Sotyktu

(Deucravacitinib)

ApprovedSmall molecule

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Deucravacitinib is used to treat atopic dermatitis (a chronic skin condition that causes itching, redness, and inflammation). It works by reducing the immune system's overactive response that causes the skin problems.[2] Sotyktu is currently approved and in use across 23 indications[4].[1]

Sotyktu is one of 375 small molecule programs targeting Lupus. It is currently in Approved.

Indications

Total Trials

Active Trials

374

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

LupusApproved

PyodermaApproved

Lichen PlanopilarisCompleted

Decreased Liver FunctionApproved

Sjogren SyndromeApproved

Kidney DiseaseApproved

Immune System DiseaseApproved

Psoriasis VulgarisActive, not recruiting

Pustular PsoriasisActive, not recruiting

LupusApproved

Approved

PyodermaApproved

Approved

Lichen PlanopilarisApproved

Completed

Decreased Liver FunctionApproved

Approved

Sjogren SyndromeApproved

Approved

Kidney DiseaseApproved

Approved

Immune System DiseaseApproved

Approved

Psoriasis VulgarisApproved

Active, not recruiting

Pustular PsoriasisApproved

Active, not recruiting

Showing 10 of 23 indications

Competition

Competitive Landscape

242 competitors in Efficacy and Safety

#DrugCompanyPhaseTrials

Sotyktu

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Approved

3 2

Rinvoq

AbbVie

Phase 3

4 3

BESREMI

PPharmaEssentia

Phase 3

2 4

HLX10

Shanghai Henlius Biotech

Phase 3

2 5

Becotatug Vedotin

FFudan University

Phase 3

1 6

NTQ5082

NNanjing Chia-tai Tianqing Pharmaceutical

Phase 3

1 7

S1,

CChinese Academy of Medical Sciences

Phase 3

1 8

NVX-Cov2705

Sanofi

Phase 3

1 9

Rhtpo

SShandong University

Phase 3

1 10

Efsubaglutide Alfa

SShanghai Yinnuo Pharmaceutical Technology Co., Ltd.

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Efficacy and Safety

NCT06136403

Phase 2Recruiting

Vitiligo

NCT06327321

Phase 3Active, not recruiting

Psoriatic Arthritis

NCT04908189

Q2 2027

Phase 3Active, not recruiting

Plaque Psoriasis

NCT06143878

Phase 3Active, not recruiting

Psoriatic Arthritis

NCT04908202

Q3 2027

Recruiting

Psoriasis

NCT07256015

Clinical

Trials by Indication[1]

Psoriasis17 trials

Efficacy and Safety of Deucravacitinib Versus Placebo in Participants With Moderate-to-severe Scalp Psoriasis

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 4·NCT05478499·154 enrolled

TYK2 Inhibition in Paradoxical Psoriasis

Terminated·PProf Curdin Conrad·Phase 2/3·NCT06281106·2 enrolled

A Real-world Study to Evaluate the Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in France (RePhlect)

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT06701513·350 enrolled

Show 14 more trials

Real-World Safety and Effectiveness of Sotyktu (Deucravacitinib) in Patients With Moderate-to-Severe Plaque Psoriasis in Korea

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT06258668·505 enrolled

A Study Comparing Zasocitinib (TAK-279) With Deucravacitinib in Adults With Plaque Psoriasis

Active, not recruiting· Takeda logo

Takeda·Phase 3·NCT06973291·606 enrolled

A Study of the Comparative Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in Japan (RePhlect)

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT06382987·600 enrolled

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

Completed·UUniversity of Alabama at Birmingham·Phase 1·NCT05124080·1 enrolled

Combination of Sotyktu and Enstilar for Plaque Psoriasis

Completed·PPsoriasis Treatment Center of Central New Jersey·Phase 4·NCT06329258·30 enrolled

A Study to Evaluate Deucravacitinib in Participants With Moderate-to-Severe Plaque Psoriasis in Germany

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT06104644·550 enrolled

A Study to Evaluate Effectiveness and Safety of Deucravacitinib in Participants With Non-Pustular Palmoplantar and Genital Psoriasis

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 4·NCT06042920·130 enrolled

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)

