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upadacitinib

Generic: UPADACITINIB·Brand: RINVOQ, RINVOQ LQ, Rinvoq

upadacitinib: sourced relationships with 1 company · 27 clinical trials tracked · 2 FDA decisions.

upadacitinib evidence translation

What we can confirm

2 FDA records · 27 tracked trials

What it means

Source-backed records connect upadacitinib to ABBV; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could upadacitinib → ABBV affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence8 indications · 0 study sponsors

Study sponsors

No additional listed-company sponsor is linked.

Dated Pipeline Records (3)
CompanyDated record stage
AbbVie Inc. (ABBV)
Reported 2019-08-16 · Current development: unknownSource
Atopic Dermatitis; Healthy Volunteer; Healthy Volunteers
Phase 4
AbbVie Inc. (ABBV)
Reported 2019-08-16 · Current development: unknownSource
Atopic Dermatitis
Phase 4
AbbVie Inc. (ABBV)
Reported 2019-08-16 · Current development: unknownSource
Atopic Dermatitis
Phase 4
Clinical Trial Registry Records (27)showing 10 most recent

Expanded Access to Upadacitinib

NCT04159597Registry updated 2026-08-20·ABBV
Available
Expanded AccessAbbVie

An Open-Label, Investigator-Initiated Study Evaluating the Use of Upadacitinib in Patients Hospitalized With Acute Severe Ulcerative Colitis

NCT07502339Registry updated 2026-09-24·Phase 4
Not yet recruiting

Primary endpoint: Treatment Failure

Interventionalopen50 targetStarted 2026-10Completion 2028-121 site · United StatesUniversity of California, San Francisco

Safety and Efficacy of Upadacitinib in Treatment of JAK/STAT Pathway Disorders With Activating Mutations

NCT07670156Registry updated 2026-09-08·Phase 1/Phase 2
Not yet recruiting

Primary endpoint: Treatment Efficacy - TIme to first occurrence of disease reactivation

InterventionalRandomizedtriple30 targetStarted 2026-10Completion 2028-083 sites · United StatesLisa Satter

Application of the Personalized N-of-1 Trial Design in Patients With Rheumatoid Arthritis

NCT06016517Registry updated 2026-07-22
Not yet recruiting

Primary endpoint: Change in Disease Activity Score (DAS) 28

Observational18 targetStarted 2026-09Completion 2028-121 site · United StatesTufts Medical Center

A Phase 1 Open-label, Multiple Dose Study of Upadacitinib, Tofacitinib, and Baricitinib in Healthy Subjects to Evaluate Pharmacodynamic Biomarkers

NCT07843693Registry updated 2026-09-28·Phase 1·ABBV
Recruiting

Primary endpoint: Number of Participants With Treatment Emergent Adverse Events (TEAE)

Interventionalopen60 targetStarted 2026-08Completion 2026-121 site · United StatesAbbVie

A Phase 3 Randomized, Placebo-controlled, Double-blind Study to Evaluate Efficacy and Safety of Upadacitinib in Pediatric Subjects With Severe Alopecia Areata

NCT07772492Registry updated 2026-10-06·Phase 3·ABBV
Recruiting

Primary endpoint: Percentage of Participants with the Achievement of Severity of Alopecia Tool (SALT) Score <= 20, defined as less than or equal to 20% scalp hair loss.

InterventionalRandomizedtriple300 targetStarted 2026-08Completion 2032-0310 sites · Taiwan, United StatesAbbVie

A Phase 1 Study to Evaluate the Pharmacokinetic Interaction and Safety of ABBV-722 and Upadacitinib Following Multiple Oral Doses in Healthy Adult Subjects

NCT07425899Registry updated 2026-04-17·Phase 1·ABBV
Recruiting

Primary endpoint: Maximum observed plasma concentration at steady state (Cmax,ss) of ABBV-722

Interventionalopen32 targetStarted 2026-02Completion 2026-081 site · United StatesAbbVie

A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects With Alopecia Areata and at Least 25% Scalp Hair Loss

NCT07023302Registry updated 2026-07-30·Phase 3·ABBV
Active, not recruiting

Primary endpoint: Percentage of Participants with the Achievement of Severity of Alopecia Tool (SALT) Score <= 10

InterventionalRandomizeddouble125 enrolledStarted 2025-06Completion 2029-0215 sites · JapanAbbVie

