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 · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed psoriasis 2 milestones | |||||
| Filed | EU (EMA) | — | psoriasis | 2021-11-29 | “the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis.” bms.com ↗ |
| Filed | US (FDA) | — | psoriasis | 2021-11-29 | “The FDA has accepted the NDA and the EMA has validated the Marketing Authorization Application for deucravacitinib” bms.com ↗ |
| Filed psoriatic arthritis 2 milestones | |||||
| Filed | EU (EMA) | Sotyktu | psoriatic arthritis | 2025-07-21 | “The European Medicines Agency has also validated Bristol Myers Squibb's Type II variation application to expand the indication for Sotyktu to include this disease.” bms.com ↗ |
| Filed | US (FDA) | Sotyktu | psoriatic arthritis | 2025-07-21 | “the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Sotyktu (deucravacitinib) for the treatment of adults with...” bms.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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 77 · started per year
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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| Phase 0 | NCT05821374 | Apr 2024 | pyoderma gangrenosum | Dartmouth-Hitchcock Medical Center | Withdrawn | No outcome recorded Stop: Business |
| 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 · 3 met primary · 2 missed | ||||||
| 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 | Active not 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 Stop: Business |
| 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 Stop: Business |
| 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 Stop: Business |
| 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 | Missed primary |
| Phase 2 | NCT03943147 | Jul 2019 → Oct 2020 | lupus nephritis | Bristol-Myers Squibb | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03934216 | Jul 2019 → Jun 2021 | ulcerative colitis | Bristol-Myers Squibb | Completed | Missed primary |
| Phase 2 | NCT03881059 | Apr 2019 → Apr 2020 | psoriatic arthritis | Bristol-Myers Squibb | Completed | Met primary |
| 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 | Mixed |
| Phase 2 | NCT03252587 | Sep 2017 → Jun 2021 | systemic lupus erythematosus | Bristol-Myers Squibb | Completed | Met primary |
| Phase 2 | NCT02931838 | Nov 2016 → Nov 2017 | psoriasis | Bristol-Myers Squibb | Completed | Met primary |
| Phase 314 trials · 5 met primary | ||||||
| Phase 3 | NCT07791199 | Dec 2026 → Oct 2030 expected | Sjogren syndrome, psoriasis, psoriatic arthritis, systemic lupus erythematosus | Bristol-Myers Squibb | Not yet recruiting | No outcome recorded |
| 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 → Nov 2024 overdue | psoriatic arthritis | Bristol-Myers Squibb | Active not recruiting | Met primary |
| Phase 3 | NCT04908202 | Jul 2021 → Sep 2024 overdue | psoriatic arthritis | Bristol-Myers Squibb | Active not recruiting | Met primary |
| 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 | Met primary |
| Phase 3 | NCT04036435 | Aug 2019 → Jul 2026 | psoriasis | Bristol-Myers Squibb | Completed | 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 | Met primary |
| Phase 3 | NCT03611751 | Jul 2018 → Nov 2020 | psoriasis | Bristol-Myers Squibb | Completed | Met primary |
| Phase 412 trials · 3 met primary | ||||||
| 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 | Jun 2026 → Dec 2027 expected | psoriatic arthritis | University of Texas Southwestern Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT06875960 | Feb 2026 → Jan 2028 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 | Met primary |
| Phase 4 | NCT06042920 | Oct 2023 → Apr 2025 | psoriasis | Bristol-Myers Squibb | Terminated | No outcome recorded Stop: Business |
| 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 Stop: Business |
| Phase 4 | NCT05701995 | Jan 2023 → Aug 2024 | psoriasis | Bristol-Myers Squibb | Completed | Met primary |
| 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 | Met primary |
| Phase not applicable1 trial | ||||||
| — | NCT07000630 | Jun → Nov 2025 | palmoplantar pustulosis | Peking University First Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Comparator or background therapy8 trials | ||||||
