Deucravacitinib

Generic Name: Deucravacitinib

Brand Names: Sotyktu

Drug Type: Small Molecule

Chemical Formula: C_₂₀H_₂₂N_₈O_₃

CAS Number: 1609392-27-9

Unique Ingredient Identifier: N0A21N6RAU

Background: Deucravacitinib is a novel oral selective tyrosine kinase 2 (TYK2) inhibitor. Unlike other Janus kinase 1/2/3 inhibitors that bind to the conserved active domain of these non-receptor tyrosine kinases, deucravacitinib binds to the regulatory domain of TYK2 with high selectivity to this therapeutic target. This selectivity towards TYK2 may lead to an improved safety profile of deucravacitinib, as nonselective JAK inhibitors are associated with a range of adverse effects such as altered cholesterol and triglyceride levels and liver and kidney dysfunction.

Deucravacitinib was first approved by the FDA in September 2022 to treat moderate-to-severe plaque psoriasis. It was later approved by Health Canada in November 2022 and by the European Medicines Agency in March 2023.

Indication: Deucravacitinib is a tyrosine kinase 2 (TYK2) inhibitor indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. It is not recommended for use in combination with other potent immunosuppressants.

Associated Conditions: Severe Plaque psoriasis, Moderate Plaque psoriasis

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

Phase 3

Not yet recruiting

Conditions: Plaque Psoriasis

Interventions: Drug: Deucravacitinib
Other: Placebo

First Posted Date: 2025-05-20

Last Posted Date: 2025-05-20

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 366

Registration Number: NCT06979453

Locations: 🇺🇸
Local Institution - 0025, Fountain Valley, California, United States
🇺🇸
Local Institution - 0070, Tampa, Florida, United States
🇺🇸
Local Institution - 0202, Metairie, Louisiana, United States

and more 55 locations

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

Phase 3

Not yet recruiting

Conditions: Plaque Psoriasis

Interventions: Drug: Zasocitinib
Drug: Deucravacitinib
Drug: Placebo to match zasocitinib
Drug: Placebo to match deucravacitinib

First Posted Date: 2025-05-15

Last Posted Date: 2025-05-15

Lead Sponsor: Takeda

Target Recruit Count: 600

Registration Number: NCT06973291

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

Active, not recruiting

Conditions: Psoriasis

Interventions: Drug: Deucravacitinib
Biological: Any biologic treatment for psoriasis

First Posted Date: 2025-05-01

Last Posted Date: 2025-05-01

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 2000

Registration Number: NCT06952465

Locations: 🇯🇵
Local Institution, Tokyo, Japan
🇯🇵
Medical Data Vision, Inc, Tokyo, Japan

A Study to Continue the Administration of Deucravacitinib in Participants With Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) Who Have Completed Study IM011074 or Study IM011132

Phase 4

Not yet recruiting

Conditions: Systemic Lupus Erythematosus (SLE)
Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)

Interventions: Drug: BMS-986165

First Posted Date: 2025-03-14

Last Posted Date: 2025-03-14

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 35

Registration Number: NCT06875960

Locations: 🇺🇸
Local Institution - 0001, Farmington, Connecticut, United States
🇺🇸
Local Institution - 0002, New York, New York, United States
🇺🇸
Local Institution - 0003, Jackson, Tennessee, United States

A Study to Evaluate the Drug Levels, Efficacy, and Safety of Deucravacitinib (BMS-986165) in Pediatric Participants With Juvenile Psoriatic Arthritis

Phase 3

Recruiting

Conditions: Juvenile Psoriatic Arthritis

Interventions: Drug: Deucravacitinib
Other: Placebo

First Posted Date: 2025-03-11

Last Posted Date: 2025-05-09

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 60

Registration Number: NCT06869551

Locations: 🇨🇿
Fakultni nemocnice Olomouc, Olomouc, Olomoucký Kraj, Czechia
🇺🇸
Local Institution - 0038, Lancaster, California, United States
🇺🇸
Local Institution - 0020, Chicago, Illinois, United States

and more 34 locations

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

Phase 1

Completed

Conditions: Healthy Participants

Interventions: Drug: Deucravacitinib
Drug: Famotidine

First Posted Date: 2025-02-28

Last Posted Date: 2025-04-29

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 26

Registration Number: NCT06851871

Locations: 🇺🇸
Local Institution - 0001, Austin, Texas, United States

Tyrosine Kinase 2 (TYK2) for GA and CS

Phase 2

Withdrawn

Conditions: Sarcoidosis
Granuloma Annulare

Interventions: Drug: Deucravacitinib

First Posted Date: 2024-12-10

Last Posted Date: 2025-04-29

Lead Sponsor: Yale University

Target Recruit Count: 10

Registration Number: NCT06725264

Locations: 🇺🇸
YCCI/Church Street Research Unit (CSRU), New Haven, Connecticut, United States

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

Active, not recruiting

Conditions: Psoriasis

Interventions: Drug: Deucravacitinib
Drug: Systemic psoriasis medications
Other: No systemic medications

First Posted Date: 2024-11-28

Last Posted Date: 2024-11-28

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 833

Registration Number: NCT06710470

Locations: 🇺🇸
Bristol-Meyers Squibb, Lawrenceville, New Jersey, United States

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

Recruiting

Conditions: Psoriasis

Interventions: Drug: Deucravacitinib

First Posted Date: 2024-11-22

Last Posted Date: 2025-04-11

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 350

Registration Number: NCT06701513

Locations: 🇫🇷
Local Institution - 060, Amiens cedex 1, France
🇫🇷
Cabinet Médical Elisabeth Lion, Angers, France
🇫🇷
Local Institution - 045, Argenteuil, France

and more 36 locations

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

Phase 1

Recruiting

Conditions: Healthy Participants

Interventions: Drug: Deucravacitinib

First Posted Date: 2024-08-22

Last Posted Date: 2025-04-20

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 52

Registration Number: NCT06566768

Locations: 🇬🇧
Local Institution - 0002, Nottingham, Nottinghamshire, United Kingdom
🇬🇧
Quotient Sciences, Nottingham, Nottinghamshire, United Kingdom

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy