Secondary (Hypogonadotropic) Hypogonadism – Pipeline Review, H2 2017

Global Markets Direct’s, ‘Secondary (Hypogonadotropic) Hypogonadism – Pipeline Review, H2 2017’, provides an overview of the Secondary (Hypogonadotropic) Hypogonadism pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Secondary (Hypogonadotropic) Hypogonadism, 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 Secondary (Hypogonadotropic) Hypogonadism 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 Secondary (Hypogonadotropic) Hypogonadism

The report reviews pipeline therapeutics for Secondary (Hypogonadotropic) Hypogonadism 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 Secondary (Hypogonadotropic) Hypogonadism therapeutics and enlists all their major and minor projects

The report assesses Secondary (Hypogonadotropic) Hypogonadism 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 Secondary (Hypogonadotropic) Hypogonadism

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 Secondary (Hypogonadotropic) Hypogonadism

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 Secondary (Hypogonadotropic) Hypogonadism 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

Merck & Co Inc

Mereo Biopharma Group Plc

Repros Therapeutics Inc

The Female Health Company

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 4

List of Figures 4

Introduction 5

Global Markets Direct Report Coverage 5

Secondary (Hypogonadotropic) Hypogonadism - Overview 6

Secondary (Hypogonadotropic) Hypogonadism - Therapeutics Development 7

Pipeline Overview 7

Pipeline by Companies 8

Pipeline by Universities/Institutes 9

Products under Development by Companies 10

Products under Development by Universities/Institutes 11

Secondary (Hypogonadotropic) Hypogonadism - Therapeutics Assessment 12

Assessment by Target 12

Assessment by Mechanism of Action 14

Assessment by Route of Administration 16

Assessment by Molecule Type 18

Secondary (Hypogonadotropic) Hypogonadism - Companies Involved in Therapeutics Development 20

Merck & Co Inc 20

Mereo Biopharma Group Plc 20

Repros Therapeutics Inc 21

The Female Health Company 21

Secondary (Hypogonadotropic) Hypogonadism - Drug Profiles 23

BGS-649 - Drug Profile 23

Product Description 23

Mechanism Of Action 23

R&D Progress 23

corifollitropin alfa - Drug Profile 25

Product Description 25

Mechanism Of Action 25

R&D Progress 25

enclomiphene citrate - Drug Profile 27

Product Description 27

Mechanism Of Action 27

R&D Progress 27

IAS-167A - Drug Profile 41

Product Description 41

Mechanism Of Action 41

R&D Progress 41

Kisspeptin-10 - Drug Profile 42

Product Description 42

Mechanism Of Action 42

R&D Progress 42

leuprolide acetate - Drug Profile 44

Product Description 44

Mechanism Of Action 44

R&D Progress 44

MSS-722 - Drug Profile 45

Product Description 45

Mechanism Of Action 45

R&D Progress 45

testosterone undecanoate - Drug Profile 46

Product Description 46

Mechanism Of Action 46

R&D Progress 46

Secondary (Hypogonadotropic) Hypogonadism - Dormant Projects 47

Secondary (Hypogonadotropic) Hypogonadism - Discontinued Products 48

Secondary (Hypogonadotropic) Hypogonadism - Product Development Milestones 49

Featured News & Press Releases 49

Sep 05, 2017: Completion of Patient Enrolment in Phase 2b dose-confirmation study of BGS-649 for the treatment of hypogonadotropic hypogonadism 49

Mar 07, 2017: Mereo BioPharma Group: Positive recommendation for BGS-649 Phase 2b trial following planned IDMC interim analysis 49

Dec 06, 2016: FDA Advisory Committee Discusses Clinical Trial Designs for Obesity-Related Hypogonadism 50

Oct 05, 2016: Repros Announces Acceptance of Dossier for Enclomiphene for Secondary Hypogonadism by European Authorities 50

Sep 12, 2016: Repros Announces Submission of MAA to the European Medicines Agency for Enclomiphene in the Treatment of Secondary Hypogonadism 51

Aug 15, 2016: Repros Provides Six Month Interim Results for Enclomiphene Study in Obese Secondary Hypogonadal Men 51

Jun 01, 2016: Repros Provides Update on EU Submission of Enclomiphene for the Treatment of Secondary Hypogonadism and 3 Month Interim Results for Enclomiphene Study in Obese Secondary Hypogonadal Men 53

Mar 15, 2016: Repros Announces Initiation of Formal Approval Process by the European Medicines Agency 53

Feb 16, 2016: Repros Completes Randomization of Enclomiphene Phase 2 Proof of Concept Study in Obese Secondary Hypogonadal Men 54

Feb 08, 2016: Repros Holds Meeting With FDA to Discuss Complete Response Letter for Enclomiphene in the Treatment of Secondary Hypogonadism 55

Jan 11, 2016: Repros Announces Court of Appeals' Affirmation of Summary Judgment in Favor of the Company 55

Jan 04, 2016: Repros Updates Enclomiphene Program 55

Dec 01, 2015: Repros Therapeutics Receives Complete Response Letter From FDA for Enclomiphene 55

Oct 29, 2015: Repros Therapeutics Announces Cancellation of FDA Advisory Committee Meeting to Review Enclomiphene for the Treatment of Secondary Hypogonadism 56

Jun 08, 2015: Repros Announces Date of FDA Advisory Committee Review of NDA 56

Appendix 57

Methodology 57

Coverage 57

Secondary Research 57

Primary Research 57

Expert Panel Validation 57

Contact Us 57

Disclaimer 58

List of Tables

List of Tables

Number of Products under Development for Secondary (Hypogonadotropic) Hypogonadism, H2 2017 7

Number of Products under Development by Companies, H2 2017 8

Number of Products under Development by Universities/Institutes, H2 2017 9

Products under Development by Companies, H2 2017 10

Products under Development by Universities/Institutes, H2 2017 11

Number of Products by Stage and Target, H2 2017 13

Number of Products by Stage and Mechanism of Action, H2 2017 15

Number of Products by Stage and Route of Administration, H2 2017 17

Number of Products by Stage and Molecule Type, H2 2017 19

Secondary (Hypogonadotropic) Hypogonadism – Pipeline by Merck & Co Inc, H2 2017 20

Secondary (Hypogonadotropic) Hypogonadism – Pipeline by Mereo Biopharma Group Plc, H2 2017 21

Secondary (Hypogonadotropic) Hypogonadism – Pipeline by Repros Therapeutics Inc, H2 2017 21

Secondary (Hypogonadotropic) Hypogonadism – Pipeline by The Female Health Company, H2 2017 22

Secondary (Hypogonadotropic) Hypogonadism – Dormant Projects, H2 2017 47

Secondary (Hypogonadotropic) Hypogonadism – Discontinued Products, H2 2017 48

List of Figures

List of Figures

Number of Products under Development for Secondary (Hypogonadotropic) Hypogonadism, H2 2017 7

Number of Products under Development by Companies, H2 2017 8

Number of Products by Targets, H2 2017 12

Number of Products by Stage and Targets, H2 2017 12

Number of Products by Mechanism of Actions, H2 2017 14

Number of Products by Stage and Mechanism of Actions, H2 2017 14

Number of Products by Routes of Administration, H2 2017 16

Number of Products by Stage and Routes of Administration, H2 2017 16

Number of Products by Molecule Types, H2 2017 18

Number of Products by Stage and Molecule Types, H2 2017 18

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