Deucravacitinib Explained

Pronounce:
Tradename:Sotyktu
Dailymedid:Deucravacitinib
Pregnancy Au:B1
Pregnancy Au Comment:[1]
Routes Of Administration:By mouth
Atc Prefix:L04
Atc Suffix:AF07
Class:Tyrosine kinase 2 (TYK2) inhibitor
Legal Au:S4
Legal Au Comment:[2]
Legal Ca:Rx-only
Legal Ca Comment:[3] [4] [5]
Legal Uk:POM
Legal Uk Comment:[6]
Legal Us:Rx-only
Legal Us Comment:[7]
Legal Eu:Rx-only
Legal Eu Comment:[8] [9]
Bioavailability:99%
Protein Bound:82–90%
Metabolism:Liver (primarily CYP1A2)
Metabolites:BMT-153261 (active)
Elimination Half-Life:10 hours
Excretion:Feces, urine
Cas Number:1609392-27-9
Pubchem:134821691
Drugbank:DB16650
Chemspiderid:72380005
Unii:N0A21N6RAU
Kegg:D11817
Chembl:435170
Synonyms:BMS-986165
Iupac Name:6-(cyclopropanecarboxamido)-4-((2-methoxy-3-(1-methyl-1,2,4-triazol-3-yl)phenyl)amino)-N-(trideuteromethyl)pyridazine-3-carboxamide
C:20
H:19
D:3
N:8
O:3
Smiles:[2H]C([2H])([2H])NC(=O)C1=NN=C(C=C1NC2=CC=CC(=C2OC)C3=NN(C=N3)C)NC(=O)C4CC4
Stdinchi:1S/C20H22N8O3/c1-21-20(30)16-14(9-15(25-26-16)24-19(29)11-7-8-11)23-13-6-4-5-12(17(13)31-3)18-22-10-28(2)27-18/h4-6,9-11H,7-8H2,1-3H3,(H,21,30)(H2,23,24,25,29)/i1D3
Stdinchikey:BZZKEPGENYLQSC-FIBGUPNXSA-N

Deucravacitinib, sold under the brand name Sotyktu, is a medication used for the treatment of moderate-to-severe plaque psoriasis. It is a tyrosine kinase 2 (TYK2) inhibitor and it is taken by mouth. It was developed by Bristol Myers Squibb.[10]

Deucravacitinib was approved for medical use in the United States in September 2022,[11] [12] and in Australia in December 2022. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[13] [14]

Medical uses

Deucravacitinib is indicated for the treatment of adults with moderate-to-severe plaque psoriasis.

Mechanism of action

It acts as a highly selective allosteric inhibitor of non-receptor tyrosine-protein kinase 2 (TYK2).[15]

Molecule design

The chemical structure of deucravacitinib contains a methyl amide in which all three hydrogen atoms are replaced by deuterium.[16]

Society and culture

Legal status

In January 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Sotyktu, intended for the treatment of moderate to severe psoriasis. The applicant for this medicinal product is Bristol-Myers Squibb Pharma EEIG.[17] Deucravacitinib was approved for medical use in the European Union in March 2023.

