Irritable Bowel Syndrome – Pipeline Review, H2 2016

Global Markets Direct’s, ‘Irritable Bowel Syndrome – Pipeline Review, H2 2016’, provides an overview of the Irritable Bowel Syndrome pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Irritable Bowel Syndrome, complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The report also covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Additionally, the report provides an overview of key players involved in therapeutic development for Irritable Bowel Syndrome and features dormant and discontinued projects.

Global Markets Direct’s report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from Global Markets Direct’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Drug profiles featured in the report undergoes periodic review following a stringent set of processes to ensure that all the profiles are updated with the latest set of information. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis.

The report helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage.

Note: Certain sections in the report may be removed or altered based on the availability and relevance of data.

Scope

The report provides a snapshot of the global therapeutic landscape of Irritable Bowel Syndrome

The report reviews pipeline therapeutics for Irritable Bowel Syndrome by companies and universities/research institutes based on information derived from company and industry-specific sources

The report covers pipeline products based on various stages of development ranging from pre-registration till discovery and undisclosed stages

The report features descriptive drug profiles for the pipeline products which includes, product description, descriptive MoA, R&D brief, licensing and collaboration details & other developmental activities

The report reviews key players involved Irritable Bowel Syndrome therapeutics and enlists all their major and minor projects

The report assesses Irritable Bowel Syndrome therapeutics based on drug target, mechanism of action (MoA), route of administration (RoA) and molecule type

The report summarizes all the dormant and discontinued pipeline projects

The report reviews latest news related to pipeline therapeutics for Irritable Bowel Syndrome

Reasons to buy

Gain strategically significant competitor information, analysis, and insights to formulate effective R&D strategies

Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

Identify and understand important and diverse types of therapeutics under development for Irritable Bowel Syndrome

Identify potential new clients or partners in the target demographic

Develop strategic initiatives by understanding the focus areas of leading companies

Plan mergers and acquisitions effectively by identifying key players and it’s most promising pipeline therapeutics

Devise corrective measures for pipeline projects by understanding Irritable Bowel Syndrome pipeline depth and focus of Indication therapeutics

Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope

Modify the therapeutic portfolio by identifying discontinued projects and understanding the factors that drove them from pipeline

Companies mentioned

4D Pharma Plc

A. Menarini Industrie Farmaceutiche Riunite Srl

Alfa Wassermann S.p.A

Ardelyx, Inc.

Astellas Pharma Inc.

CJ HealthCare Corp.

Dong-A Socio Holdings Co. Ltd.

Enterome Bioscience SA

GlaxoSmithKline Plc

Innovative Med Concepts, LLC

Ironwood Pharmaceuticals, Inc.

Kissei Pharmaceutical Co., Ltd.

Lexicon Pharmaceuticals, Inc.

Napo Pharmaceuticals Inc

Ono Pharmaceutical Co., Ltd.

Pfizer Inc.

RaQualia Pharma Inc.

RedHill Biopharma Ltd.

SK Biopharmaceuticals Co., Ltd.

Sumitomo Dainippon Pharma Co Ltd

Synergy Pharmaceuticals, Inc.

Synthetic Biologics, Inc.

