Fragile X Syndrome - Pipeline Review, H1 2016 Summary Global Markets Direct's, ‘Fragile X Syndrome - Pipeline Review, H1 2016', provides an overview of the Fragile X Syndrome pipeline landscape. The report provides comprehensive information on the therapeutics under development for Fragile X Syndrome, 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 Fragile X Syndrome 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 Fragile X Syndrome - The report reviews pipeline therapeutics for Fragile X Syndrome 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 Fragile X Syndrome therapeutics and enlists all their major and minor projects - The report assesses Fragile X Syndrome 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 Fragile X Syndrome 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 Fragile X Syndrome - 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 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
Table of Content
Table of Contents 2 List of Tables 6 List of Figures 7 Introduction 8 Global Markets Direct Report Coverage 8 Fragile X Syndrome Overview 9 Therapeutics Development 10 Pipeline Products for Fragile X Syndrome - Overview 10 Pipeline Products for Fragile X Syndrome - Comparative Analysis 11 Fragile X Syndrome - Therapeutics under Development by Companies 12 Fragile X Syndrome - Therapeutics under Investigation by Universities/Institutes 13 Fragile X Syndrome - Pipeline Products Glance 14 Clinical Stage Products 14 Early Stage Products 15 Fragile X Syndrome - Products under Development by Companies 16 Fragile X Syndrome - Products under Investigation by Universities/Institutes 17 Fragile X Syndrome - Companies Involved in Therapeutics Development 18 Aelis Farma SAS 18 Alcobra Ltd 19 AMO Pharma Limited 20 Confluence Pharmaceuticals LLC 21 Eli Lilly and Company 22 F. Hoffmann-La Roche Ltd. 23 Marinus Pharmaceuticals, Inc. 24 MI.TO. Technology S.r.L. 25 Neuren Pharmaceuticals Limited 26 Ovid Therapeutics Inc. 27 Sage Therapeutics, Inc. 28 Zynerba Pharmaceuticals, Inc. 29 Fragile X Syndrome - Therapeutics Assessment 30 Assessment by Monotherapy Products 30 Assessment by Target 31 Assessment by Mechanism of Action 33 Assessment by Route of Administration 35 Assessment by Molecule Type 37 Drug Profiles 39 acamprosate calcium - Drug Profile 39 Product Description 39 Mechanism of Action 39 R&D Progress 39 ACT-01 - Drug Profile 40 Product Description 40 Mechanism of Action 40 R&D Progress 40 AMO-01 - Drug Profile 41 Product Description 41 Mechanism of Action 41 R&D Progress 41 basimglurant - Drug Profile 42 Product Description 42 Mechanism of Action 42 R&D Progress 42 Bryostatin-1 - Drug Profile 44 Product Description 44 Mechanism of Action 44 R&D Progress 44 cercosporamide - Drug Profile 46 Product Description 46 Mechanism of Action 46 R&D Progress 46 flindokalner - Drug Profile 48 Product Description 48 Mechanism of Action 48 R&D Progress 48 gaboxadol - Drug Profile 49 Product Description 49 Mechanism of Action 49 R&D Progress 49 ganaxolone - Drug Profile 51 Product Description 51 Mechanism of Action 51 R&D Progress 51 Metadoxine ER - Drug Profile 53 Product Description 53 Mechanism of Action 53 R&D Progress 53 minocycline - 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 SGE-872 - Drug Profile 57 Product Description 57 Mechanism of Action 57 R&D Progress 57 Small Molecule for FXTAS - Drug Profile 58 Product Description 58 Mechanism of Action 58 R&D Progress 58 Small Molecule to Antagonize CB1R for Fragile X Syndrome and Down Syndrome - Drug Profile 59 Product Description 59 Mechanism of Action 59 R&D Progress 59 Small Molecules to Agonize 5-HT7 for Fragile X Syndrome - Drug Profile 60 Product Description 60 Mechanism of Action 60 R&D Progress 60 Small Molecules to Inhibit PI3K for Autism and Fragile X Syndrome - Drug Profile 61 Product Description 61 Mechanism of Action 61 R&D Progress 61 SRT-278 - Drug Profile 62 Product Description 62 Mechanism of Action 62 R&D Progress 62 trofinetide - Drug Profile 63 Product Description 