Skip to main content

Irritability Associated With Autism Spectrum Disorder

5
Pipeline Programs
4
Companies
4
Clinical Trials
2 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
0
0
4
1
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
2100%
+ 3 programs with unclassified modality

On Market (1)

Approved therapies currently available

Otsuka
REXULTIApproved
brexpiprazole
Otsuka
Atypical Antipsychotic [EPC]oral2015
630M Part D

Competitive Landscape

4 companies ranked by most advanced pipeline stage

Otsuka
OtsukaJapan - Tokushima
1 program
1
1
BrexpiprazolePhase 3Small Molecule1 trial
Active Trials
NCT04258839Completed95Est. Mar 2023
Intra-Cellular Therapies
2 programs
2
Lumateperone high dosePhase 31 trial
Lumateperone high dosePhase 31 trial
Active Trials
NCT06690398Recruiting174Est. Apr 2027
NCT06706674Recruiting174Est. Apr 2027
Lundbeck
LundbeckDenmark - Copenhagen
1 program
1
BrexpiprazolePhase 3Small Molecule
Jazz Pharmaceuticals
Jazz PharmaceuticalsCA - Palo Alto
1 program
JZP541PHASE_21 trial
Active Trials
NCT05733390Withdrawn0Est. Nov 2023

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
Intra-Cellular TherapiesLumateperone high dose
Intra-Cellular TherapiesLumateperone high dose
OtsukaBrexpiprazole
Jazz PharmaceuticalsJZP541

Clinical Trials (4)

Total enrollment: 443 patients across 4 trials

NCT06706674Intra-Cellular TherapiesLumateperone high dose

Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients

Start: Dec 2024Est. completion: Apr 2027174 patients
Phase 3Recruiting
NCT06690398Intra-Cellular TherapiesLumateperone high dose

Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients

Start: Nov 2024Est. completion: Apr 2027174 patients
Phase 3Recruiting
NCT04258839OtsukaBrexpiprazole

Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder for Subjects That Have Completed Participation in 331-201-00148

Start: Jan 2020Est. completion: Mar 202395 patients
Phase 3Completed
NCT05733390Jazz PharmaceuticalsJZP541

A Study of JZP541 in Adults With Irritability Associated With Autism Spectrum Disorder

Start: Jun 2023Est. completion: Nov 20230
Phase 2Withdrawn

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

4 late-stage (Phase 3) programs, potential near-term approvals
2 actively recruiting trials targeting 443 patients
4 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.