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

Deucravacitinib Rosacea

Phase 2

Withdrawn

Conditions: Papulopustular Rosacea

Interventions: Drug: Deucravacitinib
Drug: Placebo

First Posted Date: 2024-08-01

Last Posted Date: 2025-01-24

Lead Sponsor: Icahn School of Medicine at Mount Sinai

Target Recruit Count: 33

Registration Number: NCT06532136

Locations: 🇺🇸
Icahn School of Medicine at Mount Sinai, New York, New York, United States

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

Recruiting

Conditions: Plaque Psoriasis

Interventions: Drug: Deucravacitinib

First Posted Date: 2024-07-22

Last Posted Date: 2025-02-03

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 150

Registration Number: NCT06512337

Locations: 🇨🇳
Dermatology Hospital of Southern Medical University, Guangzhou, Guangdong, China

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

Phase 4

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Deucravacitinib

First Posted Date: 2024-06-26

Last Posted Date: 2024-12-16

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 8

Registration Number: NCT06476834

Locations: 🇺🇸
Local Institution - 0001, Las Vegas, Nevada, United States

Deucravacitinib (BMS-986165) for Pityriasis Rubra Pilaris

Phase 2

Recruiting

Conditions: Pityriasis Rubra Pilaris

Interventions: Drug: Deucravacitinib

First Posted Date: 2024-06-05

Last Posted Date: 2024-07-30

Lead Sponsor: Mayo Clinic

Target Recruit Count: 12

Registration Number: NCT06444399

Locations: 🇺🇸
Mayo Clinic in Arizona, Scottsdale, Arizona, United States

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

Recruiting

Conditions: Plaque Psoriasis

Interventions: Drug: Apremilast
Drug: Deucravacitinib

First Posted Date: 2024-04-25

Last Posted Date: 2024-04-25

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 600

Registration Number: NCT06382987

Locations: 🇯🇵
Mebix. Inc., Minato-ku, Tokyo, Japan
🇯🇵
Fukuoka University Hospital, Fukuoka, Japan

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)

Phase 4

Active, not recruiting

Conditions: Moderate Plaque Psoriasis

Interventions: Drug: Risankizumab
Drug: Deucravacitinib

First Posted Date: 2024-03-27

Last Posted Date: 2025-01-13

Lead Sponsor: AbbVie

Target Recruit Count: 393

Registration Number: NCT06333860

Locations: 🇺🇸
Allcutis Research /ID# 263024, Portsmouth, New Hampshire, United States
🇺🇸
Total Skin and Beauty Dermatology Center /ID# 263011, Birmingham, Alabama, United States
🇺🇸
Advanced Research Associates - Glendale /ID# 263621, Glendale, Arizona, United States

and more 85 locations

Vitiligo Treatment by Targeting TYK2 Mediated Responses

Phase 2

Recruiting

Conditions: Vitiligo, Generalized

Interventions: Other: Volunteer without treatment
Drug: Deucravacitinib

First Posted Date: 2024-03-25

Last Posted Date: 2025-03-27

Lead Sponsor: Centre Hospitalier Universitaire de Nice

Target Recruit Count: 128

Registration Number: NCT06327321

Locations: 🇫🇷
CHU de Nice - Hôpital de l'Archet, Nice, Alpes-Maritimes, France
🇫🇷
APHP, Henri Mondor, Paris, Creteil, France
🇫🇷
CHU de Bordeaux, Bordeaux, Talence, France

and more 2 locations