Vitality Biopharma Inc

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 7

List of Figures 8

Introduction 9

Global Markets Direct Report Coverage 9

Irritable Bowel Syndrome Overview 10

Therapeutics Development 11

Pipeline Products for Irritable Bowel Syndrome - Overview 11

Irritable Bowel Syndrome - Therapeutics under Development by Companies 12

Irritable Bowel Syndrome - Pipeline Products Glance 14

Late Stage Products 14

Clinical Stage Products 15

Early Stage Products 16

Irritable Bowel Syndrome - Products under Development by Companies 17

Irritable Bowel Syndrome - Companies Involved in Therapeutics Development 19

4D Pharma Plc 19

A. Menarini Industrie Farmaceutiche Riunite Srl 20

Alfa Wassermann S.p.A 21

Ardelyx, Inc. 22

Astellas Pharma Inc. 23

CJ HealthCare Corp. 24

Dong-A Socio Holdings Co. Ltd. 25

Enterome Bioscience SA 26

GlaxoSmithKline Plc 27

Innovative Med Concepts, LLC 28

Ironwood Pharmaceuticals, Inc. 29

Kissei Pharmaceutical Co., Ltd. 30

Lexicon Pharmaceuticals, Inc. 31

Napo Pharmaceuticals Inc 32

Ono Pharmaceutical Co., Ltd. 33

Pfizer Inc. 34

RaQualia Pharma Inc. 35

RedHill Biopharma Ltd. 36

SK Biopharmaceuticals Co., Ltd. 37

Sumitomo Dainippon Pharma Co Ltd 38

Synergy Pharmaceuticals, Inc. 39

Synthetic Biologics, Inc. 40

Vitality Biopharma Inc 41

Irritable Bowel Syndrome - Therapeutics Assessment 42

Assessment by Monotherapy Products 42

Assessment by Combination Products 43

Assessment by Target 44

Assessment by Mechanism of Action 46

Assessment by Route of Administration 49

Assessment by Molecule Type 51

Drug Profiles 53

(celecoxib + famciclovir) - Drug Profile 53

Product Description 53

Mechanism Of Action 53

R&D Progress 53

ASP-1017 - Drug Profile 54

Product Description 54

Mechanism Of Action 54

R&D Progress 54

ASP-7147 - Drug Profile 55

Product Description 55

Mechanism Of Action 55

R&D Progress 55

bedoradrine sulfate - Drug Profile 56

Product Description 56

Mechanism Of Action 56

R&D Progress 56

Blautix - Drug Profile 59

Product Description 59

Mechanism Of Action 59

R&D Progress 59

CJ-14199 - Drug Profile 60

Product Description 60

Mechanism Of Action 60

R&D Progress 60

crofelemer DR - Drug Profile 61

Product Description 61

Mechanism Of Action 61

R&D Progress 61

CSTI-300 - Drug Profile 64

Product Description 64

Mechanism Of Action 64

R&D Progress 64

DA-6886 - Drug Profile 65

Product Description 65

Mechanism Of Action 65

R&D Progress 65

DSP-6952 - Drug Profile 66

Product Description 66

Mechanism Of Action 66

R&D Progress 66

EB-420 - Drug Profile 67

Product Description 67

Mechanism Of Action 67

R&D Progress 67

GSK-3179106 - Drug Profile 68

Product Description 68

Mechanism Of Action 68

R&D Progress 68

ibodutant - Drug Profile 69

Product Description 69

Mechanism Of Action 69

R&D Progress 69

linaclotide - Drug Profile 70

Product Description 70

Mechanism Of Action 70

R&D Progress 70

lovastatin - Drug Profile 77

Product Description 77

Mechanism Of Action 77

R&D Progress 77

LT-4006 - Drug Profile 81

Product Description 81

Mechanism Of Action 81

R&D Progress 81

LX-1033 - Drug Profile 82

Product Description 82

Mechanism Of Action 82

R&D Progress 82

ondansetron hydrochloride CR - Drug Profile 84

Product Description 84

Mechanism Of Action 84

R&D Progress 84

ONO-2952 - Drug Profile 89

Product Description 89

Mechanism Of Action 89

R&D Progress 89

ORP-101 - Drug Profile 90

Product Description 90

Mechanism Of Action 90

R&D Progress 90

PBF-677 - Drug Profile 91

Product Description 91

Mechanism Of Action 91

R&D Progress 91

plecanatide - Drug Profile 92

Product Description 92

Mechanism Of Action 92

R&D Progress 92

pregabalin - Drug Profile 100

Product Description 100

Mechanism Of Action 100

R&D Progress 100

relenopride hydrochloride - Drug Profile 104

Product Description 104

Mechanism Of Action 104

R&D Progress 104

rifaximin - Drug Profile 105

Product Description 105

Mechanism Of Action 105

R&D Progress 105

RQ-00202730 - Drug Profile 109

Product Description 109

Mechanism Of Action 109

R&D Progress 109

RQ-00310941 - Drug Profile 110

Product Description 110

Mechanism Of Action 110

R&D Progress 110

Small Molecules to Inhibit 5-HT2B and 5-HT7 Receptors for IBS and Migraine - Drug Profile 111

