Drugs / CRAVACITINIB
CRAVACITINIB
also known as
deucravacitinib · BMS-986165 · 6-CYCLOPROPANEAMIDO-4-{[2-METHOXY-3-(1-METHYL-1H-1,2,4-TRIAZOL-3-YL)PHENYL]AMINO}-N-(?H?)METHYLPYRIDAZINE-3-CARBOXAMIDE · DEU · DEUCRAVACITINIB (BMS-986165) · Sotyktu · TYK2-IN-4
Small molecule targets TYK2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | SOTYKTU | — | 2026-03-06 | fda.gov ↗ |
| Approved | EU (EMA) | Sotyktu | — | 2023-03-24 | europa.eu ↗ |
| Approved | US (FDA) | SOTYKTU | — | 2022-09-09 | fda.gov ↗ |
Trials 76 · started per year
today
US approved 2022
EU approved 2023
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT05821374 | Apr 2024 | pyoderma gangrenosum | Dartmouth-Hitchcock Medical Center | Withdrawn | No outcome recorded |
| Phase 0 | NCT05124080 | Mar 2024 → Dec 2025 | psoriasis | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 128 trials | ||||||
| Phase 1 | NCT06566768 | Oct 2024 → Jun 2025 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT04949269 | Jul 2021 → Jan 2022 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT04671953 | Dec 2020 → Mar 2021 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT04536961 | Sep → Dec 2020 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT04305899 | Aug → Nov 2020 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT04249284 | Feb → Mar 2020 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT04209699 | Dec 2019 → Feb 2020 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT04113668 | Oct → Nov 2019 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT04086719 | Sep → Oct 2019 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT04065932 | Aug → Dec 2019 | lupus erythematosus | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT04055506 | Aug → Sep 2019 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT03979248 | May → Jul 2019 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT03930602 | May 2019 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT03956953 | Apr → Sep 2019 | autoimmune disease | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT03890770 | Apr 2019 → Feb 2020 | impaired renal function disease | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT03890809 | Feb → Nov 2019 | liver disorder | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT03873415 | Jan → May 2019 | psoriasis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT03739788 | Dec 2018 → Feb 2019 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT03751228 | Oct → Nov 2018 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT03660436 | Aug → Oct 2018 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT03541564 | May → Sep 2018 | systemic lupus erythematosus | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT03419910 | Mar → May 2018 | psoriasis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT03402087 | Jan → Mar 2018 | lupus erythematosus, psoriatic arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT03254784 | Sep → Nov 2017 | inflammatory bowel disease, psoriasis, psoriatic arthritis, systemic lupus erythematosus | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT03262727 | Sep → Nov 2017 | inflammatory bowel disease, psoriasis, psoriatic arthritis, systemic lupus erythematosus | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT03044873 | Feb → Mar 2017 | autoimmune disease, inflammatory disease | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT03004768 | Jan → Feb 2017 | psoriasis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT02534636 | Oct 2015 → Nov 2016 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 220 trials | ||||||
| Phase 2 | NCT07508488 | May 2026 → Jun 2028 expected | central centrifugal cicatricial alopecia, frontal fibrosing alopecia | Icahn School of Medicine at Mount Sinai | Recruiting | No outcome recorded |
| Phase 2 | NCT07335796 | Jan 2026 → Jan 2030 expected | prostate cancer | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07012057 | Nov 2025 | dermatomyositis | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Withdrawn | No outcome recorded |
| Phase 2 | NCT06725264 | Mar 2025 → Jun 2026 | granuloma annulare, sarcoidosis | Yale University | Withdrawn | No outcome recorded |
| Phase 2 | NCT06444399 | Jul 2024 → Sep 2025 | pityriasis rubra pilaris | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT06327321 | May 2024 → Nov 2026 expected | generalized vitiligo | Centre Hospitalier Universitaire de Nice | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06136403 | Mar 2024 → Sep 2025 overdue | epidermolysis bullosa simplex, inherited ichthyosis | Centre Hospitalier Universitaire de Nice | Recruiting | No outcome recorded |
| Phase 2 | NCT05997277 | Nov 2023 → Feb 2025 | hidradenitis suppurativa | Beth Israel Deaconess Medical Center | Terminated | No outcome recorded |