| Phase 2 | NCT06532136 Comparator | Nov 2024 → Jan 2026 | rosacea | Icahn School of Medicine at Mount Sinai | Withdrawn | No outcome recorded Stop: Business |
| Phase 2/3 | NCT06281106 Comparator | Jun 2024 → Mar 2025 | psoriasis | Prof Curdin Conrad | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT07724366 Comparator | Sep 2026 → Sep 2027 expected | psoriasis | Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| 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 | Met primary |
| Phase 3 | NCT06220604 Comparator | Mar → Nov 2024 overdue | psoriasis | Janssen Research & Development, LLC | Active not recruiting | Met primary |
| Phase 3 | NCT06143878 Comparator | Jan → Sep 2024 overdue | psoriasis | Janssen Research & Development, LLC | Active not recruiting | Met primary |
News releases announcing trial results or a regulatory action · 40
| Date | Issuer | Release |
|---|---|---|
| 2026-09-30 | Takeda | Results Zasocitinib Delivered Superior Efficacy Versus Deucravacitinib in New Phase 3 Head-to-Head Results, Reinforcing Potential to Deliver Rapid and Durable Skin Clearance in a Convenient Once-Daily Pill takeda.com ↗
Head-to-head LATITUDE Atlas data showed zasocitinib demonstrated statistical superiority to deucravacitinib across the primary and all key secondary efficacy endpoints with higher rates of complete skin clearance observed as early as week 8 |
| 2026-09-17 | Bristol-Myers Squibb | Results Bristol Myers Squibb Presents Sotyktu (deucravacitinib) Data Showing Durable Efficacy, Consistent Safety in Adults with Psoriatic Arthritis Over Two Years bms.com ↗
Among patients who entered the OLE, Sotyktu demonstrated durable efficacy, with clinical responses continuing to improve from Week 16 through Week 52 and maintained through Week 104. |
| 2026-06-11 | Takeda | Results Takeda’s Zasocitinib Significantly Outperforms Deucravacitinib in Head-to-Head Phase 3 Psoriasis Study, Promising to Redefine Oral Treatment Expectations takeda.com ↗
In the LATITUDE Atlas (TAK-279-PsO-3004) head-to-head study, zasocitinib demonstrated statistical superiority over deucravacitinib for the primary endpoint, Psoriasis Area and Severity Index (PASI) 100 response rate at week 16. |
| 2026-05-08 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Receives European Commission Approval of Sotyktu (deucravacitinib) for the Treatment of Active Psoriatic Arthritis in Adults bms.com ↗
Bristol Myers Squibb (NYSE:BMY) today announced that the European Commission has granted approval to Sotyktu (deucravacitinib), alone or in combination with methotrexate, for the treatment of active psoriatic arthritis (PsA) in adults who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic (DMARD) therapy. |
| 2026-03-27 | AbbVie | Results AbbVie to Highlight New Clinical and Real-World Evidence Advancing Standards of Care in Immune-Mediated Skin Diseases at the 2026 AAD Annual Meeting abbvie.com ↗
Results demonstrated that patients with higher levels of skin clearance (PASI 90 [RZB 57.3% vs DEU 22.9%] and PASI 100 [RZB 27.5% vs DEU 6.5%]), had greater resolution of psoriasis symptoms and quality of life (Psoriasis Symptom Scale 0/1 [RZB 58.0% vs DEU 26.3%] and DLQI 0/1 [RZB 64.1% vs DEU 30.5%]). |
| 2026-03-06 | Bristol-Myers Squibb | Regulatory U.S. FDA Approves Bristol Myers Squibb’s Sotyktu® (deucravacitinib) for the Treatment of Adults with Active Psoriatic Arthritis bms.com ↗
Bristol Myers Squibb (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Sotyktu ® (deucravacitinib) for the treatment of adults with active psoriatic arthritis (PsA). |
| 2025-10-27 | Bristol-Myers Squibb | Results Bristol Myers Squibb Presents Two Late-Breaking Presentations Demonstrating Sotyktu (deucravacitinib) Efficacy in Psoriatic Arthritis and Systemic Lupus Erythematosus bms.com ↗
Bristol Myers Squibb (NYSE:BMY) today announced Week 52 data from the pivotal Phase 3 POETYK PsA-1 trial further confirming the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA) who were not previously treated with a biologic disease-modifying antirheumatic drug (bDMARD). |
| 2025-09-17 | Janssen Research & Development, LLC | Results Icotrokinra shows superiority to deucravacitinib in first reported head-to-head trials reinforcing promise of novel targeted oral peptide for treatment of plaque psoriasis jnj.com ↗
