Transmembrane Prolyl 4 Hydroxylase (Hypoxia Inducible Factor Prolyl Hydroxylase 4 or P4HTM or EC 1.14.11.) – Pipeline Review, H2 2016

Global Markets Direct’s, ‘Transmembrane Prolyl 4 Hydroxylase (Hypoxia Inducible Factor Prolyl Hydroxylase 4 or P4HTM or EC 1.14.11.) – Pipeline Review, H2 2016’, provides in depth analysis on Transmembrane Prolyl 4 Hydroxylase (Hypoxia Inducible Factor Prolyl Hydroxylase 4 or P4HTM or EC 1.14.11.) targeted pipeline therapeutics.

The report provides comprehensive information on the Transmembrane Prolyl 4 Hydroxylase (Hypoxia Inducible Factor Prolyl Hydroxylase 4 or P4HTM or EC 1.14.11.) , targeted therapeutics, complete with analysis by indications, stage of development, 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 Transmembrane Prolyl 4 Hydroxylase (Hypoxia Inducible Factor Prolyl Hydroxylase 4 or P4HTM or EC 1.14.11.) targeted therapeutics development 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.

Updated report will be delivered in 48 hours of order confirmation.

Scope

The report provides a snapshot of the global therapeutic landscape for Transmembrane Prolyl 4 Hydroxylase (Hypoxia Inducible Factor Prolyl Hydroxylase 4 or P4HTM or EC 1.14.11.)

The report reviews Transmembrane Prolyl 4 Hydroxylase (Hypoxia Inducible Factor Prolyl Hydroxylase 4 or P4HTM or EC 1.14.11.) targeted therapeutics under development 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 in Transmembrane Prolyl 4 Hydroxylase (Hypoxia Inducible Factor Prolyl Hydroxylase 4 or P4HTM or EC 1.14.11.) targeted therapeutics and enlists all their major and minor projects

The report assesses Transmembrane Prolyl 4 Hydroxylase (Hypoxia Inducible Factor Prolyl Hydroxylase 4 or P4HTM or EC 1.14.11.) targeted therapeutics based on 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 and deals related to Transmembrane Prolyl 4 Hydroxylase (Hypoxia Inducible Factor Prolyl Hydroxylase 4 or P4HTM or EC 1.14.11.) targeted therapeutics

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 the targeted therapy areas and indications for Transmembrane Prolyl 4 Hydroxylase (Hypoxia Inducible Factor Prolyl Hydroxylase 4 or P4HTM or EC 1.14.11.)

Identify the use of drugs for target identification and drug repurposing

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 Transmembrane Prolyl 4 Hydroxylase (Hypoxia Inducible Factor Prolyl Hydroxylase 4 or P4HTM or EC 1.14.11.) development landscape

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

Companies mentioned

Akebia Therapeutics, Inc.

Bayer AG

Daiichi Sankyo Company, Limited

FibroGen, Inc.

GlaxoSmithKline Plc

Japan Tobacco Inc.

Merck & Co., Inc.

Sigmoid Pharma Limited

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 5

List of Figures 5

Introduction 6

Global Markets Direct Report Coverage 6

Transmembrane Prolyl 4 Hydroxylase (Hypoxia Inducible Factor Prolyl Hydroxylase 4 or P4HTM or EC

1.14.11.) Overview 7

Therapeutics Development 8

Transmembrane Prolyl 4 Hydroxylase (Hypoxia Inducible Factor Prolyl Hydroxylase 4 or P4HTM or EC

1.14.11.) - Products under Development by Stage of Development 8

Transmembrane Prolyl 4 Hydroxylase (Hypoxia Inducible Factor Prolyl Hydroxylase 4 or P4HTM or EC

1.14.11.) - Products under Development by Therapy Area 9

Transmembrane Prolyl 4 Hydroxylase (Hypoxia Inducible Factor Prolyl Hydroxylase 4 or P4HTM or EC

