Irritable Bowel Syndrome – Pipeline Review, H1 2018

Global Markets Direct’s, ‘Irritable Bowel Syndrome – Pipeline Review, H1 2018’, 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

Allergan Plc

Ardelyx Inc

ConSynance Therapeutics Inc

Cosmo Pharmaceuticals NV

Dong-A ST Co Ltd

Eisai Co Ltd

Enterome Bioscience SA

GlaxoSmithKline Plc

ImmuneBiotech AB

Ironwood Pharmaceuticals Inc

Kissei Pharmaceutical Co Ltd

Metacrine Inc

Napo Pharmaceuticals Inc

RaQualia Pharma Inc

RedHill Biopharma Ltd

SK Biopharmaceuticals Co Ltd

Sumitomo Dainippon Pharma Co Ltd

Synthetic Biologics Inc

Vitality Biopharma Inc

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 7

List of Figures 7

Introduction 9

Global Markets Direct Report Coverage 9

Irritable Bowel Syndrome Overview 10

Irritable Bowel Syndrome Therapeutics Development 11

Pipeline Overview 11

Pipeline by Companies 12

Pipeline by Universities/Institutes 15

Products under Development by Companies 16

Products under Development by Universities/Institutes 18

Irritable Bowel Syndrome Therapeutics Assessment 19

Assessment by Target 19

Assessment by Mechanism of Action 21

Assessment by Route of Administration 23

Assessment by Molecule Type 24

Irritable Bowel Syndrome Companies Involved in Therapeutics Development 26

4D Pharma PLC 26

Allergan Plc 26

Ardelyx Inc 26

ConSynance Therapeutics Inc 27

Cosmo Pharmaceuticals NV 27

Dong-A ST Co Ltd 28

Eisai Co Ltd 28

Enterome Bioscience SA 29

GlaxoSmithKline Plc 29

ImmuneBiotech AB 29

Ironwood Pharmaceuticals Inc 30

Kissei Pharmaceutical Co Ltd 30

Metacrine Inc 31

Napo Pharmaceuticals Inc 31

RaQualia Pharma Inc 31

RedHill Biopharma Ltd 32

SK Biopharmaceuticals Co Ltd 32

Sumitomo Dainippon Pharma Co Ltd 33

Synthetic Biologics Inc 33

Vitality Biopharma Inc 34

Irritable Bowel Syndrome Drug Profiles 35

BC-1261 Drug Profile 35

Product Description 35

Mechanism Of Action 35

R&D Progress 35

bedoradrine sulfate Drug Profile 36

Product Description 36

Mechanism Of Action 36

R&D Progress 36

Biologic for Irritable Bowel Syndrome with Constipation Drug Profile 39

Product Description 39

Mechanism Of Action 39

R&D Progress 39

Biologic for Irritable Bowel Syndrome with Diarrhea Drug Profile 40

Product Description 40

Mechanism Of Action 40

R&D Progress 40

Blautix Drug Profile 41

Product Description 41

Mechanism Of Action 41

R&D Progress 41

Canchew Plus Drug Profile 43

Product Description 43

Mechanism Of Action 43

R&D Progress 43

CIN-103 Drug Profile 45

Product Description 45

Mechanism Of Action 45

R&D Progress 45

crofelemer DR Drug Profile 46

Product Description 46

Mechanism Of Action 46

R&D Progress 46

CSTI-300 Drug Profile 50

Product Description 50

Mechanism Of Action 50

R&D Progress 50

DA-6886 Drug Profile 51

Product Description 51

Mechanism Of Action 51

R&D Progress 51

Drugs for Irritable Bowel Syndrome with Diarrhea Drug Profile 52

Product Description 52

Mechanism Of Action 52

R&D Progress 52

DSP-6952 Drug Profile 53

Product Description 53

Mechanism Of Action 53

R&D Progress 53

E-2508 Drug Profile 54

Product Description 54

Mechanism Of Action 54

R&D Progress 54

EB-410 Drug Profile 55

Product Description 55

Mechanism Of Action 55

R&D Progress 55

EB-420 Drug Profile 56

Product Description 56

Mechanism Of Action 56

R&D Progress 56

GSK-3179106 Drug Profile 57

Product Description 57

Mechanism Of Action 57

R&D Progress 57

IB-001 Drug Profile 58

Product Description 58

