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 Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment

Phase 3

Active, not recruiting

Conditions: Psoriatic Arthritis

Interventions: Drug: Deucravacitinib
Drug: Apremilast
Other: Placebo

First Posted Date: 2021-06-01

Last Posted Date: 2025-04-13

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 729

Registration Number: NCT04908189

Locations: 🇨🇳
Local Institution - 0140, Pingxiang, Jiangxi, China
🇨🇳
Local Institution - 0191, Shenyang, Liaoning, China
🇨🇳
Local Institution - 0158, Baotou, Neimeng, China

and more 144 locations

A Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Crohn's Disease or Ulcerative Colitis

Phase 2

Completed

Conditions: Crohn Disease
Ulcerative Colitis

Interventions: Drug: Deucravacitinib

First Posted Date: 2021-05-07

Last Posted Date: 2023-10-04

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 67

Registration Number: NCT04877990

Locations: 🇺🇸
Local Institution - 0036, Shreveport, Louisiana, United States
🇯🇵
Local Institution - 0026, Bunkyo-ku, Tokyo, Japan
🇺🇸
Local Institution - 0002, Wyoming, Michigan, United States

and more 38 locations

A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)

Phase 2

Active, not recruiting

Conditions: Lupus Erythematosus, Discoid
Lupus Erythematosus, Subacute Cutaneous

Interventions: Drug: Deucravacitinib
Drug: Placebo

First Posted Date: 2021-04-23

Last Posted Date: 2024-11-19

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 75

Registration Number: NCT04857034

Locations: 🇲🇽
Local Institution - 0071, Mexico City, Mexico
🇨🇳
Local Institution - 0022, Taipei, Taiwan
🇺🇸
Local Institution - 0059, Saint Louis, Missouri, United States

and more 38 locations

A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Pediatric Participants With Moderate to Severe Plaque Psoriasis

Phase 3

Recruiting

Conditions: Plaque Psoriasis

Interventions: Drug: Deucravacitinib
Other: Placebo matching deucravacitinib

First Posted Date: 2021-02-26

Last Posted Date: 2025-05-09

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 153

Registration Number: NCT04772079

Locations: 🇵🇱
Local Institution - 0011, Krakow, Poland
🇧🇷
Centro de Pesquisas da Clínica IBIS, Salvador, Bahia, Brazil
🇦🇷
Instituto de Neumonologia Y Dermatologia, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

and more 60 locations

Effect of BMS-986165 on the Blood Levels of Metformin

Phase 1

Completed

Conditions: Healthy Participants

Interventions: Drug: BMS-986165
Drug: Metformin

First Posted Date: 2020-12-17

Last Posted Date: 2021-11-11

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 36

Registration Number: NCT04671953

Locations: 🇺🇸
PRA Health Sciences - Lenexa, Lenexa, Kansas, United States

A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis

Phase 2

Completed

Conditions: Colitis, Ulcerative

Interventions: Other: Placebo Comparator
Drug: BMS-986165

First Posted Date: 2020-11-03

Last Posted Date: 2024-07-12

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 38

Registration Number: NCT04613518

Locations: 🇺🇸
Local Institution - 0032, Garland, Texas, United States
🇦🇺
Local Institution - 0005, Sydney, New South Wales, Australia
🇨🇦
Local Institution - 0025, London, Ontario, Canada

and more 23 locations

Pharmacokinetics (Drug Levels in Blood) of BMS-986165 When Taken as Various Solid Tablet Prototypes by Healthy Participants

Phase 1

Completed

Conditions: Healthy Participants

Interventions: Drug: BMS-986165 prototype 2
Drug: BMS-986165 prototype 1
Drug: BMS-986165

First Posted Date: 2020-01-30

Last Posted Date: 2020-04-09

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 18

Registration Number: NCT04249284

Locations: 🇺🇸
Quotient Sciences Miami, Miami, Florida, United States

A Study Comparing the Effects of Famotidine Pretreatment and of Food on the Relative Bioavailability of BMS-986165 in Healthy Volunteers

Phase 1

Completed

Conditions: Healthy Participants

Interventions: Drug: BMS-986165
Drug: Famotidine

First Posted Date: 2019-12-24

Last Posted Date: 2020-04-21

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 18

Registration Number: NCT04209699

Locations: 🇺🇸
PRA Health Sciences - Salt Lake, Salt Lake City, Utah, United States

An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo in Participants With Plaque Psoriasis (POETYK-PSO-3) in Mainland China, Taiwan, and South Korea

Phase 3

Completed

Conditions: Psoriasis

Interventions: Other: Placebo
Drug: BMS-986165

First Posted Date: 2019-11-18

Last Posted Date: 2023-03-08

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 220

Registration Number: NCT04167462

Locations: 🇨🇳
Local Institution - 0031, Taipei, Taiwan
🇨🇳
Local Institution - 0012, Jingan, Shanghai, China
🇨🇳
Local Institution - 0014, Beijing, Beijing, China

and more 28 locations

The Effects Diflunisal on the Levels of BMS-986165 in Healthy Participants

Phase 1

Completed

Conditions: Healthy Participants

Interventions: Drug: BMS-986165
Drug: diflunisal

First Posted Date: 2019-10-03

Last Posted Date: 2020-08-05

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 48

Registration Number: NCT04113668

Locations: 🇺🇸
PRA Health Sciences - Lenexa, Lenexa, Kansas, United States

Drug Development Updates

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