Does balovaptan, an oral selective vasopressin 1a receptor antagonist, improve socialization and communication difficulties in children and adolescents with autism spectrum disorder (ASD)?

In this randomized clinical trial that included 167 children and adolescents in the primary analysis, there was no statistically significant difference observed between the balovaptan and placebo groups in the primary outcome measure, change from baseline on the Vineland-II two-domain composite score at week 24.

Balovaptan was well tolerated in children with ASD but did not demonstrate efficacy in improvement of socialization and communication in this population, and these findings are important to guide future development efforts.

Reference: Hollander E, Jacob S, Jou R, McNamara N, Sikich L, Tobe R, Smith J, Sanders K, Squassante L, Murtagh L, Gleissl T, Wandel C, Veenstra-VanderWeele J. Balovaptan vs Placebo for Social Communication in Childhood Autism Spectrum Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2022 Jul 6. doi: 10.1001/jamapsychiatry.2022.1717.