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Fragile X Syndrome - Pipeline Review, H1 2014
Publication Date Jun 2014
Product Type Report
Pages 92
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Fragile X Syndrome - Pipeline Review, H1 2014

Summary

Global Markets Direct’s, ‘Fragile X Syndrome - Pipeline Review, H1 2014’, provides an overview of the Fragile X Syndrome’s therapeutic pipeline.

This report provides comprehensive information on the therapeutic development for Fragile X Syndrome, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Fragile X Syndrome and special features on late-stage 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, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources, put together by Global Markets Direct’s team. Drug profiles/records featured in the report undergoes periodic updation following a stringent set of processes that ensures that all the profiles are updated with the latest set of information. Additionally, processes including live news & deals tracking, browser based alert-box and clinical trials registries tracking ensure that the most recent developments are captured on a real time basis.

The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products.

Note*: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease.

Scope

- The report provides a snapshot of the global therapeutic landscape of Fragile X Syndrome
- The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities
- The report reviews key players involved in the therapeutics development for Fragile X Syndrome and enlists all their major and minor projects
- The report summarizes all the dormant and discontinued pipeline projects
- A review of the Fragile X Syndrome products under development by companies and universities/research institutes based on information derived from company and industry-specific sources
- Pipeline products coverage based on various stages of development ranging from pre-registration till discovery and undisclosed stages
- A detailed assessment of monotherapy and combination therapy pipeline projects
- Coverage of the Fragile X Syndrome pipeline on the basis of target, MoA, route of administration and molecule type
- Latest news and deals relating related to pipeline products

Reasons to buy

- Provides strategically significant competitor information, analysis, and insights to formulate effective R&D development strategies
- Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage
- Develop strategic initiatives by understanding the focus areas of leading companies
- Identify and understand important and diverse types of therapeutics under development for Fragile X Syndrome
- Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline
- Devise corrective measures for pipeline projects by understanding Fragile X Syndrome 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

F. Hoffmann-La Roche Ltd. Paratek Pharmaceuticals, Inc. Neuren Pharmaceuticals Limited Cortex Pharmaceuticals, Inc. Seaside Therapeutics, LLC Snowdon Inc. Marinus Pharmaceuticals, Inc. Nexgenix Pharmaceuticals, LLC Alcobra Ltd Hua Medicine Ltd. Confluence Pharmaceuticals LLC

