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Autism - Pipeline Review, H1 2016

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

Autism - Pipeline Review, H1 2016

Summary

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

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

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 Autism
- 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 Autism 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

Autism - Pipeline Review, H1 2016
Table of Contents
Table of Contents 2
List of Tables 7
List of Figures 8
Introduction 9
Global Markets Direct Report Coverage 9
Autism Overview 10
Therapeutics Development 11
Pipeline Products for Autism - Overview 11
Pipeline Products for Autism - Comparative Analysis 12
Autism - Therapeutics under Development by Companies 13
Autism - Therapeutics under Investigation by Universities/Institutes 15
Autism - Pipeline Products Glance 16
Late Stage Products 16
Clinical Stage Products 17
Early Stage Products 18
Unknown Stage Products 19
Autism - Products under Development by Companies 20
Autism - Products under Investigation by Universities/Institutes 22
Autism - Companies Involved in Therapeutics Development 23
Addex Therapeutics Ltd 23
Aequus Pharmaceuticals Inc. 24
AgeneBio Inc. 25
APeT Holding BV 26
Berg LLC 27
BioCrea GmbH 28
BrainStorm Cell Therapeutics Inc. 29
Cellceutix Corporation 30
Confluence Pharmaceuticals LLC 31
Curemark, LLC 32
Domain Therapeutics SA 33
F. Hoffmann-La Roche Ltd. 34
Heptares Therapeutics Limited 35
Intra-Cellular Therapies, Inc. 36
Luc Therapeutics, Inc. 37
MedDay 38
Omeros Corporation 39
Otsuka Holdings Co., Ltd. 40
Retrophin Inc. 41
Sage Therapeutics, Inc. 42
Saniona AB 43
Sumitomo Dainippon Pharma Co., Ltd. 44
Autism - Therapeutics Assessment 45
Assessment by Monotherapy Products 45
Assessment by Combination Products 46
Assessment by Target 47
Assessment by Mechanism of Action 49
Assessment by Route of Administration 52
Assessment by Molecule Type 54
Drug Profiles 56
(dextromethorphan + quinidine sulfate) - Drug Profile 56
Product Description 56
Mechanism of Action 56
RandD Progress 56
ADX-71441 - Drug Profile 58
Product Description 58
Mechanism of Action 58
RandD Progress 58
ADX-88178 - Drug Profile 59
Product Description 59
Mechanism of Action 59
RandD Progress 59
aripiprazole - Drug Profile 60
Product Description 60
Mechanism of Action 60
RandD Progress 60
aripiprazole - Drug Profile 62
Product Description 62
Mechanism of Action 62
RandD Progress 62
carbetocin - Drug Profile 63
Product Description 63
Mechanism of Action 63
RandD Progress 63
CM-AT - Drug Profile 64
Product Description 64
Mechanism of Action 64
RandD Progress 64
Drug for Autism - Drug Profile 65
Product Description 65
Mechanism of Action 65
RandD Progress 65
histamine dihydrochloride - Drug Profile 66
Product Description 66
Mechanism of Action 66
RandD Progress 66
HTL-14242 - Drug Profile 67
Product Description 67
Mechanism of Action 67
RandD Progress 67
ITI-007 - Drug Profile 68
Product Description 68
Mechanism of Action 68
RandD Progress 68
KM-391 - Drug Profile 71
Product Description 71
Mechanism of Action 71
RandD Progress 71
lurasidone hydrochloride - Drug Profile 73
Product Description 73
Mechanism of Action 73
RandD Progress 73
MD-1103 - Drug Profile 76
Product Description 76
Mechanism of Action 76
RandD Progress 76
niacinamide CR - Drug Profile 77
Product Description 77
Mechanism of Action 77
RandD Progress 77
oxytocin - Drug Profile 78
