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Review
. 2022 Nov;82(17):1671-1679.
doi: 10.1007/s40265-022-01796-y.

Deucravacitinib: First Approval

Sheridan M Hoy  1
Affiliations
Review

Deucravacitinib: First Approval

Sheridan M Hoy. Drugs. 2022 Nov.

Abstract

Deucravacitinib (SOTYKTU™) is a first-in-class, highly selective, oral tyrosine kinase 2 (TYK2) inhibitor. It acts via an allosteric mechanism, binding to the catalytically inactive pseudokinase regulatory domain of TYK2 and stabilizing an inhibitory interaction between the regulatory and catalytic domains. Deucravacitinib is being developed by Bristol Myers Squibb for the treatment of multiple immune-mediated diseases, including psoriasis, psoriatic arthritis, lupus and inflammatory bowel disease. It received its first approval (in the USA on 9 September 2022) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. On 26 September 2022, it was subsequently approved in Japan for the treatment of plaque psoriasis, generalized pustular psoriasis and erythrodermic psoriasis. The Marketing Authorisation Application for deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis has been validated in the EU, and clinical development of the drug for the treatment of multiple immune-mediated diseases is underway in numerous countries worldwide. This article summarizes the milestones in the development of deucravacitinib leading to this first approval for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

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Conflict of interest statement

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 authors on the basis of scientific completeness and accuracy. Sheridan M. Hoy is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

References

    1. Clark JD, Flanagan ME, Telliez JB. Discovery and development of Janus kinase (JAK) inhibitors for inflammatory diseases. J Med Chem. 2014;57(12):5023–5038. doi: 10.1021/jm401490p. - DOI - PubMed
    1. Le AM, Puig L, Torres T. Deucravacitinib for the treatment of psoriatic disease. Am J Clin Dermatol. 2022 doi: 10.1007/s40257-022-00720-0. - DOI - PMC - PubMed
    1. Nogueira M, Puig L, Torres T. JAK Inhibitors for treatment of psoriasis: focus on selective TYK2 inhibitors. Drugs. 2020;80(4):341–352. doi: 10.1007/s40265-020-01261-8. - DOI - PubMed
    1. Kim LS, Wu JJ, Han G. Deucravacitinib for psoriasis. Current Dermatology Reports. 2021;10(1):1–5. doi: 10.1007/s13671-020-00326-x. - DOI
    1. Bristol Myers Squibb. SOTYKTU™ (deucravacitinib) tablets, for oral use: US prescribing information. 2022. https://packageinserts.bms.com/pi/pi_sotyktu.pdf. Accessed 12 Sep 2022.