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 to Determine the Drug Level Profile of BMS-986165 in Healthy Male Volunteers Following Transporter Inhibition.
- First Posted Date
- 2019-09-12
- Last Posted Date
- 2020-08-05
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 16
- Registration Number
- NCT04086719
- Locations
- 🇺🇸
PRA Health Sciences - Salt Lake, Salt Lake City, Utah, United States
A Study to Determine the Pharmacokinetic Profile of BMS-986165 Tablets
- Conditions
- Lupus
- Interventions
- First Posted Date
- 2019-08-22
- Last Posted Date
- 2021-01-06
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 33
- Registration Number
- NCT04065932
- Locations
- 🇬🇧
Quotient Sciences, Nottingham, United Kingdom
A Study to Investigate the Effects of Cytochrome P450 1A2 Induction by Ritonavir on BMS-986165 Drug Levels and Effects in Healthy Participants
- First Posted Date
- 2019-08-13
- Last Posted Date
- 2020-06-18
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 16
- Registration Number
- NCT04055506
- Locations
- 🇺🇸
PRA Health Sciences - Salt Lake, Salt Lake City, Utah, United States
Long-Term Study That Measures the Safety and Efficacy of Deucravacitinib (BMS-986165) in Participants With Psoriasis
- First Posted Date
- 2019-07-29
- Last Posted Date
- 2023-09-28
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 1452
- Registration Number
- NCT04036435
- Locations
- 🇺🇸
First OC Dermatology & Belle-Aimee Skincare Clinic Fountain Valley, Fountain Valley, California, United States
🇺🇸Local Institution - 0007, Miami Lakes, Florida, United States
🇺🇸Radiant Research - Anderson, Anderson, South Carolina, United States
A Study to Investigate the Effects of Gastric Acid Suppression by Rabeprazole and BMS-986165 on How Fast and Complete The Drug is Absorbed Into the Body of Healthy Participants
- First Posted Date
- 2019-06-07
- Last Posted Date
- 2020-11-02
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 21
- Registration Number
- NCT03979248
- Locations
- 🇳🇱
PRA Health Sciences - Netherlands, Groningen, Netherlands
Single and Multiple Dose Pharmacokinetics of BMS-986165 in a Randomized, Double-Blind, Placebo-Controlled Study in Healthy Chinese Subjects
- First Posted Date
- 2019-05-21
- Last Posted Date
- 2020-06-18
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 135
- Registration Number
- NCT03956953
- Locations
- 🇨🇳
Local Institution, Beijing, Beijing, China
An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus Nephritis
- Conditions
- Lupus Nephritis
- Interventions
- First Posted Date
- 2019-05-09
- Last Posted Date
- 2022-10-17
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 16
- Registration Number
- NCT03943147
- Locations
- 🇺🇸
The Regents of The University of California, Los Angeles, California, United States
🇺🇸NewYork-Presbyterian Queens, Fresh Meadows, New York, United States
🇺🇸Northwell Health Physician Partners at Great Neck, Great Neck, New York, United States
Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative Colitis
- First Posted Date
- 2019-05-01
- Last Posted Date
- 2024-03-06
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 131
- Registration Number
- NCT03934216
- Locations
- 🇺🇸
Penn State Health Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
🇧🇪Local Institution - 0065, Brussels, Belgium
🇩🇪Charite Universitatsmedizin Berlin - Campus Virchow-Klinikum, Berlin, Germany
Study to Characterize the Effects of Cytochrome p450 1A2 Inhibition on Systemic Exposure to BMS-986165
- First Posted Date
- 2019-04-29
- Last Posted Date
- 2021-11-17
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 16
- Registration Number
- NCT03930602
- Locations
- 🇺🇸
ICON Plc (PRA Health Sciences), Salt Lake City, Utah, United States
An Investigational Study to Evaluate Experimental Medication BMS-986165 in Japanese Participants With Moderate-to-Severe Psoriasis
- First Posted Date
- 2019-04-23
- Last Posted Date
- 2022-11-02
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 74
- Registration Number
- NCT03924427
- Locations
- 🇯🇵
Yokohama City University Hospital, Yokohama, Kanagawa, Japan
🇯🇵Hamamatsu University Hospital, Hamamatsu, Shizuoka, Japan
🇯🇵Kyoto University Hospital, Kyoto-City, Kyoto, Japan
Drug Development Updates
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