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Published: Sep, 2016 | Pages:
117 | Publisher: Global Markets Direct
Industry: Pharmaceuticals & Healthcare | Report Format: Electronic (PDF)
Fragile X Syndrome - Pipeline Review, H2 2016 Summary Global Markets Direct's, 'Fragile X Syndrome - Pipeline Review, H2 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 Contents
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 14 Fragile X Syndrome - Pipeline Products Glance 15 Late Stage Products 15 Clinical Stage Products 16 Early 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 Aelis Farma SAS 21 Alcobra Ltd 22 AMO Pharma Limited 23 Anavex Life Sciences Corp. 24 Confluence Pharmaceuticals LLC 25 DRI Biosciences Corporation 26 Eli Lilly and Company 27 GlaxoSmithKline Plc 28 GW Pharmaceuticals Plc 29 Kareus Therapeutics, SA 30 Marinus Pharmaceuticals, Inc. 31 Neuren Pharmaceuticals Limited 32 Neuron Biopharma SA 33 Ovid Therapeutics Inc. 34 Sage Therapeutics, Inc. 35 Zynerba Pharmaceuticals, Inc. 36 Fragile X Syndrome - Therapeutics Assessment 37 Assessment by Monotherapy Products 37 Assessment by Target 38 Assessment by Mechanism of Action 40 Assessment by Route of Administration 42 Assessment by Molecule Type 44 Drug Profiles 46 acamprosate calcium - Drug Profile 46 Product Description 46 Mechanism Of Action 46 R&D Progress 46 ACT-01 - Drug Profile 47 Product Description 47 Mechanism Of Action 47 R&D Progress 47 AMO-01 - Drug Profile 48 Product Description 48 Mechanism Of Action 48 R&D Progress 48 ANAVEX-273 - Drug Profile 49 Product Description 49 Mechanism Of Action 49 R&D Progress 49 Bryostatin-1 - Drug Profile 57 Product Description 57 Mechanism Of Action 57 R&D Progress 57 cercosporamide - Drug Profile 61 Product Description 61 Mechanism Of Action 61 R&D Progress 61 Drug to Antagonize mGluR5 for Fragile X Syndrome and 16p11.2 Microdeletion Syndrome - Drug Profile 62 Product Description 62 Mechanism Of Action 62 R&D Progress 62 flindokalner - Drug Profile 63 Product Description 63 Mechanism Of Action 63 R&D Progress 63 gaboxadol - Drug Profile 64 Product Description 64 Mechanism Of Action 64 R&D Progress 64 ganaxolone - Drug Profile 66 Product Description 66 Mechanism Of Action 66 R&D Progress 66 JRP-655 - Drug Profile 71 Product Description 71 Mechanism Of Action 71 R&D Progress 71 KU-046 - Drug Profile 72 Product Description 72 Mechanism Of Action 72 R&D Progress 72 metadoxine ER - Drug Profile 73 Product Description 73 Mechanism Of Action 73 R&D Progress 73 NNZ-2591 - Drug Profile 79 Product Description 79 Mechanism Of Action 79 R&D Progress 79 NST-0076 - Drug Profile 81 Product Description 81 Mechanism Of Action 81 R&D Progress 81 SGE-872 - Drug Profile 82 Product Description 82 Mechanism Of Action 82 R&D Progress 82 Small Molecule for Fragile X-Associated Tremor Ataxia Syndrome - Drug Profile 83 Product Description 83 Mechanism Of Action 83 R&D Progress 83 Small Molecule to Activate FMRP for Fragile X Syndrome - Drug Profile 84 Product Description 84 Mechanism Of Action 84 R&D Progress 84 Small Molecule to Antagonize CB1R for Fragile X Syndrome and Down Syndrome - Drug Profile 85 Product Description 85 Mechanism Of Action 85 R&D Progress 85 Small Molecules to Activate Slack Channels for Fragile X Syndrome - Drug Profile 86 Product Description 86 Mechanism Of Action 86 R&D Progress 86 Small Molecules to Agonize Cannabinoid Receptor 2 for Fragile X Syndrome, Pervasive Developmental Disorder and Rett Syndrome - Drug Profile 87 Product Description 87 Mechanism Of Action 87 R&D Progress 87 Small Molecules to Block Kv3.1 for Fragile X Syndrome - Drug Profile 88 Product Description 88 Mechanism Of Action 88 R&D Progress 88 Small Molecules to Inhibit PI3K for Autism and Fragile X Syndrome - Drug Profile 89 Product Description 89 Mechanism Of Action 89 R&D Progress 89 SRT-278 - Drug Profile 90 Product Description 90 Mechanism Of Action 90 R&D Progress 90 TC-2153 - Drug Profile 91 Product Description 91 Mechanism Of Action 91 R&D Progress 91 trofinetide - Drug Profile 92 Product Description 92 Mechanism Of Action 92 R&D Progress 92 ZYN-002 - Drug Profile 98 Product Description 98 Mechanism Of Action 98 R&D Progress 98 Fragile X Syndrome - Dormant Projects 101 Fragile X Syndrome - Discontinued Products 103 Fragile X Syndrome - Product Development Milestones 104 Featured News & Press Releases 104 Jul 19, 2016: Alcobra Granted European Orphan