Product Description 78
Mechanism of Action 78
RandD Progress 78
RG-7314 - Drug Profile 79
Product Description 79
Mechanism of Action 79
RandD Progress 79
SF-999 - Drug Profile 80
Product Description 80
Mechanism of Action 80
RandD Progress 80
SGE-872 - Drug Profile 81
Product Description 81
Mechanism of Action 81
RandD Progress 81
Small Molecule to Agonise GABRA5 Receptor for CNS Disorders - Drug Profile 82
Product Description 82
Mechanism of Action 82
RandD Progress 82
Small Molecule to Agonize GABAA Receptor Subunit Alpha-5 for Autism - Drug Profile 83
Product Description 83
Mechanism of Action 83
RandD Progress 83
Small Molecule to Target GPR63 for Autism - Drug Profile 84
Product Description 84
Mechanism of Action 84
RandD Progress 84
Small Molecule to Target Oxytocin for Autism and Anxiety Disorders - Drug Profile 85
Product Description 85
Mechanism of Action 85
RandD Progress 85
Small Molecules to Agonize GABAA-Beta 2 Receptor for Epilepsy and Autism - Drug Profile 86
Product Description 86
Mechanism of Action 86
RandD Progress 86
Small Molecules to Agonize Metabotropic Glutamate Receptor 4 for Autism - Drug Profile 87
Product Description 87
Mechanism of Action 87
RandD Progress 87
Small Molecules to Antagonize NMDA2A for Central Nervous System Disorders - Drug Profile 88
Product Description 88
Mechanism of Action 88
RandD Progress 88
Small Molecules to Inhibit PI3K for Autism and Fragile X Syndrome - Drug Profile 89
Product Description 89
Mechanism of Action 89
RandD Progress 89
Small Molecules to Inhibit Translation Initiation Factor-4E for Autism and Oncology - Drug Profile 90
Product Description 90
Mechanism of Action 90
RandD Progress 90
SNA-1 - Drug Profile 91
Product Description 91
Mechanism of Action 91
RandD Progress 91
Stem Cell Therapy for Multiple Sclerosis, Rheumatoid Arthritis, Osteoarthritis, Autism and Bronchopulmonary Dysplasia - Drug Profile 92
Product Description 92
Mechanism of Action 92
RandD Progress 92
Stem Cell Therapy for Neurodegenerative Disorders - Drug Profile 93
Product Description 93
Mechanism of Action 93
RandD Progress 93
Autism - Recent Pipeline Updates 96
Autism - Dormant Projects 128
Autism - Discontinued Products 130
Autism - Product Development Milestones 131
Featured News and Press Releases 131
Feb 04, 2016: Aequus Announces Positive Results from Single-Dose Bioavailability Study of Aripiprazole Transdermal Patch 131
Dec 07, 2015: Otsuka Files for Approval in Japan for an Additional Indication for the Antipsychotic ABILIFY: Excitability Associated with Juvenile Autism 131
Jul 23, 2015: Positive Preclinical Results and Patent Allowed for Aequus' Once-Weekly Transdermal Aripiprazole 132
May 11, 2015: Curemark Launches New Phase III Trial in Expanded Population of Children with Autism 132
Nov 04, 2013: Curemark Begins NDA Submission for CM-AT Autism Treatment 133
Sep 06, 2013: Avanir Pharmaceuticals Announces Settlement of NUEDEXTA Patent Litigation with Wockhardt 133
Sep 03, 2013: Avanir Pharmaceuticals Announces Settlement of NUEDEXTA Patent Litigation with Actavis 133
Aug 14, 2013: Avanir Pharmaceuticals Announces Settlement of NUEDEXTA Patent Litigation with Sandoz 134
Apr 23, 2013: Curemark Announces Positive Pre-NDA Meeting With FDA For New Drug Application For CM-AT For Autism 134
Aug 15, 2012: Omeros Unlocks Over Half Of Class A Orphan G Protein-Coupled Receptors 134
Appendix 136
Methodology 136
Coverage 136
Secondary Research 136
Primary Research 136
Expert Panel Validation 136
Contact Us 136
Disclaimer 137

