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  4. > Male Hypogonadism - Pipeline Review, H1 2016

Male Hypogonadism - Pipeline Review, H1 2016

  • February 2016
  • -
  • Global Markets Direct
  • -
  • 111 pages

Male Hypogonadism - Pipeline Review, H1 2016

Summary

Global Markets Direct’s, ‘Male Hypogonadism - Pipeline Review, H1 2016’, provides an overview of the Male Hypogonadism pipeline landscape.

The report provides comprehensive information on the therapeutics under development for Male 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 Male 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 Male Hypogonadism
- The report reviews pipeline therapeutics for Male 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 Male Hypogonadism therapeutics and enlists all their major and minor projects
- The report assesses Male 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 Male 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 Male 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 Male 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

Table Of Contents

Male Hypogonadism - Pipeline Review, H1 2016
Table of Contents
Table of Contents 2
List of Tables 6
List of Figures 7
Introduction 8
Global Markets Direct Report Coverage 8
Male Hypogonadism Overview 9
Therapeutics Development 10
Pipeline Products for Male Hypogonadism - Overview 10
Pipeline Products for Male Hypogonadism - Comparative Analysis 11
Male Hypogonadism - Therapeutics under Development by Companies 12
Male Hypogonadism - Therapeutics under Investigation by Universities/Institutes 14
Male Hypogonadism - Pipeline Products Glance 15
Late Stage Products 15
Clinical Stage Products 16
Early Stage Products 17
Unknown Stage Products 18
Male Hypogonadism - Products under Development by Companies 19
Male Hypogonadism - Products under Investigation by Universities/Institutes 20
Male Hypogonadism - Companies Involved in Therapeutics Development 21
Antares Pharma, Inc. 21
Clarus Therapeutics, Inc. 22
Diurnal Limited 23
EndoCeutics, Inc. 24
Ferring International Center S.A. 25
Forendo Pharma Limited 26
Lipocine Inc. 27
M et P Pharma AG 28
Merck and Co., Inc. 29
Mereo Biopharma Group Limited 30
Millennium Pharmaceuticals, Inc. 31
Monosol Rx, LLC 32
Pantarhei Bioscience BV 33
Repros Therapeutics Inc. 34
Variant Pharmaceuticals, Inc. 35
Male Hypogonadism - Therapeutics Assessment 36
Assessment by Monotherapy Products 36
Assessment by Target 37
Assessment by Mechanism of Action 39
Assessment by Route of Administration 41
Assessment by Molecule Type 43
Drug Profiles 45
BGS-649 - Drug Profile 45
Product Description 45
Mechanism of Action 45
RandD Progress 45
corifollitropin alfa - Drug Profile 46
Product Description 46
Mechanism of Action 46
RandD Progress 46
enclomiphene citrate - Drug Profile 48
Product Description 48
Mechanism of Action 48
RandD Progress 48
fispemifene - Drug Profile 50
Product Description 50
Mechanism of Action 50
RandD Progress 50
Kisspeptin-10 - Drug Profile 52
Product Description 52
Mechanism of Action 52
RandD Progress 52
Libidua - Drug Profile 53
Product Description 53
Mechanism of Action 53
RandD Progress 53
LPCN-1111 - Drug Profile 54
Product Description 54
Mechanism of Action 54
RandD Progress 54
MSS-722 - Drug Profile 55
Product Description 55
Mechanism of Action 55
RandD Progress 55
T-2 - Drug Profile 56
Product Description 56
Mechanism of Action 56
RandD Progress 56
TAK-448 - Drug Profile 57
Product Description 57
Mechanism of Action 57
RandD Progress 57
Testavan - Drug Profile 58
Product Description 58
Mechanism of Action 58
RandD Progress 58
testosterone - Drug Profile 59
Product Description 59
Mechanism of Action 59
RandD Progress 59
testosterone - Drug Profile 62
Product Description 62
Mechanism of Action 62
RandD Progress 62
testosterone - Drug Profile 63
Product Description 63
Mechanism of Action 63
RandD Progress 63
testosterone - Drug Profile 64
Product Description 64
Mechanism of Action 64
RandD Progress 64
testosterone - Drug Profile 66
Product Description 66
Mechanism of Action 66
RandD Progress 66
testosterone enanthate - Drug Profile 68
Product Description 68
Mechanism of Action 68
RandD Progress 68
testosterone undecanoate - Drug Profile 70
Product Description 70
Mechanism of Action 70
RandD Progress 70
testosterone undecanoate - Drug Profile 72
Product Description 72
Mechanism of Action 72
RandD Progress 72
testosterone undecanoate - Drug Profile 74
Product Description 74
Mechanism of Action 74
RandD Progress 74
testosterone undecanoate - Drug Profile 75
Product Description 75
Mechanism of Action 75
RandD Progress 75
testosterone undecanoate - Drug Profile 76
Product Description 76
Mechanism of Action 76
RandD Progress 76
VAR-100 - Drug Profile 77
Product Description 77
Mechanism of Action 77
RandD Progress 77
Male Hypogonadism - Recent Pipeline Updates 78
Male Hypogonadism - Dormant Projects 103
Male Hypogonadism - Discontinued Products 104
Male Hypogonadism - Product Development Milestones 105
Featured News and Press Releases 105
Feb 16, 2016: Repros Completes Randomization of Enclomiphene Phase 2 Proof of Concept Study in Obese Secondary Hypogonadal Men 105
Feb 08, 2016: Repros Holds Meeting With FDA to Discuss Complete Response Letter for Enclomiphene in the Treatment of Secondary Hypogonadism 106
Feb 02, 2016: Apricus Biosciences to Present at the 18th Annual BIO CEO and Investor Conference and Provide Update on Fispemifene 106
Jan 11, 2016: Repros Announces Court of Appeals' Affirmation of Summary Judgment in Favor of the Company 106
Jan 07, 2016: Acerus Receives Health Canada Approval For NATESTO 106
Jan 04, 2016: Repros Updates Enclomiphene Program 107
Jan 04, 2016: Lipocine Announces First Patient Dosed in Phase 2B Clinical Study for LPCN 1111, a Novel Testosterone Replacement Therapy 108
Jan 04, 2016: Acerus Announces NATESTO Publication in Prominent Andrology Journal 108
Dec 07, 2015: Transdermal Delivery Solutions Announces Commencement of Clinical Trials of Hormone Replacement Technologies Testagen HypoSpray 109
Dec 01, 2015: Repros Therapeutics Receives Complete Response Letter From FDA for Enclomiphene 109
Appendix 110
Methodology 110
Coverage 110
Secondary Research 110
Primary Research 110
Expert Panel Validation 110
Contact Us 110
Disclaimer 111

