Clinical data | |
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Pronunciation | /duːˌkrævəˈsɪtɪnɪb/ doo-KRA-və-SI-ti-nib |
Trade names | Sotyktu |
Other names | BMS-986165 |
AHFS/Drugs.com | Monograph |
License data | |
Pregnancy category |
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Routes of administration | By mouth |
Drug class | Tyrosine kinase 2 (TYK2) inhibitor |
ATC code | |
Legal status | |
Legal status | |
Pharmacokinetic data | |
Bioavailability | 99% |
Protein binding | 82–90% |
Metabolism | Liver (primarily CYP1A2) |
Metabolites | BMT-153261 (active) |
Elimination half-life | 10 hours |
Excretion | Feces, urine |
Identifiers | |
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CAS Number | |
Chemical and physical data | |
Formula | C20H19D3N8O3 |
Molar mass | 425.466 g·mol−1 |
3D model (JSmol) | |
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Deucravacitinib, sold under the brand name Sotyktu, is a medication used for the treatment of moderate-to-severe plaque psoriasis.[7] It is a tyrosine kinase 2 (TYK2) inhibitor and it is taken by mouth.[7] It was developed by Bristol Myers Squibb.[10]
Deucravacitinib was approved for medical use in the United States in September 2022,[7][11][12] and in Australia in December 2022.[1] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[13][14]
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Transcription
Medical uses
Deucravacitinib is indicated for the treatment of adults with moderate-to-severe plaque psoriasis.[7]
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.[8][17] The applicant for this medicinal product is Bristol-Myers Squibb Pharma EEIG.[8][17] Deucravacitinib was approved for medical use in the European Union in March 2023.[8]
References
- ^ a b c "Sotyktu". Therapeutic Goods Administration (TGA). 14 December 2022. Archived from the original on 9 June 2023. Retrieved 15 April 2023.
- ^ "Sotyktu (Bristol-Myers Squibb Australia Pty Ltd)". Therapeutic Goods Administration (TGA). 13 January 2023. Archived from the original on 27 March 2023. Retrieved 9 April 2023.
- ^ "Details for: Sotyktu". Health Canada. 14 February 2023. Archived from the original on 3 March 2024. Retrieved 3 March 2024.
- ^ "Notice: Multiple Additions to the Prescription Drug List (PDL) [2023-03-08]". Health Canada. 8 March 2023. Archived from the original on 22 March 2023. Retrieved 21 March 2023.
- ^ "Summary Basis of Decision - Sotyktu". Health Canada. 10 March 2023. Archived from the original on 25 April 2023. Retrieved 24 April 2023.
- ^ "Sotyktu Summary of Product Characteristics (SmPC)". (emc). 13 July 2023. Archived from the original on 20 December 2023. Retrieved 20 December 2023.
- ^ a b c d e "Sotyktu- deucravacitinib tablet, film coated". DailyMed. 9 September 2022. Archived from the original on 28 September 2022. Retrieved 27 September 2022.
- ^ a b c d "Sotyktu EPAR". European Medicines Agency (EMA). 24 March 2023. Archived from the original on 19 February 2024. Retrieved 3 March 2024.
- ^ "Sotyktu". Union Register of medicinal products. 27 March 2023. Archived from the original on 31 March 2023. Retrieved 30 March 2023.
- ^ "U.S. Food and Drug Administration Approves Sotyktu (deucravacitinib), Oral Treatment for Adults with Moderate-to-Severe Plaque Psoriasis" (Press release). Bristol Myers Squibb. 10 September 2022. Archived from the original on 10 September 2022. Retrieved 10 September 2022 – via Business Wire.
- ^ "Drug Approval Package: Sotyktu". U.S. Food and Drug Administration (FDA). 14 October 2022. Archived from the original on 5 January 2023. Retrieved 4 January 2023.
- ^ Truong TM, Pathak GN, Singal A, Taranto V, Rao BK (June 2023). "Deucravacitinib: The First FDA-Approved Oral TYK2 Inhibitor for Moderate to Severe Plaque Psoriasis". The Annals of Pharmacotherapy: 10600280231153863. doi:10.1177/10600280231153863. PMID 37341177. S2CID 259211735.
- ^ This article incorporates text from this source, which is in the public domain.
- ^ This article incorporates text from this source, which is in the public domain.
- ^ Chimalakonda A, Burke J, Cheng L, Catlett I, Tagen M, Zhao Q, et al. (October 2021). "Selectivity Profile of the Tyrosine Kinase 2 Inhibitor Deucravacitinib Compared with Janus Kinase 1/2/3 Inhibitors". Dermatology and Therapy. 11 (5): 1763–1776. doi:10.1007/s13555-021-00596-8. PMC 8484413. PMID 34471993.
- ^ Mullard A (September 2022). "First de novo deuterated drug poised for approval". Nature Reviews. Drug Discovery. 21 (9): 623–625. doi:10.1038/d41573-022-00139-6. PMID 35974147. S2CID 251623586.
- ^ a b "Sotyktu: Pending EC decision". European Medicines Agency (EMA). 26 January 2023. Archived from the original on 27 January 2023. Retrieved 28 January 2023.