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Autism-Pipeline Review, H1 2015

Autism-Pipeline Review, H1 2015

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Executive Summary

Autism-Pipeline Review, H1 2015


Global Markets Direct's, 'Autism-Pipeline Review, H1 2015', provides an overview of the Autism's therapeutic pipeline.

This report provides comprehensive information on the therapeutic development for Autism, 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 Autism 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.


The report provides a snapshot of the global therapeutic landscape of Autism

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 Autism and enlists all their major and minor projects

The report summarizes all the dormant and discontinued pipeline projects

A review of the Autism 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 Autism 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 Autism

Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline

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

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

List of Tables

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

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To know more information on Purchase by Section, please send a mail to query [@]

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.


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

Autism Therapeutic Products under Development, Key Players in Autism Therapeutics, Autism Pipeline Overview, Autism Pipeline, Autism Pipeline Assessment

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