Sotyktu (deucravacitinib)
An investigational treatment for Sjögren's Syndrome.
The same compound appears under different names depending on the context. Here is how to identify Deucravacitinib wherever you encounter it, plus the key facts at a glance.
- Generic name
- Deucravacitinib
- Brand name
- Sotyktu
- Development code
- BMS-986165
- Drug class
- TYK2 inhibitor
- Manufacturer
- Bristol Myers Squibb
- How it's taken
- Taken as an oral tablet, once daily.
An oral TYK2 inhibitor already FDA-approved for plaque psoriasis and, since March 2026, active psoriatic arthritis (as Sotyktu). It is now in a Phase 3 trial (POETYK SjS-1) for Sjögren's syndrome. By blocking TYK2, deucravacitinib suppresses multiple inflammatory pathways (IL-12, IL-23, type I interferons) implicated in Sjögren's autoimmune gland destruction.
Where Deucravacitinib fits
One of several investigational disease-modifying therapies for Sjögren's syndrome, which currently has no approved disease-modifying treatment. The oral formulation and selective TYK2 mechanism differentiate it from injectable biologics like ianalumab. Competes with telitacicept (dual BAFF/APRIL inhibitor) and dazodalibep (CD40L blocker) in the Sjögren's pipeline. Already approved for psoriasis, which may facilitate a regulatory pathway if Sjögren's trials succeed.
How Deucravacitinib works
TYK2 is a signaling protein inside immune cells that relays signals from multiple inflammatory pathways implicated in Sjögren's syndrome, including the interferon, IL-12, and IL-23 pathways. When these pathways are overactive, they drive the autoimmune attack on salivary and tear glands.
Deucravacitinib works differently from traditional JAK inhibitors: it binds to the regulatory domain of TYK2 (not the active site), which makes it highly selective. This selective approach blocks TYK2-mediated inflammation without affecting JAK1, JAK2, or JAK3 signaling, potentially reducing the side effects associated with broader JAK inhibition.
The oral formulation makes it more convenient than injectable biologics. Bristol Myers Squibb has said Phase 3 results in Sjögren's are expected in 2027.
Mechanism: Selective allosteric TYK2 inhibitor that blocks IL-12, IL-23, and type I interferon signaling, targeting the autoimmune pathways that drive glandular destruction in Sjögren's syndrome
Side effects and safety
Based on psoriasis trials (where it is already approved), the most common side effects include upper respiratory infections, elevated creatine phosphokinase, and acne. Because deucravacitinib selectively targets TYK2 without inhibiting other JAK family members, it may have fewer hematologic and metabolic side effects than broader JAK inhibitors. Full safety data in Sjögren's will come from the Phase 3 trial.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Deucravacitinib
Taken as an oral tablet, once daily. The dose used in psoriasis is 6 mg daily. The Phase 3 Sjögren's trial is testing 2 doses.
Availability and cost
Only available as the brand-name product.
Clinical trial results
The Phase 3 POETYK SjS-1 trial (NCT05946941) enrolled 774 people with Sjögren's disease and measures change in disease activity (ESSDAI) at week 52. It is no longer recruiting; its main data collection is scheduled to finish in November 2026, and Bristol Myers Squibb has said results are expected in 2027. The drug is already FDA-approved for psoriasis based on Phase 3 data showing superiority over placebo and apremilast.
Development history
Bristol Myers Squibb developed deucravacitinib as a first-in-class allosteric TYK2 inhibitor. It received FDA approval for moderate-to-severe plaque psoriasis in September 2022 under the brand name Sotyktu, and a second FDA approval for active psoriatic arthritis on March 6, 2026. BMS is now pursuing a Sjögren's indication based on the rationale that type I interferon and IL-23 signaling play central roles in Sjögren's pathogenesis.
Explore Sjögren's Syndrome trials
Other Sjögren's Syndrome treatments
Where to access Deucravacitinib
Investigational — available only through clinical trial enrollment
Deucravacitinib has not been approved by the FDA and is not available by prescription. The only way for a patient to receive Deucravacitinib today is by enrolling in an active clinical trial and meeting that trial's eligibility criteria. Decisions about trial participation should be made with a nephrologist familiar with the patient's current treatment and kidney function.
Trial status, site list, and eligibility are pulled from ClinicalTrials.gov. Confirm current recruitment status and nearest site directly with the study team before traveling.
Common questions about Deucravacitinib
▸What is Deucravacitinib (Sotyktu)?
An oral TYK2 inhibitor already FDA-approved for plaque psoriasis and, since March 2026, active psoriatic arthritis (as Sotyktu). It is now in a Phase 3 trial (POETYK SjS-1) for Sjögren's syndrome. By blocking TYK2, deucravacitinib suppresses multiple inflammatory pathways (IL-12, IL-23, type I interferons) implicated in Sjögren's autoimmune gland destruction.
▸How does Deucravacitinib work?
TYK2 is a signaling protein inside immune cells that relays signals from multiple inflammatory pathways implicated in Sjögren's syndrome, including the interferon, IL-12, and IL-23 pathways. When these pathways are overactive, they drive the autoimmune attack on salivary and tear glands.
Deucravacitinib works differently from traditional JAK inhibitors: it binds to the regulatory domain of TYK2 (not the active site), which makes it highly selective. This selective approach blocks TYK2-mediated inflammation without affecting JAK1, JAK2, or JAK3 signaling, potentially reducing the side effects associated with broader JAK inhibition.
The oral formulation makes it more convenient than injectable biologics. Bristol Myers Squibb has said Phase 3 results in Sjögren's are expected in 2027.
▸What are the side effects of Deucravacitinib?
Based on psoriasis trials (where it is already approved), the most common side effects include upper respiratory infections, elevated creatine phosphokinase, and acne. Because deucravacitinib selectively targets TYK2 without inhibiting other JAK family members, it may have fewer hematologic and metabolic side effects than broader JAK inhibitors. Full safety data in Sjögren's will come from the Phase 3 trial.
▸How is Deucravacitinib taken?
Taken as an oral tablet, once daily. The dose used in psoriasis is 6 mg daily. The Phase 3 Sjögren's trial is testing 2 doses.
▸Is Deucravacitinib FDA approved?
Deucravacitinib is currently in phase 3 clinical trials for Sjögren's Syndrome. It has not yet received FDA approval.
▸Is Sotyktu being studied for Sjogrens syndrome?
Yes. Deucravacitinib (Sotyktu), already FDA-approved for psoriasis, is in a Phase 3 trial (POETYK SjS-1) for Sjogren's syndrome, with results expected in 2027. It selectively blocks TYK2, targeting inflammatory pathways implicated in autoimmune gland destruction.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. Food and Drug Administration · September 9, 2022. Drugs@FDA: SOTYKTU (deucravacitinib), NDA 214958. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214958
- Bristol Myers Squibb · March 6, 2026. U.S. FDA Approves Bristol Myers Squibb's Sotyktu (deucravacitinib) for the Treatment of Adults with Active Psoriatic Arthritis. https://news.bms.com/news/corporate-financial/2026/U-S--FDA-Approves-Bristol-Myers-Squibbs-Sotyktu-deucravacitinib-for-the-Treatment-of-Adults-with-Active-Psoriatic-Arthritis/default.aspx
- ClinicalTrials.gov. POETYK SjS-1: deucravacitinib in Sjögren's syndrome (Phase 3). https://clinicaltrials.gov/study/NCT05946941