued products.

Diarrhea is a contagious gastrointestinal infection occurring mostly due to unhygienic conditions. Diarrhea may be related to a viral or bacterial infection and is sometimes the result of food poisoning. Symptoms include nausea, abdominal pain, cramping, bloating, dehydration, fever, bloody stools, frequent urge to evacuate the bowels and incontinence. There are 54 products in development for this indication and molecular targets present in the pipeline landscape include cystic fibrosis transmembrane conductance regulator and glucagon like peptide 2 receptor.

Constipation refers to the infrequent or difficult passing of stool. Constipation occurs when bowel movements become difficult or less frequent. Symptoms of constipation include swollen abdomen or abdominal pain, pain and vomiting.

The predisposing factors include eating disorders, irritable bowel syndrome, and hypothyroidism, overuse of laxatives (stool softeners) which, over time, weaken the bowel muscles, stress, inadequate water intake and inadequate fiber in the diet. There are 25 products in development for this indication and molecular targets present in the pipeline landscape include 5-hydroxytryptamine receptor 4 and heat stable enterotoxin receptor.

Companies operating in this pipeline space include Synthetic Biologics, Allergan and Ardelyx.

Scope

– Which companies are the most active within each pipeline?

– 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 this disease area?

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

Aegis Therapeutics LLC

Akthelia Pharmaceuticals Ltd

Albireo Pharma Inc

Allergan Plc

Ardelyx Inc

AzurRx BioPharma Inc

Bharat Biotech Ltd

Braintree Laboratories Inc

Chongqing Zhifei Biological Products Co Ltd

Cosmo Pharmaceuticals NV

Diarrhea

DiscoveryBiomed Inc

Dong-A ST Co Ltd

EA Pharma Co Ltd

Ferring International Center SA

GP Pharm SA

Ironwood Pharmaceuticals Inc

Johnson & Johnson

Kuhnil Pharmaceutical Co Ltd

MallInckrodt Plc

Metacrine Inc

Miyarisan Pharmaceutical Company Ltd

Napo Pharmaceuticals Inc

NGM Biopharmaceuticals Inc

Nippon Shinyaku Co Ltd

Novartis AG

Pfizer Inc

Prokarium Ltd

Protagonist Therapeutics Inc

RaQualia Pharma Inc

RedHill Biopharma Ltd

RxBio Inc

Sanwa Kagaku Kenkyusho Co Ltd

Scandinavian Biopharma Holding AB

SK Biopharmaceuticals Co Ltd

Sublimity Therapeutics Ltd

Sumitomo Dainippon Pharma Co Ltd

Summit Therapeutics Plc

Synthetic Biologics Inc

Syntiron LLC

Tasly Pharmaceutical Group Co Ltd

Vanda Pharmaceuticals Inc

Wuhan Institute of Biological Products Co Ltd

Yuhan Corp

Zealand Pharma AS

Zensun (Shanghai) Sci & Tech Co Ltd

Table of Contents

1 Table of Contents

1 Table of Contents 4

1.1 List of Tables 5

1.2 List of Figures 6

2 Introduction 7

2.1 Diarrhea and Constipation Report Coverage 7

2.2 Constipation - Overview 7

2.3 Diarrhea - Overview 7

3 Therapeutics Development 8

3.1 Constipation 8

3.2 Diarrhea 13

4 Therapeutics Assessment 20

4.1 Constipation 20

4.2 Diarrhea 26

5 Companies Involved in Therapeutics Development 33

5.1 Constipation 33

5.2 Diarrhea 41

6 Dormant Projects 57

6.1 Constipation 57

6.2 Diarrhea 58

7 Discontinued Products 61

7.1 Constipation 61

7.2 Diarrhea 61

8 Product Development Milestones 62

8.1 Constipation 62

8.2 Diarrhea 78

9 Appendix 92

9.1 Methodology 92

9.2 Coverage 92

9.3 Secondary Research 92

9.4 Primary Research 92

9.5 Expert Panel Validation 92

9.6 Contact Us 93

9.7 Disclaimer 93

List of Tables

1.1 List of Tables

Table 1: Number of Products under Development for Constipation 8

Table 2: Number of Products under Development by Companies, Constipation 10

Table 3: Number of Products under Development by Universities/Institutes, Constipation 11

Table 4: Products under Development by Companies, Constipation 12

Table 5: Products under Development by Universities/Institutes, Constipation 13

Table 6: Number of Products under Development for Diarrhea 13

Table 7: Number of Products under Development by Companies, Diarrhea 14

Table 8: Number of Products under Development by Universities/Institutes, Diarrhea 16

Table 9: Products under Development by Companies, Diarrhea 17

Table 10: Products under Development by Universities/Institutes, Diarrhea 19

Table 11: Number of Products by Stage and Target, Constipation 21

Table 12: Number of Products by Stage and Mechanism of Action, Constipation 22

Table 13: Number of Products by Stage and Route of Administration, Constipation 24

