TheraRadar
Landscape / CNS
Data updated: Jun 28, 2026

Autism Spectrum Disorder Clinical Trial Landscape

Autism Spectrum Disorder is being studied across 336 clinical trials registered since 2008, with 84 programs currently active. The competitive pipeline includes 15 active Phase 3 trials, 50 active Phase 2 trials, and 12 active Phase 1 trials.

Top industry sponsors include Intra-Cellular Therapies, Inc., Bristol-Myers Squibb, Curemark.

Trial activity

84 active / 336 total since 2008
Active by phase 15 Ph3 / 64 50 Ph2 / 187 12 Ph1 / 57 7 Ph4 / 28

Sponsor activity

Who is running trials now — green active, blue completed, red failed/terminated.

Sorted by active Active Done Failed
Intra-Cellular Therapies, Inc. 4 0 0
Bristol-Myers Squibb 2 1 0
Curemark 1 3 0
MapLight Therapeutics 1 1 0
Karuna Therapeutics, Inc., a Bristol Myers Squibb company 1 0 0
Black Tie Medical, Inc. 1 0 0
Definium Therapeutics US, Inc. 1 0 0
Fenix Innovation Group 1 0 0
Bazelet Nehushtan LtD. 1 0 0
Shanghai Auzone Biological Technology Co., Ltd. 1 0 0
Neuroventi Inc. 1 0 0
Montera Health Texas LLC 1 0 0
Roche 0 7 4
Forest Laboratories 0 4 1
Seaside Therapeutics, Inc. 0 2 2

All 15 active Autism Spectrum Disorder sponsors

Unlock the remaining 7 sponsors with active / completed / failed counts — sortable and exportable.

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How the field has grown

New-trial starts peaked in 2023 (24 registered); 2025 saw 19. The right-hand chart shows median Phase 3 enrollment by start year — the number in parentheses is that year's Phase 3 trial count (37 in total), so single-trial years (and years with no Phase 3 starts) are obvious. Both are by trial start date; the current year is partial.

New trials started by year

2016
20
2017
13
2018
22
2019
17
2020
18
2021
14
2022
18
2023
24
2024
19
2025
19
2026
17

TheraRadar.com

Median Phase 3 enrollment by start year

2016 (2)
109
2017 (2)
62
2018 (8)
134
2019 (2)
124
2020 (1)
95
2021 (2)
195
2022 (4)
185
2023 (5)
144
2024 (6)
159
2025 (1)
103
2026 (4)
176

TheraRadar.com

Full trial pipeline

Every active and completed trial across Phase 1–4, with enrollment analytics. Sortable, filterable, exportable with Pro.

