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Autistic Disorder

14
Pipeline Programs
11
Companies
15
Clinical Trials
1 recruiting
5
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
0
2
0
5
6
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
3100%
+ 13 programs with unclassified modality

On Market (5)

Approved therapies currently available

Otsuka
ABILIFY ASIMTUFIIApproved
aripiprazole
Otsuka
Atypical Antipsychotic [EPC]intramuscular2023
13M Part D
Otsuka
ABILIFYApproved
aripiprazole
Otsuka
Atypical Antipsychotic [EPC]oral2002
12M Part D
Otsuka
MEZOFYApproved
aripiprazole
Otsuka
oral2025
Otsuka
OPIPZAApproved
aripiprazole
Otsuka
Atypical Antipsychotic [EPC]oral2024
Otsuka
ABILIFY MAINTENA KITApproved
aripiprazole
Otsuka
intramuscular2013

Competitive Landscape

9 companies ranked by most advanced pipeline stage

Otsuka
OtsukaJapan - Tokushima
4 programs
4
1
AripiprazolePhase 3Small Molecule1 trial
AripiprazolePhase 3Small Molecule1 trial
AripiprazolePhase 3Small Molecule1 trial
Aripiprazole Oral SolutionPhase 31 trial
Active Trials
NCT00365859Completed330Est. Jun 2009
NCT00332241Completed98Est. Apr 2008
NCT01617460Completed86Est. Oct 2016
+1 more trials
Prevail Therapeutics
1 program
1
AtomoxetinePhase 41 trial
Active Trials
NCT00380692Completed97Est. Oct 2008
Alliance Pharmaceuticals
2 programs
1
1
D-cycloserinePhase 31 trial
N-acetylcysteinePhase 21 trial
Active Trials
NCT00453180Completed31Est. Nov 2009
NCT00198120Completed80Est. Aug 2010
Angeles Therapeutics
Angeles TherapeuticsCA - Los Angeles
3 programs
1
Cognitive-behavioral therapyPhase 21 trial
Treatment of Functional Constipation byN/A1 trial
intensive one-on-one behavioral treatmentN/A1 trial
Active Trials
NCT02442115Completed100Est. Feb 2019
NCT00004449Completed102Est. Apr 2006
NCT00280670Completed20Est. Aug 2009
Scioto Biosciences
Scioto BiosciencesIN - Indianapolis
1 program
1
SB-121Phase 11 trial
Active Trials
NCT04944901Completed15Est. Mar 2022
BioMarin Pharmaceutical
2 programs
sapropterinPHASE_21 trial
Kuvan®PHASE_2_31 trial
Active Trials
NCT00850070Completed46Est. Oct 2011
NCT00943579Completed41Est. Mar 2012
Human BioSciences
Human BioSciencesWV - Martinsburg
1 program
Autistic functional explorationN/A1 trial
Active Trials
NCT01984944Completed42Est. Aug 2013
Function Therapeutics
Function TherapeuticsWI - Milwaukee
1 program
Autistic functional explorationN/A
MediaPharma
MediaPharmaItaly - Chieti
1 program
SQUED™ series 28.1 home-useN/A1 trial
Active Trials
NCT03222375Recruiting80Est. Dec 2027

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
Prevail TherapeuticsAtomoxetine
OtsukaAripiprazole Oral Solution
OtsukaAripiprazole
OtsukaAripiprazole
OtsukaAripiprazole
Alliance PharmaceuticalsD-cycloserine
BioMarin PharmaceuticalKuvan®
BioMarin Pharmaceuticalsapropterin
Alliance PharmaceuticalsN-acetylcysteine
Angeles TherapeuticsCognitive-behavioral therapy
Scioto BiosciencesSB-121
MediaPharmaSQUED™ series 28.1 home-use
Angeles TherapeuticsTreatment of Functional Constipation by
Human BioSciencesAutistic functional exploration
Angeles Therapeuticsintensive one-on-one behavioral treatment

Clinical Trials (15)

Total enrollment: 1,279 patients across 15 trials

NCT00380692Prevail TherapeuticsAtomoxetine

Atomoxetine Versus Placebo for Symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children and Adolescents With Autism Spectrum Disorder

Start: Oct 2006Est. completion: Oct 200897 patients
Phase 4Completed
NCT03487770OtsukaAripiprazole Oral Solution

Aripiprazole Oral Solution in the Treatment of Children and Adolescents With Autistic Disorder

Start: Apr 2018Est. completion: Apr 2020111 patients
Phase 3Completed
NCT01617460OtsukaAripiprazole

A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder

Start: Sep 2012Est. completion: Oct 201686 patients
Phase 3Completed
NCT00365859OtsukaAripiprazole

Study of Aripiprazole in the Treatment of Serious Behavioral Problems in Children and Adolescents With Autistic Disorder (AD)

Start: Sep 2006Est. completion: Jun 2009330 patients
Phase 3Completed
NCT00332241OtsukaAripiprazole

Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)

Start: Jun 2006Est. completion: Apr 200898 patients
Phase 3Completed
NCT00198120Alliance PharmaceuticalsD-cycloserine

Safety and Effectiveness of D-Cycloserine in Children With Autism

Start: Feb 2004Est. completion: Aug 201080 patients
Phase 3Completed
NCT00943579BioMarin PharmaceuticalKuvan®

Open-Label Extension Study of Kuvan for Autism

Start: Aug 2009Est. completion: Mar 201241 patients
Phase 2/3Completed
NCT00850070BioMarin Pharmaceuticalsapropterin

Sapropterin as a Treatment for Autistic Disorder

Start: Mar 2009Est. completion: Oct 201146 patients
Phase 2Completed
NCT00453180Alliance PharmaceuticalsN-acetylcysteine

A Study of Oral N-Acetylcysteine in Children With Autism Spectrum Disorders

Start: Mar 2007Est. completion: Nov 200931 patients
Phase 2Completed
NCT00280670Angeles TherapeuticsCognitive-behavioral therapy

CBT for Comorbid Anxiety Disorders in Children With Autism, Asperger Syndrome, or PDD-NOS

Start: Jan 2005Est. completion: Aug 200920 patients
Phase 2Completed
NCT04944901Scioto BiosciencesSB-121

28-Day Daily-dose Crossover Study of the Safety and Tolerability of SB-121 (Lactobacillus Reuteri With Sephadex® and Maltose) in Subjects, Ages 15 to 45 Years, Diagnosed With Autistic Disorder

Start: Aug 2021Est. completion: Mar 202215 patients
Phase 1Completed
NCT03222375MediaPharmaSQUED™ series 28.1 home-use

SQUED™ Series 28.1 Home-use and Treatment of Autowave Reverberator of Autism

Start: Sep 2017Est. completion: Dec 202780 patients
N/ARecruiting
NCT02442115Angeles TherapeuticsTreatment of Functional Constipation by

Impact of Improving Gastrointestinal Symptoms on Autism Symptoms and Oxidative Stress

Start: Apr 2015Est. completion: Feb 2019100 patients
N/ACompleted
NCT01984944Human BioSciencesAutistic functional exploration

Characterisation of Circadian Rhythm in Autistic Spectrum Disorder

Start: Oct 2009Est. completion: Aug 201342 patients
N/ACompleted
NCT00004449Angeles Therapeuticsintensive one-on-one behavioral treatment

Randomized Study of Intensive One-on-one Behavioral Treatment for Preschool Aged Children With Autism

Start: May 1998Est. completion: Apr 2006102 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

5 late-stage (Phase 3) programs, potential near-term approvals
1 actively recruiting trials targeting 1,279 patients
11 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.