| Phase 2 | NCT06091956 | Nov 2023 → May 2024 | lichen planopilaris | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT05556265 | Nov 2022 → Jan 2024 | alopecia areata | Bristol-Myers Squibb | Terminated | No outcome recorded |
| Phase 2 | NCT04857034 | Jul 2021 → Aug 2024 overdue | discoid lupus erythematosus, subacute cutaneous lupus erythematosus | Bristol-Myers Squibb | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04877990 | May 2021 → Aug 2023 | Crohn disease, ulcerative colitis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT04613518 | Mar 2021 → May 2023 | ulcerative colitis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT03943147 | Jul 2019 → Oct 2020 | lupus nephritis | Bristol-Myers Squibb | Terminated | No outcome recorded |
| Phase 2 | NCT03934216 | Jul 2019 → Jun 2021 | ulcerative colitis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT03881059 | Apr 2019 → Apr 2020 | psoriatic arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT03920267 | Mar 2019 → Mar 2025 | systemic lupus erythematosus | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT03599622 | Jul 2018 → Dec 2022 | Crohn disease | Bristol-Myers Squibb | Terminated | No outcome recorded |
| Phase 2 | NCT03252587 | Sep 2017 → Jun 2021 | systemic lupus erythematosus | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT02931838 | Nov 2016 → Nov 2017 | psoriasis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 313 trials | ||||||
| Phase 3 | NCT07116967 | Sep 2025 → Jan 2031 expected | psoriasis | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 3 | NCT06869551 | Mar 2025 → Mar 2030 expected | psoriasis-related juvenile idiopathic arthritis | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 3 | NCT05946941 | Sep 2023 → Nov 2026 expected | Sjogren syndrome | Bristol-Myers Squibb | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05617677 | Jan 2023 → Oct 2026 expected | systemic lupus erythematosus | Bristol-Myers Squibb | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05620407 | Jan 2023 → Oct 2026 expected | systemic lupus erythematosus | Bristol-Myers Squibb | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04908189 | Jul 2021 → Feb 2024 overdue | psoriatic arthritis | Bristol-Myers Squibb | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04908202 | Jul 2021 → Sep 2024 overdue | psoriatic arthritis | Bristol-Myers Squibb | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04772079 | Mar 2021 → Jan 2029 expected | psoriasis | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 3 | NCT04167462 | Nov 2019 → Mar 2021 | psoriasis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT04036435 | Aug 2019 → Jul 2026 overdue | psoriasis | Bristol-Myers Squibb | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03924427 | Apr 2019 → Mar 2021 | psoriasis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT03624127 | Aug 2018 → Sep 2020 | psoriasis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT03611751 | Jul 2018 → Nov 2020 | psoriasis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 412 trials | ||||||
| Phase 4 | NCT07352566 | Aug 2026 → Jun 2030 expected | atopic eczema, psoriasis | University of California, San Francisco | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07280702 | Apr 2026 → Dec 2027 expected | psoriatic arthritis | University of Texas Southwestern Medical Center | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06875960 | Feb → Dec 2026 expected | systemic lupus erythematosus | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 4 | NCT07013838 | Jun 2025 → Dec 2027 expected | Takayasu arteritis | Chinese SLE Treatment And Research Group | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06476834 | Jun → Nov 2024 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 4 | NCT06333860 | May 2024 → Mar 2026 | psoriasis | AbbVie | Completed | No outcome recorded |
| Phase 4 | NCT06042920 | Oct 2023 → Apr 2025 | psoriasis | Bristol-Myers Squibb | Terminated | No outcome recorded |
| Phase 4 | NCT05858645 | Oct 2023 → Jun 2028 expected | psoriasis | University of California, San Francisco | Recruiting | No outcome recorded |
| Phase 4 | NCT05710185 | Jul 2023 → Dec 2024 | palmoplantar pustulosis | Brigham and Women's Hospital | Terminated | No outcome recorded |
| Phase 4 | NCT05701995 | Jan 2023 → Aug 2024 | psoriasis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 4 | NCT06329258 | Dec 2022 → Nov 2023 | psoriasis | Psoriasis Treatment Center of Central New Jersey | Completed | No outcome recorded |
| Phase 4 | NCT05478499 | Oct 2022 → Jan 2024 | psoriasis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07000630 | Jun → Nov 2025 | palmoplantar pustulosis | Peking University First Hospital | Terminated | No outcome recorded |
