Autism Spectrum Disorder

11
Pipeline Programs
16
Companies
26
Clinical Trials
3 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
3
0
6
0
2
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

15 companies ranked by most advanced pipeline stage

VP
Vanda PharmaceuticalsWASHINGTON, DC
1 program
1
Tasimelteon Oral Capsule, Tasimelteon Liquid SuspensionPhase 31 trial
Active Trials
NCT05361707Recruiting100Est. Jul 2025
City Therapeutics
City TherapeuticsMA - Cambridge
1 program
1
amitriptylinePhase 31 trial
Active Trials
NCT04725383TerminatedEst. May 2025
Jazz Pharmaceuticals
Jazz PharmaceuticalsCA - Palo Alto
3 programs
3
CannabidivarinPhase 21 trial
GWP42003-PPhase 21 trial
GWP42006Phase 21 trial
Active Trials
NCT03202303Recruiting100Est. Feb 2027
NCT04745026Completed103Est. Dec 2023
NCT03849456Terminated1Est. May 2020
MapLight Therapeutics
MapLight TherapeuticsMA - Burlington
2 programs
2
ML-004Phase 21 trial
ML-004Phase 21 trial
Active Trials
NCT05889273Enrolling By Invitation120Est. Dec 2027
NCT05081245Active Not Recruiting150Est. Nov 2026
Acadia Pharmaceuticals
1 program
1
Pimavanserin Tartrate 34 Mg ORAL CAPSULE [NUPLAZID]Phase 21 trial
Active Trials
NCT05999240Recruiting30Est. Dec 2026
Roche
RocheSTAVANGER NORWAY, Norway
2 programs
2
BalovaptanPhase 15 trials
RO7017773Phase 11 trial
Active Trials
NCT03912350Withdrawn0Est. Oct 2022
NCT04049578Terminated2Est. May 2020
NCT04156646Completed16Est. Jan 2020
+3 more trials
Genomics
GenomicsUK - Oxford
1 program
1
FlorePhase 11 trial
Active Trials
NCT04655326Unknown350Est. Dec 2024
Jerusalem Pharmaceuticals
Jerusalem PharmaceuticalsIsrael - Ramallah
3 programs
"Parent training for disruptive behaviors" manualN/A1 trial
"Parentship"- a multi dimensional intervention program to improve parental resilienceN/A1 trial
Parent interventionN/A1 trial
Active Trials
NCT04097457Unknown100Est. Jan 2021
NCT03361787Completed10Est. Sep 2019
NCT05879705Unknown50Est. Sep 2023
Providence Therapeutics
2 programs
Autism ALERTN/A1 trial
Autism ALERTN/A1 trial
Active Trials
NCT04861740CompletedEst. Jan 2024
NCT06246890Active Not RecruitingEst. Jan 2028
ProgenaBiome
ProgenaBiomeCA - Ventura
1 program
Fecal Microbiota Transplant; VancomycinN/A1 trial
Active Trials
NCT04878718No Longer Available
Seed Therapeutics
Seed TherapeuticsNY - New York
1 program
Launching! to AdulthoodN/A1 trial
Active Trials
NCT06107972Active Not RecruitingEst. Dec 2025
Carrick Therapeutics
Carrick TherapeuticsIreland - Dublin
1 program
Mente Autism™N/A1 trial
Active Trials
NCT02773303CompletedEst. Dec 2017
T-Therapeutics
T-TherapeuticsUK - Cambridge
1 program
Use of Expert Guiding TechnologyN/A1 trial
Active Trials
NCT04518358CompletedEst. Aug 2022
Hamilton medical
Hamilton medicalSwitzerland - Bonaduz
1 program
e-health applicationN/A1 trial
Active Trials
NCT03852550TerminatedEst. May 2023
BioMarin Pharmaceutical
1 program
sapropterin dihydrochlorideN/A1 trial
Active Trials
NCT01141595Completed10Est. Sep 2011

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
City Therapeuticsamitriptyline
Vanda PharmaceuticalsTasimelteon Oral Capsule, Tasimelteon Liquid Suspension
Acadia PharmaceuticalsPimavanserin Tartrate 34 Mg ORAL CAPSULE [NUPLAZID]
MapLight TherapeuticsML-004
MapLight TherapeuticsML-004
Jazz PharmaceuticalsGWP42003-P
Jazz PharmaceuticalsGWP42006
Jazz PharmaceuticalsCannabidivarin
RocheBalovaptan
GenomicsFlore
RocheBalovaptan
RocheBalovaptan
RocheBalovaptan
RocheBalovaptan
RocheRO7017773

Showing 15 of 25 trials with date data

Clinical Trials (26)

Total enrollment: 1,179 patients across 26 trials

NCT04725383City Therapeuticsamitriptyline

Amitriptyline for Repetitive Behaviors in Autism Spectrum Disorders

Start: Nov 2023Est. completion: May 2025
Phase 3Terminated
NCT05361707Vanda PharmaceuticalsTasimelteon Oral Capsule, Tasimelteon Liquid Suspension

Evaluating the Effects of Tasimelteon in Individuals With Autism Spectrum Disorder (ASD) and Sleep Disturbances

Start: Jul 2021Est. completion: Jul 2025100 patients
Phase 3Recruiting
NCT05999240Acadia PharmaceuticalsPimavanserin Tartrate 34 Mg ORAL CAPSULE [NUPLAZID]

Pimavanserin for Rigid-compulsive Symptoms in Autism Spectrum Disorder

Start: Oct 2025Est. completion: Dec 202630 patients
Phase 2Recruiting
NCT05889273MapLight TherapeuticsML-004