Table of Contents
Table of Contents 2
List of Tables 5
List of Figures 6
Introduction 7
Global Markets Direct Report Coverage 7
Fragile X Syndrome Overview 8
Therapeutics Development 9
Pipeline Products for Fragile X Syndrome - Overview 9
Pipeline Products for Fragile X Syndrome - Comparative Analysis 10
Fragile X Syndrome - Therapeutics under Development by Companies 11
Fragile X Syndrome - Therapeutics under Investigation by Universities/Institutes 13
Fragile X Syndrome - Pipeline Products Glance 14
Late Stage Products 14
Clinical Stage Products 15
Early Stage Products 16
Unknown Stage Products 17
Fragile X Syndrome - Products under Development by Companies 18
Fragile X Syndrome - Products under Investigation by Universities/Institutes 20
Fragile X Syndrome - Companies Involved in Therapeutics Development 21
F. Hoffmann-La Roche Ltd. 21
Paratek Pharmaceuticals, Inc. 22
Neuren Pharmaceuticals Limited 23
Cortex Pharmaceuticals, Inc. 24
Seaside Therapeutics, LLC 25
Snowdon Inc. 26
Marinus Pharmaceuticals, Inc. 27
Nexgenix Pharmaceuticals, LLC 28
Alcobra Ltd 29
Hua Medicine Ltd. 30
Confluence Pharmaceuticals LLC 31
MI.TO. Technology S.r.L. 32
Fragile X Syndrome - Therapeutics Assessment 33
Assessment by Monotherapy Products 33
Assessment by Target 34
Assessment by Mechanism of Action 37
Assessment by Route of Administration 40
Assessment by Molecule Type 42
Drug Profiles 44
arbaclofen - Drug Profile 44
Product Description 44
Mechanism of Action 44
R&D Progress 44
basimglurant - Drug Profile 46
Product Description 46
Mechanism of Action 46
R&D Progress 46
STX-107 - Drug Profile 47
Product Description 47
Mechanism of Action 47
R&D Progress 47
NNZ-2566 - Drug Profile 48
Product Description 48
Mechanism of Action 48
R&D Progress 48
ganaxolone - Drug Profile 50
Product Description 50
Mechanism of Action 50
R&D Progress 50
Metadoxine ER - Drug Profile 52
Product Description 52
Mechanism of Action 52
R&D Progress 52
CX-929 - Drug Profile 54
Product Description 54
Mechanism of Action 54
R&D Progress 54
PTK-MS-01 - Drug Profile 55
Product Description 55
Mechanism of Action 55
R&D Progress 55
NNZ-2591 - Drug Profile 56
Product Description 56
Mechanism of Action 56
R&D Progress 56
Small Molecules To Inhibit Pak Oncology And Genetic Disorders - Drug Profile 57
Product Description 57
Mechanism of Action 57
R&D Progress 57
Small Molecules for Neurological Disorders - Drug Profile 58
Product Description 58
Mechanism of Action 58
R&D Progress 58
STX-110 - Drug Profile 59
Product Description 59
Mechanism of Action 59
R&D Progress 59
Drugs to Inhibit mGluR5 for Fragile X Syndrome - Drug Profile 60
Product Description 60
Mechanism of Action 60
R&D Progress 60
acamprosate calcium - Drug Profile 61
Product Description 61
Mechanism of Action 61
R&D Progress 61
Small Molecules to Inhibit PI3K for Autism and Fragile X Syndrome - Drug Profile 62
Product Description 62
Mechanism of Action 62
R&D Progress 62
SRT-278 - Drug Profile 63
Product Description 63
Mechanism of Action 63
R&D Progress 63
Small Molecules to Agonize 5-HT7 for Fragile X Syndrome - Drug Profile 64
Product Description 64
Mechanism of Action 64
R&D Progress 64
Bryostatin 1 - Drug Profile 65
Product Description 65
Mechanism of Action 65
R&D Progress 65
Small molecules to Inhibit mGLUR5 for Fragile X Syndrome - Drug Profile 66
Product Description 66
Mechanism of Action 66
R&D Progress 66
Small Molecule for FXTAS - Drug Profile 67
Product Description 67
Mechanism of Action 67
R&D Progress 67
Fragile X Syndrome Program - Drug Profile 68
Product Description 68
Mechanism of Action 68
R&D Progress 68
Fragile X Syndrome - Recent Pipeline Updates 69
Fragile X Syndrome - Dormant Projects 82
Fragile X Syndrome - Discontinued Products 83
Fragile X Syndrome - Product Development Milestones 84
Featured News & Press Releases 84
May 12, 2014: Alcobra Presents Evidence of Novel Mechanism of Action for Metadoxine Extended Release (MDX) in Cognitive Disorders at the Society of Biological Psychiatry Annual Meeting 84
May 08, 2014: Alcobra Announces FDA Clearance of Protocol for Phase IIb Study of Metadoxine Extended Release in the Treatment of Fragile X Syndrome 85
May 01, 2014: Alcobra Issued New US Patent Covering Metadoxine Use for Cognitive Disorders 85
Apr 24, 2014: Alcobra to Present New Data for Metadoxine Extended Release at Upcoming Meetings 86
Apr 10, 2014: Alcobra Submits Protocol to FDA for Phase IIb Clinical Study of Metadoxine Extended Release in the Treatment of Fragile X Syndrome 86
Mar 06, 2014: Alcobra Announces FDA Clearance of IND for Metadoxine Extended Release 87
Jan 28, 2014: Neuren reports progress in its NNZ-2566 clinical trial programs 87
Jan 27, 2014: Alcobra Announces New Biomarker Finding in a Follow-Up Fragile X Animal Study for MG01CI 89
Dec 18, 2013: FDA Grants Orphan Drug Status to Metadoxine in Fragile X Syndrome 89
Oct 30, 2013: Neuren receives orphan drug designation from the FDA for NNZ-2566 in Fragile X Syndrome 90
Appendix 91
Methodology 91
Coverage 91
Secondary Research 91
Primary Research 91
Expert Panel Validation 91
Contact Us 92
Disclaimer 92

