Balovaptan

Balovaptan
Clinical data
Other namesRG7314
Legal status
Legal status
Identifiers
IUPAC name
  • 8-Chloro-5-methyl-1-(4-pyridin-2-yloxycyclohexyl)-4,6-dihydro-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
Chemical and physical data
FormulaC22H24ClN5O
Molar mass409.92 g·mol−1
3D model (JSmol)
SMILES
  • CN1CC2=NN=C([C@H]3CC[C@@H](CC3)OC3=CC=CC=N3)N2C2=C(C1)C=C(Cl)C=C2
InChI
  • 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 (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.[1]

Uses

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

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 phase III adult study (March 2020) is called V1aduct and the currently-closed (August 2019) phase II child study is called Av1ation.

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]

See also

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. ↑ Bolognani F, Del Valle Rubido M, Squassante L, Wandel C, Derks M, Murtagh L, et al. (May 2019). "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). doi:10.1126/scitranslmed.aat7838. PMID 31043521.
  5. ↑ Jacob, Suma; Veenstra-VanderWeele, Jeremy; Murphy, Declan; McCracken, James; Smith, Janice; Sanders, Kevin; Meyenberg, Christoph; Wiese, Thomas; Deol-Bhullar, Gurpreet; Wandel, Christoph; Ashford, Elizabeth; Anagnostou, Evdokia (10 February 2022). "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. doi:10.1016/s2215-0366(21)00429-6. ISSN 2215-0366.
  6. ↑ "Balovaptan". Adis Insight. Springer Nature Switzerland AG. Retrieved 5 April 2023.
  • "Balovaptan". Drug Information Portal. U.S. National Library of Medicine.


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