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Diabetic Gastroparesis-Pipeline Review, H2 2016

Diabetic Gastroparesis-Pipeline Review, H2 2016


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Executive Summary

Diabetic Gastroparesis-Pipeline Review, H2 2016

Summary

Global Markets Direct's, 'Diabetic Gastroparesis-Pipeline Review, H2 2016', provides an overview of the Diabetic Gastroparesis pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Diabetic Gastroparesis, 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 Diabetic Gastroparesis 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 Diabetic Gastroparesis

The report reviews pipeline therapeutics for Diabetic Gastroparesis 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 Diabetic Gastroparesis therapeutics and enlists all their major and minor projects

The report assesses Diabetic Gastroparesis 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 Diabetic Gastroparesis

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 Diabetic Gastroparesis

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 Diabetic Gastroparesis 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

Table of Contents

Table of Contents 2

List of Tables 5

List of Figures 5

Introduction 6

Global Markets Direct Report Coverage 6

Diabetic Gastroparesis Overview 7

Therapeutics Development 8

Pipeline Products for Diabetic Gastroparesis-Overview 8

Pipeline Products for Diabetic Gastroparesis-Comparative Analysis 9

Diabetic Gastroparesis-Therapeutics under Development by Companies 10

Diabetic Gastroparesis-Therapeutics under Investigation by Universities/Institutes 11

Diabetic Gastroparesis-Pipeline Products Glance 12

Late Stage Products 12

Clinical Stage Products 13

Early Stage Products 14

Diabetic Gastroparesis-Products under Development by Companies 15

Diabetic Gastroparesis-Products under Investigation by Universities/Institutes 16

Diabetic Gastroparesis-Companies Involved in Therapeutics Development 17

Cempra Inc 17

Evoke Pharma, Inc. 18

GlaxoSmithKline Plc 19

Motus Therapeutics Inc 20

Shire Plc 21

Theravance Biopharma, Inc. 22

Diabetic Gastroparesis-Therapeutics Assessment 23

Assessment by Monotherapy Products 23

Assessment by Target 24

Assessment by Mechanism of Action 26

Assessment by Route of Administration 28

Assessment by Molecule Type 30

Drug Profiles 32

camicinal-Drug Profile 32

Product Description 32

Mechanism Of Action 32

R&D Progress 32

CEM-031-Drug Profile 34

Product Description 34

Mechanism Of Action 34

R&D Progress 34

ETX-101-Drug Profile 35

Product Description 35

Mechanism Of Action 35

R&D Progress 35

ETX-301-Drug Profile 36

Product Description 36

Mechanism Of Action 36

R&D Progress 36

metoclopramide hydrochloride-Drug Profile 37

Product Description 37

Mechanism Of Action 37

R&D Progress 37

prucalopride succinate-Drug Profile 42

Product Description 42

Mechanism Of Action 42

R&D Progress 42

relamorelin-Drug Profile 44

Product Description 44

Mechanism Of Action 44

R&D Progress 44

Small Molecules to Activate nNOS for Diabetic Gastroparesis-Drug Profile 49

Product Description 49

Mechanism Of Action 49

R&D Progress 49

velusetrag hydrochloride-Drug Profile 50

Product Description 50

Mechanism Of Action 50

R&D Progress 50

Diabetic Gastroparesis-Dormant Projects 52

Diabetic Gastroparesis-Discontinued Products 53

Diabetic Gastroparesis-Product Development Milestones 54

Featured News & Press Releases 54

Jul 26, 2016: Evoke Pharma Receives Conditional FDA Acceptance of Proposed Brand Name for EVK-001 54

Jul 18, 2016: Evoke Pharma Reports Topline Results from EVK-001 Phase 3 Clinical Trial 54

Jul 07, 2016: Evoke Advances Commercial Preparations for EVK-001 with inVentiv Agreement 55

Jun 01, 2016: Evoke Completes Phase 3 Clinical Trial of EVK-001 in Women with Symptoms Associated with Diabetic Gastroparesis 55

May 24, 2016: Evoke Pharma Presents Data from Successful Thorough ECG (TQT) Study of EVK-001 at Digestive Disease Week 2016 56

May 19, 2016: Evoke Enters Exclusive Commercial Supply Agreement for Active Pharmaceutical Ingredient in EVK-001 56

