SOTYKTU (deucravacitinib)
SOTYKTU is indicated for the treatment of Plaque Psoriasis.
How SOTYKTU Works
Deucravacitinib is an allosteric inhibitor of tyrosine kinase 2 (TYK2), a member of the Janus kinase (JAK) family. It binds to the regulatory domain of TYK2, stabilizing an inhibitory interaction between the regulatory and catalytic domains. This prevents receptor-mediated activation of TYK2 and the subsequent activation of downstream Signal Transducers and Activators of Transcription (STATs). While this interferes with cytokine signaling, the precise mechanism linking TYK2 inhibition to clinical effectiveness in plaque psoriasis remains unknown.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2022-09-09
- Patent Cliff
- 2043
- Revenue
- $86M (Q4-2025)
- Routes
- ORAL
- Dosage Forms
- TABLET
SOTYKTU Approval History
What SOTYKTU Treats
1 indicationsSOTYKTU is approved for 1 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Plaque Psoriasis
SOTYKTU Target & Pathway
ProTarget
A member of the JAK family involved in signaling for interferons and several interleukins. JAK1 inhibition is effective in rheumatoid arthritis, atopic dermatitis, and other inflammatory conditions by blocking multiple cytokine pathways.
SOTYKTU Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to SOTYKTU
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
38 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07508488 | STUDY-25-01566 | Ph 2 | recruiting | Deucravacitinib in the Treatment of Cicatricial Alopecias |
| NCT07116967 | IM011-1130 U1111-1291-5815, 2023-503766-24 | Ph 3 | recruiting | Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK) |
| NCT06973291 | TAK-279-PsO-3004 2024-512497-10-00, jRCT2011250014 | Ph 3 | completed | A Study Comparing Zasocitinib (TAK-279) With Deucravacitinib in Adults With Plaque Psoriasis |
| NCT06979453 POETYK-PsO-Ped | IM011-1128 2023-506296-97, U1111-1289-8030 | Ph 3 | recruiting | A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis |
| NCT04908202 results posted | IM011-054 2023-506256-25, U1111-1259-9443 | Ph 3 | active not recruiting | A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs |
| NCT06042920 results posted | IM011-1112 2023-504663-16, U1111-1289-6934 | Ph 4 | terminated | A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis |
| NCT06333860 IMMpactful | M24-541 2023-509738-20-00 | Ph 4 | completed | A Study to Learn How Safe and Effective Risankizumab is When Compared to Deucravacitinib to Treat Participants With Moderate Plaque Psoriasis and Who Need to Try Systemic Treatment (Works Throughout the Whole Body) |
| NCT06869551 | IM011-1071 | Ph 3 | recruiting | A Study to Evaluate the Drug Levels, Efficacy, and Safety of Deucravacitinib (BMS-986165) in Pediatric Participants With Juvenile Psoriatic Arthritis |
| NCT07280702 COMBo | STU-2025-0977 | Ph 4 | not yet recruiting | Deucravacitinib-TNFi Combination Therapy for Difficult-to-Control Psoriatic Disease |
| NCT05710185 results posted | 2023P000194 | Ph 4 | terminated | Deucravacitinib for the Treatment of Palmoplantar Pustulosis |
| NCT05946941 POETYK SjS-1 | IM011-1069 2023-503327-26, U111-1289-6072 | Ph 3 | active not recruiting | A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome |
| NCT06143878 | 77242113PSO3002 77242113PSO3002 | Ph 3 | active not recruiting | A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis |
| NCT06220604 | 77242113PSO3004 77242113PSO3004, 2023-507039-39-00 | Ph 3 | active not recruiting | A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2) |
| NCT06444399 | 23-012923 | Ph 2 | recruiting | Deucravacitinib (BMS-986165) for Pityriasis Rubra Pilaris |
| NCT07352566 | 25-43621 | Ph 4 | not yet recruiting | Utilization of a Microdevice for Psoriasis and Atopic Dermatitis |
| NCT05617677 POETYK SLE-1 | IM011-246 2022-500699-76 | Ph 3 | active not recruiting | A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE) |
