Polycystic Kidney Disease – Pipeline Review, H2 2017

Global Markets Direct’s, ‘Polycystic Kidney Disease – Pipeline Review, H2 2017’, provides an overview of the Polycystic Kidney Disease pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Polycystic Kidney Disease, 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 Polycystic Kidney Disease 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 Polycystic Kidney Disease

The report reviews pipeline therapeutics for Polycystic Kidney Disease 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 Polycystic Kidney Disease therapeutics and enlists all their major and minor projects

The report assesses Polycystic Kidney Disease 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 Polycystic Kidney Disease

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 Polycystic Kidney Disease

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 Polycystic Kidney Disease 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

Angion Biomedica Corp

Aptevo Therapeutics Inc

Celgene Corp

Conatus Pharmaceuticals Inc

DiscoveryBiomed Inc

Endocyte Inc

IC-MedTech Inc

Ipsen SA

Kadmon Corp LLC

Madrigal Pharmaceuticals Inc.

ManRos Therapeutics

Metabolic Solutions Development Company LLC

Mironid Ltd

NovaTarg Therapeutics Inc

Otsuka Holdings Co Ltd

Q BioMed Inc

Regulus Therapeutics Inc

XORTX Pharma Corp

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 6

List of Figures 6

Introduction 7

Global Markets Direct Report Coverage 7

Polycystic Kidney Disease - Overview 8

Polycystic Kidney Disease - Therapeutics Development 9

Pipeline Overview 9

Pipeline by Companies 10

Pipeline by Universities/Institutes 13

Products under Development by Companies 14

Products under Development by Universities/Institutes 16

Polycystic Kidney Disease - Therapeutics Assessment 17

Assessment by Target 17

Assessment by Mechanism of Action 19

Assessment by Route of Administration 21

Assessment by Molecule Type 23

Polycystic Kidney Disease - Companies Involved in Therapeutics Development 25

Angion Biomedica Corp 25

Aptevo Therapeutics Inc 25

Celgene Corp 26

Conatus Pharmaceuticals Inc 26

DiscoveryBiomed Inc 27

Endocyte Inc 27

IC-MedTech Inc 28

Ipsen SA 28

Kadmon Corp LLC 29

Madrigal Pharmaceuticals Inc. 29

ManRos Therapeutics 30

Metabolic Solutions Development Company LLC 30

Mironid Ltd 30

NovaTarg Therapeutics Inc 31

Otsuka Holdings Co Ltd 31

Q BioMed Inc 32

Regulus Therapeutics Inc 32

XORTX Pharma Corp 32

Polycystic Kidney Disease - Drug Profiles 33

(sodium ascorbate + menadione sodium bisulfite) - Drug Profile 33

Product Description 33

Mechanism Of Action 33

R&D Progress 33

ANG-3070 - Drug Profile 35

Product Description 35

Mechanism Of Action 35

R&D Progress 35

CIM-2 - Drug Profile 36

Product Description 36

Mechanism Of Action 36

R&D Progress 36

CR-8 - Drug Profile 37

Product Description 37

Mechanism Of Action 37

R&D Progress 37

DBM-43H11 - Drug Profile 38

Product Description 38

Mechanism Of Action 38

R&D Progress 38

Drug for Cystic Kidney Disease - Drug Profile 39

Product Description 39

Mechanism Of Action 39

R&D Progress 39

EC-0371 - Drug Profile 40

Product Description 40

Mechanism Of Action 40

R&D Progress 40

IDN-8050 - Drug Profile 41

Product Description 41

Mechanism Of Action 41

R&D Progress 41

JP-153 - Drug Profile 42

Product Description 42

Mechanism Of Action 42

R&D Progress 42

lanreotide acetate - Drug Profile 43

Product Description 43

Mechanism Of Action 43

R&D Progress 43

lixivaptan - Drug Profile 49