Icotrokinra showed superior skin clearance vs placebo (Week 16) and deucravacitinib (Weeks 16 and 24). |
| 2025-09-17 | Janssen Research & Development, LLC | Results Icotrokinra shows superiority to deucravacitinib in first reported head-to-head trials reinforcing promise of novel targeted oral peptide for treatment of plaque psoriasis jnj.com ↗
Icotrokinra showed superior skin clearance vs placebo (Week 16) and deucravacitinib (Weeks 16 and 24). |
| 2025-07-21 | Janssen Research & Development, LLC | Results Johnson & Johnson seeks first icotrokinra U.S. FDA approval aiming to revolutionize treatment paradigm for adults and adolescents with plaque psoriasis jnj.com ↗ |
| 2025-07-21 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb’s Supplemental New Drug Application (sNDA) for Sotyktu (deucravacitinib) for the Treatment of Adults with Active Psoriatic Arthritis Accepted for Review Across Four Regions Globally bms.com ↗
Bristol Myers Squibb (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis. |
| 2025-06-11 | Bristol-Myers Squibb | Results Bristol Myers Squibb Presents Late-Breaking Data from Pivotal Phase 3 POETYK PsA-1 Trial Demonstrating Superiority of Sotyktu (deucravacitinib) Compared with Placebo in Adults with Psoriatic Arthritis bms.com ↗
Significantly more patients treated with Sotyktu achieved improvements in joint and skin symptoms, measures of disease activity and quality of life at Week 16 in POETYK PsA-1 |
| 2025-03-08 | Janssen Research & Development, LLC | Results Icotrokinra results show potential to set a new standard of treatment in plaque psoriasis jnj.com ↗
Icotrokinra also met all key secondary endpoints at Weeks 16 and 24 that measured superiority to deucravacitinib in patients with moderate-to-severe plaque PsO. |
| 2025-03-08 | Janssen Research & Development, LLC | Results Icotrokinra results show potential to set a new standard of treatment in plaque psoriasis jnj.com ↗
Topline results from Phase 3 ICONIC-ADVANCE 1&2 studies show icotrokinra achieved co-primary endpoints and showed superiority to deucravacitinib in moderate-to-severe plaque PsO |
| 2025-03-08 | Bristol-Myers Squibb | Results Bristol Myers Squibb Presents Late-Breaking Data from Phase 3 POETYK PsA-2 Trial Demonstrating Superiority of Sotyktu (deucravacitinib) Compared with Placebo in Adults with Psoriatic Arthritis bms.com ↗
Bristol Myers Squibb (NYSE:BMY) today announced positive data from the pivotal Phase 3 POETYK PsA-2 trial (IM011-055) evaluating the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA). |
| 2025-02-16 | Bristol-Myers Squibb | Results New Five-Year Sotyktu (deucravacitinib) Data Show Consistent Safety and Durable Response Rates in Moderate-to-Severe Plaque Psoriasis bms.com ↗
Bristol Myers Squibb (NYSE:BMY) today announced new five-year results from the POETYK PSO long-term extension (LTE) trial of Sotyktu (deucravacitinib) treatment in adult patients with moderate-to-severe plaque psoriasis. |
| 2024-12-23 | Bristol-Myers Squibb | Results Bristol Myers Squibb Announces Positive Topline Results from Two Pivotal Phase 3 Trials Evaluating Sotyktu (deucravacitinib) in Adults with Psoriatic Arthritis bms.com ↗ |
| 2024-09-27 | Bristol-Myers Squibb | Results Bristol Myers Squibb Presents New Data from Two Trials Demonstrating Sotyktu (deucravacitinib) Efficacy in both Moderate-to-Severe Scalp Psoriasis and in a Real-World Setting bms.com ↗
Bristol Myers Squibb (NYSE:BMY) today announced positive results from the Phase 3b/4 PSORIATYK SCALP trial evaluating Sotyktu (deucravacitinib) for the treatment of patients with moderate-to-severe scalp psoriasis, including those with less extensive overall psoriasis. |
| 2024-05-16 | Bristol-Myers Squibb | Results New Four-Year Sotyktu (deucravacitinib) Data Demonstrate Durable Response Rates and Consistent Safety in Moderate-to-Severe Plaque Psoriasis bms.com ↗
Bristol Myers Squibb (NYSE:BMY) today announced new four-year results from the POETYK PSO long-term extension (LTE) trial of Sotyktu (deucravacitinib) treatment in adult patients with moderate-to-severe plaque psoriasis. |
| 2023-10-11 | Bristol-Myers Squibb | Results Sotyktu (deucravacitinib) Long-Term Data Demonstrate Durable Efficacy and Consistent Safety for up to Three Years in Moderate-to-Severe Plaque Psoriasis bms.com ↗