Table 14: Number of Products by Stage and Molecule Type, Constipation 25

Table 15: Number of Products by Stage and Target, Diarrhea 27

Table 16: Number of Products by Stage and Mechanism of Action, Diarrhea 29

Table 17: Number of Products by Stage and Route of Administration, Diarrhea 31

Table 18: Number of Products by Stage and Molecule Type, Diarrhea 32

Table 19: Constipation – Pipeline by Allergan Plc 33

Table 20: Constipation – Pipeline by Ardelyx Inc 33

Table 21: Constipation – Pipeline by Braintree Laboratories Inc 34

Table 22: Constipation – Pipeline by Dong-A ST Co Ltd 34

Table 23: Constipation – Pipeline by EA Pharma Co Ltd 35

Table 24: Constipation – Pipeline by Ironwood Pharmaceuticals Inc 35

Table 25: Constipation – Pipeline by Johnson & Johnson 36

Table 26: Constipation – Pipeline by MallInckrodt Plc 37

Table 27: Constipation – Pipeline by NGM Biopharmaceuticals Inc 37

Table 28: Constipation – Pipeline by RaQualia Pharma Inc 38

Table 29: Constipation – Pipeline by Sanwa Kagaku Kenkyusho Co Ltd 38

Table 30: Constipation – Pipeline by SK Biopharmaceuticals Co Ltd 38

Table 31: Constipation – Pipeline by Sumitomo Dainippon Pharma Co Ltd 39

Table 32: Constipation – Pipeline by Synthetic Biologics Inc 39

Table 33: Constipation – Pipeline by Vanda Pharmaceuticals Inc 40

Table 34: Constipation – Pipeline by Yuhan Corp 40

Table 35: Constipation – Pipeline by Zensun (Shanghai) Sci & Tech Co Ltd 41

Table 36: Diarrhea – Pipeline by Aegis Therapeutics LLC 41

Table 37: Diarrhea – Pipeline by Akthelia Pharmaceuticals Ltd 42

Table 38: Diarrhea – Pipeline by Albireo Pharma Inc 42

Table 39: Diarrhea – Pipeline by Allergan Plc 43

Table 40: Diarrhea – Pipeline by Ardelyx Inc 43

Table 41: Diarrhea – Pipeline by AzurRx BioPharma Inc 43

Table 42: Diarrhea – Pipeline by Bharat Biotech Ltd 44

Table 43: Diarrhea – Pipeline by Chongqing Zhifei Biological Products Co Ltd 44

Table 44: Diarrhea – Pipeline by Cosmo Pharmaceuticals NV 45

Table 45: Diarrhea – Pipeline by DiscoveryBiomed Inc 45

Table 46: Diarrhea – Pipeline by Ferring International Center SA 46

Table 47: Diarrhea – Pipeline by GP Pharm SA 46

Table 48: Diarrhea – Pipeline by Kuhnil Pharmaceutical Co Ltd 47

Table 49: Diarrhea – Pipeline by Metacrine Inc 47

Table 50: Diarrhea – Pipeline by Miyarisan Pharmaceutical Company Ltd 48

Table 51: Diarrhea – Pipeline by Napo Pharmaceuticals Inc 48

Table 52: Diarrhea – Pipeline by Nippon Shinyaku Co Ltd 49

Table 53: Diarrhea – Pipeline by Novartis AG 49

Table 54: Diarrhea – Pipeline by Pfizer Inc 50

Table 55: Diarrhea – Pipeline by Prokarium Ltd 50

Table 56: Diarrhea – Pipeline by Protagonist Therapeutics Inc 51

Table 57: Diarrhea – Pipeline by RaQualia Pharma Inc 51

Table 58: Diarrhea – Pipeline by RedHill Biopharma Ltd 52

Table 59: Diarrhea – Pipeline by RxBio Inc 52

Table 60: Diarrhea – Pipeline by Scandinavian Biopharma Holding AB 53

List of Figures

1.2 List of Figures

Figure 1: Number of Products under Development for Constipation 8

Figure 2: Number of Products under Development by Companies, Constipation 9

Figure 3: Number of Products under Development for Diarrhea 13

Figure 4: Number of Products under Development by Companies, Diarrhea 14

Figure 5: Number of Products under Development by Universities/Institutes, Diarrhea 16

Figure 6: Number of Products by Targets, Constipation 20

Figure 7: Number of Products by Stage and Targets, Constipation 20

Figure 8: Number of Products by Top 10 Mechanism of Actions, Constipation 21

Figure 9: Number of Products by Stage and Top 10 Mechanism of Actions, Constipation 22

Figure 10: Number of Products by Routes of Administration, Constipation 23

Figure 11: Number of Products by Stage and Routes of Administration, Constipation 23

Figure 12: Number of Products by Molecule Types, Constipation 24

Figure 13: Number of Products by Stage and Molecule Types, Constipation 25

Figure 14: Number of Products by Top 10 Targets, Diarrhea 26

Figure 15: Number of Products by Stage and Top 10 Targets, Diarrhea 26

Figure 16: Number of Products by Top 10 Mechanism of Actions, Diarrhea 28

Figure 17: Number of Products by Stage and Top 10 Mechanism of Actions, Diarrhea 28

Figure 18: Number of Products by Routes of Administration, Diarrhea 30

Figure 19: Number of Products by Stage and Routes of Administration, Diarrhea 30

Figure 20: Number of Products by Top 10 Molecule Types, Diarrhea 31

Figure 21: Number of Products by Stage and Top 10 Molecule Types, Diarrhea 32

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