RINVOQ
RINVOQ (upadacitinib) is a Janus kinase (JAK) inhibitor indicated for the treatment of several moderate to severe inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and Crohn’s disease. It is primarily used for patients who have had an inadequate response or intolerance to one or more TNF blockers or other systemic therapies. The medication is also approved for pediatric patients as young as 2 years old for psoriatic arthritis and 12 years old for refractory atopic dermatitis. Use of this therapy in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants is not recommended.
How RINVOQ Works
Upadacitinib is an intracellular enzyme inhibitor that targets the Janus kinase (JAK) family to influence immune cell function and hematopoiesis. It works by blocking JAKs from phosphorylating and activating signal transducers and activators of transcription (STATs), which are responsible for modulating gene expression. By preventing this activation, the drug modulates signaling pathways arising from cytokine or growth factor-receptor interactions on the cellular membrane. In laboratory assays, the drug demonstrates greater inhibitory potency at JAK1 and JAK2 relative to JAK3 and TYK2.
Details
- Status
- Prescription
- First Approved
- 2019-08-16
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
RINVOQ Approval History
What RINVOQ Treats
5 indicationsRINVOQ is approved for 5 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Moderately to severely active rheumatoid arthritis
- Active psoriatic arthritis
- Refractory, moderate to severe atopic dermatitis
- Moderately to severely active ulcerative colitis
- Moderately to severely active Crohn’s disease
RINVOQ Boxed Warning
SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS SERIOUS INFECTIONS Patients treated with RINVOQ /RINVOQ LQ are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6.1 )]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt RINVOQ /R...
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS SERIOUS INFECTIONS Patients treated with RINVOQ /RINVOQ LQ are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6.1 )]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt RINVOQ /RINVOQ LQ until the infection is controlled. Reported infections include: Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before RINVOQ /RINVOQ LQ use and during therapy. Treatment for latent infection should be considered prior to RINVOQ /RINVOQ LQ use. Invasive fungal infections, including cryptococcosis and pneumocystosis. Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens. The risks and benefits of treatment with RINVOQ /RINVOQ LQ should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with RINVOQ /RINVOQ LQ , including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy [see Warnings and Precautions ( 5.1 )]. MORTALITY In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor [see Warnings and Precautions ( 5.2 )] . MALIGNANCIES Lymphoma and other malignancies have been observed in patients t
RINVOQ Target & Pathway
ProTarget
A member of the JAK family involved in signaling for interferons and several interleukins. JAK1 inhibition is effective in rheumatoid arthritis, atopic dermatitis, and other inflammatory conditions by blocking multiple cytokine pathways.
RINVOQ Competitors
Pro10 other drugs also target JAK1. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (JAK1). Earlier expiry dates signal biosimilar/generic opportunities.
Drugs Similar to RINVOQ
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
RINVOQ FDA Label Details
ProIndications & Usage
FDA Label (PDF)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. 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. 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 in...
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS SERIOUS INFECTIONS Patients treated with RINVOQ /RINVOQ LQ are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 ), ...
RINVOQ Patents & Exclusivity
Patents (288 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.