According to the Centers for Disease Control and Prevention (CDC), approximately 1 in 54 children has been identified with Autism Spectrum Disorder (ASD). Core symptoms of ASD include impairments in social interaction, communication, and the presence of stereotyped repetitive behaviors. Co-occurring conditions that impact quality of life are extensive and diverse, and include irritability, anxiety, ADHD, allergies, autoimmune disorder, neuroinflammation, and epilepsy. Physicians have reported irritability impacts a majority of pediatric ASD patients. Although the presentation of ASD-associated irritability can vary with severity and age, and can be caused by a broad array of different factors including lack of sleep, the inability to communicate pain, and mental health disorders.


Medicines for treating core symptoms and co-occurring conditions associated with ASD such as irritability have long represented a significant area of unmet medical need. The prevalence and severity of challenges faced by people with autism and the lack of safe and effective treatment options make ASD an important focus of novel drug discovery to bring forward innovative medical interventions.


Axial is developing AB-2004, a therapeutic candidate for the reduction of irritability in children with autism.


1. Prevalence of Autism Spectrum Disorder Among Children Aged 8 Years — Autism and Developmental Disabilities Monitoring Network, 11 Sites, United States, 2016. MMWR Surveillance Summaries / March 27, 2020