Drug Designation for Metadoxine in Fragile X Syndrome 104 Jun 28, 2016: Results from Phase 2 Exploratory Clinical Study Support Continued Development of Ganaxolone in Fragile X Syndrome 104 Jun 27, 2016: Marinus Pharmaceuticals to Host Conference Call on Tuesday, June 28 105 Jun 27, 2016: Zynerba Pharmaceuticals Announces Positive Top Line Results from ZYN002 CBD Gel Phase 1 Multiple Rising Dose Trial and Initiation of Phase 2 Study in Adult Epilepsy Patients with Refractory Focal Seizures 106 Jun 22, 2016: Neuren receives grant of new Australian patent for trofinetide to treat Autism Spectrum Disorders 107 Jun 21, 2016: Bryostatin, a PKC epsilon Activator, Generates New Synapses Through Accumulation of the Synaptic Anchoring Protein PSD-95 at Neuronal Membranes 107 Jun 13, 2016: Neurotrope's Chief Scientific Officer Dr. Daniel Alkon Presents at the Gordon Conference: Drugs That Target Common Mechanisms for Synaptic Restoration in Mental Retardation and Alzheimer's Disease 108 Jun 07, 2016: AMO Pharma Presents Pre-clinical Data Showing AMO-01 Successfully Inhibits Activated Pathway Associated with Fragile X Syndrome 108 Jun 06, 2016: Anavex Announces Positive Preclinical Results with ANAVEX 2-73 in Fragile X - Autism-Related Disorders 109 Apr 12, 2016: Cannabis and Cannabinoid Research Publishes Data Demonstrating the Degradation of Cannabidiol to Psychoactive Cannabinoids when Exposed to Simulated Gastric Fluid 110 Mar 08, 2016: Neurotrope Announces Publication Demonstrating Synaptic Regeneration with the PKC epsilon Activator Bryostatin, in a Fragile X Disease Late Brain Development Model 111 Feb 25, 2016: Zynerba Pharmaceuticals Announces ZYN002 Granted Orphan Drug Designation for Fragile X Syndrome 111 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 112 Dec 07, 2015: Neuren's trofinetide successful in proof of concept Phase 2 clinical trial in Fragile X syndrome 113 Nov 30, 2015: Neuren receives grant of composition patent in Europe for NNZ-2591 115 Appendix 116 Methodology 116 Coverage 116 Secondary Research 116 Primary Research 116 Expert Panel Validation 116 Contact Us 116 Disclaimer 117
List of Tables
Number of Products under Development for Fragile X Syndrome, H2 2016 10 Number of Products under Development for Fragile X Syndrome - Comparative Analysis, H2 2016 11 Number of Products under Development by Companies, H2 2016 13 Number of Products under Investigation by Universities/Institutes, H2 2016 14 Comparative Analysis by Late Stage Development, H2 2016 15 Comparative Analysis by Clinical Stage Development, H2 2016 16 Comparative Analysis by Early Stage Development, H2 2016 17 Products under Development by Companies, H2 2016 18 Products under Development by Companies, H2 2016 (Contd..1) 19 Products under Investigation by Universities/Institutes, H2 2016 20 Fragile X Syndrome - Pipeline by Aelis Farma SAS, H2 2016 21 Fragile X Syndrome - Pipeline by Alcobra Ltd, H2 2016 22 Fragile X Syndrome - Pipeline by AMO Pharma Limited, H2 2016 23 Fragile X Syndrome - Pipeline by Anavex Life Sciences Corp., H2 2016 24 Fragile X Syndrome - Pipeline by Confluence Pharmaceuticals LLC, H2 2016 25 Fragile X Syndrome - Pipeline by DRI Biosciences Corporation, H2 2016 26 Fragile X Syndrome - Pipeline by Eli Lilly and Company, H2 2016 27 Fragile X Syndrome - Pipeline by GlaxoSmithKline Plc, H2 2016 28 Fragile X Syndrome - Pipeline by GW Pharmaceuticals Plc, H2 2016 29 Fragile X Syndrome - Pipeline by Kareus Therapeutics, SA, H2 2016 30 Fragile X Syndrome - Pipeline by Marinus Pharmaceuticals, Inc., H2 2016 31 Fragile X Syndrome - Pipeline by Neuren Pharmaceuticals Limited, H2 2016 32 Fragile X Syndrome - Pipeline by Neuron Biopharma SA, H2 2016 33 Fragile X Syndrome - Pipeline by Ovid Therapeutics Inc., H2 2016 34 Fragile X Syndrome - Pipeline by Sage Therapeutics, Inc., H2 2016 35 Fragile X Syndrome - Pipeline by Zynerba Pharmaceuticals, Inc., H2 2016 36 Assessment by Monotherapy Products, H2 2016 37 Number of Products by Stage and Target, H2 2016 39 Number of Products by Stage and Mechanism of Action, H2 2016 41 Number of Products by Stage and Route of Administration, H2 2016 43 Number of Products by Stage and Molecule Type, H2 2016 45 Fragile X Syndrome - Dormant Projects, H2 2016 101 Fragile X Syndrome - Dormant Projects (Contd..1), H2 2016 102 Fragile X Syndrome - Discontinued Products, H2 2016 103
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