At Week 148, clinical response rates were maintained with continuous treatment with modified nonresponder imputation (mNRI) responses of 73.2% for Psoriasis Area and Severity Index (PASI) 75, 48.1% for PASI 90 and 54.1% for static Physician’s Global Assessment (sPGA) 0/1. |
| 2023-03-28 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Receives European Commission Approval of Sotyktu (deucravacitinib), a Once-Daily Oral Treatment for Adults With Moderate-to-Severe Plaque Psoriasis bms.com ↗
Sotyktu is the first oral therapy with a new mechanism of action approved in nearly 10 years for moderate-to-severe plaque psoriasis |
| 2023-01-27 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Announces Positive CHMP Opinion for Once-Daily Sotyktu (deucravacitinib) as a Treatment for Adults With Moderate-to-Severe Plaque Psoriasis bms.com ↗
Bristol Myers Squibb (NYSE: BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Sotyktu (deucravacitinib) for the treatment of adults with moderate-to-severe plaque psoriasis. |
| 2022-10-25 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Reports Third Quarter Financial Results for 2022 bms.com ↗
The FDA approved Sotyktu, a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. |
| 2022-09-10 | Bristol-Myers Squibb | Results Bristol Myers Squibb Announces New Sotyktu™ (deucravacitinib) Long-Term Data Showing Clinical Efficacy Maintained for Up to Two Years with Continuous Treatment in Moderate-to-Severe Plaque Psoriasis bms.com ↗
Bristol Myers Squibb (NYSE:BMY) today announced new two-year results from the POETYK PSO long-term extension (LTE) trial demonstrating clinical efficacy was maintained with continuous Sotyktu™ (deucravacitinib) treatment in adult patients with moderate-to-severe plaque psoriasis. |
| 2022-09-09 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Approves Sotyktu™ (deucravacitinib), Oral Treatment for Adults with Moderate-to-Severe Plaque Psoriasis bms.com ↗
Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Sotyktu ™ (deucravacitinib), a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. |
| 2022-06-01 | Bristol-Myers Squibb | Results Late-Breaking Data at EULAR 2022 Demonstrate Deucravacitinib Significantly Improved Disease Activity in Phase 2 PAISLEY Study in Systemic Lupus Erythematosus bms.com ↗
Bristol Myers Squibb (NYSE: BMY) announced positive results from the Phase 2 PAISLEY study evaluating deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, compared to placebo in patients with moderate to severe systemic lupus erythematosus (SLE). |
| 2022-05-12 | Bristol-Myers Squibb | Results New Two-Year Deucravacitinib Data Reinforce Durable Efficacy and Consistent Safety Profile in Treatment of Moderate to Severe Plaque Psoriasis bms.com ↗
Bristol Myers Squibb (NYSE: BMY) today announced two-year results from the POETYK PSO long-term extension (LTE) trial demonstrating durable efficacy and a consistent safety profile with deucravacitinib treatment in adult patients with moderate to severe plaque psoriasis. |
| 2021-11-29 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb’s Applications for Deucravacitinib for the Treatment of Moderate to Severe Plaque Psoriasis Accepted by U.S. Food and Drug Administration and Validated by European Medicines Agency bms.com ↗
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of September 10, 2022. |
| 2021-11-03 | Bristol-Myers Squibb | Results Bristol Myers Squibb Data at ACR Convergence 2021 Illustrate Scientific Advances for Immune-Mediated Rheumatic Diseases bms.com ↗
Biomarker analyses from a Phase 2 study that showed deucravacitinib suppressed blood biomarkers of the IL-23/IL-17 and IFN-1 pathways and key markers of joint damage, concomitant with clinical symptom improvements in patients with psoriatic arthritis in comparison with placebo (abstract number 0490). |
| 2021-10-07 | Bristol-Myers Squibb | Results Bristol Myers Squibb Provides Update on Phase 2 Study of Deucravacitinib in Patients With Moderate to Severe Ulcerative Colitis bms.com ↗
LATTICE-UC proof of concept study did not meet primary nor secondary endpoints |
| 2021-09-30 | Bristol-Myers Squibb | Results Bristol Myers Squibb Data at the EADV 30th Anniversary Congress Highlight the Growing Body of Evidence on Deucravacitinib and Scientific Advancements for Patients with Serious Dermatologic Diseases bms.com ↗
