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Autism Spectrum Disorder (ASD)

4
Pipeline Programs
5
Companies
7
Clinical Trials
1 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
0
1
0
2
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

5 companies ranked by most advanced pipeline stage

Servier
ServierFrance - Suresnes
2 programs
2
BUMETANIDEPhase 31 trial
Bumetanide Oral SolutionPhase 31 trial
Active Trials
NCT03715153Terminated211Est. Oct 2021
NCT03715166Terminated211Est. Sep 2021
Vertero Therapeutics
1 program
1
AB-2004Phase 21 trial
Active Trials
NCT04895215Completed156Est. Dec 2023
Angeles Therapeutics
Angeles TherapeuticsCA - Los Angeles
2 programs
1
FMT versus placeboPhase 11 trial
RUBIESN/A1 trial
Active Trials
NCT07276750Recruiting373Est. Aug 2030
NCT03426826Active Not Recruiting10Est. Jun 2026
Plus Therapeutics
1 program
Continuous Theta Burst Stimulation to Bilateral DLPFCN/A1 trial
Active Trials
NCT07182331Enrolling By InvitationEst. Jun 2026
Human BioSciences
Human BioSciencesWV - Martinsburg
1 program
¡Iniciando! mHealth AppN/A1 trial
Active Trials
NCT07170163Not Yet Recruiting30Est. Jun 2027

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
ServierBUMETANIDE
ServierBumetanide Oral Solution
Vertero TherapeuticsAB-2004
Angeles TherapeuticsFMT versus placebo
Human BioSciences¡Iniciando! mHealth App
Angeles TherapeuticsRUBIES
Plus TherapeuticsContinuous Theta Burst Stimulation to Bilateral DLPFC

Clinical Trials (7)

Total enrollment: 991 patients across 7 trials

NCT03715153ServierBUMETANIDE

Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children Aged From 2 to Less Than 7 Years Old With Autism Spectrum Disorder.

Start: Oct 2018Est. completion: Oct 2021211 patients
Phase 3Terminated
NCT03715166ServierBumetanide Oral Solution

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

Start: Sep 2018Est. completion: Sep 2021211 patients
Phase 3Terminated
NCT04895215Vertero TherapeuticsAB-2004

AB-2004 in Treatment of Irritability Associated With Autism Spectrum Disorder (ASD)

Start: Aug 2021Est. completion: Dec 2023156 patients
Phase 2Completed
NCT03426826Angeles TherapeuticsFMT versus placebo

The Gut-Brain Study

Start: Aug 2019Est. completion: Jun 202610 patients
Phase 1Active Not Recruiting
NCT07170163Human BioSciences¡Iniciando! mHealth App

Navigating the Transition to Adulthood: A Dual Language Mobile App for Latino Youth With ASD and Their Families

Start: Jun 2026Est. completion: Jun 202730 patients
N/ANot Yet Recruiting
NCT07276750Angeles TherapeuticsRUBIES

Coaching and Leadership in Autism Support Settings

Start: Feb 2026Est. completion: Aug 2030373 patients
N/ARecruiting
NCT07182331Plus TherapeuticsContinuous Theta Burst Stimulation to Bilateral DLPFC

Brain Stimulation and Sensory Integration in Children With ASD

Start: Aug 2025Est. completion: Jun 2026
N/AEnrolling By Invitation

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

2 late-stage (Phase 3) programs, potential near-term approvals
1 actively recruiting trials targeting 991 patients
5 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.