Product Description 111

Mechanism Of Action 111

R&D Progress 111

solabegron hydrochloride - Drug Profile 112

Product Description 112

Mechanism Of Action 112

R&D Progress 112

tenapanor hydrochloride - Drug Profile 114

Product Description 114

Mechanism Of Action 114

R&D Progress 114

VB-210 - Drug Profile 119

Product Description 119

Mechanism Of Action 119

R&D Progress 119

Irritable Bowel Syndrome - Dormant Projects 120

Irritable Bowel Syndrome - Discontinued Products 125

Irritable Bowel Syndrome - Product Development Milestones 126

Featured News & Press Releases 126

Nov 03, 2016: RedHill Biopharma Provides Update on Ongoing Phase III and Phase II studies with BEKINDA and Expected Timing of Top-Line Results 126

Oct 19, 2016: Ardelyx Announces the Presentation of Positive Global Endpoint Findings from Phase 2b Trial of Tenapanor in Patients with IBS-C at ACG Annual Meeting 127

Oct 17, 2016: Synergy Pharmaceuticals Presents Long-Term Data for Plecanatide in Chronic Idiopathic Constipation at the American College of Gastroenterology Annual Scientific Meeting 128

Sep 28, 2016: Synergy Pharmaceuticals Announces New Plecanatide Data Presentations at Upcoming Scientific Meeting and Provides Update on IBS-C Program 129

Aug 02, 2016: Synthetic Biologics Announces Completion of End of Phase 2 Meeting with FDA for SYN-010, Intended for the Treatment of Irritable Bowel Syndrome with Constipation 130

Jul 19, 2016: 4D Pharma Provides Phase I Clinical Trial Update 130

Jul 15, 2016: Synergy Pharmaceuticals Provides Update on Ongoing FDA Review of Plecanatide CIC NDA and IBS-C Clinical Development Program 131

Jun 20, 2016: RedHill Biopharma Announces First Patients Dosed in Phase II Study with BEKINDA for IBS-D 132

May 24, 2016: Synergy Pharmaceuticals Presents New In Vitro Data Showing the pH-Dependent Activity of Plecanatide Replicates That of Naturally Occurring GI Peptide Uroguanylin 133

May 23, 2016: Phase I trial Update On Blautix For The Treatment Of Irritable Bowel Syndrome : 4D pharma 133

May 23, 2016: Synthetic Biologics Announces Detailed Data from Two SYN-010 Phase 2 Clinical Trials for the Treatment of Irritable Bowel Syndrome with Constipation (IBS-C) 134

May 17, 2016: Ironwood Pharmaceuticals to Present Linaclotide Data at Digestive Disease Week 2016 135

May 17, 2016: Synthetic Biologics to Host Post-DDW 2016 Conference Call to Recap SYN-010 Phase 2 Clinical Trial Results for the Treatment of Irritable Bowel Syndrome with Constipation (IBS-C) 136

May 16, 2016: Synergy Pharmaceuticals to Present New Plecanatide Data at Digestive Disease Week 2016 136

May 11, 2016: Isaac J. Bright, MD, Joins Synthetic Biologics as Vice President, Corporate Development 137

Appendix 139

Methodology 139

Coverage 139

Secondary Research 139

Primary Research 139

Expert Panel Validation 139

Contact Us 139

Disclaimer 140

List of Tables

List of Tables

Number of Products under Development for Irritable Bowel Syndrome, H2 2016 11

Number of Products under Development by Companies, H2 2016 12

Number of Products under Development by Companies, H2 2016 (Contd..1) 13

Comparative Analysis by Late Stage Development, H2 2016 14

Comparative Analysis by Clinical Stage Development, H2 2016 15

Comparative Analysis by Early Stage Development, H2 2016 16

Products under Development by Companies, H2 2016 17

Products under Development by Companies, H2 2016 (Contd..1) 18

Irritable Bowel Syndrome – Pipeline by 4D Pharma Plc, H2 2016 19

Irritable Bowel Syndrome – Pipeline by A. Menarini Industrie Farmaceutiche Riunite Srl, H2 2016 20

