Balovaptan

Balovaptan (INNTooltip International Nonproprietary Name; developmental code name RG7314), is a selective small molecule antagonist of the vasopressin V1A receptor which is under development by Roche for the treatment of post-traumatic stress disorder (PTSD).

[1] It was in a phase III clinical trial for adults and a phase II clinical trial for children for post-traumatic stress disorder.

[2] In January 2018, Roche announced that the US Food and Drug Administration (FDA) had granted breakthrough therapy designation for balovaptan in people with autism spectrum disorder (ASD).

[3] The FDA granted this based on the results of the adult phase II clinical trial called VANILLA (Vasopressin ANtagonist to Improve sociaL communication in Autism) study.

[4] The phase III study concluded that balovaptan did not improve social communication in autistic adults.