Pituitary ACTH Hypersecretion (Cushing Disease) – Pipeline Review, H2 2016

Global Markets Direct’s, ‘Pituitary ACTH Hypersecretion (Cushing Disease) – Pipeline Review, H2 2016’, provides an overview of the Pituitary ACTH Hypersecretion (Cushing Disease) pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Pituitary ACTH Hypersecretion (Cushing 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 Pituitary ACTH Hypersecretion (Cushing 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 Pituitary ACTH Hypersecretion (Cushing Disease)

The report reviews pipeline therapeutics for Pituitary ACTH Hypersecretion (Cushing 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 Pituitary ACTH Hypersecretion (Cushing Disease) therapeutics and enlists all their major and minor projects

The report assesses Pituitary ACTH Hypersecretion (Cushing 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 Pituitary ACTH Hypersecretion (Cushing 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 Pituitary ACTH Hypersecretion (Cushing 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 Pituitary ACTH Hypersecretion (Cushing 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

Amryt Pharma plc

Corcept Therapeutics Inc

Cyclacel Pharmaceuticals Inc

ElexoPharm GmbH

Ipsen SA

Millendo Therapeutics Inc

Novartis AG

Orphagen Pharmaceuticals Inc

Pfizer Inc

Reset Therapeutics Inc

Strongbridge Biopharma plc

XOMA Corp

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 5

List of Figures 6

Introduction 7

Global Markets Direct Report Coverage 7

Pituitary ACTH Hypersecretion (Cushing Disease) Overview 8

Therapeutics Development 9

Pipeline Products for Pituitary ACTH Hypersecretion (Cushing Disease) - Overview 9

Pipeline Products for Pituitary ACTH Hypersecretion (Cushing Disease) - Comparative Analysis 10

Pituitary ACTH Hypersecretion (Cushing Disease) - Therapeutics under Development by Companies 11

Pituitary ACTH Hypersecretion (Cushing Disease) - Therapeutics under Investigation by Universities/Institutes 12

Pituitary ACTH Hypersecretion (Cushing Disease) - Pipeline Products Glance 13

Late Stage Products 13

Clinical Stage Products 14

Early Stage Products 15

Pituitary ACTH Hypersecretion (Cushing Disease) - Products under Development by Companies 16

Pituitary ACTH Hypersecretion (Cushing Disease) - Products under Investigation by Universities/Institutes 17

Pituitary ACTH Hypersecretion (Cushing Disease) - Companies Involved in Therapeutics Development 18

Amryt Pharma plc 18

Corcept Therapeutics Inc 19

Cyclacel Pharmaceuticals Inc 20

ElexoPharm GmbH 21

Ipsen SA 22

Millendo Therapeutics Inc 23

Novartis AG 24

Orphagen Pharmaceuticals Inc 25

Pfizer Inc 26

Reset Therapeutics Inc 27

Strongbridge Biopharma plc 28

XOMA Corp 29

Pituitary ACTH Hypersecretion (Cushing Disease) - Therapeutics Assessment 30

Assessment by Monotherapy Products 30

Assessment by Target 31

Assessment by Mechanism of Action 34

Assessment by Route of Administration 37

Assessment by Molecule Type 39

Drug Profiles 41

AP-102 - Drug Profile 41

Product Description 41

Mechanism Of Action 41

R&D Progress 41

ATR-101 - Drug Profile 43

Product Description 43

Mechanism Of Action 43

R&D Progress 43

BIM-23B065 - Drug Profile 45

Product Description 45

Mechanism Of Action 45

R&D Progress 45

ketoconazole - Drug Profile 46

Product Description 46

Mechanism Of Action 46

R&D Progress 46

levoketoconazole - Drug Profile 47

Product Description 47

Mechanism Of Action 47

R&D Progress 47

mifepristone - Drug Profile 50

Product Description 50

Mechanism Of Action 50

R&D Progress 50

Monoclonal Antibodies to Antagonize Adrenal Corticotropic Hormone Receptor for Cushing’s Disease - Drug Profile 56

Product Description 56

Mechanism Of Action 56

R&D Progress 56

MPP-482 - Drug Profile 57

Product Description 57

Mechanism Of Action 57

R&D Progress 57

osilodrostat phosphate - Drug Profile 58

Product Description 58

Mechanism Of Action 58

R&D Progress 58

pasireotide ER - Drug Profile 60

Product Description 60

Mechanism Of Action 60

R&D Progress 60

seliciclib - Drug Profile 63

Product Description 63

Mechanism Of Action 63

R&D Progress 63

Small Molecule to Antagonize Melanocortin Receptor 2 for Cushing's Disease and Congenital Adrenal Hyperplasia - Drug Profile 65

Product Description 65

Mechanism Of Action 65

R&D Progress 65

Small Molecules to Antagonize Steroidogenic Factor-1 for Endometriosis, Cancer and Cushing's Disease - Drug Profile 66

Product Description 66

Mechanism Of Action 66

R&D Progress 66

Small Molecules to Inhibit CYP11B1 for Cushing's Disease and Subclinical Hypercortisolism - Drug Profile 67

Product Description 67

Mechanism Of Action 67

R&D Progress 67

Small Molecules to Modulate Cryptochrome for Metabolic and CNS Disorders - Drug Profile 68

Product Description 68

Mechanism Of Action 68

R&D Progress 68

veldoreotide - Drug Profile 69

Product Description 69

Mechanism Of Action 69

R&D Progress 69

Pituitary ACTH Hypersecretion (Cushing Disease) - Dormant Projects 72

Pituitary ACTH Hypersecretion (Cushing Disease) - Discontinued Products 73

Pituitary ACTH Hypersecretion (Cushing Disease) - Product Development Milestones 74

Featured News & Press Releases 74

Jul 02, 2015: First Patient Dosed in IST of CDK Inhibitor Seliciclib in Cushing's Disease, a Serious Endocrine Disorder 74

Jan 29, 2015: COR-003 Phase 3 Study Protocol to be Presented at ENDO 2015: The Endocrine Society’s 97th Annual Meeting & Expo 74

Oct 03, 2014: Cortendo AB to Present at the 13th Annual BIO Investor Forum in San Francisco October 7, 2014 75

Sep 30, 2014: Cortendo AB to Present at the Epic Biotech Conference in London on October 2, 2014 75

Sep 29, 2014: Cortendo AB to Present at the 14th Annual BIOTECH in Europe Forum in Basel September 30, 2014 75

Aug 12, 2014: First Patient Enrolled into NormoCort Phase 3 SONICS Trial Following a Successful EU Investigator Meeting 75

Jul 09, 2014: CORTENDO Reports Continued Progress On Phase 3 SONICS Trial 76

Jul 30, 2012: Cortendo's NormoCort Receives Orphan Drug Designation From EMA To Treat Cushing’s Syndrome 76

Mar 15, 2012: Cortendo Receives FDA Orphan Drug Designation For NormoCort In Cushing’s Syndrome 77

Appendix 78

Methodology 78

Coverage 78

Secondary Research 78

Primary Research 78

Expert Panel Validation 78

Contact Us 78

Disclaimer 79

List of Tables

List of Tables

Number of Products under Development for Pituitary ACTH Hypersecretion (Cushing Disease), H2 2016 9

Number of Products under Development for Pituitary ACTH Hypersecretion (Cushing Disease) – Comparative Analysis, H2 2016 10

Number of Products under Development by Companies, H2 2016 11

Number of Products under Investigation by Universities/Institutes, H2 2016 12

Comparative Analysis by Late Stage Development, H2 2016 13

Comparative Analysis by Clinical Stage Development, H2 2016 14

Comparative Analysis by Early Stage Development, H2 2016 15

Products under Development by Companies, H2 2016 16

Products under Investigation by Universities/Institutes, H2 2016 17

Pituitary ACTH Hypersecretion (Cushing Disease) – Pipeline by Amryt Pharma plc, H2 2016 18

Pituitary ACTH Hypersecretion (Cushing Disease) – Pipeline by Corcept Therapeutics Inc, H2 2016 19

Pituitary ACTH Hypersecretion (Cushing Disease) – Pipeline by Cyclacel Pharmaceuticals Inc, H2 2016 20

Pituitary ACTH Hypersecretion (Cushing Disease) – Pipeline by ElexoPharm GmbH, H2 2016 21

Pituitary ACTH Hypersecretion (Cushing Disease) – Pipeline by Ipsen SA, H2 2016 22

Pituitary ACTH Hypersecretion (Cushing Disease) – Pipeline by Millendo Therapeutics Inc, H2 2016 23

Pituitary ACTH Hypersecretion (Cushing Disease) – Pipeline by Novartis AG, H2 2016 24

Pituitary ACTH Hypersecretion (Cushing Disease) – Pipeline by Orphagen Pharmaceuticals Inc, H2 2016 25

Pituitary ACTH Hypersecretion (Cushing Disease) – Pipeline by Pfizer Inc, H2 2016 26

Pituitary ACTH Hypersecretion (Cushing Disease) – Pipeline by Reset Therapeutics Inc, H2 2016 27

Pituitary ACTH Hypersecretion (Cushing Disease) – Pipeline by Strongbridge Biopharma plc, H2 2016 28

Pituitary ACTH Hypersecretion (Cushing Disease) – Pipeline by XOMA Corp, H2 2016 29

Assessment by Monotherapy Products, H2 2016 30

Number of Products by Stage and Target, H2 2016 32

Number of Products by Stage and Mechanism of Action, H2 2016 35

Number of Products by Stage and Route of Administration, H2 2016 38

Number of Products by Stage and Molecule Type, H2 2016 40

Pituitary ACTH Hypersecretion (Cushing Disease) – Dormant Projects, H2 2016 72

Pituitary ACTH Hypersecretion (Cushing Disease) – Discontinued Products, H2 2016 73

List of Figures

List of Figures

Number of Products under Development for Pituitary ACTH Hypersecretion (Cushing Disease), H2 2016 9

Number of Products under Development for Pituitary ACTH Hypersecretion (Cushing Disease) – Comparative Analysis, H2 2016 10

Number of Products under Development by Companies, H2 2016 11

Comparative Analysis by Late Stage Development, H2 2016 13

Comparative Analysis by Clinical Stage Development, H2 2016 14

Comparative Analysis by Early Stage Products, H2 2016 15

Assessment by Monotherapy Products, H2 2016 30

Number of Products by Top 10 Targets, H2 2016 31

Number of Products by Stage and Top 10 Targets, H2 2016 31

Number of Products by Top 10 Mechanism of Actions, H2 2016 34

Number of Products by Stage and Top 10 Mechanism of Actions, H2 2016 34

Number of Products by Routes of Administration, H2 2016 37

Number of Products by Stage and Routes of Administration, H2 2016 37

Number of Products by Molecule Types, H2 2016 39

Number of Products by Stage and Top 10 Molecule Types, H2 2016 39

    Pricing

Discounts available for multiple report purchases.

reportstore@globalmarketsdirect.com
+44 (0) 161 359 5414

Saved reports