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Autism Spectrum Disorder Pipeline Analysis Report 2025

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    Report

  • 200 Pages
  • June 2025
  • Region: Global
  • Expert Market Research
  • ID: 6102853
Autism, also known as autism spectrum disorder (ASD), is a neurodevelopmental condition affecting communication, behavior, and social interaction. According to the World Health Organization, it accounts for around 1 in 100 children worldwide. With a growing demand for better therapies, advancements in autism spectrum disorder therapeutics are gaining momentum. Recent breakthroughs in gene therapy, novel drug formulations, increasing public awareness, and substantial research investments in targeted treatments are driving significant growth in the drug market for ASD. The autism spectrum disorder pipeline analysis by the publisher examines emerging drug candidates, clinical trials, and regulatory progress, highlighting innovative treatments expected to shape the market in the coming years.

Report Coverage

The Autism Spectrum Disorder Pipeline Analysis Report by the publisher gives comprehensive insights into autism spectrum disorder therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for autism spectrum disorder. The autism spectrum disorder report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The autism spectrum disorder 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 spectrum disorder 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 spectrum disorder.

Autism Spectrum Disorder Pipeline Outlook

Autism spectrum disorder (ASD) is a neurodevelopmental condition characterized by challenges in communication, behavior, and social interaction. It results from a combination of genetic and environmental factors that influence brain development. Individuals with ASD experience a wide range of symptoms, varying in severity.

Autism spectrum disorder treatment focuses on symptom management through behavioral therapy, medications, and support. FDA-approved drugs like Risperidone (Risperdal) and Aripiprazole (Abilify) help manage irritability and aggression in children. These drugs remain crucial in the autism spectrum disorder pipeline, aimed at improving their therapeutic effectiveness and providing better treatment options for ASD symptoms.

Autism Spectrum Disorder Epidemiology

According to the World Health Organization, autism spectrum disorder (ASD) affects approximately 1 in 100 children globally. The Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2021 estimates 61.8 million individuals with ASD, with an age-standardized prevalence of 788.3 per 100,000 people. The autism spectrum disorder pipeline analysis highlights emerging drug candidates, addressing the increasing need for effective treatments to improve patient outcomes and reduce the global burden of the disorder.

Autism Spectrum Disorder - Pipeline Therapeutic Assessment

This section of the report covers the analysis of autism spectrum disorder drug candidates based on several segmentations, including:

By Phase

  • Late-Stage Products (Phase 3 and Phase 4)
  • Mid-Stage Products (Phase 2)
  • Early-Stage Products (Phase I)
  • Preclinical and Discovery Stage Products

By Drug Class

  • Small Molecules
  • Monoclonal Antibodies
  • Peptides
  • Gene Therapies
  • RNA-based Therapies
  • Stem Cell Therapies
  • Others

By Route of Administration

  • Oral
  • Parenteral
  • Others

Autism Spectrum Disorder Pipeline Assessment Segmentation by Phases

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 analysis, phase II, with 57.32%, covers a major share of the total autism spectrum disorder clinical trials, showcasing significant development potential. Phase 1 follows with 17.07%, demonstrating early-stage progress. Early Phase 1 accounts for 2.44%, reflecting early exploratory studies. Phase 3 represents 17.07%, while Phase 4 comprises 6.10%. These phases collectively drive innovation and promise to significantly impact the ASD market with improved therapeutics.

Autism Spectrum Disorder Pipeline Assessment Segmentation by Drug Classes

The drug molecule categories covered under the autism spectrum disorder pipeline analysis include small molecules, monoclonal antibodies, peptides, gene therapies, RNA-based therapies, stem cell therapies, and others. The autism spectrum disorder report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for autism spectrum disorder. In the pipeline, several drug classes are under investigation. For instance, selective serotonin reuptake inhibitors (SSRIs), like escitalopram, are being studied for their potential to improve irritability and behavioral issues in ASD patients.

Autism Spectrum Disorder Clinical Trials - Key Players

The report for the autism spectrum disorder pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed autism spectrum disorder therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in autism spectrum disorder clinical trials:
  • Astrogen, Inc.
  • Vanda Pharmaceuticals
  • MapLight Therapeutics
  • Intra-Cellular Therapies, Inc.
  • AbbVie
  • Shanghai Auzone Biological Technology Co., Ltd.
  • Biocodex
  • Acadia Pharmaceuticals Inc.
  • Kuzani Pharmaceuticals, Inc.

Autism Spectrum Disorder - Emerging Drugs Profile

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 autism spectrum disorder. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of autism spectrum disorder drug candidates.