Also used as a comparator or background therapy in 7 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT06532136 Comparator | Nov 2024 → Jan 2026 | rosacea | Icahn School of Medicine at Mount Sinai | Withdrawn | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06281106 Comparator | Jun 2024 → Mar 2025 | psoriasis | Prof Curdin Conrad | Terminated | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT07326813 Comparator | Jan 2026 → Jul 2027 expected | psoriasis | InventisBio Co., Ltd | Recruiting | No outcome recorded |
| Phase 3 | NCT06979453 Comparator | Dec 2025 → Oct 2029 expected | psoriasis | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 3 | NCT06973291 Comparator | Jul 2025 → Apr 2026 | psoriasis | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT06220604 Comparator | Mar → Nov 2024 overdue | psoriasis | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06143878 Comparator | Feb → Sep 2024 overdue | psoriasis | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-06-11 | Takeda | Takeda’s Zasocitinib Significantly Outperforms Deucravacitinib in Head-to-Head Phase 3 Psoriasis Study, Promising to Redefine Oral Treatment Expectations takeda.com ↗ |
| 2026-05-08 | Bristol-Myers Squibb | Bristol Myers Squibb Receives European Commission Approval of Sotyktu (deucravacitinib) for the Treatment of Active Psoriatic Arthritis in Adults bms.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 88 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CRAVACITINIB | ChEMBL registry synonym — accepted as the source's own label CHEMBL4596392 ↗ |
| Known as | 6-CYCLOPROPANEAMIDO-4-{[2-METHOXY-3-(1-METHYL-1H-1,2,4-TRIAZOL-3-YL)PHENYL]AMINO}-N-(?H?)METHYLPYRIDAZINE-3-CARBOXAMIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4596392 ↗ |
| Known as | BMS-986165 | “A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Deucravacitinib (BMS-986165) in Pediatric...” NCT04772079 ↗44“A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Deucravacitinib (BMS-986165) in Participants With Active Discoid and/or Subacute...” NCT04857034 ↗ “A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus” NCT05620407 ↗ “A Study to Evaluate the Drug Levels, Efficacy, and Safety of Deucravacitinib (BMS-986165) in Pediatric Participants With Juvenile Psoriatic Arthritis” NCT06869551 ↗ “Deucravacitinib (BMS-986165) for Pityriasis Rubra Pilaris” NCT06444399 ↗ |
| Known as | DEU | “Risankizumab (RZB) and deucravacitinib (DEU) are both approved for the treatment of moderate-to-severe psoriasis.” PMID 42143644 ↗ May 2026 |
| Known as | deucravacitinib | “This randomized, double-blind, single- and multiple-ascending dose study assessed the pharmacokinetics (PKs), pharmacodynamics, and safety of deucravacitinib (Sotyktu™), a...” PMID 36325947 ↗ Nov 202245“Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in Japan for adults with plaque, generalized pustular, and erythrodermic psoriasis who...” PMID 40304108 ↗ Apr 2025 “A Study to Continue the Administration of Deucravacitinib in Participants With Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus...” NCT06875960 ↗ “Deucravacitinib is an oral, selective tyrosine kinase 2 inhibitor that demonstrated therapeutic benefit in a Phase 2 clinical trial of adults with moderate to severe plaque psoriasis.” PMID 35025062 ↗ Jan 2022 “To evaluate the efficacy and safety of an oral selective tyrosine kinase 2 (TYK2) inhibitor, deucravacitinib, in patients with active psoriatic arthritis (PsA).” PMID 35241426 ↗ Mar 2022 “The main goal of this study is to see if the study drug called "Deucravacitinib" is safe and effective in treating people with pyoderma gangrenosum (PG).” NCT05821374 ↗ “FDA has approved a drug called deucravacitinib to treat people with plaque psoriasis.” NCT07012057 ↗ |
| Known as | DEUCRAVACITINIB (BMS-986165) | ChEMBL registry synonym — accepted as the source's own label CHEMBL4596392 ↗ |
| Known as | Sotyktu | “This randomized, double-blind, single- and multiple-ascending dose study assessed the pharmacokinetics (PKs), pharmacodynamics, and safety of deucravacitinib (Sotyktu™), a...” PMID 36325947 ↗ Nov 2022 |
| Known as | TYK2-IN-4 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4596392 ↗ |
| Action | Inhibit | “a selective and potent small-molecule inhibitor of tyrosine kinase 2” PMID 36325947 ↗ Nov 2022 |
| Modality | Small molecule | “a selective and potent small-molecule inhibitor of tyrosine kinase 2” PMID 36325947 ↗ Nov 2022 |
| Route | Oral | “Part A will investigate single oral doses of drug” NCT02534636 ↗ |
| Target | TYK2 | “inhibitor of tyrosine kinase 2” PMID 36325947 ↗ Nov 2022 |