Mechanism Of Action 58

R&D Progress 58

linaclotide Drug Profile 59

Product Description 59

Mechanism Of Action 59

R&D Progress 59

linaclotide DR2 Drug Profile 67

Product Description 67

Mechanism Of Action 67

R&D Progress 67

lovastatin MR Drug Profile 68

Product Description 68

Mechanism Of Action 68

R&D Progress 68

LT-4006 Drug Profile 72

Product Description 72

Mechanism Of Action 72

R&D Progress 72

ondansetron hydrochloride CR Drug Profile 73

Product Description 73

Mechanism Of Action 73

R&D Progress 73

OP-687 Drug Profile 82

Product Description 82

Mechanism Of Action 82

R&D Progress 82

ORP-101 Drug Profile 83

Product Description 83

Mechanism Of Action 83

R&D Progress 83

PR-38 Drug Profile 84

Product Description 84

Mechanism Of Action 84

R&D Progress 84

RDX-023 Drug Profile 85

Product Description 85

Mechanism Of Action 85

R&D Progress 85

relenopride hydrochloride Drug Profile 86

Product Description 86

Mechanism Of Action 86

R&D Progress 86

rifamycin CR Drug Profile 88

Product Description 88

Mechanism Of Action 88

R&D Progress 88

RQ-00310941 Drug Profile 92

Product Description 92

Mechanism Of Action 92

R&D Progress 92

Small Molecules to Inhibit TPH1 for Gastrointestinal, Metabolic Disorder and Oncology Drug Profile 93

Product Description 93

Mechanism Of Action 93

R&D Progress 93

solabegron Drug Profile 94

Product Description 94

Mechanism Of Action 94

R&D Progress 94

tenapanor Drug Profile 97

Product Description 97

Mechanism Of Action 97

R&D Progress 97

VB-210 Drug Profile 104

Product Description 104

Mechanism Of Action 104

R&D Progress 104

Irritable Bowel Syndrome Dormant Projects 105

Irritable Bowel Syndrome Discontinued Products 108

Irritable Bowel Syndrome Product Development Milestones 109

Featured News & Press Releases 109

Apr 25, 2018: FDA Grants Fast Track Designation for OrphoMed's ORP-101 for Treatment of IBS-D 109

Apr 03, 2018: AXIM Biotech Reaches Preliminary Agreement for Distribution of CanChew Product Throughout South Korea 109

Mar 26, 2018: RedHill Biopharma Announces DDW 2018 Poster of Distinction on Positive Phase II Results with BEKINDA for IBS-D 109

Jan 17, 2018: Outpost Medicine Announces Acceptance of Two Investigational New Drug Applications for OP-687 by U.S. FDA 110

Jan 16, 2018: Sun Pharma Announces Settlement of Patent Litigation for Generic Linzess in US 110

Jan 16, 2018: RedHill Biopharma Announces Final Results from Phase II Study with BEKINDA for IBS-D 110

Jan 04, 2018: OrphoMed Appoints Gastroenterology Expert and Industry Veteran Mark Sostek, M.D. as Chief Medical Officer 111

Jan 03, 2018: Ardelyx Successfully Completes T3MPO-3 Safety Extension Study of Tenapanor for IBS-C 111

Dec 12, 2017: Cosmo Pharmaceuticals Announces First Patient Randomized In Its Proof Of Concept Phase II Clinical Trial Of Rifamycin SV In IBS-D 112

Oct 19, 2017: Jaguar Health Subsidiary Napo Pharmaceuticals Establishes Scientific Advisory Boards for Planned Follow-on Indications for Mytesi, Napo’s FDA-approved Human Prescription Drug 112

Oct 16, 2017: Allergan to Present New Data on Gastrointestinal Drug Candidate Linaclotide at the World Congress of Gastroenterology at ACG 2017 113

Oct 16, 2017: Ardelyx Announces Tenapanor Reduces Pain Caused by IBS-C Through Inhibition of TRPV-1 Signaling 114

Oct 11, 2017: Ardelyxs Pivotal Phase 3 Study of Tenapanor for IBS-C Hits Primary and All Secondary Endpoints to Support NDA Submission in 2018 115

