Autism Pipeline Analysis Report 2025
Description
As per the estimates from CDC's (Centers for Disease Control and Prevention) Autism and Developmental Disabilities Monitoring (ADDM) Network, around 1 in 36 children were reported to be identified with autism spectrum disorder. With the growing number of cases, there is a heightened focus on expediting the development of promising autism drugs and accelerating clinical trials. The autism pipeline analysis by Expert Market Research includes major drugs currently under development. Moreover, rising public awareness and advocacy from autism organizations are also fueling the demand for advanced treatment options.
Report Coverage
The Autism Pipeline Analysis Report by Expert Market Research gives comprehensive insights into autism therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for Autism. The autism report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The autism pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials including their adverse effects on patients suffering from the condition, and alignment with autism treatment guidelines to ensure optimal care practices.
The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to autism.
Autism Drug Pipeline Outlook
Autism or autism spectrum disorder (ASD) refers to a neurological and developmental disorders characterized by deficits in social communication and social interaction. Autistic individuals typically show inflexible, repetitive, and restricted patterns of interests, behaviors, and activities. Some people with autism can live independently whereas certain individuals may require life-long support and care.
Behavioral therapy is a widely used approach to improve social, communication, and learning skills in autistic people. For irritability and aggression, autism therapeutics include FDA-approved risperidone and aripiprazole for managing severe behavioral symptoms. Pharmaceutical companies are actively developing novel drug candidates such as gene and RNA-based therapies, cannabidiol (CBD), and oxytocin therapies. Additionally, the adoption of innovative technologies in drug development, along with adherence to autism treatment guidelines, is expected to improve patient outcomes and aid pipeline expansion in the near future.
Autism Epidemiology
According to the World Health Organisation (WHO ), approximately 1 in 100 children are affected by autism, with the prevalence of the condition unknown in many low- and middle-income countries. On the other hand, the CDC's Autism and Developmental Disabilities Monitoring (ADDM) Network estimates that 1 in 36 children has been identified with autism.
Autism spectrum disorder is roughly 4 times more common in boys than in girls. It is reported to occur in all ethnic, racial, and socioeconomic groups.
Autism Pipeline Therapeutic Assessment
This section of the report covers the analysis of autism drug candidates based on several segmentations including:
By Phase
The pipeline assessment report covers 50+ drug analyses based on phase:
The pipeline assessment report covers 50+ drug analyses based on drug classes:
The autism report assessment covers 50+ drug analyses based on the route of administration.
The report covers phase I, phase II, phase III, phase IV, and early phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase II covers a major share of the total clinical trials, with a substantial number of autism emerging drugs undergoing clinical development. Phase II holds the largest share at 50%, demonstrating strong progress in syphilis drug development. Phase I follows at 15%, reflecting early-stage advancements. Phase III also accounts for 15%, indicating promising late-stage trials. Phase IV contributes 5%, supporting post-market evaluation. Early Phase I at 3% highlights emerging innovations. These developments can drive market growth and improve treatment outcomes.
Autism Pipeline Assessment Segmentation, By Drug Classes
The drug molecule categories covered under the autism pipeline analysis include small molecules, biologics, peptides, gene and RNA-based therapies, and natural compounds and cannabinoids. The autism report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for autism. Endocannabinoid system modulators are emerging as a promising drug class in autism spectrum disorder (ASD) treatment. For instance, KT-20610, an orally administered therapy by Kingdom Therapeutics, is under investigation. It targets the gut-brain axis by modulating the endocannabinoid system, aiming to restore physiological balance and address core ASD symptoms while utilizing a delivery method that enhances bioavailability and reduces adverse effects.
Autism Clinical Trials Therapeutic Assessment – Competitive Dynamics
The EMR report for the autism drug pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed autism therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in autism clinical trials:
This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for vitiligo. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of autism drug candidates.
Drug: AST-001
Sponsored by Astrogen, Inc., the objective of this randomized, double-blinded, multicenter clinical trial is to investigate the efficacy and safety of AST-001 in children with autism spectrum disorder. The study is under Phase III clinical development and has an estimated 160 participants.
Drug: CM-AT
Curemark is conducting a Phase III open-label extension study aimed at examining the efficacy and safety of autism drug candidate CM-AT in treating autism with all levels of fecal chymotrypsin. The interventional study has enrolled about 405 children and is expected to be completed by January 2025.
Key Questions Answered in the Autism Pipeline Analysis Report
The Autism Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for autism. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into market trends, regulatory environments, and potential growth opportunities within autism pipeline insights.