A Randomized, Double-Blind, Phase 3b Study to Evaluate the Short- and Long-Term Efficacy and Safety of Dual Targeted Therapy With Intravenous Vedolizumab and Oral Upadacitinib Compared With Intravenous Vedolizumab and Oral Placebo for Induction Followed by Intravenous Vedolizumab Monotherapy for Maintenance in the Treatment of Adults With Moderately to Severely Active Crohn's Disease

NCT06227910Registry updated 2026-05-27·Phase 3
Recruiting

Primary endpoint: Percentage of Participants Achieving Clinical Remission Based on the CDAI at Week 12

InterventionalRandomizedquadruple396 targetStarted 2025-01Completion 2028-0850 sites · Austria, Belgium, Brazil, Canada…Takeda

A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Upadacitinib in Combination With Topical Corticosteroids in Children From 2 to Less Than 12 Years of Age in Japan With Moderate to Severe Atopic Dermatitis

NCT06701331Registry updated 2026-02-23·Phase 3·ABBV
Active, not recruiting

Primary endpoint: Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 75

InterventionalRandomizedtriple99 targetStarted 2024-12Completion 2027-0125 sites · JapanAbbVie
FDA Decisions2 records
Approval(ABBV)FDA ↗
NDA218347Type 3 - New Dosage FormOrphan DrugStandardOralSolution
Approval1 INDICATIONS AND USAGE 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 is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants. ( 1.3 ) RINVOQ is indicated for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more TNF blockers. If TNF blockers are clinically inadvisable, patients should have received at least one approved systemic therapy prior to use of RINVOQ. ( 1.4 ) Limitations of Use RINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for UC, or with potent immunosuppressants such as azathioprine and cyclosporine. ( 1.4 ) RINVOQ is indicated for the treatment of adults with moderately to severely active Crohn’s disease (CD) who have had an inadequate response or intolerance to one or more TNF blockers. If TNF blockers are clinically inadvisable, patients should have received at least one approved systemic therapy prior to use of RINVOQ. ( 1.5 ) Limitations of Use RINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for CD, or with potent immunosuppressants such as azathioprine and cyclosporine. ( 1.5 ) RINVOQ is indicated for the treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers. ( 1.6 ) 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. ( 1.6 ) RINVOQ is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to TNF blocker therapy. ( 1.7 ) 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. ( 1.7 ) RINVOQ/RINVOQ LQ is indicated for the treatment of patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis who have had an inadequate response or intolerance to one or more TNF blockers. ( 1.8 ) Limitations 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. ( 1.8 ) RINVOQ is indicated for the treatment of adults with giant cell arteritis ( 1.9 ) 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. ( 1.9 ) 1.1 Rheumatoid Arthritis 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 disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine. 1.2 Psoriatic Arthritis 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. Limitations 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. 1.3 Atopic Dermatitis 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. Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants. 1.4 Ulcerative Colitis RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more TNF blockers. If TNF blockers are clinically inadvisable, patients should have received at least one approved systemic therapy prior to use of RINVOQ. Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for UC, or with potent immunosuppressants such as azathioprine and cyclosporine. 1.5 Crohn’s Disease RINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease (CD) who have had an inadequate response or intolerance to one or more TNF blockers. If TNF blockers are clinically inadvisable, patients should have received at least one approved systemic therapy prior to use of RINVOQ. Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for CD, or with potent immunosuppressants such as azathioprine and cyclosporine. 1. 6 Ankylosing Spondylitis RINVOQ is indicated for the treatment of adults with active ankylosing spondylitis 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. 1. 7 Non-radiographic Axial Spondyloarthritis RINVOQ is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to TNF blocker therapy. 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. 1.8 Polyarticular Juvenile Idiopathic Arthritis RINVOQ/RINVOQ LQ is indicated for the treatment of patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis (pJIA) who have had an inadequate response or intolerance to one or more TNF blockers. Limitations 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. 1.9 Giant Cell Arteritis RINVOQ is indicated for the treatment of adults with giant cell arteritis. 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.(ABBV)FDA ↗
NDA211675Type 1 - New Molecular EntityOrphan DrugPriorityOralTablet, Extended Release

Frequently asked questions

Which companies have sourced relationships with upadacitinib?

upadacitinib has dated SEC/FDA relationship records for AbbVie Inc..

How many clinical trials involve upadacitinib?

BioSniper tracks 27 clinical trials involving upadacitinib.

What is upadacitinib's latest FDA decision?

The most recent tracked FDA decision for upadacitinib is Approval, dated April 26, 2024.