Active, not recruiting· AbbVie logo

AbbVie·Phase 4·NCT06333860·393 enrolled

A Real-world Study of Deucravacitinib in the Treatment of Moderate to Severe Plaque Psoriasis With Eczematous Features

Enrolling by invitation·XXi Tan··NCT06999941·50 enrolled

A Observational Study to Evaluate Deucravacitinib in Patients With Moderate Plaque Psoriasis in China

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT06512337·150 enrolled

A Study to Evaluate the Effect of Deucravacitinib on Quality of Life in Participants With Plaque Psoriasis in a Community Setting

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 4·NCT05701995·180 enrolled

A Real-world Observational Study to Compare Effectiveness of Deucravacitinib Vs Apremilast in Adults With Plaque Psoriasis

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT05744466·1,500 enrolled

A Study Comparing the Risk of Serious Infections and Malignancies With Deucravacitinib or Biologics in Japanese Patients With Psoriasis

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT06952465·2,000 enrolled

Deucravacitinib for Patients With Moderate/Severe Psoriasis: A Real-Life Experience in Italy

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT07256015·200 enrolled

Plaque Psoriasis5 trials

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

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT06979453·366 enrolled

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

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT06220604·731 enrolled

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

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT07116967·3,040 enrolled

Show 2 more trials

A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Deucravacitinib (BMS-986165) in Pediatric Subjects With Moderate to Severe Plaque Psoriasis

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT04772079·153 enrolled

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT06143878·774 enrolled

Systemic Lupus Erythematosus3 trials

A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT05617677·516 enrolled

A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT05620407·513 enrolled

A Continuation Protocol for Deucravacitinib in Adult Patients With Systemic Lupus Erythematosus (SLE) or Sjögren's Disease (SjD) and Pediatric Patients With Psoriasis (PsO) or Psoriatic Arthritis (PsA) Who Have Completed Parent Studies

Not yet recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT07791199·2,300 enrolled

Efficacy and Safety3 trials

A 44-week Monocentric Open Study Assessing the Efficacy and Safety of Deucravacitinib in Adults With Inflammatory Genodermatoses

Recruiting·—·Phase 2·NCT06136403·10 enrolled

The Efficacy and Safety of Deucravacitinib in Takayasu's Arteritis

Not yet recruiting·CChinese SLE Treatment And Research Group·Phase 4·NCT07013838·50 enrolled

A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT05946941·774 enrolled

Palmoplantar Pustulosis2 trials

Efficacy and Tolerability of Deucravacitinib in the Management of Palmoplantar Pustulosis

Terminated·PPeking University First Hospital·N/A·NCT07000630·3 enrolled

Deucravacitinib for the Treatment of Palmoplantar Pustulosis

Terminated·—·Phase 4·NCT05710185·3 enrolled

21 more indications

Psoriatic Arthritis2 trials

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

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT04908202·670 enrolled

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT04908189·729 enrolled

Ulcerative Colitis1 trial

A Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Crohn's Disease or Ulcerative Colitis

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT04877990·67 enrolled

Pregnant Women and Their Offspring1 trial

A Study on the Safety of Deucravacitinib Exposure in Pregnant Women and Their Offspring

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT06710470·833 enrolled

Oral1 trial

A Study to Evaluate the Drug Levels of Deucravacitinib From Tablets After Oral Administration in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04949269·61 enrolled

Drug1 trial

Study to Evaluate Drug Levels of Various Solid Gastro-retentive Formulations of Deucravacitinib (BMS-986165) in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT06566768·52 enrolled

Alopecia Areata1 trial

A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Alopecia Areata

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT05556265·94 enrolled

Atopic Dermatitis1 trial

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

Not yet recruiting·UUniversity of California, San Francisco·Phase 4·NCT07352566·10 enrolled

Hidradenitis Suppurativa1 trial

Evaluating the Safety and Efficacy of Deucravacitinib Compared to Placebo Hidradenitis Suppurativa (HS).