Related Reports
Autism Spectrum Disorders Market
Autism Spectrum Disorder Therapeutics Market
Report Coverage
The Autism Pipeline Analysis Report by Expert Market Research gives comprehensive insights into autism therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for Autism. The autism report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The autism pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials including their adverse effects on patients suffering from the condition, and alignment with autism treatment guidelines to ensure optimal care practices.
The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to autism.
Autism Drug Pipeline Outlook
Autism or autism spectrum disorder (ASD) refers to a neurological and developmental disorders characterized by deficits in social communication and social interaction. Autistic individuals typically show inflexible, repetitive, and restricted patterns of interests, behaviors, and activities. Some people with autism can live independently whereas certain individuals may require life-long support and care.
Behavioral therapy is a widely used approach to improve social, communication, and learning skills in autistic people. For irritability and aggression, autism therapeutics include FDA-approved risperidone and aripiprazole for managing severe behavioral symptoms. Pharmaceutical companies are actively developing novel drug candidates such as gene and RNA-based therapies, cannabidiol (CBD), and oxytocin therapies. Additionally, the adoption of innovative technologies in drug development, along with adherence to autism treatment guidelines, is expected to improve patient outcomes and aid pipeline expansion in the near future.
Autism Epidemiology
According to the World Health Organisation (WHO ), approximately 1 in 100 children are affected by autism, with the prevalence of the condition unknown in many low- and middle-income countries. On the other hand, the CDC's Autism and Developmental Disabilities Monitoring (ADDM) Network estimates that 1 in 36 children has been identified with autism.
Autism spectrum disorder is roughly 4 times more common in boys than in girls. It is reported to occur in all ethnic, racial, and socioeconomic groups.
Autism Pipeline Therapeutic Assessment
This section of the report covers the analysis of autism drug candidates based on several segmentations including:
By Phase
The pipeline assessment report covers 50+ drug analyses based on phase:
- Late-Stage Products (Phase 3 and Phase 4)
- Mid-Stage Products (Phase 2)
- Early-Stage Products (Phase I)
- Preclinical and Discovery Stage Products
The pipeline assessment report covers 50+ drug analyses based on drug classes:
- Small Molecules
- Biologics
- Peptides
- Gene and RNA-based Therapies
- Natural Compounds and Cannabinoids
The autism report assessment covers 50+ drug analyses based on the route of administration.
- Oral
- Parenteral
- Others
The report covers phase I, phase II, phase III, phase IV, and early phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase II covers a major share of the total clinical trials, with a substantial number of autism emerging drugs undergoing clinical development. Phase II holds the largest share at 50%, demonstrating strong progress in syphilis drug development. Phase I follows at 15%, reflecting early-stage advancements. Phase III also accounts for 15%, indicating promising late-stage trials. Phase IV contributes 5%, supporting post-market evaluation. Early Phase I at 3% highlights emerging innovations. These developments can drive market growth and improve treatment outcomes.
Autism Pipeline Assessment Segmentation, By Drug Classes
The drug molecule categories covered under the autism pipeline analysis include small molecules, biologics, peptides, gene and RNA-based therapies, and natural compounds and cannabinoids. The autism report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for autism. Endocannabinoid system modulators are emerging as a promising drug class in autism spectrum disorder (ASD) treatment. For instance, KT-20610, an orally administered therapy by Kingdom Therapeutics, is under investigation. It targets the gut-brain axis by modulating the endocannabinoid system, aiming to restore physiological balance and address core ASD symptoms while utilizing a delivery method that enhances bioavailability and reduces adverse effects.
Autism Clinical Trials Therapeutic Assessment – Competitive Dynamics
The EMR report for the autism drug pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed autism therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in autism clinical trials:
- Curemark
- Aardvark Therapeutics, Inc.
- MapLight Therapeutics
- Intra-Cellular Therapies, Inc.
- Astrogen, Inc.
- ACADIA Pharmaceuticals Inc.
- AbbVie
This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for vitiligo. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of autism drug candidates.
Drug: AST-001
Sponsored by Astrogen, Inc., the objective of this randomized, double-blinded, multicenter clinical trial is to investigate the efficacy and safety of AST-001 in children with autism spectrum disorder. The study is under Phase III clinical development and has an estimated 160 participants.
Drug: CM-AT
Curemark is conducting a Phase III open-label extension study aimed at examining the efficacy and safety of autism drug candidate CM-AT in treating autism with all levels of fecal chymotrypsin. The interventional study has enrolled about 405 children and is expected to be completed by January 2025.
