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 16
Autism – Pipeline Products Glance 17
Late Stage Products 17
Clinical Stage Products 18
Early Stage Products 19
Unknown Stage Products 20
Autism – Products under Development by Companies 21
Autism – Products under Investigation by Universities/Institutes 23
Autism – Companies Involved in Therapeutics Development 24
Addex Therapeutics Ltd 24
Avanir Pharmaceuticals, Inc. 25
BioCrea GmbH 26
BrainStorm Cell Therapeutics Inc. 27
Cellceutix Corporation 28
Confluence Pharmaceuticals LLC 29
Curemark, LLC 30
Edison Pharmaceuticals, Inc. 31
Egenix, Inc. 32
F. Hoffmann-La Roche Ltd. 33
Heptares Therapeutics Ltd. 34
Intra-Cellular Therapies, Inc. 35
MedDay 36
Merz Pharma GmbH & Co. KgaA 37
Mitsubishi Tanabe Pharma Corporation 38
Mnemosyne Pharmaceuticals, Inc. 39
Novartis AG 40
Omeros Corporation 41
Otsuka Holdings Co., Ltd. 42
Reviva Pharmaceuticals Inc. 43
Saniona AB 44
Sumitomo Dainippon Pharma Co., Ltd. 45
Teva Pharmaceutical Industries Limited 46
Autism – Therapeutics Assessment 47
Assessment by Monotherapy Products 47
Assessment by Combination Products 48
Assessment by Target 49
Assessment by Mechanism of Action 51
Assessment by Route of Administration 53
Assessment by Molecule Type 55
Drug Profiles 57
(dextromethorphan hydrobromide + quinidine sulfate) – Drug Profile 57
Product Description 57
Mechanism of Action 57
R&D Progress 57
acamprosate calcium – Drug Profile 59
Product Description 59
Mechanism of Action 59
R&D Progress 59
ADX-88178 – Drug Profile 60
Product Description 60
Mechanism of Action 60
R&D Progress 60
aripiprazole – Drug Profile 61
Product Description 61
Mechanism of Action 61
R&D Progress 61
carbetocin – Drug Profile 64
Product Description 64
Mechanism of Action 64
R&D Progress 64
CM-AT – Drug Profile 65
Product Description 65
Mechanism of Action 65
R&D Progress 65
CN-2097 – Drug Profile 66
Product Description 66
Mechanism of Action 66
R&D Progress 66
CNDO-201 – Drug Profile 67
Product Description 67
Mechanism of Action 67
R&D Progress 67
Drug for Autism – Drug Profile 69
Product Description 69
Mechanism of Action 69
R&D Progress 69
Drug for Autism Spectrum Disorders – Drug Profile 70
Product Description 70
Mechanism of Action 70
R&D Progress 70
fingolimod hydrochloride – Drug Profile 71
Product Description 71
Mechanism of Action 71
R&D Progress 71
fluoxetine – Drug Profile 74
Product Description 74
Mechanism of Action 74
R&D Progress 74
glatiramer acetate – Drug Profile 76
Product Description 76
Mechanism of Action 76
R&D Progress 76
HTL-14242 – Drug Profile 78
Product Description 78
Mechanism of Action 78
R&D Progress 78
ITI-007 – Drug Profile 79
Product Description 79
Mechanism of Action 79
R&D Progress 79
KM-391 – Drug Profile 81
Product Description 81
Mechanism of Action 81
R&D Progress 81
lurasidone hydrochloride – Drug Profile 83
Product Description 83
Mechanism of Action 83
R&D Progress 83
MD-1103 – Drug Profile 85
Product Description 85
Mechanism of Action 85
R&D Progress 85
memantine hydrochloride – Drug Profile 86
Product Description 86
Mechanism of Action 86
R&D Progress 86
oxytocin – Drug Profile 88
Product Description 88
Mechanism of Action 88
R&D Progress 88
oxytocin – Drug Profile 90
Product Description 90
Mechanism of Action 90
R&D Progress 90
RG-7314 – Drug Profile 91
Product Description 91
Mechanism of Action 91
R&D Progress 91
RP-5063 – Drug Profile 92
Product Description 92
Mechanism of Action 92
R&D Progress 92
Small Molecule to Agonize GABAA Receptor Subunit Alpha-5 for Autism – Drug Profile 93
Product Description 93
Mechanism of Action 93
R&D Progress 93