Oct 03, 2017: RedHill Biopharma Announces Positive Top-Line Results from Phase II Study of BEKINDA in Patients with IBS-D 116

Sep 28, 2017: RedHill Biopharma to Announce Top-Line Results from BEKINDA 12 mg Phase II Study for IBS-D on October 3rd, 2017 118

Appendix 119

Methodology 119

Coverage 119

Secondary Research 119

Primary Research 119

Expert Panel Validation 119

Contact Us 119

Disclaimer 120

List of Tables

List of Tables

Number of Products under Development for Irritable Bowel Syndrome, H1 2018 11

Number of Products under Development by Companies, H1 2018 13

Number of Products under Development by Companies, H1 2018 (Contd..1), H1 2018 14

Number of Products under Development by Universities/Institutes, H1 2018 15

Products under Development by Companies, H1 2018 16

Products under Development by Companies, H1 2018 (Contd..1), H1 2018 17

Products under Development by Universities/Institutes, H1 2018 18

Number of Products by Stage and Target, H1 2018 20

Number of Products by Stage and Mechanism of Action, H1 2018 22

Number of Products by Stage and Route of Administration, H1 2018 23

Number of Products by Stage and Molecule Type, H1 2018 25

Irritable Bowel Syndrome Pipeline by 4D Pharma PLC, H1 2018 26

Irritable Bowel Syndrome Pipeline by Allergan Plc, H1 2018 26

Irritable Bowel Syndrome Pipeline by Ardelyx Inc, H1 2018 27

Irritable Bowel Syndrome Pipeline by ConSynance Therapeutics Inc, H1 2018 27

Irritable Bowel Syndrome Pipeline by Cosmo Pharmaceuticals NV, H1 2018 28

Irritable Bowel Syndrome Pipeline by Dong-A ST Co Ltd, H1 2018 28

Irritable Bowel Syndrome Pipeline by Eisai Co Ltd, H1 2018 28

Irritable Bowel Syndrome Pipeline by Enterome Bioscience SA, H1 2018 29

Irritable Bowel Syndrome Pipeline by GlaxoSmithKline Plc, H1 2018 29

Irritable Bowel Syndrome Pipeline by ImmuneBiotech AB, H1 2018 30

Irritable Bowel Syndrome Pipeline by Ironwood Pharmaceuticals Inc, H1 2018 30

Irritable Bowel Syndrome Pipeline by Kissei Pharmaceutical Co Ltd, H1 2018 31

Irritable Bowel Syndrome Pipeline by Metacrine Inc, H1 2018 31

Irritable Bowel Syndrome Pipeline by Napo Pharmaceuticals Inc, H1 2018 31

Irritable Bowel Syndrome Pipeline by RaQualia Pharma Inc, H1 2018 32

Irritable Bowel Syndrome Pipeline by RedHill Biopharma Ltd, H1 2018 32

Irritable Bowel Syndrome Pipeline by SK Biopharmaceuticals Co Ltd, H1 2018 33

Irritable Bowel Syndrome Pipeline by Sumitomo Dainippon Pharma Co Ltd, H1 2018 33

Irritable Bowel Syndrome Pipeline by Synthetic Biologics Inc, H1 2018 34

Irritable Bowel Syndrome Pipeline by Vitality Biopharma Inc, H1 2018 34

Irritable Bowel Syndrome Dormant Projects, H1 2018 105

Irritable Bowel Syndrome Dormant Projects, H1 2018 (Contd..1), H1 2018 106

Irritable Bowel Syndrome Dormant Projects, H1 2018 (Contd..2), H1 2018 107

Irritable Bowel Syndrome Discontinued Products, H1 2018 108

List of Figures

List of Figures

Number of Products under Development for Irritable Bowel Syndrome, H1 2018 11

Number of Products under Development by Companies, H1 2018 12

Number of Products under Development by Universities/Institutes, H1 2018 15

Number of Products by Top 10 Targets, H1 2018 19

Number of Products by Stage and Top 10 Targets, H1 2018 19

Number of Products by Top 10 Mechanism of Actions, H1 2018 21

Number of Products by Stage and Top 10 Mechanism of Actions, H1 2018 21

Number of Products by Stage and Routes of Administration, H1 2018 23

Number of Products by Molecule Types, H1 2018 24

Number of Products by Stage and Molecule Types, H1 2018 24

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