Autism Spectrum Disorder Clinical Trials 2025: EMA, PDMA, FDA Approvals, Medication, Therapies, Treatment Market, Mechanism of Action, Route of Administration, and Companies by DelveInsight

Autism Spectrum Disorder Clinical Trials

(Albany, USA) DelveInsight’s ‘Autism Spectrum Disorder Pipeline Insight 2025’ report provides comprehensive global coverage of pipeline autism spectrum disorder therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the autism spectrum disorder pipeline domain.

Autism Spectrum Disorder is defined as a group of developmental disorders that includes a wide range of symptoms, skills, and levels of disability. The rising prevalence of Autism Spectrum Disorder (ASD), driven by improved diagnostics and greater public awareness, is boosting demand for treatments. This trend is significantly shaping the ASD therapy market.

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Key Takeaways from the Autism Spectrum Disorder Pipeline Report

• DelveInsight’s autism spectrum disorder pipeline report depicts a robust space with 20+ active players working to develop 22+ pipeline autism spectrum disorder drugs.
• Key autism spectrum disorder companies, such as Astrogen, MapLight Therapeutics, Axial Therapeutics, Aardvark Therapeutics, Ajna BioSciences, IntraCellular Therapies, Finch Therapeutics Group, PharmAla Biotech, Neuroventi Inc., Shanghai Auzone Biological Technology Co., Ltd., and others, are evaluating new autism spectrum disorder drugs to improve the treatment landscape.
• Promising pipeline therapies for autism spectrum disorder, such as AST-001, AST-003, ML004, AB-2004, ARD-501, AJA001, Lumateperone, FIN211, ALA-002, NV01-A02, NV01-A03, TTYP01, and others, are in various phases of clinical trials for autism spectrum disorder.
• In May 2025, Yamo Pharmaceuticals, a clinical-stage biopharmaceutical company dedicated to treating the core symptoms of autism spectrum disorder (ASD) announced positive Phase II results for L1-79, presented at the International Society for Autism Research (INSAR) 2025 Annual Meeting. The 12-week randomized, double-blind, placebo-controlled crossover study (n = 58, ages 12-21) showed statistically significant and clinically meaningful improvements in the Vineland-3 Socialization Standard Score (VSSS) and several secondary outcome measures during the first period, while maintaining a favorable safety profile.
• In February 2025, Charlotte’s Web Holdings, Inc. announced that the U.S. Food and Drug Administration (FDA) had completed its review of Phase I data and the Investigational New Drug (IND) application submitted by DeFloria, Inc. The FDA has concluded that DeFloria may now proceed with its planned FDA Phase II clinical trial for its botanical pharmaceutical candidate, AJA001 Oral Solution, a treatment for symptoms of autism spectrum disorder (ASD).
• In December 2024, SciSparc Ltd. a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system, announced the renewal of its approval from the Israeli Medical Cannabis Agency (“IMCA”) at the Israeli Ministry of Health to conduct its clinical trial for SCI-210 in children with autism spectrum disorder (“ASD”).
• In December 2024, DeFloria, a joint venture between Ajna BioSciences and Charlotte’s Web reported positive results from a Phase I single ascending and multiple ascending dose trial of AJA001 in development for the treatment of symptoms of autism spectrum disorder (ASD) in a poster presentation at the 63rd Annual Meeting of the American College of Neuropsychopharmacology in Phoenix, Arizona.
• In September 2024, Mitsubishi Tanabe Pharma and Nobias Therapeutics announced the successful completion of a collaboration to explore how Nobias’ proprietary AI technology and access to unique datasets could help advance MTPA’s potential drug discovery for autism spectrum disorder (ASD).
• In July 2024, Yamo Pharmaceuticals announced positive topline results from its Phase II clinical trial evaluating the effects of L1-79 in adolescents and young adults with autism spectrum disorder (ASD).
• In January 2024, Israeli pharmaceutical company SciSparc began recruiting subjects in a clinical trial of SCI-210 for treating children with autism spectrum disorder (ASD).

