Upadacitinib: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Upadacitinib appears in the FDA drug-label database. Marketed as Rinvoq.
- Drug class
- Janus Kinase Inhibitor (FDA established pharmacologic class)
- Mechanism of action
- Janus Kinase Inhibitors (as stated on the FDA label)
- Boxed warning
- The FDA label for Upadacitinib carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
RINVOQ/RINVOQ LQ is a Janus kinase (JAK) inhibitor. RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers. ( 1.1 ) Limitations of Use RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. ( 1.1 ) RINVOQ/RINVOQ LQ is indicated for the treatment of adults and pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers. ( 1.2 ) Limitation s of Use RINVOQ/RINVOQ LQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. ( 1.2 ) RINVOQ is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable. ( 1.3 ) Limitations of Use RINVOQ i…
Phase breakdown
Conditions being studied
Recruiting trials involving Upadacitinib
- A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease
- A Study to Assess Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Children From 2 to Less Than 12 Years of Age With Moderate to Severe Atopic Dermatitis
- Comparative Effectiveness of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis（UPFRONT）
- Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease
- Efficacy and Safety of Upadacitinib in Inflammatory Bowel Disease
- Efficacy and Safety of Upatinib in the Treatment of Active Anal Fistulas in Crohn's Disease
- Efficacy and Safety of Vedolizumab Combined With Upadacitinib in Patients With Ulcerative Colitis
- Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
- Molecular Signatures in Inflammatory Skin Disease
- Real-World Effectiveness and Safety of Upadacitinib Plus Vedolizumab vs Upadacitinib Monotherapy During Induction in Moderate-to-Severe Ulcerative Colitis
- Replication of the Heads Up Atopic Dermatitis Trial With Registry Data
- TNFi Plus Low-Dose Upadacitinib vs TNFi Intensification in Crohn's Disease With Suboptimal Response
- Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis（UPRISE）
Common questions
Is Upadacitinib FDA-approved?
Yes, marketed as Rinvoq. Its FDA label carries a boxed warning.
How many recruiting trials involve Upadacitinib?
13 recruiting trials across 15 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.