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 26 indications[4].[1]

Sotyktu is one of 429 small molecule programs targeting Systemic Lupus Erythematosus. It is currently in Approved.

Indications

Total Trials

Active Trials

428

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Systemic Lupus ErythematosusActive, not recruiting

PyodermaApproved

Palmoplantar PustulosisActive, not recruiting

Psoriasis VulgarisActive, not recruiting

RosaceaActive, not recruiting

Immune System DiseaseApproved

Kidney DiseaseApproved

Pustular PsoriasisActive, not recruiting

Inflammatory Bowel DiseaseApproved

Pityriasis Rubra PilarisActive, not recruiting

Systemic Lupus ErythematosusPhase 3

Active, not recruiting

PyodermaApproved

Approved

Palmoplantar PustulosisPreclinical

Active, not recruiting

Psoriasis VulgarisApproved

Active, not recruiting

RosaceaPhase 2

Active, not recruiting

Immune System DiseaseApproved

Approved

Kidney DiseaseApproved

Approved

Pustular PsoriasisApproved

Active, not recruiting

Inflammatory Bowel DiseaseApproved

Approved

Pityriasis Rubra PilarisPhase 2

Active, not recruiting

Showing 10 of 26 indications

Competition

Competitive Landscape

605 competitors in Psoriasis

#DrugCompanyPhaseTrials

Sotyktu

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Approved

19 2

Cosentyx

Novartis

Preclinical

53 3

Stelara

Johnson & Johnson

Preclinical

37 4

Taltz

Eli Lilly

Preclinical

20 5

Humira

CCelltrion

Preclinical

42 6

Ilumya

Sun Pharmaceutical Industries, Inc.

Preclinical

15 7

Raptiva

Roche

Preclinical

10 8

Remicade

OOrganon and Co

Preclinical

20 9

Siliq

BBausch Health Americas, Inc.

Victoza

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

Timeline

Expected Milestones

Q3 2026

Recruiting

Psoriasis

NCT06512337

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

Clinical

Trials by Indication[1]

Psoriasis19 trials

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 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

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

Show 16 more trials

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

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 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

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

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

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT07256015·200 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 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 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 Drug Levels, Efficacy and Safety of Deucravacitinib in Pediatric Participants With Moderate to Severe Plaque Psoriasis

Recruiting· Bristol-Myers Squibb logo

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

A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT06979453·366 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 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

Efficacy and Safety3 trials

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

Recruiting·—·Phase 2·NCT06136403·10 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

Plaque Psoriasis3 trials

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

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT06143878·774 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

Palmoplantar Pustulosis2 trials

Deucravacitinib for the Treatment of Palmoplantar Pustulosis

Terminated·—·Phase 4·NCT05710185·3 enrolled

Efficacy and Tolerability of Deucravacitinib in the Management of Palmoplantar Pustulosis

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

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 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

Active, not recruiting· Bristol-Myers Squibb logo

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

21 more indications

Systemic Lupus Erythematosus2 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

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

Rosacea1 trial

Deucravacitinib Rosacea

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

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

Combination Therapy1 trial

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

Not yet recruiting·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT07280702·128 enrolled

T Cell1 trial

Correction of Psoriatic T Cell Signatures by Deucravacitinib

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

Pregnancy1 trial

A Study to Assess Deucravacitinib Safety in Pregnancy

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT07017699·900 enrolled

Vitiligo1 trial

Vitiligo Treatment by Targeting TYK2 Mediated Responses

Recruiting·—·Phase 2·NCT06327321·128 enrolled

Pityriasis Rubra Pilaris1 trial

Deucravacitinib (BMS-986165) for Pityriasis Rubra Pilaris

Recruiting·MMayo Clinic·Phase 2·NCT06444399·12 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

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

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

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

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

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

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

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

Sources

References

[1]
ClinicalTrials.gov — 53 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

Q3 2026

Q4 2026

Q2 2027

Trials by Indication[1]

Psoriasis19 trials

Efficacy and Safety3 trials

Plaque Psoriasis3 trials

Palmoplantar Pustulosis2 trials

Psoriatic Arthritis2 trials

Systemic Lupus Erythematosus2 trials

Alopecia Areata1 trial

Rosacea1 trial

Drug1 trial

Combination Therapy1 trial

T Cell1 trial

Ulcerative Colitis1 trial

Pregnancy1 trial

Vitiligo1 trial

Pityriasis Rubra Pilaris1 trial

Concentration1 trial

Hidradenitis Suppurativa1 trial

Cutaneous Lupus Erythematosus1 trial

Pregnant Women and Their Offspring1 trial

Oral1 trial

Atopic Dermatitis1 trial

Adult1 trial

Central Centrifugal Cicatricial Alopecia1 trial

Idiopathic Inflammatory Myopathies (IIMs)1 trial

Juvenile Psoriatic Arthritis1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

Key Publications[7]

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