List of Tables
List of Tables
Number of Products under Development for Fragile X Syndrome, H1 2014 9
Number of Products under Development for Fragile X Syndrome - Comparative Analysis, H1 2014 10
Number of Products under Development by Companies, H1 2014 12
Number of Products under Investigation by Universities/Institutes, H1 2014 13
Comparative Analysis by Late Stage Development, H1 2014 14
Comparative Analysis by Clinical Stage Development, H1 2014 15
Comparative Analysis by Early Stage Development, H1 2014 16
Comparative Analysis by Unknown Stage Development, H1 2014 17
Products under Development by Companies, H1 2014 18
Products under Development by Companies, H1 2014 (Contd..1) 19
Products under Investigation by Universities/Institutes, H1 2014 20
Fragile X Syndrome - Pipeline by F. Hoffmann-La Roche Ltd., H1 2014 21
Fragile X Syndrome - Pipeline by Paratek Pharmaceuticals, Inc., H1 2014 22
Fragile X Syndrome - Pipeline by Neuren Pharmaceuticals Limited, H1 2014 23
Fragile X Syndrome - Pipeline by Cortex Pharmaceuticals, Inc., H1 2014 24
Fragile X Syndrome - Pipeline by Seaside Therapeutics, LLC, H1 2014 25
Fragile X Syndrome - Pipeline by Snowdon Inc., H1 2014 26
Fragile X Syndrome - Pipeline by Marinus Pharmaceuticals, Inc., H1 2014 27
Fragile X Syndrome - Pipeline by Nexgenix Pharmaceuticals, LLC, H1 2014 28
Fragile X Syndrome - Pipeline by Alcobra Ltd, H1 2014 29
Fragile X Syndrome - Pipeline by Hua Medicine Ltd., H1 2014 30
Fragile X Syndrome - Pipeline by Confluence Pharmaceuticals LLC, H1 2014 31
Fragile X Syndrome - Pipeline by MI.TO. Technology S.r.L., H1 2014 32
Assessment by Monotherapy Products, H1 2014 33
Number of Products by Stage and Target, H1 2014 36
Number of Products by Stage and Mechanism of Action, H1 2014 39
Number of Products by Stage and Route of Administration, H1 2014 41
Number of Products by Stage and Molecule Type, H1 2014 43
Fragile X Syndrome Therapeutics - Recent Pipeline Updates, H1 2014 69
Fragile X Syndrome - Dormant Projects, H1 2014 82
Fragile X Syndrome - Discontinued Products, H1 2014 83

List of Figures
List of Figures
Number of Products under Development for Fragile X Syndrome, H1 2014 9
Number of Products under Development for Fragile X Syndrome - Comparative Analysis, H1 2014 10
Number of Products under Development by Companies, H1 2014 11
Number of Products under Investigation by Universities/Institutes, H1 2014 13
Comparative Analysis by Early Stage Products, H1 2014 16
Assessment by Monotherapy Products, H1 2014 33
Number of Products by Top 10 Target, H1 2014 34
Number of Products by Stage and Top 10 Target, H1 2014 35
Number of Products by Top 10 Mechanism of Action, H1 2014 37
Number of Products by Stage and Top 10 Mechanism of Action, H1 2014 38
Number of Products by Top 10 Route of Administration, H1 2014 40
Number of Products by Stage and Top 10 Route of Administration, H1 2014 41
Number of Products by Top 10 Molecule Type, H1 2014 42
Number of Products by Stage and Top 10 Molecule Type, H1 2014 43

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