Chemistry: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 post-traumatic stress disorder (PTSD).[1]
Research
Post-traumatic stress disorder
It was in a phase III clinical trial for adults and a phase II clinical trial for children for post-traumatic stress disorder.[2]
Autism
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.[5]
Stroke
It was also in phase II studies for the treatment of stroke. However, it has since been discontinued for both of those indications.[6]
References
- ↑ "Roche - Pipeline". 2023. http://www.roche.com/research_and_development/who_we_are_how_we_work/pipeline.htm.
- ↑ Clinical trial number NCT01793441 for "Study of RG7314 to Investigate Efficacy and Safety in Individuals With Autism Spectrum Disorders" at ClinicalTrials.gov
- ↑ "FDA grants Breakthrough Therapy Designation for Roche's balovaptan in autism spectrum disorder" (Press release). 2018-01-29. Retrieved 2018-02-06.
- ↑ "A phase 2 clinical trial of a vasopressin V1a receptor antagonist shows improved adaptive behaviors in men with autism spectrum disorder". Science Translational Medicine 11 (491). May 2019. doi:10.1126/scitranslmed.aat7838. PMID 31043521.
- ↑ "Efficacy and safety of balovaptan for socialisation and communication difficulties in autistic adults in North America and Europe: a phase 3, randomised, placebo-controlled trial". The Lancet. Psychiatry 9 (3): 199–210. March 2022. doi:10.1016/s2215-0366(21)00429-6. PMID 35151410.
- ↑ "Balovaptan". Adis Insight. Springer Nature Switzerland AG. https://adis.springer.com/drugs/800035102.
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