List of Tables
Number of Products under Development for Male Hypogonadism, H1 2016 10
Number of Products under Development for Male Hypogonadism - Comparative Analysis, H1 2016 11
Number of Products under Development by Companies, H1 2016 13
Number of Products under Investigation by Universities/Institutes, H1 2016 14
Comparative Analysis by Late Stage Development, H1 2016 15
Comparative Analysis by Clinical Stage Development, H1 2016 16
Comparative Analysis by Early Stage Development, H1 2016 17
Comparative Analysis by Unknown Stage Development, H1 2016 18
Products under Development by Companies, H1 2016 19
Products under Investigation by Universities/Institutes, H1 2016 20
Male Hypogonadism - Pipeline by Antares Pharma, Inc., H1 2016 21
Male Hypogonadism - Pipeline by Clarus Therapeutics, Inc., H1 2016 22
Male Hypogonadism - Pipeline by Diurnal Limited, H1 2016 23
Male Hypogonadism - Pipeline by EndoCeutics, Inc., H1 2016 24
Male Hypogonadism - Pipeline by Ferring International Center S.A., H1 2016 25
Male Hypogonadism - Pipeline by Forendo Pharma Limited, H1 2016 26
Male Hypogonadism - Pipeline by Lipocine Inc., H1 2016 27
Male Hypogonadism - Pipeline by M et P Pharma AG, H1 2016 28
Male Hypogonadism - Pipeline by Merck and Co., Inc., H1 2016 29
Male Hypogonadism - Pipeline by Mereo Biopharma Group Limited, H1 2016 30
Male Hypogonadism - Pipeline by Millennium Pharmaceuticals, Inc., H1 2016 31
Male Hypogonadism - Pipeline by Monosol Rx, LLC, H1 2016 32
Male Hypogonadism - Pipeline by Pantarhei Bioscience BV, H1 2016 33
Male Hypogonadism - Pipeline by Repros Therapeutics Inc., H1 2016 34
Male Hypogonadism - Pipeline by Variant Pharmaceuticals, Inc., H1 2016 35
Assessment by Monotherapy Products, H1 2016 36
Number of Products by Stage and Target, H1 2016 38
Number of Products by Stage and Mechanism of Action, H1 2016 40
Number of Products by Stage and Route of Administration, H1 2016 42
Number of Products by Stage and Molecule Type, H1 2016 44
Male Hypogonadism Therapeutics - Recent Pipeline Updates, H1 2016 78
Male Hypogonadism - Dormant Projects, H1 2016 103
Male Hypogonadism - Discontinued Products, H1 2016 104

List of Figures
Number of Products under Development for Male Hypogonadism, H1 2016 10
Number of Products under Development for Male Hypogonadism - Comparative Analysis, H1 2016 11
Number of Products under Development by Companies, H1 2016 12
Comparative Analysis by Late Stage Development, H1 2016 15
Comparative Analysis by Clinical Stage Development, H1 2016 16
Assessment by Monotherapy Products, H1 2016 36
Number of Products by Targets, H1 2016 37
Number of Products by Stage and Targets, H1 2016 37
Number of Products by Top 10 Mechanism of Actions, H1 2016 39
Number of Products by Stage and Top 10 Mechanism of Actions, H1 2016 39
Number of Products by Routes of Administration, H1 2016 41
Number of Products by Stage and Routes of Administration, H1 2016 41
Number of Products by Molecule Types, H1 2016 43
Number of Products by Stage and Molecule Types, H1 2016 43

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