Overview
Upadacitinib is an oral Janus kinase (JAK)1-selective inhibitor and a disease-modifying antirheumatic drug (DMARD) used in the treatment of rheumatoid arthritis to slow down disease progression. Rheumatoid arthritis is a chronic autoimmune inflammatory disease affecting the peripheral joints. It is characterized by synovial inflammation and hyperplasia, autoantibody production, cartilage damage and bone destruction, leading to co-morbidities. Despite a variety of therapeutic agents available for treatment, up to 40% of the patients do not respond to current therapies, including biological therapies. The etiology of the disease is mostly unknown; however, the role of JAK as a driver of immune-mediated conditions was discovered, leading to the use of JAK as therapeutic targets for rheumatoid arthritis. To reduce dose-related toxicity (as seen with some pan-JAK inhibitors) without significantly affecting efficacy, more selective JAK1 inhibitors, upadacitinib and filgotinib, were developed. The FDA approved upadacitinib in August 2019 and it is used for the treatment of active rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, and ankylosing spondylitis. In December 2019, it was additionally approved by the European Commission. Upadacitinib is marketed under the brand name RINVOQ for oral administration.
Indication
Upadacitinib is indicated for the treatment of moderately to severely active rheumatoid arthritis or active psoriatic arthritis in adult patients who have had an inadequate response or intolerance to one or more disease-modifying anti-rheumatic drugs (DMARDs), such as TNF blockers. In Europe, upadacitinib may be used as monotherapy or in combination with methotrexate for rheumatoid or psoriatic arthritis. Upadacitinib is indicated for use in patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is inadequately controlled with other systemic therapies or when other therapies are inadvisable. Upadacitinib is indicated for the treatment of active ankylosing spondylitis or radiographic axial spondyloarthritis in adult patients who have an inadequate response to conventional therapy. It is also indicated to treat non-radiographic axial spondyloarthritis with objective signs of inflammation in adults who have had an inadequate response or intolerance to TNF blocker therapy. Upadacitinib is also indicated to treat moderately to severely active ulcerative colitis in adults who have had an inadequate response or intolerance to either conventional therapy or a biologic agent, such as to one or more TNF blockers. Upadacitinib is indicated to treat moderately to severely active Crohn’s disease in adults who have had an inadequate response or intolerance to one or more TNF blockers. Combining upadacitinib with other JAK inhibitors, biologic DMARDs, or other potent immunosuppressive agents is not recommended.
Associated Conditions
- Ankylosing Spondylitis (AS)
- Moderately to Severely Active Rheumatoid Arthritis
- Moderately to Severely Active Ulcerative Colitis
- Severe Atopic Dermatitis
- Active Ankylosing spondylitis
- Active Non-radiographic Axial Spondyloarthritis
- Active Psoriatic arthritis
- Moderate, active Crohn´s Disease
- Moderate, refractory Atopic dermatitis
- Refractory, severe Atopic Dermatitis
- Severe, active Crohn´s Disease
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/16 | Phase 3 | Recruiting | |||
2025/06/12 | Phase 4 | Not yet recruiting | |||
2025/04/22 | N/A | Active, not recruiting | |||
2025/04/15 | Phase 3 | Not yet recruiting | Douglas D. Fraser | ||
2025/04/10 | N/A | Completed | Sixth Affiliated Hospital, Sun Yat-sen University | ||
2025/03/30 | Phase 1 | Recruiting | Sixth Affiliated Hospital, Sun Yat-sen University | ||
2025/03/12 | Phase 1 | Recruiting | |||
2025/03/06 | Phase 2 | Not yet recruiting | |||
2025/01/17 | N/A | Recruiting | Xiang Gao | ||
2025/01/14 | Phase 4 | Recruiting | Psoriasis Treatment Center of Central New Jersey |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| AbbVie Inc. | 0074-2310 | ORAL | 30 mg in 1 1 | 11/17/2023 | |
| AbbVie Inc. | 0074-1043 | ORAL | 45 mg in 1 1 | 11/17/2023 | |
| AbbVie Inc. | 0074-2306 | ORAL | 15 mg in 1 1 | 11/17/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 12/16/2019 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| RINVOQ EXTENDED-RELEASE TABLET 30MG | SIN16518P | TABLET, FILM COATED, EXTENDED RELEASE | 30mg | 6/21/2022 | |
| RINVOQ EXTENDED-RELEASE TABLET 15MG | SIN15959P | TABLET, FILM COATED, EXTENDED RELEASE | 15mg | 6/16/2020 | |
| RINVOQ EXTENDED-RELEASE TABLET 45MG | SIN16687P | TABLET, FILM COATED, EXTENDED RELEASE | 45mg | 2/10/2023 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Upadacitinib Sustained - release Tablets | 国药准字HJ20220011 | 化学药品 | 片剂 | 2/18/2022 | |
| Upadacitinib Sustained - release Tablets | 国药准字HJ20233125 | 化学药品 | 片剂 | 2/14/2023 | |
| Upadacitinib Sustained - release Tablets | 国药准字HJ20220010 | 化学药品 | 片剂 | 2/18/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| RINVOQ PROLONGED-RELEASE TABLETS 15MG | N/A | N/A | N/A | 10/30/2020 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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