Small Molecule to Antagonize NMDA2A for Central Nervous System Disorder – Drug Profile 94
Product Description 94
Mechanism of Action 94
R&D Progress 94
Small Molecule to Modulate GABRA5 Receptor for Alzheimer’s Disease, Schizophrenia and Autism – Drug Profile 95
Product Description 95
Mechanism of Action 95
R&D Progress 95
Small Molecule to Target GPR63 for Autism – Drug Profile 96
Product Description 96
Mechanism of Action 96
R&D Progress 96
Small Molecules to Agonize GABAA-Beta 2 Receptor for Epilepsy and Autism – Drug Profile 97
Product Description 97
Mechanism of Action 97
R&D Progress 97
Small Molecules to Inhibit PI3K for Autism and Fragile X Syndrome – Drug Profile 98
Product Description 98
Mechanism of Action 98
R&D Progress 98
Small Molecules to Inhibit Translation Initiation Factor-4E for Cancer and Autism – Drug Profile 99
Product Description 99
Mechanism of Action 99
R&D Progress 99
Small Molecules to Target Oxytocin for Autism and Anxiety Disorders – Drug Profile 100
Product Description 100
Mechanism of Action 100
R&D Progress 100
Stem Cell Therapy for Autism – Drug Profile 101
Product Description 101
Mechanism of Action 101
R&D Progress 101
Stem Cell Therapy for Neurodegenerative Disorders – Drug Profile 102
Product Description 102
Mechanism of Action 102
R&D Progress 102
suramin hexasodium – Drug Profile 105
Product Description 105
Mechanism of Action 105
R&D Progress 105
vatiquinone – Drug Profile 106
Product Description 106
Mechanism of Action 106
R&D Progress 106
Autism – Recent Pipeline Updates 108
Autism – Dormant Projects 144
Autism – Discontinued Products 146
Autism – Product Development Milestones 147
Featured News & Press Releases 147
Jun 26, 2014: Coronado Biosciences Reports Topline Results from Investigator Initiated Pilot Study of TSO in Adults with Autism Spectrum Disorder 147
May 14, 2014: Coronado Biosciences Initiates Phase 2a Clinical Study of TSO in Pediatric Patients With Autism Spectrum Disorder 147
Dec 12, 2013: Coronado Biosciences Announces Presentation of Interim Data From Autism Study at Neuropsychopharmacology Meeting 147
Nov 04, 2013: Curemark Begins NDA Submission for CM-AT Autism Treatment 148
Sep 06, 2013: Avanir Pharmaceuticals Announces Settlement of NUEDEXTA Patent Litigation with Wockhardt 148
Sep 03, 2013: Avanir Pharmaceuticals Announces Settlement of NUEDEXTA Patent Litigation with Actavis 149
Aug 14, 2013: Avanir Pharmaceuticals Announces Settlement of NUEDEXTA Patent Litigation with Sandoz 149
Apr 23, 2013: Curemark Announces Positive Pre-NDA Meeting With FDA For New Drug Application For CM-AT For Autism 150
Mar 13, 2013: Researchers Use Old Drug Treatment To Correct Autism Symptoms In Mouse Model 150
Nov 12, 2012: Coronado Biosciences Announces Initiation Of Investigator-initiated Study Evaluating TSO In Autism Spectrum Disorders 151
Appendix 153
Methodology 153
Coverage 153
Secondary Research 153
Primary Research 153
Expert Panel Validation 153
Contact Us 154
Disclaimer 154
Number of Products under Development for Autism, H1 2015 11
Number of Products under Development for Autism - Comparative Analysis, H1 2015 12
Number of Products under Development by Companies, H1 2015 14
Number of Products under Development by Companies, H1 2015 (Contd..1) 15
Number of Products under Investigation by Universities/Institutes, H1 2015 16
Comparative Analysis by Late Stage Development, H1 2015 17
Comparative Analysis by Clinical Stage Development, H1 2015 18
Comparative Analysis by Early Stage Development, H1 2015 19
Comparative Analysis by Unknown Stage Development, H1 2015 20
Products under Development by Companies, H1 2015 21