Notes and References

  1. Web site: Sotyktu . Therapeutic Goods Administration (TGA) . 14 December 2022 . 15 April 2023 . 9 June 2023 . https://web.archive.org/web/20230609012234/https://www.tga.gov.au/resources/auspmd/sotyktu . live .
  2. Web site: Sotyktu (Bristol-Myers Squibb Australia Pty Ltd) . Therapeutic Goods Administration (TGA) . 13 January 2023 . 9 April 2023 . 27 March 2023 . https://web.archive.org/web/20230327062418/https://www.tga.gov.au/resources/prescription-medicines-registrations/sotyktu-bristol-myers-squibb-australia-pty-ltd . live .
  3. Web site: Details for: Sotyktu . . 14 February 2023 . 3 March 2024 . 3 March 2024 . https://web.archive.org/web/20240303052906/https://dhpp.hpfb-dgpsa.ca/dhpp/resource/102205 . live .
  4. Web site: Notice: Multiple Additions to the Prescription Drug List (PDL) [2023-03-08] ]. . 8 March 2023 . 21 March 2023 . 22 March 2023 . https://web.archive.org/web/20230322024545/https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/prescription-drug-list/notices-changes/mutliple-additions-2023-03-08.html . live .
  5. Web site: Summary Basis of Decision - Sotyktu . . 10 March 2023 . 24 April 2023 . 25 April 2023 . https://web.archive.org/web/20230425001504/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00628&lang=en . live .
  6. Web site: Sotyktu Summary of Product Characteristics (SmPC) . (emc) . 13 July 2023 . 20 December 2023 . 20 December 2023 . https://web.archive.org/web/20231220061538/https://www.medicines.org.uk/emc/product/14871/smpc . live .
  7. Web site: Sotyktu- deucravacitinib tablet, film coated . DailyMed . 9 September 2022 . 27 September 2022 . 28 September 2022 . https://web.archive.org/web/20220928042407/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ff4d7258-5068-4cdf-9692-8cae04c3198e . live .
  8. Web site: Sotyktu EPAR . European Medicines Agency (EMA) . 24 March 2023 . 3 March 2024 . 19 February 2024 . https://web.archive.org/web/20240219214724/https://www.ema.europa.eu/en/medicines/human/EPAR/sotyktu . live .
  9. Web site: Sotyktu . Union Register of medicinal products . 27 March 2023 . 30 March 2023 . 31 March 2023 . https://web.archive.org/web/20230331060619/https://ec.europa.eu/health/documents/community-register/html/h1718.htm . live .
  10. U.S. Food and Drug Administration Approves Sotyktu (deucravacitinib), Oral Treatment for Adults with Moderate-to-Severe Plaque Psoriasis . Bristol Myers Squibb . Business Wire . 10 September 2022 . 10 September 2022 . 10 September 2022 . https://web.archive.org/web/20220910143525/https://www.businesswire.com/news/home/20220817005643/en/ . live .
  11. Web site: Drug Approval Package: Sotyktu . U.S. Food and Drug Administration (FDA) . 14 October 2022 . 4 January 2023 . 5 January 2023 . https://web.archive.org/web/20230105034534/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214958Orig1s000TOC.cfm . live .
  12. Truong TM, Pathak GN, Singal A, Taranto V, Rao BK . Deucravacitinib: The First FDA-Approved Oral TYK2 Inhibitor for Moderate to Severe Plaque Psoriasis . The Annals of Pharmacotherapy . 58. 4. 416–427 . June 2023 . 37341177 . 10.1177/10600280231153863 . 259211735 .
  13. Web site: Advancing Health Through Innovation: New Drug Therapy Approvals 2022 . U.S. Food and Drug Administration (FDA) . 10 January 2023 . 22 January 2023 . 21 January 2023 . https://web.archive.org/web/20230121035714/https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2022 . live .
  14. New Drug Therapy Approvals 2022 . U.S. Food and Drug Administration (FDA) . January 2024 . PDF . 14 January 2024 . https://web.archive.org/web/20240114065648/https://www.fda.gov/media/164429/download . 14 January 2024 . live .
  15. Chimalakonda A, Burke J, Cheng L, Catlett I, Tagen M, Zhao Q, Patel A, Shen J, Girgis IG, Banerjee S, Throup J . Selectivity Profile of the Tyrosine Kinase 2 Inhibitor Deucravacitinib Compared with Janus Kinase 1/2/3 Inhibitors . Dermatology and Therapy . 11 . 5 . 1763–1776 . October 2021 . 34471993 . 10.1007/s13555-021-00596-8 . 8484413 .
  16. Mullard A . First de novo deuterated drug poised for approval . Nature Reviews. Drug Discovery . 21 . 9 . 623–625 . September 2022 . 35974147 . 10.1038/d41573-022-00139-6 . 251623586 .
  17. Web site: Sotyktu: Pending EC decision . European Medicines Agency (EMA) . 26 January 2023 . 28 January 2023 . 27 January 2023 . https://web.archive.org/web/20230127225406/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/sotyktu . dead .

This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "Deucravacitinib".

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