May 03, 2016: Evoke Announces Timing of Phase 3 Results from its Recently Fully Enrolled Pivotal Clinical Trial of EVK-001 57

Apr 25, 2016: Evoke Successfully Completes Phase 3 Clinical Trial Enrollment of EVK-001 in Women with Symptoms Associated with Diabetic Gastroparesis 57

Apr 04, 2016: Motus Completes Enrollment of Phase 2b Clinical Trial of Relamorelin for Diabetic Gastroparesis 58

Mar 03, 2016: Evoke Accelerates New Drug Application Process by Engaging Regulatory Experts 58

Mar 01, 2016: Evoke Nears Completion of Phase 3 Clinical Trial Enrollment and Secures Extension to Credit Facility 59

Feb 17, 2016: Evoke Pharma to Present Results From Successful Thorough ECG (TQT) Study of EVK-001 at Digestive Disease Week 2016 59

Sep 28, 2015: Evoke Reaches Study Enrollment Milestone Associated With Credit Facility 60

Aug 18, 2015: Evoke Receives Favorable Response From U.S. Food and Drug Administration Regarding Pediatric Study Plan for EVK-001 60

Jun 24, 2015: Evoke Pharma Announces Publication of Clinical Data Demonstrating EVK-001 Significantly Improves Symptoms in Women With Diabetic Gastroparesis 61

Appendix 62

Methodology 62

Coverage 62

Secondary Research 62

Primary Research 62

Expert Panel Validation 62

Contact Us 62

Disclaimer 63

List of Figures

Number of Products under Development for Diabetic Gastroparesis, H2 2016 8

Number of Products under Development for Diabetic Gastroparesis-Comparative Analysis, H2 2016 9

Number of Products under Development by Companies, H2 2016 10

Comparative Analysis by Early Stage Products, H2 2016 14

Assessment by Monotherapy Products, H2 2016 23

Number of Products by Targets, H2 2016 24

Number of Products by Stage and Targets, H2 2016 24

Number of Products by Mechanism of Actions, H2 2016 26

Number of Products by Stage and Mechanism of Actions, H2 2016 26

Number of Products by Routes of Administration, H2 2016 28

Number of Products by Stage and Routes of Administration, H2 2016 28

Number of Products by Molecule Types, H2 2016 30

Number of Products by Stage and Molecule Types, H2 2016 30

List of Tables

Number of Products under Development for Diabetic Gastroparesis, H2 2016 8

Number of Products under Development for Diabetic Gastroparesis-Comparative Analysis, H2 2016 9

Number of Products under Development by Companies, H2 2016 10

Number of Products under Investigation by Universities/Institutes, H2 2016 11

Comparative Analysis by Late Stage Development, H2 2016 12

Comparative Analysis by Clinical Stage Development, H2 2016 13

Comparative Analysis by Early Stage Development, H2 2016 14

Products under Development by Companies, H2 2016 15

Products under Investigation by Universities/Institutes, H2 2016 16

Diabetic Gastroparesis-Pipeline by Cempra Inc, H2 2016 17

Diabetic Gastroparesis-Pipeline by Evoke Pharma, Inc., H2 2016 18

Diabetic Gastroparesis-Pipeline by GlaxoSmithKline Plc, H2 2016 19

Diabetic Gastroparesis-Pipeline by Motus Therapeutics Inc, H2 2016 20

Diabetic Gastroparesis-Pipeline by Shire Plc, H2 2016 21

Diabetic Gastroparesis-Pipeline by Theravance Biopharma, Inc., H2 2016 22

Assessment by Monotherapy Products, H2 2016 23

Number of Products by Stage and Target, H2 2016 25

Number of Products by Stage and Mechanism of Action, H2 2016 27

Number of Products by Stage and Route of Administration, H2 2016 29

Number of Products by Stage and Molecule Type, H2 2016 31

Diabetic Gastroparesis-Dormant Projects, H2 2016 52

Diabetic Gastroparesis-Discontinued Products, H2 2016 53

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Cempra Inc

Evoke Pharma, Inc.

GlaxoSmithKline Plc

Motus Therapeutics Inc

Shire Plc

Theravance Biopharma, Inc.

Diabetic Gastroparesis Therapeutic Products under Development, Key Players in Diabetic Gastroparesis Therapeutics, Diabetic Gastroparesis Pipeline Overview, Diabetic Gastroparesis Pipeline, Diabetic Gastroparesis Pipeline Assessment


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