Products under Development by Companies, H1 2015 (Contd..1) 22
Products under Investigation by Universities/Institutes, H1 2015 23
Autism - Pipeline by Addex Therapeutics Ltd, H1 2015 24
Autism - Pipeline by Avanir Pharmaceuticals, Inc., H1 2015 25
Autism - Pipeline by BioCrea GmbH, H1 2015 26
Autism - Pipeline by BrainStorm Cell Therapeutics Inc., H1 2015 27
Autism - Pipeline by Cellceutix Corporation, H1 2015 28
Autism - Pipeline by Confluence Pharmaceuticals LLC, H1 2015 29
Autism - Pipeline by Curemark, LLC, H1 2015 30
Autism - Pipeline by Edison Pharmaceuticals, Inc., H1 2015 31
Autism - Pipeline by Egenix, Inc., H1 2015 32
Autism - Pipeline by F. Hoffmann-La Roche Ltd., H1 2015 33
Autism - Pipeline by Heptares Therapeutics Ltd., H1 2015 34
Autism - Pipeline by Intra-Cellular Therapies, Inc., H1 2015 35
Autism - Pipeline by MedDay, H1 2015 36
Autism - Pipeline by Merz Pharma GmbH & Co. KgaA, H1 2015 37
Autism - Pipeline by Mitsubishi Tanabe Pharma Corporation, H1 2015 38
Autism - Pipeline by Mnemosyne Pharmaceuticals, Inc., H1 2015 39
Autism - Pipeline by Novartis AG, H1 2015 40
Autism - Pipeline by Omeros Corporation, H1 2015 41
Autism - Pipeline by Otsuka Holdings Co., Ltd., H1 2015 42
Autism - Pipeline by Reviva Pharmaceuticals Inc., H1 2015 43
Autism - Pipeline by Saniona AB, H1 2015 44
Autism - Pipeline by Sumitomo Dainippon Pharma Co., Ltd., H1 2015 45
Autism - Pipeline by Teva Pharmaceutical Industries Limited, H1 2015 46
Assessment by Monotherapy Products, H1 2015 47
Assessment by Combination Products, H1 2015 48
Number of Products by Stage and Target, H1 2015 50
Number of Products by Stage and Mechanism of Action, H1 2015 52
Number of Products by Stage and Route of Administration, H1 2015 54
Number of Products by Stage and Molecule Type, H1 2015 56
Autism Therapeutics - Recent Pipeline Updates, H1 2015 108
Autism - Dormant Projects, H1 2015 144
Autism - Dormant Projects (Contd..1), H1 2015 145
Autism - Discontinued Products, H1 2015 146
[List of Figures]
Number of Products under Development for Autism, H1 2015 11
Number of Products under Development for Autism - Comparative Analysis, H1 2015 12
Number of Products under Development by Companies, H1 2015 13
Number of Products under Investigation by Universities/Institutes, H1 2015 16
Comparative Analysis by Late Stage Development, H1 2015 17
Comparative Analysis by Clinical Stage Development, H1 2015 18
Comparative Analysis by Early Stage Products, H1 2015 19
Assessment by Monotherapy Products, H1 2015 47
Number of Products by Top 10 Targets, H1 2015 49
Number of Products by Stage and Top 10 Targets, H1 2015 49
Number of Products by Top 10 Mechanism of Actions, H1 2015 51
Number of Products by Stage and Top 10 Mechanism of Actions, H1 2015 51
Number of Products by Top 10 Routes of Administration, H1 2015 53
Number of Products by Stage and Top 10 Routes of Administration, H1 2015 53
Number of Products by Top 10 Molecule Types, H1 2015 55
Number of Products by Stage and Top 10 Molecule Types, H1 2015 55
【掲載企業】
Addex Therapeutics Ltd
Avanir Pharmaceuticals, Inc.
BioCrea GmbH
BrainStorm Cell Therapeutics Inc.
Cellceutix Corporation
Confluence Pharmaceuticals LLC
Curemark, LLC
Edison Pharmaceuticals, Inc.
Egenix, Inc.
F. Hoffmann-La Roche Ltd.
Heptares Therapeutics Ltd.
Intra-Cellular Therapies, Inc.
MedDay
Merz Pharma GmbH & Co. KgaA
Mitsubishi Tanabe Pharma Corporation
Mnemosyne Pharmaceuticals, Inc.
Novartis AG
Omeros Corporation
Otsuka Holdings Co., Ltd.
Reviva Pharmaceuticals Inc.
Saniona AB
Sumitomo Dainippon Pharma Co., Ltd.
Teva Pharmaceutical Industries Limited