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upadacitinib

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

upadacitinib: developed by 1 company · 26 clinical trials tracked · 2 FDA decisions.

upadacitinib evidence translation

What we can confirm

2 FDA records · 26 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 · 1 study sponsors
Development Pipeline (3)
CompanyPhase
AbbVie Inc. (ABBV)
Atopic Dermatitis; Healthy Volunteer; Alopecia Areata
Phase 4
AbbVie Inc. (ABBV)Phase 4
AbbVie Inc. (ABBV)Phase 4
Clinical Trials (26)showing 10 most recent

Expanded Access to Upadacitinib

Available
Expanded AccessAbbVie

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

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

NCT07772492·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 2032-034 sites · United StatesAbbVie

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

NCT07670156·Phase 1/Phase 2
Not yet recruiting

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

InterventionalRandomizedtriple30 targetStarted 2026-08Completion 2028-083 sites · United StatesLisa Satter

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

NCT07502339·Phase 4
Not yet recruiting

Primary endpoint: Treatment Failure

Interventionalopen50 targetStarted 2026-07Completion 2028-081 site · United StatesUniversity of California, San Francisco

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

NCT07425899·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

NCT07023302·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

NCT06227910·Phase 3·TAK
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

NCT06701331·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

A Phase 3, Open-label, Efficacy-Assessor-Blinded Study, Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Children From 2 to Less Than 12 Years of Age With Moderate to Severe Atopic Dermatitis

NCT06461897·Phase 3·ABBV
Recruiting

Primary endpoint: Percentage of Participants Achieving a 75% Reduction from Baseline in Eczema Area and Severity Index 75 (EASI 75) Score (other than US)

InterventionalRandomizedsingle675 targetStarted 2024-08Completion 2030-0750 sites · Argentina, Australia, Austria, Brazil…AbbVie
FDA Decisions2 records
NDA218347Type 3 - New Dosage FormOrphan DrugStandardOralSolution
NDA211675Type 1 - New Molecular EntityOrphan DrugPriorityOralTablet, Extended Release

Frequently asked questions

Who is developing upadacitinib?

upadacitinib is being developed by AbbVie Inc..

How many clinical trials involve upadacitinib?

BioSniper tracks 26 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.