Functional (Non Ulcer) Dyspepsia - Pipeline Review, H1 2015

Published: Jan, 2015 | Pages: 48 | Publisher: Global Markets Direct
Industry: Pharmaceuticals & Healthcare | Report Format: Electronic (PDF)

Functional (non ulcer) dyspepsia is a condition characterized by symptoms of indigestion, without any obvious cause. It causes signs that resemble those of an ulcer e.g. pain and discomfort in upper abdomen, bloating, nausea, belching, etc. Functional (non ulcer) dyspepsia is chronic in nature. It is called functional as measurable or observable structural abnormalities are absent, however the symptoms are persistent. Alternative terms for the disorder include gastritis, nervous dyspepsia, pseudo-ulcer syndrome, and pyloro-duodenal irritability.

Common triggers of functional (non ulcer) dyspepsia are improper lifestyle and diet, medications, inflammation of duodenum or stomach, and excessive acid secretion. It is also triggered by food allergies and Helicobacter Pylori infection. Management of the condition calls for limiting or avoiding fatty or fried foods, excessive alcohol, caffeine, and tomatoes, among other. Having smaller, more frequent meals also has a favorable effect. Reduction in the overall stress level helps to lowers symptoms.

Key factors in the therapeutic development for functional (non ulcer) dyspepsia involve RoA – Route of Administration, MoA – Mechanism of Action, molecule type, and drug target. Medications encompass low-dose antidepressants, over-the-counter gas remedies, H2-receptor blockers, proton pump inhibitors, etc.

While H-2 receptor blockers reduce acid production, proton pump inhibitors shut down acid ‘pumps’ in the stomach cells. Antibiotics are prescribed if the presence of H. pylori bacterium is detected. Prokinetic agents strengthen the esophageal sphincter and help the stomach empty faster. This reduces upper abdominal discomfort. However these drugs may not work for all. Moreover they are associated with significant side-effects.

Eminent participants in the market for treatment of functional (non ulcer) dyspepsia are Almirall S.A., Ironwood Pharmaceuticals Inc., Eisai Co. Ltd., Zeria Pharmaceutical Co. Ltd., RaQualia Pharmaceuticals Inc., and Rottapharm SpA. Leading drugs include 5-BOIP, acotiamide hydrochloride, cinitapride, and dexloxiglumide. Drugs in the research and development phase are IW-9179, RQ-00000010, RQ-00201894, rabeprazole sodium, etc.

RaQualia, in 2012, got approval for conducting a First-In-Human study of RQ-00000010. Ministry of Health in Japan approved the marketing of Acofide developed by Zeria Pharmaceuticals, for treating functional (non ulcer) dyspepsia, in 2013. On the other hand, Ironwood recently announced that it has abandoned the Phase IIa Study of IW-9179 as data was non-indicative of reduction in symptoms.