1.14.11.) - Products under Development by Indication 10

Transmembrane Prolyl 4 Hydroxylase (Hypoxia Inducible Factor Prolyl Hydroxylase 4 or P4HTM or EC

1.14.11.) - Pipeline Products Glance 11

Late Stage Products 11

Early Stage Products 12

Transmembrane Prolyl 4 Hydroxylase (Hypoxia Inducible Factor Prolyl Hydroxylase 4 or P4HTM or EC

1.14.11.) - Products under Development by Companies 13

Transmembrane Prolyl 4 Hydroxylase (Hypoxia Inducible Factor Prolyl Hydroxylase 4 or P4HTM or EC

1.14.11.) - Therapeutics Assessment 15

Assessment by Monotherapy/Combination Products 15

Assessment by Mechanism of Action 16

Assessment by Route of Administration 17

Assessment by Molecule Type 19

Transmembrane Prolyl 4 Hydroxylase (Hypoxia Inducible Factor Prolyl Hydroxylase 4 or P4HTM or EC

1.14.11.) - Companies Involved in Therapeutics Development 20

Akebia Therapeutics, Inc. 20

Bayer AG 21

Daiichi Sankyo Company, Limited 22

FibroGen, Inc. 23

GlaxoSmithKline Plc 24

Japan Tobacco Inc. 25

Merck & Co., Inc. 26

Sigmoid Pharma Limited 27

Transmembrane Prolyl 4 Hydroxylase (Hypoxia Inducible Factor Prolyl Hydroxylase 4 or P4HTM or EC

1.14.11.) - Drug Profiles 28

AKB-6899 - Drug Profile 28

Product Description 28

Mechanism Of Action 28

R&D Progress 28

daprodustat - Drug Profile 29

Product Description 29

Mechanism Of Action 29

R&D Progress 29

dimethyloxalylglycine - Drug Profile 31

Product Description 31

Mechanism Of Action 31

R&D Progress 31

DS-1093 - Drug Profile 32

Product Description 32

Mechanism Of Action 32

R&D Progress 32

FG-2216 - Drug Profile 33

Product Description 33

Mechanism Of Action 33

R&D Progress 33

FG-4497 - Drug Profile 35

Product Description 35

Mechanism Of Action 35

R&D Progress 35

FG-6874 - Drug Profile 36

Product Description 36

Mechanism Of Action 36

R&D Progress 36

FG-8205 - Drug Profile 37

Product Description 37

Mechanism Of Action 37

R&D Progress 37

JTZ-951 - Drug Profile 38

Product Description 38

Mechanism Of Action 38

R&D Progress 38

molidustat - Drug Profile 39

Product Description 39

Mechanism Of Action 39

R&D Progress 39

roxadustat - Drug Profile 41

Product Description 41

Mechanism Of Action 41

R&D Progress 41

Small Molecules to Inhibit Prolyl Hydroxylase for Anemia - Drug Profile 47

Product Description 47

Mechanism Of Action 47

R&D Progress 47

vadadustat - Drug Profile 48

Product Description 48

Mechanism Of Action 48

R&D Progress 48

Transmembrane Prolyl 4 Hydroxylase (Hypoxia Inducible Factor Prolyl Hydroxylase 4 or P4HTM or EC

1.14.11.) - Dormant Projects 54

Transmembrane Prolyl 4 Hydroxylase (Hypoxia Inducible Factor Prolyl Hydroxylase 4 or P4HTM or EC

1.14.11.) - Featured News & Press Releases 55

Sep 19, 2016: Akebia Announces Publication of Phase 2b Data for Vadadustat in Non-Dialysis Patients with Anemia Related to Chronic Kidney Disease 55

Aug 22, 2016: Akebia Announces Publication Highlighting Need for New Solutions in Treating Dialysis Patients 56

Aug 08, 2016: Akebia Initiates INNO2VATE Phase 3 Program for Vadadustat in Dialysis Patients With Anemia Related to Chronic Kidney Disease 56