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Autism Spectrum Disorder Overview

Autism spectrum disorder (ASD) is a developmental condition that arises from differences in brain structure or function. While some individuals with ASD have identifiable genetic differences, the exact causes remain largely unknown. Experts believe that multiple factors work together to influence typical developmental pathways. People with ASD may communicate, interact, learn, and behave in ways that differ from most others. Despite these differences, they usually do not have any physical traits that visibly distinguish them. The abilities of individuals with ASD can vary widely. ASD is an umbrella term that encompasses several subtypes, including Autistic Disorder, Asperger’s Syndrome, and Pervasive Developmental Disorder–Not Otherwise Specified (PDD-NOS).

Common signs of ASD include difficulties with social communication, such as limited eye contact, not responding to their name by 9 months, and not displaying usual facial expressions. Repetitive behaviors like echolalia are also typical. Additionally, individuals may face gastrointestinal issues, unusual emotional responses, and distinctive patterns in learning, movement, or attention. The causes of ASD involve a complex interplay of genetic, neurological, and environmental influences. Brain imaging often reveals differences in areas like the frontal and temporal lobes. Symptoms, such as delayed speech development and inflexible routines, generally become noticeable in early childhood. The term “spectrum” reflects the broad range in the severity and type of symptoms, from mild to more pronounce.

Diagnosing ASD is challenging since there is no definitive medical test, such as a blood test. Instead, doctors rely on observing a child’s behavior and developmental milestones. Signs can sometimes be detected as early as 18 months, and by the age of 2, experienced clinicians can make a reliable diagnosis. However, many individuals are not diagnosed until later in childhood, adolescence, or even adulthood, potentially delaying access to crucial support. Treatment focuses on managing symptoms that interfere with daily life and improving overall well-being. Because each person with ASD has distinct strengths and needs, treatment plans are highly individualized and often involve a team of professionals. These interventions can take place in various settings, including schools, healthcare facilities, homes, or community environments.

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A snapshot of the Pipeline Autism Spectrum Disorder Drugs mentioned in the report:

• AST-001: Astrogen
• ML004: MapLight Therapeutics
• NV01-A02: Neuroventi Inc.
• ARD-501: Aardvark Therapeutics
• AJA001: Ajna BioSciences
• ALA-002: PharmAla Biotech

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Autism Spectrum Disorder Therapeutics Assessment

The autism spectrum disorder pipeline report proffers an integral view of the emerging autism spectrum disorder therapies segmented by stage, product type, molecule type, route of administration, and mechanism of action.

Scope of the Autism Spectrum Disorder Pipeline Report

• Coverage: Global
• Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination
• Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
• Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical
• Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy
• Therapeutics Assessment By Mechanism of Action: Mitochondrial protein modulators, Serotonin receptor agonists, Microbiome modulators, Adrenergic receptor agonists, Central nervous system stimulants
• Key Autism Spectrum Disorder Companies: Astrogen, MapLight Therapeutics, Axial Therapeutics, Aardvark Therapeutics, Ajna BioSciences, Intra-Cellular Therapies, Finch Therapeutics Group, PharmAla Biotech, Neuroventi Inc., Shanghai Auzone Biological Technology Co., Ltd. and others.
• Key Autism Spectrum Disorder Pipeline Therapies: AST-001, AST-003, ML004, AB-2004, ARD-501, AJA001, Lumateperone, FIN211, ALA-002, NV01-A02, NV01-A03, TTYP01 and others.

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Table of Contents

1. Autism Spectrum Disorder Pipeline Report Introduction

2. Autism Spectrum Disorder Pipeline Report Executive Summary

3. Autism Spectrum Disorder Pipeline: Overview

4. Analytical Perspective In-depth Commercial Assessment

5. Autism Spectrum Disorder Clinical Trial Therapeutics

6. Autism Spectrum Disorder Pipeline: Late-Stage Products (Pre-registration)

7. Autism Spectrum Disorder Pipeline: Late-Stage Products (Phase III)

8. Autism Spectrum Disorder Pipeline: Mid-Stage Products (Phase II)

9. Autism Spectrum Disorder Pipeline: Early-Stage Products (Phase I)

10. Autism Spectrum Disorder Pipeline Therapeutics Assessment

11. Inactive Products in the Autism Spectrum Disorder Pipeline

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Key Companies

14. Key Products in the Autism Spectrum Disorder Pipeline

15. Unmet Needs

16. Market Drivers and Barriers

17. Future Perspectives and Conclusion

18. Analyst Views

19. Appendix

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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