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Deucravacitinib

Generic Name
Deucravacitinib
Brand Names
Sotyktu
Drug Type
Small Molecule
Chemical Formula
C20H22N8O3
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

An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants to Study Electrocardiogram Effects

Phase 1
Completed
Conditions
Systemic Lupus Erythematosus
Healthy Participants
Interventions
First Posted Date
2018-05-30
Last Posted Date
2020-01-27
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
84
Registration Number
NCT03541564
Locations
🇺🇸

PRA Health Sciences, Lenexa, Kansas, United States

An Investigational Study of Cyclosporine on Experimental Medication BMS-986165 in Healthy Male Participants

Phase 1
Completed
Conditions
Psoriasis
Interventions
First Posted Date
2018-02-05
Last Posted Date
2020-03-18
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
54
Registration Number
NCT03419910
Locations
🇺🇸

PRA Health Sciences, Salt Lake City, Utah, United States

A Study to Investigate BMS-986165 and Methotrexate in Healthy Male Patients

Phase 1
Completed
Conditions
Lupus
Psoriatic Arthritis
Interventions
First Posted Date
2018-01-18
Last Posted Date
2020-02-25
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
30
Registration Number
NCT03402087
Locations
🇳🇱

PRA Health Sciences, Groningen, Netherlands

The Effect of BMS-986165 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Patients

Phase 1
Completed
Conditions
Systemic Lupus Erythematosus
Psoriasis
Inflammatory Bowel Diseases
Arthritic Psoriasis
Interventions
First Posted Date
2017-08-25
Last Posted Date
2020-03-19
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
49
Registration Number
NCT03262727
Locations
🇺🇸

Miami Research Associates, Miami, Florida, United States

A Study to Evaluate BMS-986165 Tablet Formulation Relative to BMS-986165 Capsule Formulation and the Effect of a High-Fat/ High-Calorie Meal and Increased Gastric pH on the BMS-986165 Tablet Formulation

Phase 1
Completed
Conditions
Inflammatory Bowel Diseases
Systemic Lupus Erythematosus
Arthritic Psoriasis
Psoriasis
Interventions
Drug: BMS-986165 Capsule
First Posted Date
2017-08-18
Last Posted Date
2020-02-25
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
49
Registration Number
NCT03254784
Locations
🇺🇸

PRA Health Sciences, Lenexa, Kansas, United States

An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus

Phase 2
Completed
Conditions
Systemic Lupus Erythematosus
Interventions
Other: Placebo
First Posted Date
2017-08-17
Last Posted Date
2022-12-20
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
363
Registration Number
NCT03252587
Locations
🇺🇸

Local Institution - 0022, Decatur, Georgia, United States

🇺🇸

Local Institution - 0023, El Cajon, California, United States

🇺🇸

Little Rock Diagnostic Clinic, Little Rock, Arkansas, United States

and more 176 locations

Effect of BMS-986165 on the Pharmacokinetics of Rosuvastatin

Phase 1
Completed
Conditions
Inflammatory Diseases
Autoimmune Diseases
Interventions
First Posted Date
2017-02-07
Last Posted Date
2017-04-17
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
20
Registration Number
NCT03044873
Locations
🇺🇸

PPD Phase I Clinic, Austin, Texas, United States

Pharmacokinetics and Metabolism of [14C]BMS-986165 in Healthy Male Participants

Phase 1
Completed
Conditions
Psoriasis
Interventions
First Posted Date
2016-12-29
Last Posted Date
2018-02-12
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
6
Registration Number
NCT03004768
Locations
🇺🇸

Covance Madison Clinical Research Unit, Madison, Wisconsin, United States

Study to Evaluate Effectiveness and Safety in Subjects With Moderate to Severe Psoriasis

Phase 2
Completed
Conditions
Psoriasis
Interventions
Drug: Placebo for BMS-986165
First Posted Date
2016-10-13
Last Posted Date
2020-11-27
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
268
Registration Number
NCT02931838
Locations
🇺🇸

Renstar Medical Research, Ocala, Florida, United States

🇺🇸

NorthShore University Health System, Skokie, Illinois, United States

🇺🇸

Dawes Fretzin Clinical Research Group, LLC, Indianapolis, Indiana, United States

and more 13 locations

Safety Study of BMS-986165 in Healthy Subjects and to Treat Psoriasis

Phase 1
Completed
Conditions
Healthy Subjects
Interventions
Drug: Interferon alpha-2a recombinant
Other: Placebo
First Posted Date
2015-08-27
Last Posted Date
2016-12-28
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
140
Registration Number
NCT02534636
Locations
🇦🇺

Local Institution, Melbourne, Victoria, Australia

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