Terminated·—·Phase 2·NCT05997277·7 enrolled

Cutaneous Lupus Erythematosus1 trial

A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT04857034·74 enrolled

Vitiligo1 trial

Vitiligo Treatment by Targeting TYK2 Mediated Responses

Recruiting·—·Phase 2·NCT06327321·128 enrolled

Concentration1 trial

A Study Evaluating Deucravacitinib Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 4·NCT06476834·8 enrolled

T Cell1 trial

Correction of Psoriatic T Cell Signatures by Deucravacitinib

Recruiting·UUniversity of California, San Francisco·Phase 4·NCT05858645·25 enrolled

Rosacea1 trial

Deucravacitinib Rosacea

Withdrawn·IIcahn School of Medicine at Mount Sinai·Phase 2·NCT06532136

Adult1 trial

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

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT06851871·26 enrolled

Pregnancy1 trial

A Study to Assess Deucravacitinib Safety in Pregnancy

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT07017699·900 enrolled

Psoriatic Arthritis (PsA)1 trial

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

Recruiting·UUniversity of Texas Southwestern Medical Center·Approved·NCT07280702·128 enrolled

Pityriasis Rubra Pilaris1 trial

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

Completed·MMayo Clinic·Phase 2·NCT06444399·7 enrolled

Juvenile Psoriatic Arthritis1 trial

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

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT06869551·60 enrolled

Central Centrifugal Cicatricial Alopecia1 trial

Deucravacitinib in the Treatment of Cicatricial Alopecias

Recruiting·IIcahn School of Medicine at Mount Sinai·Phase 2·NCT07508488·20 enrolled

Idiopathic Inflammatory Myopathies (IIMs)1 trial

Real-world Experience With Deucravacitinib for the Treatment of Idiopathic Inflammatory Myopathies -- a Prospective Observational Study

Withdrawn·PPeking University People's Hospital··NCT07564271

Unspecified3 trials

Deucravacitinib in PG

Withdrawn·—·Phase 1·NCT05821374

Tyrosine Kinase 2 (TYK2) for GA and CS

Withdrawn·YYale University·Phase 2·NCT06725264

A Study of Deucravacitinib to Treat LPP and FFA

Completed·MMayo Clinic·Phase 2·NCT06091956·12 enrolled

Regulatory

FDA Approval Timeline[5]

Sep 9, 2022

SOTYKTU

NDA NDA214958

Sep 9, 2022

SOTYKTU

NDA NDA214958

Oct 27, 2025

SOTYKTU

NDA NDA214958

Mar 6, 2026

SOTYKTU

NDA NDA214958

Jun 30, 2026

SOTYKTU

NDA NDA214958

Sources

References

[1]
ClinicalTrials.gov — 54 trial records for Deucravacitinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Sotyktu drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Deucravacitinib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Deucravacitinib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA214958). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Sotyktu. U.S. Food & Drug Administration.
[7]
PubMed — 1 publication indexed for Deucravacitinib. U.S. National Library of Medicine.
[8]
SEC EDGAR — Karuna Therapeutics, Inc., a Bristol Myers Squibb company company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: TYK2 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Patent Landscape[6]

Patent Cliff

Nov 7, 2033

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11021475Nov 7, 2033

RE47929Nov 7, 2033

10000480Nov 7, 2033

12521390Feb 11, 2043

Key Publications[7]

Deucravacitinib in Moderate-to-Severe Plaque Psoriasis: POETYK PSO-1

N Engl J MedAug 25, 2022DOI: 10.1056/NEJMoa2205826

Sotyktu

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q3 2027

Trials by Indication[1]

Psoriasis17 trials

Plaque Psoriasis5 trials

Systemic Lupus Erythematosus3 trials

Efficacy and Safety3 trials

Palmoplantar Pustulosis2 trials

Psoriatic Arthritis2 trials

Ulcerative Colitis1 trial

Pregnant Women and Their Offspring1 trial

Oral1 trial

Drug1 trial

Alopecia Areata1 trial

Atopic Dermatitis1 trial

Hidradenitis Suppurativa1 trial

Cutaneous Lupus Erythematosus1 trial

Vitiligo1 trial

Concentration1 trial

T Cell1 trial

Rosacea1 trial

Adult1 trial

Pregnancy1 trial

Psoriatic Arthritis (PsA)1 trial

Pityriasis Rubra Pilaris1 trial

Juvenile Psoriatic Arthritis1 trial

Central Centrifugal Cicatricial Alopecia1 trial

Idiopathic Inflammatory Myopathies (IIMs)1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

Key Publications[7]

Related News