 Table of Contents
Table of Contents 2
List of Tables 4
List of Figures 4
Introduction 5
Global Markets Direct Report Coverage 5
Functional (Non Ulcer) Dyspepsia Overview 6
Therapeutics Development 7
Pipeline Products for Functional (Non Ulcer) Dyspepsia - Overview 7
Pipeline Products for Functional (Non Ulcer) Dyspepsia - Comparative Analysis 8
Functional (Non Ulcer) Dyspepsia - Therapeutics under Development by Companies 9
Functional (Non Ulcer) Dyspepsia - Therapeutics under Investigation by Universities/Institutes 10
Functional (Non Ulcer) Dyspepsia - Pipeline Products Glance 11
Late Stage Products 11
Clinical Stage Products 12
Early Stage Products 13
Functional (Non Ulcer) Dyspepsia - Products under Development by Companies 14
Functional (Non Ulcer) Dyspepsia - Products under Investigation by Universities/Institutes 15
Functional (Non Ulcer) Dyspepsia - Companies Involved in Therapeutics Development 16
Almirall, S.A. 16
Eisai Co., Ltd. 17
Ironwood Pharmaceuticals, Inc. 18
RaQualia Pharma Inc. 19
Rottapharm SpA 20
Zeria Pharmaceutical Co Ltd 21
Functional (Non Ulcer) Dyspepsia - Therapeutics Assessment 22
Assessment by Monotherapy Products 22
Assessment by Target 23
Assessment by Mechanism of Action 25
Assessment by Route of Administration 27
Assessment by Molecule Type 28
Drug Profiles 29
5-BOIP - Drug Profile 29
Product Description 29
Mechanism of Action 29
R&D Progress 29
acotiamide hydrochloride - Drug Profile 30
Product Description 30
Mechanism of Action 30
R&D Progress 30
cinitapride - Drug Profile 32
Product Description 32
Mechanism of Action 32
R&D Progress 32
dexloxiglumide - Drug Profile 33
Product Description 33
Mechanism of Action 33
R&D Progress 33
IW-9179 - Drug Profile 34
Product Description 34
Mechanism of Action 34
R&D Progress 34
rabeprazole sodium DR - Drug Profile 35
Product Description 35
Mechanism of Action 35
R&D Progress 35
RQ-00000010 - Drug Profile 37
Product Description 37
Mechanism of Action 37
R&D Progress 37
RQ-00201894 - Drug Profile 38
Product Description 38
Mechanism of Action 38
R&D Progress 38
Functional (Non Ulcer) Dyspepsia - Recent Pipeline Updates 39
Functional (Non Ulcer) Dyspepsia - Dormant Projects 43
Functional (Non Ulcer) Dyspepsia - Discontinued Products 44
Functional (Non Ulcer) Dyspepsia - Product Development Milestones 45
Featured News & Press Releases 45
Oct 20, 2014: Ironwood Presents IW-9179 Phase IIa Data at American College of Gastroenterology 2014 Annual Scientific Meeting 45
Mar 25, 2013: Zeria Pharma Receives Approval For Acofide In Japan For Treating Functional Dyspepsia 45
Feb 29, 2012: RaQualia Pharma Receives MHRA Approval To Initiate First-In-Human Study For 5-HT4 Partial Agonist RQ-00000010 46
Appendix 47
Methodology 47
Coverage 47
Secondary Research 47
Primary Research 47
Expert Panel Validation 47
Contact Us 47
Disclaimer 48

List of Tables
Number of Products under Development for Functional (Non Ulcer) Dyspepsia, H1 2015 7
Number of Products under Development for Functional (Non Ulcer) Dyspepsia - Comparative Analysis, H1 2015 8
Number of Products under Development by Companies, H1 2015 9
Number of Products under Investigation by Universities/Institutes, H1 2015 10
Comparative Analysis by Late Stage Development, H1 2015 11
Comparative Analysis by Clinical Stage Development, H1 2015 12
Comparative Analysis by Early Stage Development, H1 2015 13
Products under Development by Companies, H1 2015 14
Products under Investigation by Universities/Institutes, H1 2015 15
Functional (Non Ulcer) Dyspepsia - Pipeline by Almirall, S.A., H1 2015 16
Functional (Non Ulcer) Dyspepsia - Pipeline by Eisai Co., Ltd., H1 2015 17
Functional (Non Ulcer) Dyspepsia - Pipeline by Ironwood Pharmaceuticals, Inc., H1 2015 18
Functional (Non Ulcer) Dyspepsia - Pipeline by RaQualia Pharma Inc., H1 2015 19
Functional (Non Ulcer) Dyspepsia - Pipeline by Rottapharm SpA, H1 2015 20
Functional (Non Ulcer) Dyspepsia - Pipeline by Zeria Pharmaceutical Co Ltd, H1 2015 21
Assessment by Monotherapy Products, H1 2015 22
Number of Products by Stage and Target, H1 2015 24
Number of Products by Stage and Mechanism of Action, H1 2015 26
Number of Products by Stage and Route of Administration, H1 2015 27
Number of Products by Stage and Molecule Type, H1 2015 28
Functional (Non Ulcer) Dyspepsia Therapeutics - Recent Pipeline Updates, H1 2015 39
Functional (Non Ulcer) Dyspepsia - Dormant Projects, H1 2015 43
Functional (Non Ulcer) Dyspepsia - Discontinued Products, H1 2015 44