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 of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2)

Phase 3

Active, not recruiting

Conditions: Plaque Psoriasis

Interventions: Drug: JNJ-77242113
Drug: Deucravacitinib Matching Placebo
Drug: JNJ-77242113 Matching Placebo
Drug: Deucravacitinib

First Posted Date: 2024-01-24

Last Posted Date: 2025-04-27

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 731

Registration Number: NCT06220604

Locations: 🇩🇪
Universitatsmedizin der Johannes Gutenberg Universitat Mainz, Mainz, Germany
🇵🇱
WroMedica I Bielicka A Strzalkowska s c, Wroclaw, Poland
🇺🇸
Essential Medical Research, Tulsa, Oklahoma, United States

and more 123 locations

A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

Phase 3

Active, not recruiting

Conditions: Plaque Psoriasis

Interventions: Drug: JNJ-77242113
Drug: JNJ-77242113 Matching Placebo
Drug: Deucravacitinib Matching Placebo
Drug: Deucravacitinib

First Posted Date: 2023-11-22

Last Posted Date: 2025-04-25

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 774

Registration Number: NCT06143878

Locations: 🇭🇺
SZTE AOK Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati és Allergologiai Klinika, Szeged, Hungary
🇭🇺
Allergo-Derm Bakos Kft., Szolnok, Hungary
🇭🇺
Medmare Egeszsegugyi Es Szolgaltato Bt., Veszprem, Hungary

and more 157 locations

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

Phase 2

Recruiting

Conditions: Epidermolysis Bullosa Simplex
Ichthyosis
Genodermatosis
Inflammatory Congenital Ichthyoses

Interventions: Drug: deucravacitinib

First Posted Date: 2023-11-18

Last Posted Date: 2025-02-24

Lead Sponsor: Centre Hospitalier Universitaire de Nice

Target Recruit Count: 10

Registration Number: NCT06136403

Locations: 🇫🇷
CHU de Nice, Nice, Chu de Nice, France

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

Recruiting

Conditions: Plaque Psoriasis

Interventions: Drug: Deucravacitinib

First Posted Date: 2023-10-27

Last Posted Date: 2024-12-16

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 550

Registration Number: NCT06104644

Locations: 🇩🇪
Dermatologische Spezial- und Schwerpunktpraxis Selters, Selters, Rhineland-Palatinate, Germany
🇩🇪
Company for Medical Study & Service Selters, Selters, Germany

A Study of Deucravacitinib to Treat LPP and FFA

Phase 2

Active, not recruiting

Conditions: Lichen Planopilaris

Interventions: Drug: Deucravacitinib

First Posted Date: 2023-10-23

Last Posted Date: 2025-01-29

Lead Sponsor: Mayo Clinic

Target Recruit Count: 12

Registration Number: NCT06091956

Locations: 🇺🇸
Mayo Clinic Arizona, Scottsdale, Arizona, United States
🇺🇸
Mayo Clinic Florida, Jacksonville, Florida, United States

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

Phase 4

Terminated

Conditions: Palmoplantar Psoriasis
Genital Psoriasis

Interventions: Drug: Deucravacitinib
Drug: Placebo

First Posted Date: 2023-09-21

Last Posted Date: 2025-05-14

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 131

Registration Number: NCT06042920

Locations: 🇨🇦
Local Institution - 0065, Montreal, Quebec, Canada
🇨🇦
Local Institution - 0054, Montreal, Quebec, Canada
🇨🇦
Local Institution - 0059, Québec, Quebec, Canada

and more 28 locations

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

Phase 2

Terminated

Conditions: Hidradenitis Suppurativa

Interventions: Drug: Placebo
Drug: Deucravacitinib

First Posted Date: 2023-08-18

Last Posted Date: 2025-05-07

Lead Sponsor: Beth Israel Deaconess Medical Center

Target Recruit Count: 7

Registration Number: NCT05997277

Locations: 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

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

Phase 3

Recruiting

Conditions: Sjögren's Syndrome

Interventions: Drug: Deucravacitinib
Other: Placebo

First Posted Date: 2023-07-14

Last Posted Date: 2025-05-06

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 756

Registration Number: NCT05946941

Locations: 🇮🇹
Local Institution - 0062, Rome, Italy
🇮🇹
Santa Maria della Misericordia, Udine, Italy
🇺🇸
Local Institution - 0225, The Woodlands, Texas, United States

and more 226 locations