NCT07424404 RECRUITING
A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Autism-Related Irritability in Adolescents, Respectively
Karuna Therapeutics, Inc., a Bristol Myers Squibb company n=400
NCT07285798 NOT YET RECRUITING
A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder
Bristol-Myers Squibb n=176
NCT07284745 NOT YET RECRUITING
A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism
Bristol-Myers Squibb n=176
NCT06678685 RECRUITING
Spironolactone Improved Children With Gene Mutations Related to NCOR
Qilu Hospital of Shandong University n=2
NCT02649959 ACTIVE NOT RECRUITING
An Open Label Study of CM-AT for the Treatment of Children With Autism
Curemark n=405
NCT07450443 RECRUITING
Role of the Gut Vascular Barrier and Microbiota in Autism Spectrum Disorders
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta n=90
NCT05664789 RECRUITING
Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Trial
Stanford University n=144
NCT05494398 ENROLLING BY INVITATION
Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Open Label
Stanford University n=144
NCT07257939 NOT YET RECRUITING
NTI164 in Autism Spectrum Disorder
Fenix Innovation Group n=98
NCT06229210 RECRUITING
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
Intra-Cellular Therapies, Inc. n=500
NCT06706674 RECRUITING
Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients
Intra-Cellular Therapies, Inc. n=174
NCT06690398 RECRUITING
Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients
Intra-Cellular Therapies, Inc. n=174
NCT05268796 RECRUITING
Telehealth-Enabled Versus In-Person Parent-Mediated Behavioral Treatment for Challenging Behaviors in Children With ASD
Stanford University n=90
NCT04766177 RECRUITING
Role of Bumetanide in Treatment of Autism
Sherief Abd-Elsalam n=80
NCT07655115 RECRUITING
Single Dose Double-blind, Placebo-controlled Cross-over (SDDBPCCO) Shiftability Study, Will be Followed by a 10-week Open-label Study With Arbaclofen (4 Weeks of Titration and Then 6 Weeks of Active/Stable Treatment). The Effects of Arbaclofen on Target EEG and ERG Metrics Will be Associated With th
Hospital General Universitario Gregorio Marañon n=103
NCT03553875 TERMINATED
Memantine for the Treatment of Social Deficits in Youth With Disorders of Impaired Social Interactions
Massachusetts General Hospital n=25
NCT06333964 COMPLETED
A Study to Evaluate the Efficacy and Safety of AST-001 in ASD Children
Astrogen, Inc. n=169
NCT05555615 TERMINATED
Extension Study of Pimavanserin in Irritability Associated With Autism Spectrum Disorder
ACADIA Pharmaceuticals Inc. n=209
NCT04578756 COMPLETED
Open-Label, Flexible-dose Study to Evaluate the Long-Term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Participants With Schizophrenia, Bipolar I Disorder, or Autism Spectrum Disorder
AbbVie n=310
NCT04623398 COMPLETED
Effect of Lithium in Patients With Autism Spectrum Disorder and Phelan-McDermid Syndrome (SHANK3 Haploinsufficiency)
Assistance Publique - Hôpitaux de Paris n=22
NCT03204786 COMPLETED
Intranasal Vasopressin Treatment in Children With Autism
Stanford University n=157
NCT01740869 COMPLETED
Autologous Bone Marrow Stem Cells for Children With Autism Spectrum Disorders
Hospital Universitario Dr. Jose E. Gonzalez n=30
NCT05927792 COMPLETED
Efficacy and Mechanism of Repetitive Transcranial Magnetic Stimulation in Children With Autism Spectrum Disorders
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine n=200
NCT04174365 COMPLETED
Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder
Otsuka Pharmaceutical Development & Commercialization, Inc. n=119
NCT05523895 COMPLETED
Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum Disorder
ACADIA Pharmaceuticals Inc. n=237
NCT01825798 COMPLETED
Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorders (ASD)
Holland Bloorview Kids Rehabilitation Hospital n=60
NCT04725383 TERMINATED
Amitriptyline for Repetitive Behaviors in Autism Spectrum Disorders
University of Missouri, Kansas City n=1
NCT05439616 COMPLETED
Study of Cariprazine Oral Capsules or Solution to Assess Adverse Events and Change in Irritability Due to Autism Spectrum Disorder (ASD) in Participants Aged 5-17 Years With ASD
AbbVie n=161
NCT01617460 COMPLETED
A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder
Otsuka Pharmaceutical Co., Ltd. n=86
NCT05212493 COMPLETED
The Effects of Medical Cannabis in Children With Autistic Spectrum Disorder
Assaf-Harofeh Medical Center n=128
NCT03715166 TERMINATED
Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children and Adolescents Aged From 7 to Less Than 18 Years Old With Autism Spectrum Disorder
Institut de Recherches Internationales Servier n=211
NCT01972074 COMPLETED
Behavioral and Neural Response to Memantine in Adolescents With Autism Spectrum Disorder
Massachusetts General Hospital n=84
NCT02985749 COMPLETED
A Study of Oxytocin for the Treatment of Social Impairment in Individuals With High Functioning Autism Spectrum Disorder
Massachusetts General Hospital n=7
NCT04258839 COMPLETED
Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder for Subjects That Have Completed Participation in 331-201-00148
Otsuka Pharmaceutical Development & Commercialization, Inc. n=95
NCT03197922 COMPLETED
Treatment of Encopresis in Children With Autism Spectrum Disorders
Emory University n=117
NCT03715153 TERMINATED
Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children Aged From 2 to Less Than 7 Years Old With Autism Spectrum Disorder.
Institut de Recherches Internationales Servier n=211
NCT02410902 COMPLETED
A Trial of CM-AT in Children With Autism With All Levels of FCT (The Blum Study)
Curemark n=190
NCT03504917 TERMINATED
A Study of Balovaptan in Adults With Autism Spectrum Disorder With a 2-Year Open-Label Extension
Hoffmann-La Roche n=322
NCT04233502 WITHDRAWN
Efficacy and Safety of Slenyto for Insomnia in Children With ASD
Neurim Pharmaceuticals Ltd.
NCT03487770 COMPLETED
Aripiprazole Oral Solution in the Treatment of Children and Adolescents With Autistic Disorder
Otsuka Beijing Research Institute n=111
NCT03015272 COMPLETED
Testing a Novel Speech Intervention in Minimally Verbal Children With Autism Spectrum Disorder (ASD)
Beth Israel Deaconess Medical Center n=14
NCT03640156 COMPLETED
Modulating Socially Adaptive Mirror System Functioning in Autism by Oxytocin
KU Leuven n=25
NCT01914393 COMPLETED
Pediatric Open-Label Extension Study
Sumitomo Pharma America, Inc. n=702
NCT03771560 COMPLETED
Folinic Acid in Autism
University of California, San Francisco n=18
NCT02007447 TERMINATED
Oxytocin in Adolescents With Autism Spectrum Disorders
University of Sao Paulo General Hospital n=30
NCT01535508 COMPLETED
Open Label Clinical Trial of Vitamin D in Children With Autism
University of California, San Francisco n=10
NCT02757066 COMPLETED
Verification of the Efficacy of NPC-15 for Sleep Disorders of Children With Autism Spectrum Disorders
Nobelpharma n=196
NCT02654743 COMPLETED
Open Label of Clinical Trial of Sulforaphane in Children With Autism
University of California, San Francisco n=21
NCT00912691 COMPLETED
A Trial of CM-AT in Children With Autism- Open Label Extension Study
Curemark n=165
NCT01302964 COMPLETED
Mirtazapine Treatment of Anxiety in Children and Adolescents With Pervasive Developmental Disorders
Massachusetts General Hospital n=30
NCT00943579 COMPLETED
Open-Label Extension Study of Kuvan for Autism
The Children's Health Council n=41
NCT00881452 COMPLETED
A Trial of CM-AT in Children With Autism
Curemark n=182
NCT01617447 COMPLETED
A Short Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder
Otsuka Pharmaceutical Co., Ltd. n=92
NCT01039792 COMPLETED
Trial of Methyl B12 on Behavioral and Metabolic Measures in Children With Autism
University of California, San Francisco n=57
NCT02212275 WITHDRAWN
Cortical Metrics in Intervention Trials With Autism Spectrum Disorders
Duke University
NCT00873509 COMPLETED
Buspirone in the Treatment of 2-6 Year Old Children With Autistic Disorder
Chugani, Diane C. n=166
NCT01801696 COMPLETED
Parent-delivered Massage for Children With Autism
Western Oregon University n=103
NCT01086475 COMPLETED
D-Cycloserine and Social Skills Training in Autism Spectrum Disorders
Indiana University n=68
NCT01911442 COMPLETED
Lurasidone Pediatric Autism Study
Sumitomo Pharma America, Inc. n=150
NCT01624675 COMPLETED
A Study to Evaluate the Efficacy and Safety of Risperidone (R064766) in Children and Adolescents With Irritability Associated With Autistic Disorder
Janssen Pharmaceutical K.K. n=39
NCT01706523 TERMINATED
Open Label Extension Study of STX209 (Arbaclofen) in Autism Spectrum Disorders
Seaside Therapeutics, Inc. n=165
NCT01178385 COMPLETED
Cognitive-Behavioral Treatment for Anxiety Disorders in Children With Autism Spectrum Disorders
University of South Florida n=45
NCT00584701 COMPLETED
Pharmacogenomics in Autism Treatment
University of California, San Francisco n=49
NCT00787111 TERMINATED
Extended Management and Measurement of Autism
Neuropharm n=128

Full Autism Spectrum Disorder Pipeline

Every trial across Phase 1–4, plus enrollment analytics. Sortable, filterable, exportable.

Unlock with Pro

Data: ClinicalTrials.gov · Trials registered 2008 onwards · Industry sponsors only