List of Tables
Number of Products under Development for Autism, H1 2016 11
Number of Products under Development for Autism - Comparative Analysis, H1 2016 12
Number of Products under Development by Companies, H1 2016 14
Number of Products under Investigation by Universities/Institutes, H1 2016 15
Comparative Analysis by Late Stage Development, H1 2016 16
Comparative Analysis by Clinical Stage Development, H1 2016 17
Comparative Analysis by Early Stage Development, H1 2016 18
Comparative Analysis by Unknown Stage Development, H1 2016 19
Products under Development by Companies, H1 2016 20
Products under Development by Companies, H1 2016 (Contd..1) 21
Products under Investigation by Universities/Institutes, H1 2016 22
Autism - Pipeline by Addex Therapeutics Ltd, H1 2016 23
Autism - Pipeline by Aequus Pharmaceuticals Inc., H1 2016 24
Autism - Pipeline by AgeneBio Inc., H1 2016 25
Autism - Pipeline by APeT Holding BV, H1 2016 26
Autism - Pipeline by Berg LLC, H1 2016 27
Autism - Pipeline by BioCrea GmbH, H1 2016 28
Autism - Pipeline by BrainStorm Cell Therapeutics Inc., H1 2016 29
Autism - Pipeline by Cellceutix Corporation, H1 2016 30
Autism - Pipeline by Confluence Pharmaceuticals LLC, H1 2016 31
Autism - Pipeline by Curemark, LLC, H1 2016 32
Autism - Pipeline by Domain Therapeutics SA, H1 2016 33
Autism - Pipeline by F. Hoffmann-La Roche Ltd., H1 2016 34
Autism - Pipeline by Heptares Therapeutics Limited, H1 2016 35
Autism - Pipeline by Intra-Cellular Therapies, Inc., H1 2016 36
Autism - Pipeline by Luc Therapeutics, Inc., H1 2016 37
Autism - Pipeline by MedDay, H1 2016 38
Autism - Pipeline by Omeros Corporation, H1 2016 39
Autism - Pipeline by Otsuka Holdings Co., Ltd., H1 2016 40
Autism - Pipeline by Retrophin Inc., H1 2016 41
Autism - Pipeline by Sage Therapeutics, Inc., H1 2016 42
Autism - Pipeline by Saniona AB, H1 2016 43
Autism - Pipeline by Sumitomo Dainippon Pharma Co., Ltd., H1 2016 44
Assessment by Monotherapy Products, H1 2016 45
Assessment by Combination Products, H1 2016 46
Number of Products by Stage and Target, H1 2016 48
Number of Products by Stage and Mechanism of Action, H1 2016 50
Number of Products by Stage and Route of Administration, H1 2016 53
Number of Products by Stage and Molecule Type, H1 2016 55
Autism Therapeutics - Recent Pipeline Updates, H1 2016 96
Autism - Dormant Projects, H1 2016 128
Autism - Dormant Projects (Contd..1), H1 2016 129
Autism - Discontinued Products, H1 2016 130

List of Figures
Number of Products under Development for Autism, H1 2016 11
Number of Products under Development for Autism - Comparative Analysis, H1 2016 12
Number of Products under Development by Companies, H1 2016 13
Comparative Analysis by Late Stage Development, H1 2016 16
Comparative Analysis by Clinical Stage Development, H1 2016 17
Comparative Analysis by Early Stage Products, H1 2016 18
Assessment by Monotherapy Products, H1 2016 45
Number of Products by Top 10 Targets, H1 2016 47
Number of Products by Stage and Top 10 Targets, H1 2016 47
Number of Products by Top 10 Mechanism of Actions, H1 2016 49
Number of Products by Stage and Top 10 Mechanism of Actions, H1 2016 49
Number of Products by Routes of Administration, H1 2016 52
Number of Products by Stage and Routes of Administration, H1 2016 52
Number of Products by Molecule Types, H1 2016 54
Number of Products by Stage and Molecule Types, H1 2016 54

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