Balovaptan

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Balovaptan
Clinical data
Other namesRG7314
ATC code
  • None
Legal status
Legal status
Identifiers
  • 8-Chloro-5-methyl-1-(4-pyridin-2-yloxycyclohexyl)-4,6-dihydro-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine
JSmol)
  • CN1CC2=NN=C([C@H]3CC[C@@H](CC3)OC3=CC=CC=N3)N2C2=C(C1)C=C(Cl)C=C2
  • InChI=1S/C22H24ClN5O/c1-27-13-16-12-17(23)7-10-19(16)28-20(14-27)25-26-22(28)15-5-8-18(9-6-15)29-21-4-2-3-11-24-21/h2-4,7,10-12,15,18H,5-6,8-9,13-14H2,1H3/t15-,18-
  • Key:GMPZPHGHNDMRKL-RZDIXWSQSA-N

Balovaptan (

Roche for the treatment of post-traumatic stress disorder.[1]

Clinical studies

Post-traumatic stress disorder

It was in a phase III clinical trial for adults and a phase II clinical trial for children for this indication.[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 adult study (March 2020) is called V1aduct and the phase II child study is called Av1ation.[citation needed]

The phase III study concluded that balovaptan did not improve social communication in autistic adults.[5]

It was also in phase II studies for the treatment of stroke. However, it has since been discontinued for both of those indications, and is only being developed for post-traumatic stress disorder, with plans to submit regulatory filings in 2025 or later.[6]

References

  1. ^ "Roche - Pipeline". 2023. Retrieved 5 April 2023.
  2. ^ Clinical trial number NCT01793441 for "Study of RG7314 to Investigate Efficacy and Safety in Individuals With Autism Spectrum Disorders" at ClinicalTrials.gov
  3. ^ "FDA grants Breakthrough Therapy Designation for Roche's balovaptan in autism spectrum disorder" (Press release). 29 January 2018. Retrieved 6 February 2018.
  4. PMID 31043521
    .
  5. PMID 35151410
    .
  6. ^ "Balovaptan". Adis Insight. Springer Nature Switzerland AG. Retrieved 5 April 2023.
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