deucravacitinib
Trade name: Sotkyktu
Small moleculeapproved
Approved
Sep 9, 2022
Clinical trial activity
77 trials · 20 clinical orgs · 2 marketing orgs
Phase 1
28
Phase 2
37
Phase 3
21
Phase 4
10
Earliest trial started Apr 26, 2016 (NCT03419975)
Timeline
2010s
- Jan 1, 2016
Earliest Phase 3 Sponsor(trial)
- Jan 1, 2017
Bristol-Myers Squibb — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2017
Bristol-Myers Squibb — Earliest Phase 2 Sponsor(trial)
2020s
- Sep 9, 2022
Bristol-Myers Squibb — Earliest FDA Approval
- Sep 9, 2022
Bristol-Myers — Marketing Organization
- Sep 9, 2022
Bristol-Myers Squibb — NDA Secondary Org
- Sep 9, 2022
Bristol-Myers Squibb — NDA Organization
Indications
Approved for
Studied for
- Alopecia Areata · Phase 2
- Arthritis, Juvenile · Phase 3
- Arthritis, Psoriatic · Phase 3
- Autoimmune Diseases · Phase 1
- Colitis, Ulcerative · Phase 2
- Crohn Disease · Phase 2
- Dermatomyositis · Phase 2
- Epidermolysis Bullosa Simplex · Phase 2
- Glaucoma, Open-Angle · Phase 3
- Granuloma Annulare · Phase 2
- Healthy Volunteers · Phase 4
- Hidradenitis Suppurativa · Phase 2
- Ichthyosis · Phase 2
- Inflammatory Bowel Diseases · Phase 1
- Kidney Failure, Chronic · Phase 1
- Lichen Planus · Phase 2
- Liver Diseases · Phase 1
- Lupus Erythematosus, Cutaneous · Phase 4
- Lupus Erythematosus, Discoid · Phase 2
- Lupus Erythematosus, Systemic · Phase 4
- Lupus Nephritis · Phase 2
- Myositis · Phase 2
- Ocular Hypertension · Phase 3
- Pityriasis Rubra Pilaris · Phase 2
- Psoriasis · Phase 4
- Pyoderma Gangrenosum · Early Phase 1
- Rosacea · Phase 2
- Sarcoidosis · Phase 2
- Sjogren's Syndrome · Phase 3
- Skin Diseases · Phase 2
- Takayasu Arteritis · Phase 4
- Vitiligo · Phase 3
Mechanism of action
TYK2 antagonist
- Tyrosine-protein kinase TYK2NEGATIVE ALLOSTERIC MODULATOR
Tyrosine-protein kinase TYK2 negative allosteric modulator
Approval history
- approvedSep 9, 2022
Chemistry & pharmacology
Loading structure…
SMILES
[2H]C([2H])([2H])NC(=O)c1nnc(NC(=O)C2CC2)cc1Nc1cccc(-c2ncn(C)n2)c1OC- Mol. weight
- 425.47 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
First in class
Sources
- ChEMBLCHEMBL4435170 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07280702 | Phase 4 | Dec 15, 2025 | The University of Texas, Dallas |
| NCT07012057 | Phase 2 | Nov 21, 2025 | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
| NCT06979453 | Phase 3 | Nov 15, 2025 | Bristol-Myers Squibb |
| NCT07116967 | Phase 3 | Sep 22, 2025 | Bristol-Myers Squibb |
| NCT06973291 | Phase 3 | Jul 9, 2025 | Takeda |
| NCT07013838 | Phase 4 | Jun 15, 2025 | Chinese Academy of Medical Sciences, Chinese SLE Treatment And Research Group |
| NCT07000630 | N/A | Jun 4, 2025 | Peking University |
| NCT06875960 | Phase 4 | Mar 17, 2025 | Bristol-Myers Squibb |
| NCT06869551 | Phase 3 | Mar 10, 2025 | Bristol-Myers Squibb |
| NCT06725264 | Phase 2 | Jan 31, 2025 | Bristol-Myers Squibb, Yale University |
| NCT06851871 | Phase 1 | Jan 23, 2025 | Bristol-Myers Squibb |
| NCT06532136 | Phase 2 | Nov 30, 2024 | Bristol-Myers Squibb, Icahn School of Medicine at Mount Sinai |
| NCT06566768 | Phase 1 | Oct 7, 2024 | Bristol-Myers Squibb |
| NCT06444399 | Phase 2 | Jul 29, 2024 | Mayo Clinic |
| NCT06476834 | Phase 4 | Jun 21, 2024 | Bristol-Myers Squibb |
| NCT06333860 | Phase 4 | May 10, 2024 | AbbVie |
| NCT06327321 | Phase 3 | May 5, 2024 | University of Nice Sophia Antipolis |
| NCT06281106 | Phase 2/Phase 3 (Phase 3) | Apr 30, 2024 | University of Lausanne |
| NCT06220604 | Phase 3 | Mar 9, 2024 | — |
| NCT06143878 | Phase 3 | Feb 5, 2024 | — |
Showing 20 of 77 trials
Page 1 / 4
Organizations
Research & Development (20)
20 organizations
Page 1 / 1
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Bristol-Myers | For profit | MKTG | Sep 9, 2022 |
| Bristol-Myers Squibb | For profit | NDA2 | Sep 9, 2022 |
| Bristol-Myers Squibb | For profit | NDA | Sep 9, 2022 |