| NCT06476834 results posted | IM011-1123 | Ph 4 | completed | A Study Evaluating Deucravacitinib Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants |
| NCT05620407 POETYK SLE-2 | IM011-247 2022-500700-22 | Ph 3 | active not recruiting | A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus |
| NCT05478499 results posted | IM011-220 2022-000797-26, U1111-1274-7417 | Ph 4 | completed | Efficacy and Safety of Deucravacitinib Versus Placebo in Participants With Moderate-to-severe Scalp Psoriasis |
| NCT04772079 | IM011-126 2019-004879-39 | Ph 3 | recruiting | A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Pediatric Participants With Moderate to Severe Plaque Psoriasis |
| NCT04857034 results posted | IM011-132 2020-000071-21, U1111-1246-1726 | Ph 2 | active not recruiting | A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) |
| NCT05701995 ARTISTYK results posted | IM011-237 U1111-1276-5158 | Ph 4 | completed | A Study to Evaluate the Effect of Deucravacitinib on Quality of Life in Participants With Plaque Psoriasis in a Community Setting |
| NCT06136403 GENEPID | 22-PP-20 2022-502879-32-00 | Ph 2 | recruiting | A 44-week Monocentric Open Study Assessing the Efficacy and Safety of Deucravacitinib in Adults With Inflammatory Genodermatoses |
| NCT06566768 | IM011-1201 | Ph 1 | completed | Study to Evaluate Drug Levels of Various Solid Gastro-retentive Formulations of Deucravacitinib (BMS-986165) in Healthy Participants |
| NCT04908189 results posted | IM011-055 2020-005099-36, U1111-1259-9466 | Ph 3 | active not recruiting | A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment |
| NCT07013838 | TYK2-TAK-01 | Ph 4 | not yet recruiting | The Efficacy and Safety of Deucravacitinib in Takayasu's Arteritis |
| NCT06091956 results posted | 23-001929 | Ph 2 | completed | A Study of Deucravacitinib to Treat LPP and FFA |
| NCT05556265 results posted | IM011-134 U1111-1246-1767, 2020-000113-33 | Ph 2 | terminated | A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Alopecia Areata |
| NCT05997277 | 2023P000400 | Ph 2 | terminated | Evaluating the Safety and Efficacy of Deucravacitinib Compared to Placebo Hidradenitis Suppurativa (HS). |
| NCT06851871 | IM011-1178 | Ph 1 | completed | A Study to Evaluate the Bioequivalence Between Immediate Release Tablets and Minitablets of Deucravacitinib (BMS-986165), and the Effect of Food and pH on the Drug Levels of the Minitablets in Healthy Adults |
| NCT06725264 | 2000038598 | Ph 2 | withdrawn | Tyrosine Kinase 2 (TYK2) for GA and CS |
| NCT06281106 TYPP | IM011-1118 KOFAM 2023-01731 | Ph 2, Ph 3 | terminated | TYK2 Inhibition in Paradoxical Psoriasis |
| NCT06327321 ViTYK | 23-PP-08 | Ph 2 | active not recruiting | Vitiligo Treatment by Targeting TYK2 Mediated Responses |
| NCT06532136 | STUDY-24-00593 | Ph 2 | withdrawn | Deucravacitinib Rosacea |
| NCT04877990 results posted | IM011-077 2020-004461-40, U1111-1258-3838 | Ph 2 | completed | A Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Crohn's Disease or Ulcerative Colitis |
| NCT05858645 | 22-37660 | Ph 4 | recruiting | Correction of Psoriatic T Cell Signatures by Deucravacitinib |
| NCT06329258 | PTC09 | Ph 4 | completed | Combination of Sotyktu and Enstilar for Plaque Psoriasis |
| NCT04949269 | IM011-120 | Ph 1 | completed | A Study to Evaluate the Drug Levels of Deucravacitinib From Tablets After Oral Administration in Healthy Participants |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SOTYKTU FDA Label Details
Indications & Usage
FDA Label (PDF)SOTYKTU is indicated for the treatment of Plaque Psoriasis.
SOTYKTU Patents & Exclusivity
Patents (4 active)
Exclusivity
Pro Intelligence Preview
Deep insights for SOTYKTU
Revenue Insights
- • Q4-2025: $86M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2043
- • 6 active patents
Trial Analysis
- • 38 total trials
- • Stage: Expansion
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment