Anavex Life Sciences Corp (AVXL)

[Pioneer10257]

Roche Autism Clinical trials of Balovaptan.

Balovaptan (INN; 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 autism.[1] As of August 2019, it is in a phase III clinical trial for adults and a phase II clinical trial for children for this indication.[2] On 29 January 2018, Roche announced that the US Food and Drug Administration (FDA) had granted Breakthrough Therapy Designation for balovaptan in individuals 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 currently-recruiting (Until March 2020) phase III adult study is called V1aduct and the currently-closed (August 2019) phase II child study is called Av1ation.[citation needed]