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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

Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus Erythematosus

Phase 2
Completed
Conditions
Systemic Lupus Erythematosus
Interventions
First Posted Date
2019-04-18
Last Posted Date
2025-04-17
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
261
Registration Number
NCT03920267
Locations
🇷🇺

Local Institution - 0061, Ekaterinburg, Russian Federation

🇷🇴

Local Institution - 0002, Ramnicu Valcea, Romania

🇺🇸

Local Institution - 0114, Dallas, Texas, United States

and more 94 locations

A Study to Assess the Safety of Experimental Medication BMS986165 in Participants With Normal Kidney Function and Participants With Mild to End-Stage Kidney Disease.

Phase 1
Completed
Conditions
Healthy Volunteer
Renal Impairment
Interventions
First Posted Date
2019-03-26
Last Posted Date
2021-03-12
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
44
Registration Number
NCT03890770
Locations
🇺🇸

Orlando Clinical Research Center, Orlando, Florida, United States

🇭🇺

Szent Imre Egyetemi Oktatokorhaz, Budapest, Hungary

🇨🇿

Pharmaceutical Research Associates CZ, s.r.o, Praha 7, Czechia

and more 3 locations

An Investigational Study of BMS-986165 in Participants With Normal Liver Function and Participants With Mild to Severe Liver Damage

Phase 1
Completed
Conditions
Healthy Volunteers
Liver Dysfunction
Interventions
First Posted Date
2019-03-26
Last Posted Date
2020-08-26
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
32
Registration Number
NCT03890809
Locations
🇭🇺

Kenezy Gyula Korhaz es Rendelointezet, Debrecen, Hungary

🇭🇺

Clinical Research Unit Hungary, Miskolc, Hungary

🇨🇿

Pharmaceutical Research Associates CZ, s.r.o, Praha 7, Czechia

and more 1 locations

Assessment of Gut Absorption of Experimental Medication BMS-986165 in Healthy Males

Phase 1
Completed
Conditions
Psoriasis
Interventions
First Posted Date
2019-03-13
Last Posted Date
2019-11-26
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
9
Registration Number
NCT03873415
Locations
🇺🇸

Scintipharma, Lexington, Kentucky, United States

A Taste Assessment of BMS-986165 in Healthy Participants

Phase 1
Completed
Conditions
Healthy Participants
Interventions
Drug: Active Pharmaceutical Ingredient
First Posted Date
2018-11-23
Last Posted Date
2019-10-01
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
9
Registration Number
NCT03751228
Locations
🇺🇸

Senopsys, Woburn, Massachusetts, United States

An Investigational Study to Evaluate Experimental Medication BMS-986165 Given as a Tablet and Solution in Healthy Male Participants

Phase 1
Completed
Conditions
Healthy Participants
Interventions
First Posted Date
2018-11-14
Last Posted Date
2021-02-26
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
8
Registration Number
NCT03739788
Locations
🇬🇧

Quotient Sciences, Nottingham, United Kingdom

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

Phase 1
Completed
Conditions
Healthy Participants
Interventions
First Posted Date
2018-09-06
Last Posted Date
2018-12-19
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
131
Registration Number
NCT03660436
Locations
🇺🇸

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

Effectiveness and Safety of BMS-986165 Compared to Placebo and Active Comparator in Participants With Psoriasis

Phase 3
Completed
Conditions
Psoriasis
Interventions
First Posted Date
2018-08-09
Last Posted Date
2023-01-30
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
666
Registration Number
NCT03624127
Locations
🇺🇸

Keck School of Medicine, Los Angeles, California, United States

🇯🇵

Sapporo Skin Clinic, Sapporo, Hokkaido, Japan

🇵🇱

DermoDent - Centrum Medyczne Czajkowscy, Osielsko, Poland

and more 150 locations

An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants With Moderate-to-Severe Plaque Psoriasis

Phase 3
Completed
Conditions
Psoriasis
Interventions
First Posted Date
2018-08-02
Last Posted Date
2022-12-20
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
1020
Registration Number
NCT03611751
Locations
🇺🇸

Interspond - Savin Medical Group, Miami Lakes, Florida, United States

🇺🇸

Tufts Medical Center, Boston, Massachusetts, United States

🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

and more 195 locations

An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's Disease

Phase 2
Terminated
Conditions
Granulomatous Colitis
Crohn's Enteritis
Crohn's Disease
Granulomatous Enteritis
Interventions
Other: Placebo
First Posted Date
2018-07-26
Last Posted Date
2024-07-03
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
239
Registration Number
NCT03599622
Locations
🇺🇸

Local Institution - 0319, Chicago, Illinois, United States

🇺🇸

Local Institution - 0232, Miami, Florida, United States

🇺🇸

Local Institution - 0011, Las Vegas, Nevada, United States

and more 254 locations
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