Skip to main content

Valbenazine: First Global Approval

Drugs volume 77, pages 1123–1129 (2017)Cite this article

Abstract

Valbenazine (Ingrezza™) is an orally bioavailable, selective, vesicular monoamine transporter 2 (VMAT2) inhibitor being developed by Neurocrine Biosciences for the treatment of various central nervous system disorders. Valbenazine has been approved in the USA for the treatment of adults with tardive dyskinesia (TD), is at various stages of development in other countries for TD and is in phase 2 development in the USA for Tourette syndrome. This article summarizes the milestones in the development of valbenazine leading to its first global approval in the USA for the treatment of adults with TD.

This is a preview of subscription content, access via your institution.

Access options

Buy single article

Instant access to the full article PDF.

USD 49.95

Price includes VAT (USA)
Tax calculation will be finalised during checkout.

References

  1. Waln O, Jankovic J. An update on tardive dyskinesia: from phenomenology to treatment. Tremor Other Hyperkinet Mov (NY). 2013. doi:10.7916/D88P5Z71.

    Google Scholar 

  2. Aia PG, Revuelta GJ, Cloud LJ, et al. Tardive dyskinesia. Curr Treat Options Neurol. 2011;13(3):231–41.

    Article  PubMed  Google Scholar 

  3. Grigoriadis DE, Smith E, Hoare SRJ, et al. Pharmacologic characterization of valbenazine (NBI-98854) and its metabolites. J Pharm Exp Ther. 2017. doi:10.1124/jpet.116.239160.

    Google Scholar 

  4. US FDA. FDA approves first drug to treat tardive dyskinesia [media release]. 11 Apr 2017. https://www.fda.gov.

  5. Neurocrine Biosciences Inc. IngrezzaTM (valbenazine) capsules: US prescribing information. 2017. https://www.fda.gov. Accessed 3 May 2017.

  6. Adis Insight. Drug profile: valbenazine. 2017. http://www.adisinsight.springer.com. Accessed 3 May 2017.

  7. Mitsubishi Tanabe Pharma Corporation. Business briefing—open up the future. 2016. http://www.mt-pharma.co.jp. Accessed 5 May 2017.

  8. Neurocrine Biosciences. Neurocrine Biosciences and Mitsubishi Tanabe Pharma announce agreement to develop and commercialize VMAT2 inhibitor NBI-98854 for movement disorders in Japan and other select Asian markets [media release]. 31 Mar 2015. http://www.neurocrine.com/.

  9. Neurocrine Biosciences. Neurocrine Biosciences announces notice of allowance for composition of matter patent on VMAT2 inhibitor [media release]. 23 Jun 2011. http://www.neurocrine.com.

  10. Neurocrine Biosciences. Neurocrine Biosciences announces additional European and United States patents issued on proprietary VMAT2 inhibitor [media release]. 23 Jan 2013. http://www.neurocrine.com/.

  11. Hauser RA, Factor SA, Marder SR, et al. KINECT 3: a phase 3 randomized, double-blind, placebo-controlled trial of valbenazine for tardive dyskinesia. Am J Psychiatry. 2017;174(5):476–84.

    Article  PubMed  Google Scholar 

  12. Factor S, Comella C, Correll C, et al. Efficacy of valbenazine (NBI-98854) in subjects with tardive dyskinesia: results of a long-term study (KINECT 3 extension) [abstract no. S56.005]. Neurology. 2017;88(16 Suppl).

  13. National Library of Medicine. Clinicaltrials.gov. 2017. https://clinicaltrials.gov/. Accessed 12 May 2017.

  14. Neurocrine Biosciences. Neurocrine Biosciences reports first quarter 2017 results [media release]. 9 May 2017. http://www.neurocrine.com/.

  15. O’Brien CF, Jimenez R, Hauser RA, et al. NBI-98854, a selective monoamine transport inhibitor for the treatment of tardive dyskinesia: a randomized, double-blind, placebo-controlled study. Mov Disord. 2015;30(12):1681–7.

    Article  PubMed  PubMed Central  Google Scholar 

  16. Neurocrine Biosciences. Neurocrine announces phase IIb results of VMAT2 inhibitor NBI-98854 for treatment of tardive dyskinesia [media release]. 9 Sep 2013. http://www.neurocrine.com/.

  17. Bari M, Shiwach R, Jimenez R, et al. Open-label extension of kinect: a phase 2 study of valbenazine (NBI-98854) for tardive dyskinesia [abstract no. S27.001]. Neurology. 2016;86(16 Suppl 1).

  18. Neurocrine Biosciences. Neurocrine announces phase II results of VMAT2 inhibitor NBI-98854 for treatment of tardive dyskinesia [media release]. 26 Mar 2012. http://www.neurocrine.com/.

  19. Neurocrine Biosciences. Neurocrine Biosciences announces successful phase IIa clinical trial for VMAT2 inhibitor [media release]. 5 Apr 2011. http://www.neurocrine.com/.

  20. Neurocrine Biosciences. Neurocrine announces completion of phase II clinical study of VMAT2 inhibitor INGREZZA™ (valbenazine) in adults with Tourette Syndrome [media release]. 17 Jan 2017. http://www.neurocrine.com/.

  21. Remington G, Comella C, Grigoriadis D, et al. Safety and tolerability of valbenazine (NBI-98854) in subjects with tardive dyskinesia: results of long-term exposure data from three studies [abstract no. M150]. Neuropsychopharmacology. 2016;41(Suppl S1):S212–3.

  22. Neurocrine Biosciences. Neurocrine announces initiation of phase II clinical study of VMAT2 inhibitor valbenazine in children and adolescents with Tourette Syndrome [media release]. 2 Feb 2016. http://www.neurocrine.com/.

  23. Neurocrine Biosciences. Neurocrine announces initiation of a long-term phase II clinical study of VMAT2 inhibitor valbenazine in Tourette syndrome [media release]. 28 Jul 2016. http://www.neurocrine.com/.

Download references

Disclosure

The preparation of this review was not supported by any external funding. During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the author on the basis of scientific completeness and accuracy. E. S. Kim is a salaried employee of Adis, Springer SBM.

Additional information about this Adis Drug Review can be found at http://www.medengine.com/Redeem/7C48F06022B8809D.

Author information

Authors and Affiliations

  1. Springer, Private Bag 65901, Mairangi Bay 0754, Auckland, New Zealand

    Esther S. Kim

Authors
  1. Esther S. Kim
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Esther S. Kim.

Additional information

This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Kim, E.S. Valbenazine: First Global Approval. Drugs 77, 1123–1129 (2017). https://doi.org/10.1007/s40265-017-0770-9

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40265-017-0770-9