Key Questions Answered in the Autism Pipeline Analysis Report
- Which companies/institutions are leading the autism drug development?
- What is the efficacy and safety profile of autism pipeline drugs?
- Which company is leading the autism pipeline development activities?
- What is the current autism commercial assessment?
- What are the opportunities and challenges present in the autism pipeline landscape?
- What is the efficacy and safety profile of autism pipeline drugs?
- Which company is conducting major trials for autism drugs?
- Which companies/institutions are involved in autism collaborations aimed at providing enhanced therapeutic alternatives for patients?
- What are the geographies covered for clinical trials in autism?
The Autism Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for autism. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into market trends, regulatory environments, and potential growth opportunities within autism pipeline insights.
Related Reports
Autism Spectrum Disorders Market
Autism Spectrum Disorder Therapeutics Market
Table of Contents
200 Pages
- 1 Preface
- 1.1 Introduction
- 1.2 Objectives of the Study
- 1.3 Research Methodology & Assumptions
- 2 Executive Summary
- 3 Overview of Autism
- 3.1 Signs and Symptoms
- 3.2 Causes
- 3.3 Risk Factors
- 3.4 Types of Autism
- 3.5 Diagnosis
- 3.6 Treatment
- 4 Patient Profile: Autism
- 4.1 Patient Profile Overview
- 4.2 Patient Psychology and Emotional Impact Factors
- 4.3 Risk Assessment and Treatment Success Rate
- 5 Autism: Epidemiology Snapshot
- 5.1 Autism Incidence by Key Markets
- 5.2 Autism – Patients Seeking Treatment in Key Markets
- 6 Autism: Market Dynamics
- 6.1 Market Drivers and Constraints
- 6.2 SWOT Analysis
- 7 Autism: Key Facts Covered
- 7.1 Top Countries Contributing to Clinical Trials in Asia-Pacific
- 7.2 Top Countries Contributing to Clinical Trials in Europe
- 7.3 Top Countries Contributing to Clinical Trials in North America
- 7.4 Top Countries Contributing to Clinical Trials in Other Regions
- 8 Autism, Drug Pipeline Assessment
- 8.1 Assessment by Treatment Type
- 8.2 Assessment by Route of Administration
- 8.3 Assessment by Drug Class
- 9 EMR Drug Pipeline Comparative Analysis
- 9.1 List of Autism Pipeline Drugs
- 9.1.1 By Company
- 9.1.2 By Phase
- 9.1.3 By Indication
- 9.1.4 By Trial Status
- 9.1.5 By Funder Type
- 9.2 EMR Attribute Scoring Analysis of Pipeline Drugs (Top Drugs)
- 10 Autism Drug Pipeline - Late-Stage Products (Phase III and IV) (Top Drugs)
- 10.1 Comparative Analysis for Late-Stage Drugs
- 10.1.1 Study Type
- 10.1.2 Recruitment Status
- 10.1.3 Company
- 10.1.4 Funder Type
- 10.2 Product Level Analysis*
- 10.2.1 Drug: CM-AT
- 10.2.1.1 Product Description
- 10.2.1.2 Trial ID
- 10.2.1.3 Sponsor Name
- 10.2.1.4 Study Type
- 10.2.1.5 Drug Class
- 10.2.1.6 Eligibility Criteria
- 10.2.1.7 Study Record Dates
- 10.2.1.7.1 First Submitted
- 10.2.1.7.2 First Posted
- 10.2.1.7.3 Last Update Posted
- 10.2.1.7.4 Last Verified
- 10.2.1.8 Indication
- 10.2.1.9 Study Design
- 10.2.1.10 Recruitment Status
- 10.2.1.11 Enrollment (Estimated)
- 10.2.1.12 Location Countries
- 10.2.1.13 Recent Results
- 10.2.2 Drug: AST-001
- 10.2.3 Drug: Pimavanserin
- 10.2.4 Other Drugs
- 11 Autism Drug Pipeline - Mid-Stage Products (Phase II) (Top Drugs)
- 11.1 Comparative Analysis for Mid-Stage Drugs
- 11.1.1 Study Type
- 11.1.2 Recruitment Status