Results from the Phase 3 POETYK PSO-1 and POETYK PSO-2 trials show that response rates for deucravacitinib continued to increase through Week 24 and were maintained through Week 52 in patients with moderate to severe plaque psoriasis |
| 2021-06-02 | Bristol-Myers Squibb | Results Bristol Myers Squibb Data at EULAR 2021 Highlight Commitment to Driving Advancements Across Multiple Immune-Mediated Rheumatic Diseases bms.com ↗
These data (abstract OP0227) will be featured as an oral presentation on Friday, June 4 from 10:15 a.m. – 11:45 a.m. CEST. |
| 2021-04-23 | Bristol-Myers Squibb | Results Bristol Myers Squibb Presents Positive Data from Two Pivotal Phase 3 Psoriasis Studies Demonstrating Superiority of Deucravacitinib Compared to Placebo and Otezla® (apremilast) bms.com ↗
Bristol Myers Squibb (NYSE:BMY) today announced positive results from two pivotal Phase 3 trials evaluating deucravacitinib, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, for the treatment of patients with moderate to severe plaque psoriasis. |
| 2021-02-04 | Bristol-Myers Squibb | Results Bristol Myers Squibb Reports Fourth Quarter and Full-Year Financial Results for 2020 bms.com ↗
Delivers Positive Results from POETYK-PSO-2 Evaluating Deucravacitinib (TYK2 inhibitor) for Treatment of Moderate to Severe Plaque Psoriasis |
| 2021-02-02 | Bristol-Myers Squibb | Results Bristol Myers Squibb Announces Positive Topline Results from Second Pivotal Phase 3 Psoriasis Study Showing Superiority of Deucravacitinib Compared to Placebo and Otezla® (apremilast) bms.com ↗
Bristol Myers Squibb (NYSE:BMY) today announced positive results from POETYK PSO-2, the second pivotal Phase 3 trial evaluating deucravacitinib, a novel, oral, selective tyrosine kinase 2 (TYK2) inhibitor, for the treatment of patients with moderate to severe plaque psoriasis. |
| 2020-11-09 | Bristol-Myers Squibb | Results Bristol Myers Squibb Presents Late-Breaking Phase 2 Data Demonstrating the Safety and Efficacy of Deucravacitinib (BMS-986165) in Patients with Psoriatic Arthritis bms.com ↗
Bristol Myers Squibb (NYSE:BMY) today announced results from an ongoing Phase 2 study evaluating the safety and efficacy of deucravacitinib (BMS-986165) 6 mg or 12 mg once daily, compared with placebo in adults with active psoriatic arthritis. |
| 2020-11-05 | Bristol-Myers Squibb | Results Bristol Myers Squibb Reports Third Quarter 2020 Financial Results bms.com ↗
Our financial strength and flexibility combined with our robust inline businesses, multiple launches and progress in our deep pipeline, including the promising results from the deucravacitinib trial, strongly position the company to deliver our mission and help more patients. |
| 2020-11-05 | Bristol-Myers Squibb | Results Bristol Myers Squibb Data at ACR Convergence 2020 Underscore Commitment to Advancing Science for Patients with Difficult-to-Treat Immune-Mediated Diseases bms.com ↗
Late-breaking data from a Phase 2 trial evaluating deucravacitinib in patients with active psoriatic arthritis, which met the primary endpoint and key secondary objectives. |
| 2020-11-03 | Bristol-Myers Squibb | Results Bristol Myers Squibb Announces Deucravacitinib (BMS-986165) Demonstrated Superiority to Placebo and Otezla® (apremilast) in Pivotal Phase 3 Psoriasis Study bms.com ↗
Bristol Myers Squibb (NYSE:BMY) today announced positive results from POETYK PSO-1, the first pivotal Phase 3 trial evaluating deucravacitinib (BMS-986165), a novel, oral, selective tyrosine kinase 2 (TYK2) inhibitor, for the treatment of patients with moderate to severe plaque psoriasis. |
| 2018-09-12 | Bristol-Myers Squibb | Results Bristol-Myers Squibb’s Novel, Oral, Selective TYK2 Inhibitor Delivered Significant Skin Clearance in Patients with Moderate to Severe Plaque Psoriasis in Phase 2 Trial bms.com ↗
Bristol-Myers Squibb Company (NYSE:BMY) today announced results from a Phase 2 study of BMS-986165, an investigational oral, selective tyrosine kinase 2 (TYK2) inhibitor, in patients with moderate to severe plaque psoriasis. |
All press releases naming this drug 41 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 90 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 202247“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 |