Irritable Bowel Syndrome – Pipeline by Alfa Wassermann S.p.A, H2 2016 21

Irritable Bowel Syndrome – Pipeline by Ardelyx, Inc., H2 2016 22

Irritable Bowel Syndrome – Pipeline by Astellas Pharma Inc., H2 2016 23

Irritable Bowel Syndrome – Pipeline by CJ HealthCare Corp., H2 2016 24

Irritable Bowel Syndrome – Pipeline by Dong-A Socio Holdings Co. Ltd., H2 2016 25

Irritable Bowel Syndrome – Pipeline by Enterome Bioscience SA, H2 2016 26

Irritable Bowel Syndrome – Pipeline by GlaxoSmithKline Plc, H2 2016 27

Irritable Bowel Syndrome – Pipeline by Innovative Med Concepts, LLC, H2 2016 28

Irritable Bowel Syndrome – Pipeline by Ironwood Pharmaceuticals, Inc., H2 2016 29

Irritable Bowel Syndrome – Pipeline by Kissei Pharmaceutical Co., Ltd., H2 2016 30

Irritable Bowel Syndrome – Pipeline by Lexicon Pharmaceuticals, Inc., H2 2016 31

Irritable Bowel Syndrome – Pipeline by Napo Pharmaceuticals Inc, H2 2016 32

Irritable Bowel Syndrome – Pipeline by Ono Pharmaceutical Co., Ltd., H2 2016 33

Irritable Bowel Syndrome – Pipeline by Pfizer Inc., H2 2016 34

Irritable Bowel Syndrome – Pipeline by RaQualia Pharma Inc., H2 2016 35

Irritable Bowel Syndrome – Pipeline by RedHill Biopharma Ltd., H2 2016 36

Irritable Bowel Syndrome – Pipeline by SK Biopharmaceuticals Co., Ltd., H2 2016 37

Irritable Bowel Syndrome – Pipeline by Sumitomo Dainippon Pharma Co Ltd, H2 2016 38

Irritable Bowel Syndrome – Pipeline by Synergy Pharmaceuticals, Inc., H2 2016 39

Irritable Bowel Syndrome – Pipeline by Synthetic Biologics, Inc., H2 2016 40

Irritable Bowel Syndrome – Pipeline by Vitality Biopharma Inc, H2 2016 41

Assessment by Monotherapy Products, H2 2016 42

Assessment by Combination Products, H2 2016 43

Number of Products by Stage and Target, H2 2016 45

Number of Products by Stage and Mechanism of Action, H2 2016 47

Number of Products by Stage and Route of Administration, H2 2016 50

Number of Products by Stage and Molecule Type, H2 2016 52

Irritable Bowel Syndrome – Dormant Projects, H2 2016 120

Irritable Bowel Syndrome – Dormant Projects (Contd..1), H2 2016 121

Irritable Bowel Syndrome – Dormant Projects (Contd..2), H2 2016 122

Irritable Bowel Syndrome – Dormant Projects (Contd..3), H2 2016 123

Irritable Bowel Syndrome – Dormant Projects (Contd..4), H2 2016 124

Irritable Bowel Syndrome – Discontinued Products, H2 2016 125

List of Figures

List of Figures

Number of Products under Development for Irritable Bowel Syndrome, H2 2016 11

Number of Products under Development by Companies, H2 2016 12

Comparative Analysis by Late Stage Development, H2 2016 14

Comparative Analysis by Clinical Stage Development, H2 2016 15

Comparative Analysis by Early Stage Products, H2 2016 16

Assessment by Monotherapy Products, H2 2016 42

Number of Products by Top 10 Targets, H2 2016 44

Number of Products by Stage and Top 10 Targets, H2 2016 44

Number of Products by Top 10 Mechanism of Actions, H2 2016 46

Number of Products by Stage and Top 10 Mechanism of Actions, H2 2016 46

Number of Products by Routes of Administration, H2 2016 49

Number of Products by Stage and Routes of Administration, H2 2016 49

Number of Products by Molecule Types, H2 2016 51

Number of Products by Stage and Molecule Types, H2 2016 51

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