- 11.1.3 Company
- 11.1.4 Funder Type
- 11.2 Product Level Analysis*
- 11.2.1 Drug: ARD-501
- 11.2.1.1 Product Description
- 11.2.1.2 Trial ID
- 11.2.1.3 Sponsor Name
- 11.2.1.4 Study Type
- 11.2.1.5 Drug Class
- 11.2.1.6 Eligibility Criteria
- 11.2.1.7 Study Record Dates
- 11.2.1.7.1 First Submitted
- 11.2.1.7.2 First Posted
- 11.2.1.7.3 Last Update Posted
- 11.2.1.7.4 Last Verified
- 11.2.1.8 Indication
- 11.2.1.9 Study Design
- 11.2.1.10 Recruitment Status
- 11.2.1.11 Enrollment (Estimated)
- 11.2.1.12 Location Countries
- 11.2.1.13 Recent Results
- 11.2.2 Drug: ML-004
- 11.2.3 Other Drugs
- 12 Autism Drug Pipeline - Early-Stage Products (Phase I) (Top Drugs)
- 12.1 Comparative Analysis for Early-Stage Drugs
- 12.1.1 Study Type
- 12.1.2 Recruitment Status
- 12.1.3 Company
- 12.1.4 Funder Type
- 12.2 Product Level Analysis*
- 12.2.1 Drug: Lumateperone
- 12.2.1.1 Product Description
- 12.2.1.2 Trial ID
- 12.2.1.3 Sponsor Name
- 12.2.1.4 Study Type
- 12.2.1.5 Drug Class
- 12.2.1.6 Eligibility Criteria
- 12.2.1.7 Study Record Dates
- 12.2.1.7.1 First Submitted
- 12.2.1.7.2 First Posted
- 12.2.1.7.3 Last Update Posted
- 12.2.1.7.4 Last Verified
- 12.2.1.8 Indication
- 12.2.1.9 Study Design
- 12.2.1.10 Recruitment Status
- 12.2.1.11 Enrollment (Estimated)
- 12.2.1.12 Location Countries
- 12.2.2 Drug: Cannabidiol
- 12.2.3 Other Drugs
- 13 Autism Drug Pipeline - Preclinical and Discovery Stage Products (Top Drugs)
- 13.1 Comparative Analysis for Preclinical and Discovery Stage Drugs
- 13.1.1 Study Type
- 13.1.2 Recruitment Status
- 13.1.3 Company
- 13.1.4 Funder Type
- 13.2 Product Level Analysis*
- 13.2.1 Drug 1
- 13.2.1.1 Product Description
- 13.2.1.2 Trial ID
- 13.2.1.3 Sponsor Name
- 13.2.1.4 Study Type
- 13.2.1.5 Drug Class
- 13.2.1.6 Eligibility Criteria
- 13.2.1.7 Study Record Dates
- 13.2.1.7.1 First Submitted
- 13.2.1.7.2 First Posted
- 13.2.1.7.3 Last Update Posted
- 13.2.1.7.4 Last Verified
- 13.2.1.8 Indication
- 13.2.1.9 Study Design
- 13.2.1.10 Recruitment Status
- 13.2.1.11 Enrollment (Estimated)
- 13.2.1.12 Location Countries
- 13.2.2 Other Drugs
- 14 Autism, Key Drug Pipeline Companies
- 14.1 Curemark
- 14.1.1 Company Snapshot
- 14.1.2 Pipeline Product Portfolio
- 14.1.3 Financial Analysis
- 14.1.4 Recent News and Developments
- 14.2 Aardvark Therapeutics, Inc.
- 14.2.1 Company Snapshot
- 14.2.2 Pipeline Product Portfolio
- 14.2.3 Financial Analysis
- 14.2.4 Recent News and Developments
- 14.3 MapLight Therapeutics
- 14.3.1 Company Snapshot
- 14.3.2 Pipeline Product Portfolio
- 14.3.3 Financial Analysis
- 14.3.4 Recent News and Developments
- 14.4 Intra-Cellular Therapies, Inc.
- 14.4.1 Company Snapshot
- 14.4.2 Pipeline Product Portfolio
- 14.4.3 Financial Analysis
- 14.4.4 Recent News and Developments
- 14.5 Astrogen, Inc.
- 14.5.1 Company Snapshot
- 14.5.2 Pipeline Product Portfolio
- 14.5.3 Financial Analysis
- 14.5.4 Recent News and Developments
- 14.6 ACADIA Pharmaceuticals Inc.
- 14.6.1 Company Snapshot
- 14.6.2 Pipeline Product Portfolio
- 14.6.3 Financial Analysis
- 14.6.4 Recent News and Developments
- 14.7 AbbVie
- 14.7.1 Company Snapshot
- 14.7.2 Pipeline Product Portfolio
- 14.7.3 Financial Analysis
- 14.7.4 Recent News and Developments
- 15 Regulatory Framework for Drug Approval, By Region
- 16 Terminated or Suspended Pipeline Products
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