Drug: AST-001

AST-001, developed by Astrogen, Inc., is a novel syrup formulation of L-serine designed to treat core symptoms of autism spectrum disorder (ASD) in pediatric patients. It is a part of a Phase III study, which aims to assess its efficacy and safety compared to a placebo. AST-001 has shown promising results in improving adaptive behavior and social cognition by targeting dopamine neuron activity. The trial, a randomized, double-blind, placebo-controlled study, is expected to conclude by June 2025, with dosage recommendations based on body weight for optimized ASD symptom management.

Drug: ML-004

ML-004 is an investigational small molecule drug targeting the 5-HT1B receptor. It is being evaluated in a Phase 2 open-label extension study for autism spectrum disorder (ASD) by MapLight Therapeutics. The study is designed to assess the safety and tolerability of ML-004, which functions as a serotonin 1B receptor agonist to modulate serotonin signaling, a pathway often implicated in ASD. By targeting serotonin pathways, ML-004 aims to offer potential therapeutic benefits for individuals with ASD, addressing symptoms such as social deficits and repetitive behaviors.

Key Questions Answered in the Autism Spectrum Disorder Pipeline Analysis Report

  • Which companies/institutions are leading the autism spectrum disorder drug development?
  • What is the efficacy and safety profile of autism spectrum disorder pipeline drugs?
  • Which company is leading the autism spectrum disorder pipeline development activities?
  • What is the current autism spectrum disorder commercial assessment?
  • What are the opportunities and challenges present in the autism spectrum disorder pipeline landscape?
  • What is the efficacy and safety profile of autism spectrum disorder pipeline drugs?
  • Which company is conducting major trials for autism spectrum disorder drugs?
  • Which companies/institutions are involved in autism spectrum disorder collaborations aimed at providing enhanced therapeutic alternatives for patients?
  • What are the geographies covered for clinical trials in autism spectrum disorder?

Reasons To Buy This Report

The Autism Spectrum Disorder Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for autism spectrum disorder. 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 spectrum disorder pipeline insights.

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Table of Contents

1 Preface
1.1 Introduction
1.2 Objectives of the Study
1.3 Research Methodology & Assumptions
2 Executive Summary
3 Overview of Autism Spectrum Disorder
3.1 Signs and Symptoms
3.2 Causes
3.3 Risk Factors
3.4 Diagnosis
3.5 Treatment
4 Patient Profile: Autism Spectrum Disorder
4.1 Patient Profile Overview
4.2 Patient Psychology and Emotional Impact Factors
4.3 Risk Assessment and Treatment Success Rate
5 Autism Spectrum Disorder: Epidemiology Snapshot
5.1 Autism Spectrum Disorder Incidence by Key Markets
5.2 Autism Spectrum Disorder - Patients Seeking Treatment in Key Markets
6 Autism Spectrum Disorder: Market Dynamics
6.1 Market Drivers and Constraints
6.2 SWOT Analysis
7 Autism Spectrum Disorder: 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 Spectrum Disorder, Drug Pipeline Assessment
8.1 Assessment by Treatment Type
8.2 Assessment by Route of Administration
8.3 Assessment by Drug Class
9 Drug Pipeline Comparative Analysis
9.1 List of Autism Spectrum Disorder 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 Attribute Scoring Analysis of Pipeline Drugs (Top Drugs)
10 Autism Spectrum Disorder 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: AST-001
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: Lumateperone High Dose
10.2.3 Drug: Tasimelteon Oral Capsule
10.2.4 Other Drugs
11 Autism Spectrum Disorder 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: ML-004
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: TTYP01 Tablets
11.2.3 Drug: KZ101
11.2.4 Other Drugs
12 Autism Spectrum Disorder 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: Cannabidiol
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 Other Drugs
13 Autism Spectrum Disorder 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 Spectrum Disorder, Key Drug Pipeline Companies
14.1 Astrogen, Inc.
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 Vanda Pharmaceuticals
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 AbbVie
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 Shanghai Auzone Biological Technology Co., Ltd.
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 Biocodex
14.7.1 Company Snapshot
14.7.2 Pipeline Product Portfolio
14.7.3 Financial Analysis
14.7.4 Recent News and Developments
14.8 Acadia Pharmaceuticals Inc.
14.8.1 Company Snapshot
14.8.2 Pipeline Product Portfolio
14.8.3 Financial Analysis
14.8.4 Recent News and Developments
14.9 Kuzani Pharmaceuticals, Inc.
14.9.1 Company Snapshot
14.9.2 Pipeline Product Portfolio
14.9.3 Financial Analysis
14.9.4 Recent News and Developments
15 Regulatory Framework for Drug Approval, By Region16 Terminated or Suspended Pipeline Products