upadacitinib
Trade name: Rinvoq
Approved
Aug 16, 2019
Upadacitinib (ABT-494) is a Janus kinase 1 (JAK1) inhibitor currently being developed by AbbVie for the treatment of rheumatoid arthritis (RA), Crohn’s disease, ulcerative colitis, atopic dermatitis, and psoriatic arthritis. It is also being investigated as a potential treatment for people with active ankylosing spondylitis (AS). Currently, upadacitinib is being evaluatedin six global phase III studies in RA and twophase III studies in psoriatic arthritis (PsA), inaddition to phase II studies in Crohn’s disease and atopicdermatitis and a combined phase II/III study inulcerative colitis. Upadacitinib is a potent and selective Janus kinase (JAK) 1 inhibitor with an IC50 of 43 nM. — NCATS
Clinical trial activity
84 trials · 32 clinical orgs · 3 marketing orgs
Earliest trial started Nov 1, 2012 (NCT01741493)
Timeline
2010s
2020s
- Jan 3, 2025
Aurobindo Pharma — Marketing Organization
- Nov 14, 2025
Sandoz — Marketing Organization
Indications
Approved for
Studied for
- Alopecia Areata · Phase 3
- Arthritis, Juvenile · Phase 3
- Arthritis, Psoriatic · Phase 4
- Arthritis, Rheumatoid · Phase 4
- Axial Spondyloarthritis · Phase 4
- Behcet Syndrome · Phase 2
- Biomarkers · Phase 3
- Carcinoma, Giant Cell · Phase 3
- Colitis, Ulcerative · Phase 4
- COVID-19 · Phase 3
- Crohn Disease · Phase 4
- Dermatitis · Early Phase 1
- Dermatitis, Atopic · Phase 4
- Hidradenitis Suppurativa · Phase 3
- Janus Kinase Inhibitors · Phase 3
- Lung Diseases · Phase 3
- Lupus Erythematosus, Systemic · Phase 3
- Pharmacokinetics · Phase 1
- Polychondritis, Relapsing · Phase 1/Phase 2
- Prurigo · Phase 4
- Purpura, Thrombocytopenic, Idiopathic · Phase 2
- Rheumatic Diseases · Phase 2
- Sjogren's Syndrome · Phase 2
- Sleep Disorders, Intrinsic · Phase 3
- Spondylarthritis · Phase 4
- Spondylitis, Ankylosing · Phase 2
- Takayasu Arteritis · Phase 3
- Ultrasonography · Phase 3
- Vitiligo · Phase 3
Mechanism of action
Approval history
- approvedPriority reviewAug 16, 2019
Chemistry & pharmacology
SMILES
CC[C@@H]1CN(C(=O)NCC(F)(F)F)C[C@@H]1c1cnc2cnc3[nH]ccc3n12- Mol. weight
- 380.37 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL3622821 ↗
- WikipediaUpadacitinib ↗
- NCATS4RA0KN46E0 ↗
- ChEMBLCHEMBL3707269 ↗
Also known as
- abt-494
- abt-494
- abt-494
- upadacitinib
- upadacitinib
- upadacitinib
- upadacitinib tartrate
- upadacitinib tartrate
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07258771 | Phase 4 | Dec 31, 2025 | AbbVie, University of Michigan |
| NCT07018206 | Phase 4 | Nov 30, 2025 | CaRe Arthritis Ltd. |
| NCT07138898 | Phase 2 | Sep 30, 2025 | New York University |
| NCT06928272 | Phase 3 | Sep 10, 2025 | University of Western Ontario |
| NCT07149467 | Phase 3 | Sep 10, 2025 | Sun Yat-Sen University |
| NCT07064889 | Phase 2 | Jul 30, 2025 | Capital Medical University, Government of China, Peking University, Shandong University |
| NCT07023302 | Phase 3 | Jun 19, 2025 | AbbVie |
| NCT06660693 | Phase 3 | May 31, 2025 | AbbVie, McMaster University |
| NCT07008846 | Phase 3 | May 10, 2025 | Bangladesh Medical University |
| NCT06862284 | Phase 2 | Mar 10, 2025 | Peking University |
| NCT06227910 | Phase 3 | Jan 8, 2025 | Takeda |
| NCT06687551 | Phase 4 | Jan 1, 2025 | University of Toulouse |
| NCT06684522 | Early Phase 1 (Phase 1) | Dec 31, 2024 | Northwestern University |
| NCT06701331 | Phase 3 | Dec 23, 2024 | AbbVie |
| NCT06873100 | Phase 1/Phase 2 (Phase 2) | Nov 15, 2024 | Peking University |
| NCT06454188 | Phase 4 | Sep 30, 2024 | CaRe Arthritis Ltd. |
| NCT06454461 | N/A | Sep 1, 2024 | Jilin University |
| NCT06461897 | Phase 3 | Aug 19, 2024 | AbbVie |
| NCT06332534 | Phase 3 | Jul 26, 2024 | AbbVie |
| NCT06520397 | Phase 4 | Jul 15, 2024 | Sun Yat-Sen University |
Organizations
Research & Development (32)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| AbbVie | For profit | 62 | 57 | 5 | 2012 |
| Peking University | Academic/Hospital | 4 | 4 | 1 | 2024 |
| Sun Yat-Sen University | Academic/Hospital | 4 | 4 | 4 | 2023 |
| CaRe Arthritis Ltd. | Academic/Hospital | 2 | 2 | 1 | 2024 |
| University of Michigan | Academic/Hospital | 2 | 2 | 1 | 2023 |
| Assiut University | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Bangladesh Medical University | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Bristol-Myers Squibb | For profit | 1 | 0 | 1 | 2021 |
| Capital Medical University | Academic/Hospital | 1 | 0 | 1 | 2025 |
| Eli Lilly | For profit | 1 | 0 | 1 | 2021 |
| Foundation for Advancing Science Technology Education and Research | Academic/Hospital | 1 | 1 | 1 | 2021 |
| Government of China | Government | 1 | 0 | 1 | 2025 |
| Illumination Health | For profit | 1 | 0 | 1 | 2021 |
| Jilin University | Academic/Hospital | 1 | 1 | 1 | 2024 |
| McGill University | Academic/Hospital | 1 | 1 | 1 | 2023 |
| McMaster University | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Modern Biosciences plc | For profit | 1 | 1 | 1 | 2024 |
| New York University | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Northwestern University | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Novartis | For profit | 1 | 0 | 1 | 2021 |
Marketing (5)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| AbbVie | For profit | MKTG | Aug 16, 2019 |
| AbbVie | For profit | NDA | Aug 16, 2019 |
| AbbVie | For profit | SYN | Aug 16, 2019 |
| Aurobindo Pharma | For profit | MKTG | Jan 3, 2025 |
| Sandoz | For profit | MKTG | Nov 14, 2025 |