Active Ingredient History

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Balovaptan, is a selective small molecule antagonist of the vasopressin V1A receptor which is under development by Roche for the treatment of autism. 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. 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). The FDA granted this based on the results of the adult phase II clinical trial called VANILLA study. The currently-recruiting phase III adult study is called V1aduct and the currently-closed phase II child study is called Av1ation.   Wikipedia

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