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Sotyktu (DEUCRAVACITINIB)
Sotyktu works by blocking the TYK2 enzyme, which is involved in the inflammatory response and contributes to the development of psoriasis.
At a glance
| Generic name | DEUCRAVACITINIB |
|---|---|
| Sponsor | Bristol-Myers Squibb |
| Drug class | Tyrosine Kinase 2 Inhibitor [EPC] |
| Target | Non-receptor tyrosine-protein kinase TYK2 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2022 |
| Annual revenue | 291 |
Mechanism of action
Deucravacitinib is an inhibitor of tyrosine kinase (TYK2). TYK2 is member of the Janus kinase (JAK) family. Deucravacitinib binds to the regulatory domain of TYK2, stabilizing an inhibitory interaction between the regulatory and the catalytic domains of the enzyme. This results in allosteric inhibition of receptor-mediated activation of TYK2 and its downstream activation of Signal Transducers and Activators of Transcription (STATs) as shown in cell-based assays. JAK kinases, including TYK2, function as pairs of homo- or heterodimers in the JAK-STAT pathways. TYK2 pairs with JAK1 to mediate multiple cytokine pathways and also pairs with JAK2 to transmit signals as shown in cell-based assays. The precise mechanism linking inhibition of TYK2 enzyme to therapeutic effectiveness in the treatment of adults with moderate-to-severe plaque psoriasis is not currently known.
Approved indications
- Moderate-to-severe plaque psoriasis
- Active psoriatic arthritis
Common side effects
- Upper respiratory infections
- Increased CPK
- Herpes simplex
- Mouth ulcers
- Folliculitis
- Acne
- Herpes zoster
- ALT elevations >=3 times the ULN
- AST elevations >=3 times the ULN
- Decreased GFR
- Lipid Elevations
- Serious infections
Key clinical trials
- A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis (PHASE3)
- Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus Erythematosus (PHASE2)
- Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO)
- A Study of BMS986365 in Combination With Degarelix in People With Prostate Cancer (PHASE2)
- A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (PHASE3)
- A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2) (PHASE3)
- Efficacy and Tolerability of Deucravacitinib in the Management of Palmoplantar Pustulosis (NA)
- Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK) (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Sotyktu CI brief — competitive landscape report
- Sotyktu updates RSS · CI watch RSS
- Bristol-Myers Squibb portfolio CI