ML-004 Open-Label Extension Study in Adults and Adolescents With Autism Spectrum Disorders (ASD)

Start: Jun 2023Est. completion: Dec 2027120 patients
Phase 2Enrolling By Invitation
NCT05081245MapLight TherapeuticsML-004

ML-004 in Adolescents and Adults With Autism Spectrum Disorders (ASD)

Start: Sep 2022Est. completion: Nov 2026150 patients
Phase 2Active Not Recruiting
NCT04745026Jazz PharmaceuticalsGWP42003-P

Trial to Investigate the Safety and Efficacy of Cannabidiol Oral Solution (GWP42003-P; CBD-OS) in Children and Adolescents With Autism Spectrum Disorder

Start: May 2021Est. completion: Dec 2023103 patients
Phase 2Completed
NCT03849456Jazz PharmaceuticalsGWP42006

Safety and Tolerability of Cannabidivarin (CBDV) in Children and Young Adults With Autism Spectrum Disorder

Start: Jan 2020Est. completion: May 20201 patients
Phase 2Terminated
NCT03202303Jazz PharmaceuticalsCannabidivarin

Cannabidivarin (CBDV) vs. Placebo in Children With Autism Spectrum Disorder (ASD)

Start: Apr 2019Est. completion: Feb 2027100 patients
Phase 2Recruiting
NCT03912350RocheBalovaptan

The Effect of Hepatic Impairment on the Pharmacokinetics of Balovaptan

Start: Jun 2022Est. completion: Oct 20220
Phase 1Withdrawn
NCT04655326GenomicsFlore

Probiotic Therapy for Children and Adults With Autism Spectrum Disorder

Start: Oct 2020Est. completion: Dec 2024350 patients
Phase 1Unknown
NCT04049578RocheBalovaptan

A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Balovaptan in Children With Autism Spectrum Disorder

Start: Dec 2019Est. completion: May 20202 patients
Phase 1Terminated
NCT04156646RocheBalovaptan

A Study to Investigate the Effect of Esomeprazole and the Effect of Food on the Pharmacokinetics of Balovaptan in Healthy Volunteers

Start: Nov 2019Est. completion: Jan 202016 patients
Phase 1Completed
NCT03586726RocheBalovaptan

A Study to Investigate the Effect of Rifampicin on the PK of Multiple Doses of Balovaptin In Healthy Volunteers

Start: Jul 2018Est. completion: Nov 201816 patients
Phase 1Completed
NCT03579719RocheBalovaptan

A Study to Investigate the Effect of Itraconazole on the PK of Multiple Doses of Balovaptan in Healthy Volunteers

Start: Jul 2018Est. completion: Nov 201815 patients
Phase 1Completed
NCT03507569RocheRO7017773

Open Label, Adaptive, Parallel Group PET Study Using RO7017773 And [11C] RO15-4513

Start: Apr 2018Est. completion: Jun 20186 patients
Phase 1Completed
NCT04878718ProgenaBiomeFecal Microbiota Transplant; Vancomycin

Vancomycin and Fecal Microbiota Transplant in a Single Patient With Autism Spectrum Disorder

N/ANo Longer Available
NCT06107972Seed TherapeuticsLaunching! to Adulthood

Developing a Culturally Adapted Intervention for Latino Youth Transitioning to Adulthood

Start: Apr 2024Est. completion: Dec 2025
N/AActive Not Recruiting
NCT06246890Providence TherapeuticsAutism ALERT

Autism ALERT Expansion

Start: Jan 2024Est. completion: Jan 2028
N/AActive Not Recruiting
NCT05879705Jerusalem PharmaceuticalsParent intervention

The Effectiveness of OT-ParentShip on Parental Resilience and Functioning of Adolescents With High Functioning Autism

Start: Mar 2021Est. completion: Sep 202350 patients
N/AUnknown
NCT04861740Providence TherapeuticsAutism ALERT

Autism Access Link for Early Referral and Treatment

Start: Sep 2020Est. completion: Jan 2024
N/ACompleted
NCT03852550Hamilton medicale-health application

READYorNot[TM] Brain-Based Disabilities Trial

Start: Jun 2020Est. completion: May 2023
N/ATerminated
NCT04518358T-TherapeuticsUse of Expert Guiding Technology

Expert Guiding Technology to Help Individuals With Developmental Challenges Build Life and Vocational Skills

Start: Sep 2019Est. completion: Aug 2022
N/ACompleted
NCT03361787Jerusalem Pharmaceuticals"Parentship"- a multi dimensional intervention program to improve parental resilience

A Multi-dimensional Program for Parents of Adolescents With High-functioning Autism

Start: Jan 2018Est. completion: Sep 201910 patients
N/ACompleted
NCT04097457Jerusalem Pharmaceuticals"Parent training for disruptive behaviors" manual

Group Based Parent Training for Children With Autism and Disruptive Behaviors

Start: Oct 2017Est. completion: Jan 2021100 patients
N/AUnknown
NCT02773303Carrick TherapeuticsMente Autism™

Neurofeedback Therapy for Children Diagnosed With Autism

Start: May 2016Est. completion: Dec 2017
N/ACompleted
NCT01141595BioMarin Pharmaceuticalsapropterin dihydrochloride

Tetrahydrobiopterin Treatment in Children With Idiopathic Cognitive Developmental Disorders

Start: Jul 2010Est. completion: Sep 201110 patients
N/ACompleted

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
3 actively recruiting trials targeting 1,179 patients
16 companies competing in this space