63 Mechanism of Action 63 R&D Progress 63 ZYN-002 - Drug Profile 66 Product Description 66 Mechanism of Action 66 R&D Progress 66 Fragile X Syndrome - Recent Pipeline Updates 67 Fragile X Syndrome - Dormant Projects 83 Fragile X Syndrome - Discontinued Products 85 Fragile X Syndrome - Product Development Milestones 86 Featured News & Press Releases 86 Mar 08, 2016: Neurotrope Announces Publication Demonstrating Synaptic Regeneration with the PKC epsilon Activator Bryostatin, in a Fragile X Disease Late Brain Development Model 86 Feb 25, 2016: Zynerba Pharmaceuticals Announces ZYN002 Granted Orphan Drug Designation for Fragile X Syndrome 86 Jan 06, 2016: Zynerba Pharmaceuticals Announces Positive Initial Results From ZYN002 CBD Gel Phase 1 Single Rising Dose Trial and Initiation of Phase 1 Multiple Rising Dose Trial 87 Dec 07, 2015: Neuren's trofinetide successful in proof of concept Phase 2 clinical trial in Fragile X syndrome 88 Nov 30, 2015: Neuren receives grant of composition patent in Europe for NNZ-2591 90 Sep 29, 2015: Neuren provides update on Fragile X and
List of Tables
Number of Products under Development for Fragile X Syndrome, H1 2016 10 Number of Products under Development for Fragile X Syndrome - Comparative Analysis, H1 2016 11 Number of Products under Development by Companies, H1 2016 12 Number of Products under Investigation by Universities/Institutes, H1 2016 13 Comparative Analysis by Clinical Stage Development, H1 2016 14 Comparative Analysis by Early Stage Development, H1 2016 15 Products under Development by Companies, H1 2016 16 Products under Investigation by Universities/Institutes, H1 2016 17 Fragile X Syndrome - Pipeline by Aelis Farma SAS, H1 2016 18 Fragile X Syndrome - Pipeline by Alcobra Ltd, H1 2016 19 Fragile X Syndrome - Pipeline by AMO Pharma Limited, H1 2016 20 Fragile X Syndrome - Pipeline by Confluence Pharmaceuticals LLC, H1 2016 21 Fragile X Syndrome - Pipeline by Eli Lilly and Company, H1 2016 22 Fragile X Syndrome - Pipeline by F. Hoffmann-La Roche Ltd., H1 2016 23 Fragile X Syndrome - Pipeline by Marinus Pharmaceuticals, Inc., H1 2016 24 Fragile X Syndrome - Pipeline by MI.TO. Technology S.r.L., H1 2016 25 Fragile X Syndrome - Pipeline by Neuren Pharmaceuticals Limited, H1 2016 26 Fragile X Syndrome - Pipeline by Ovid Therapeutics Inc., H1 2016 27 Fragile X Syndrome - Pipeline by Sage Therapeutics, Inc., H1 2016 28 Fragile X Syndrome - Pipeline by Zynerba Pharmaceuticals, Inc., H1 2016 29 Assessment by Monotherapy Products, H1 2016 30 Number of Products by Stage and Target, H1 2016 32 Number of Products by Stage and Mechanism of Action, H1 2016 34 Number of Products by Stage and Route of Administration, H1 2016 36 Number of Products by Stage and Molecule Type, H1 2016 38 Fragile X Syndrome Therapeutics - Recent Pipeline Updates, H1 2016 67 Fragile X Syndrome - Dormant Projects, H1 2016 83 Fragile X Syndrome - Dormant Projects (Contd..1), H1 2016 84 Fragile X Syndrome - Discontinued Products, H1 2016 85
List of Figures
Number of Products under Development for Fragile X Syndrome, H1 2016 10 Number of Products under Development for Fragile X Syndrome - Comparative Analysis, H1 2016 11 Number of Products under Development by Companies, H1 2016 12 Number of Products under Investigation by Universities/Institutes, H1 2016 13 Comparative Analysis by Clinical Stage Development, H1 2016 14 Comparative Analysis by Early Stage Products, H1 2016 15 Assessment by Monotherapy Products, H1 2016 30 Number of Products by Top 10 Targets, H1 2016 31 Number of Products by Stage and Top 10 Targets, H1 2016 31 Number of Products by Top 10 Mechanism of Actions, H1 2016 33 Number of Products by Stage and Top 10 Mechanism of Actions, H1 2016 33 Number of Products by Routes of Administration, H1 2016 35 Number of Products by Stage and Routes of Administration, H1 2016 35 Number of Products by Molecule Types, H1 2016 37 Number of Products by Stage and Top 10 Molecule Types, H1 2016 37
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