Jul 25, 2016: Astellas And Fibrogen Announce First Patient Treated In Phase 3 Studies And Positive Phase 2 Results Of Roxadustat In Patients With Chronic Kidney Disease In Japan 57

Jun 09, 2016: Fibrogen Announces Initiation By Astellas Of Phase 3 Clinical Study In Japan Of Roxadustat/ASP1517 For The Treatment Of Anemia Of Chronic Kidney Disease Triggering $10.0 Million Milestone Payment 58

May 23, 2016: Akebia Announces Positive Vadadustat Data Demonstrating No Clinically Significant Drug-Drug Interaction 59

May 05, 2016: Akebia Provides Update On Phase 3 INNO2VATE Program For Vadadustat 59

Apr 26, 2016: Akebia Therapeutics Announces Presentation of Vadadustat Phase 2 Dialysis Data at Upcoming National Kidney Foundation 2016 Spring Clinical Meetings 60

Apr 20, 2016: Promising Phase 2 Data Show Roxadustat Corrected Anemia In Chronic Kidney Disease Patients Before Intervention With Dialysis 61

Mar 09, 2016: Akebia Prevails in European Patent Dispute and Preserves Access to Key Market for Vadadustat 62

Feb 16, 2016: FibroGen Publishes Encouraging Phase 2 Anemia Data Demonstrating Roxadustat’s Ability to Maintain Hemoglobin Levels in Patients With Chronic Kidney Disease 62

Jan 04, 2016: Akebia Initiates Phase 3 PRO2TECT Program 64

Nov 07, 2015: Akebia Announces Presentation of Vadadustat Phase 2 Dialysis Data at American Society of Nephrology Kidney Week 2015 Annual Meeting 65

Nov 03, 2015: FibroGen to Present Roxadustat Clinical Data in Four Presentations at American Society of Nephrology - Kidney Week 2015 66

Oct 28, 2015: Akebia Announces Presentations at the Upcoming American Society of Nephrology Kidney Week 2015 Annual Meeting 67

Appendix 69

Methodology 69

Coverage 69

Secondary Research 69

Primary Research 69

Expert Panel Validation 69

Contact Us 69

Disclaimer 70

List of Tables

List of Tables

Number of Products under Development for, H2 2016 8

Number of Products under Development by Therapy Area, H2 2016 9

Number of Products under Development by Indication, H2 2016 10

Comparative Analysis by Late Stage Development, H2 2016 11

Comparative Analysis by Early Stage Products, H2 2016 12

Number of Products under Development by Companies, H2 2016 13

Products under Development by Companies, H2 2016 14

Assessment by Monotherapy/Combination Products, H2 2016 15

Number of Products by Stage and Mechanism of Action, H2 2016 16

Number of Products by Stage and Route of Administration, H2 2016 18

Number of Products by Stage and Molecule Type, H2 2016 19

Pipeline by Akebia Therapeutics, Inc., H2 2016 20

Pipeline by Bayer AG, H2 2016 21

Pipeline by Daiichi Sankyo Company, Limited, H2 2016 22

Pipeline by FibroGen, Inc., H2 2016 23

Pipeline by GlaxoSmithKline Plc, H2 2016 24

Pipeline by Japan Tobacco Inc., H2 2016 25

Pipeline by Merck & Co., Inc., H2 2016 26

Pipeline by Sigmoid Pharma Limited, H2 2016 27

Dormant Projects, H2 2016 54

List of Figures

List of Figures

Number of Products under Development for, H2 2016 8

Number of Products under Development by Therapy Area, H2 2016 9

Number of Products under Development by Top 10 Indication, H2 2016 10

Comparative Analysis by Late Stage Development, H2 2016 11

Comparative Analysis by Early Stage Products, H2 2016 12

Assessment by Monotherapy/Combination Products, H2 2016 15

Number of Products by Stage and Mechanism of Actions, H2 2016 16

Number of Products by Routes of Administration, H2 2016 17

Number of Products by Stage and Routes of Administration, H2 2016 17

Number of Products by Stage and Molecule Type, H2 2016 19

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