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Drug

Deucravacitinib

Approved · FDA / EMA
Late-stage development

Also known as Sotyktu.

RxNorm2612087ChEMBLCHEMBL4435170UNIIN0A21N6RAU
19
Active clinical trials
5
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Deucravacitinib in the Treatment of Cicatricial Alopecias

Clinical trial2026-07-10Results expected Q2 2028 · ClinicalTrials.gov

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Deucravacitinib Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

Clinical trial2026-07-07Results posted · ClinicalTrials.gov

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Deucravacitinib Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

Clinical trial2026-07-07Results posted · ClinicalTrials.gov

A Phase 3b/4 Multi-center, Randomized, Open-label, Long-term Safety Study of Deucravacitinib in Comparison to Ustekinumab in Participants With Moderate-to-Severe Plaque Psoriasis

Clinical trial2026-07-07Results expected Q1 2031 · ClinicalTrials.gov

Label change: DEUCRAVACITINIB (NDA214958)

Regulatory2026-06-30FDA

A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Deucravacitinib in Children and Adolescents From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis

Clinical trial2026-06-26Results expected Q1 2030 · ClinicalTrials.gov

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Deucravacitinib in Adolescent Participants (12 Years to Less Than 18 Years) With Moderate to Severe Plaque Psoriasis

Clinical trial2026-06-18Results expected Q4 2029 · ClinicalTrials.gov

Takeda’s TYK2 inhibitor beats Bristol Myers’ Sotyktu in phase 3 psoriasis showdown

Clinical trial2026-06-11Trial news · Fierce Biotech

Takeda’s TYK2 inhibitor beats Bristol Myers’ Sotyktu in phase 3 psoriasis showdown

Clinical trial2026-06-11Trial news · Fierce Pharma

Indication expansion: DEUCRAVACITINIB (NDA214958)

Regulatory2026-03-06FDA

Supplemental approval: DEUCRAVACITINIB (NDA214958)

Regulatory2025-10-27FDA

Approval: Sotyktu (EMA)

Regulatory2023-03-24EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Deucravacitinib
Aliases & brands
Sotyktu
RxNorm CUI
2612087
ChEMBL ID
CHEMBL4435170
UNII
N0A21N6RAU
Regulatory jurisdictions
emafda

Regulatory timeline

5 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2022-09-09 → 2023-03-24)
Earliest approval
2022-09-09
Latest approval
2026-03-06
Authorities
FDA · EMA
Total events
5
fdaU.S. Food and Drug Administration· 4 events
2026-06-30Label change
Label change: DEUCRAVACITINIB (NDA214958)
Evidence ↗
2026-03-06Indication expansion
Indication expansion: DEUCRAVACITINIB (NDA214958)
Evidence ↗
2025-10-27Supplemental approval
Supplemental approval: DEUCRAVACITINIB (NDA214958)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2023-03-24ApprovalMulti-authority
Approval: Sotyktu (EMA)
Indication: Plaque psoriasis Sotyktu is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Psoriatic… Show full indication

Plaque psoriasis Sotyktu is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Psoriatic arthritis Sotyktu, alone or in combination with methotrexate (MTX), is indicated 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.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

41 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
41
registered trials across all phases
LATEST COMPLETION 2026
19
Active studies
10
Recruiting
25
Late-stage (III+)
13
Completed
9
Discontinued
PHASE DISTRIBUTIONn = 41
Early Phase 12Phase 13Phase 211Phase 2 / 31Phase 312Phase 411Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Utilization of a Cutaneous Therapy In Situ Microdevice

Not yet recruitingPH IVUniversity of California, San Franciscon=102030

Correction of Psoriatic T Cell Signatures by Deucravacitinib

RecruitingPH IVUniversity of California, San Franciscon=252028

Comparison of Deucravacitinib and Adalimumab for the Treatment of Relapsed Takayasu's Arteritis: The TYK-TAK Trial

Not yet recruitingPH IVChinese SLE Treatment And Research Groupn=502028

Deucravacitinib-TNFi Combination Therapy for Difficult-to-Control Psoriatic Disease

Not yet recruitingPH IVUniversity of Texas Southwestern Medical Centern=1282027

A Phase 4 Multicenter, Randomized, Open-label, Efficacy Assessor Blinded Study of Risankizumab Compared to Deucravacitinib for the Treatment of Adult Subjects With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy

CompletedPH IVAbbVien=3932026

Recent completions

Trials that read out recently, adding to the completed evidence base.

Deucravacitinib (BMS-986165) in the Treatment of Pityriasis Rubra Pilaris

CompletedPH IIMayo Clinicn=72026

A Phase 3, Randomized, Multicenter, Double-Blind Trial to Evaluate the Efficacy, Safety, and Tolerability of Zasocitinib (TAK-279) Compared to Deucravacitinib in Participants With Moderate-to-Severe Plaque Psoriasis

CompletedPH IIITakedan=6062026

A Phase 4 Multicenter, Randomized, Open-label, Efficacy Assessor Blinded Study of Risankizumab Compared to Deucravacitinib for the Treatment of Adult Subjects With Moderate Plaque Psoriasis Who Are Candidates for Systemic Therapy

CompletedPH IVAbbVien=3932026

An Investigator Initiated Open Label Study Evaluating the Efficacy and Tolerability of Oral Deucravacitinib for the Treatment of Nail Psoriasis

CompletedPH IUniversity of Alabama at Birminghamn=12025

A Phase 1, Open-label, Single-dose Study to Evaluate the Pharmacokinetics of Deucravacitinib (BMS-986165) Administered as Various Solid Oral Gastro-retentive Tablet Formulation Prototypes in Healthy Participants

CompletedPH IBristol-Myers Squibbn=522025

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Effect of Deucravacitinib on Quality of Life in Participants With Plaque Psoriasis in a Community Setting

CompletedPH IVBristol-Myers Squibbn=1802025
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.