Product Description 49

Mechanism Of Action 49

R&D Progress 49

menadione sodium bisulfite - Drug Profile 51

Product Description 51

Mechanism Of Action 51

R&D Progress 51

MSDC-0160 - Drug Profile 52

Product Description 52

Mechanism Of Action 52

R&D Progress 52

oxypurinol - Drug Profile 55

Product Description 55

Mechanism Of Action 55

R&D Progress 55

pyrimethamine - Drug Profile 56

Product Description 56

Mechanism Of Action 56

R&D Progress 56

RGLS-4326 - Drug Profile 57

Product Description 57

Mechanism Of Action 57

R&D Progress 57

ricolinostat - Drug Profile 58

Product Description 58

Mechanism Of Action 58

R&D Progress 58

Small Molecule to Inhibit EnaC and CFTR for Cystic Fibrosis, Secretory Diarrhea and Autosomal Dominant Polycystic Kidney Disease - Drug Profile 66

Product Description 66

Mechanism Of Action 66

R&D Progress 66

Small Molecules to Activate AMPK for Polycystic Kidney Disease - Drug Profile 67

Product Description 67

Mechanism Of Action 67

R&D Progress 67

Small Molecules to Inhibit Hsp90 for Polycystic Kidney Disease - Drug Profile 68

Product Description 68

Mechanism Of Action 68

R&D Progress 68

Small Molecules to Inhibit PDE4 for Polycystic Kidney Disease and Oncology - Drug Profile 69

Product Description 69

Mechanism Of Action 69

R&D Progress 69

STA-2842 - Drug Profile 70

Product Description 70

Mechanism Of Action 70

R&D Progress 70

tesevatinib tosylate - Drug Profile 71

Product Description 71

Mechanism Of Action 71

R&D Progress 71

TNFR x TWEAKR - Drug Profile 75

Product Description 75

Mechanism Of Action 75

R&D Progress 75

tolvaptan - Drug Profile 76

Product Description 76

Mechanism Of Action 76

R&D Progress 76

Polycystic Kidney Disease - Dormant Projects 81

Polycystic Kidney Disease - Discontinued Products 82

Polycystic Kidney Disease - Product Development Milestones 83

Featured News & Press Releases 83

Oct 04, 2017: Palladio Biosciences Receives Orphan Drug Designation from the U.S. FDA for Lixivaptan for the Treatment of Autosomal Dominant Polycystic Kidney Disease 83

Jun 12, 2017: Palladio Biosciences Announces Appointment of Frank C. Condella, Jr. to Board of Directors 83

Jun 12, 2017: Regulus Announces Pipeline Update and Advancement on RGLS-4326 84

May 22, 2017: Otsuka Announces Results of Phase 3 Data on Tolvaptan Under Development for ADPKD in U.S 84

May 22, 2017: Otsuka Announces Results of Phase 3 Data on Tolvaptan Under Development for ADPKD in U.S. 84

Mar 16, 2017: Otsuka Pharmaceutical Receives Approval for the Additional Formulation of Samsca Granules 1% in Japan 85

Feb 16, 2017: Regulus Announces Publication in Nature Communications Identifying miR-17 as a Promising Drug Target for ADPKD 85

Dec 06, 2016: Regulus Announces Update on RGLS4326 85

Nov 19, 2016: Kadmon to Present Additional Data Demonstrating Tesevatinib Safety for the Treatment of Polycystic Kidney Disease at ASN Kidney Week 2016 86

Jan 11, 2016: Scottish Medicines Consortium Issues Positive Advice For First Ever Treatment For Autosomal dominant polycystic kidney disease 86

Nov 02, 2015: Kadmon to Present Clinical Data on Tesevatinib for the Treatment of Polycystic Kidney Disease at ASN's Kidney Week 2015 87

May 28, 2015: Otsuka’s JINARC the First-Ever Treatment Approved in Europe for Adults Living with ADPKD, a Chronic Genetic Kidney Disease 88

Apr 14, 2015: DiscoveryBioMed is developing a novel and unprecedented “dual action” small molecule monotherapy for all cystic fibrosis (CF) patients and for other chronic larger market or rare lung and vascular diseases 89

Feb 27, 2015: CHMP Recommends JINARC (Tolvaptan) for Approval in EU: The First Pharmaceutical Treatment for Autosomal Dominant Polycystic Kidney Disease 90

Feb 26, 2015: First-Ever Treatment Approved in Canada for Adults Living with ADPKD, a Life-Threatening Kidney Disease 90

Appendix 92

Methodology 92

Coverage 92

Secondary Research 92

Primary Research 92

Expert Panel Validation 92

Contact Us 92

Disclaimer 93

List of Tables

List of Tables

Number of Products under Development for Polycystic Kidney Disease, H2 2017 9

Number of Products under Development by Companies, H2 2017 11

Number of Products under Development by Companies, H2 2017 (Contd..1), H2 2017 12

Number of Products under Development by Universities/Institutes, H2 2017 13

Products under Development by Companies, H2 2017 14

Products under Development by Companies, H2 2017 (Contd..1), H2 2017 15

Products under Development by Universities/Institutes, H2 2017 16

Number of Products by Stage and Target, H2 2017 18

Number of Products by Stage and Mechanism of Action, H2 2017 20

Number of Products by Stage and Route of Administration, H2 2017 22

Number of Products by Stage and Molecule Type, H2 2017 24

Polycystic Kidney Disease – Pipeline by Angion Biomedica Corp, H2 2017 25

Polycystic Kidney Disease – Pipeline by Aptevo Therapeutics Inc, H2 2017 25

Polycystic Kidney Disease – Pipeline by Celgene Corp, H2 2017 26

Polycystic Kidney Disease – Pipeline by Conatus Pharmaceuticals Inc, H2 2017 26

Polycystic Kidney Disease – Pipeline by DiscoveryBiomed Inc, H2 2017 27

Polycystic Kidney Disease – Pipeline by Endocyte Inc, H2 2017 27

Polycystic Kidney Disease – Pipeline by IC-MedTech Inc, H2 2017 28

Polycystic Kidney Disease – Pipeline by Ipsen SA, H2 2017 28

Polycystic Kidney Disease – Pipeline by Kadmon Corp LLC, H2 2017 29

Polycystic Kidney Disease – Pipeline by Madrigal Pharmaceuticals Inc., H2 2017 29

Polycystic Kidney Disease – Pipeline by ManRos Therapeutics, H2 2017 30

Polycystic Kidney Disease – Pipeline by Metabolic Solutions Development Company LLC, H2 2017 30

Polycystic Kidney Disease – Pipeline by Mironid Ltd, H2 2017 30

Polycystic Kidney Disease – Pipeline by NovaTarg Therapeutics Inc, H2 2017 31

Polycystic Kidney Disease – Pipeline by Otsuka Holdings Co Ltd, H2 2017 31

Polycystic Kidney Disease – Pipeline by Q BioMed Inc, H2 2017 32

Polycystic Kidney Disease – Pipeline by Regulus Therapeutics Inc, H2 2017 32

Polycystic Kidney Disease – Pipeline by XORTX Pharma Corp, H2 2017 32

Polycystic Kidney Disease – Dormant Projects, H2 2017 81

Polycystic Kidney Disease – Discontinued Products, H2 2017 82

List of Figures

List of Figures

Number of Products under Development for Polycystic Kidney Disease, H2 2017 9

Number of Products under Development by Companies, H2 2017 10

Number of Products by Top 10 Targets, H2 2017 17

Number of Products by Stage and Top 10 Targets, H2 2017 17

Number of Products by Top 10 Mechanism of Actions, H2 2017 19

Number of Products by Stage and Top 10 Mechanism of Actions, H2 2017 19

Number of Products by Routes of Administration, H2 2017 21

Number of Products by Stage and Routes of Administration, H2 2017 21

Number of Products by Molecule Types, H2 2017 23

Number of Products by Stage and Molecule Types, H2 2017 23

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