Rinvoq

(Upadacitinib)

ApprovedSmall molecule

Upadacitinib is used to treat rheumatoid arthritis and other autoimmune conditions by reducing the immune system's overactive response that causes joint inflammation and damage.[2] Rinvoq is currently approved and in use across 33 indications[4].[1]

Rinvoq is one of 572 small molecule programs targeting Prurigo Nodularis. It is currently in Approved.

Indications

103

Total Trials

Active Trials

571

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Prurigo NodularisActive, not recruiting

Alopecia AreataActive, not recruiting

Efficacy and SafetyActive, not recruiting

Skin DiseaseActive, not recruiting

Inflammatory Bowel DiseaseActive, not recruiting

Temporal ArteritisApproved

Atopic EczemaApproved

JAK1 GOFNot yet recruiting

Primary Biliary Cholangitis (PBC)Not yet recruiting

Rheumatic DiseaseRecruiting

Prurigo NodularisApproved

Active, not recruiting

Alopecia AreataPhase 3

Active, not recruiting

Efficacy and SafetyPhase 3

Active, not recruiting

Skin DiseasePreclinical

Active, not recruiting

Inflammatory Bowel DiseasePreclinical

Active, not recruiting

Temporal ArteritisApproved

Approved

Atopic EczemaApproved

Approved

JAK1 GOFPreclinical

Not yet recruiting

Primary Biliary Cholangitis (PBC)Phase 2

Not yet recruiting

Rheumatic DiseasePhase 2

Recruiting

Showing 10 of 33 indications

Competition

Competitive Landscape

317 competitors in COVID-19

#DrugCompanyPhaseTrials

Rinvoq

AbbVie

Approved

1 2

Stivarga

Bayer

Preclinical

1 3

Aimovig

Amgen

Preclinical

1 4

Nexavar

Bayer

Preclinical

1 5

Calciferol

Activella

Benadryl

1 8

Statins

Sanofi

Preclinical

1 9

Rayaldee

OOrganon and Co

Preclinical

1 10

Biological Collection

AAssistance Publique - Hôpitaux de Paris

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Multiple Sclerosis

NCT03568318

N/ARecruiting

Ulcerative Colitis

NCT06095596

Post-ApprovalRecruiting

Psoriatic Arthritis

NCT06454188

Phase 1Recruiting

Anal Fistula

NCT06902987

Recruiting

Efficacy and Safety

NCT06573593

Phase 1/2Recruiting

Relapsing Polychondritis

NCT06873100

Clinical

Trials by Indication[1]

Rheumatoid Arthritis18 trials

Microbiota Analysis to Predict Outcomes of Rheumatoid Arthritis Patients Treated With JAK-inhibitor

Unknown status·UUniversity Hospital, Montpellier··NCT04530305·60 enrolled

A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis (RA) Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs

Completed· AbbVie logo

AbbVie·Phase 2/3·NCT02720523·197 enrolled

A Study in Rheumatoid Arthritis Patients Who Have Completed a Preceding Study With ABBV-105 Given Alone or in Combination With Upadacitinib

Terminated· AbbVie logo

AbbVie·Phase 2·NCT03823378·97 enrolled

Show 15 more trials

A Study to Investigate the Safety and Efficacy of ABBV-105 Alone or in Combination With Upadacitinib (ABBV-599 Combination) in Participants With Active Rheumatoid Arthritis

Completed· AbbVie logo

AbbVie·Phase 2·NCT03682705·242 enrolled

A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) With an Inadequate Response or Intolerance to Biologic DMARDs

Completed· AbbVie logo

AbbVie·Phase 3·NCT02706847·499 enrolled

A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone

Completed· AbbVie logo

AbbVie·Phase 3·NCT02675426·661 enrolled

An Open-label Extension Study Evaluating the Safety and Efficacy of Upadacitinib (ABT-494) in Adults With Rheumatoid Arthritis

Completed· AbbVie logo

AbbVie·Phase 2·NCT02049138·493 enrolled

Efficacy Of Upadacitinib In Psoriatic Arthritis And Comparison To Rheumatoid Arthritis.

Recruiting·II.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio··NCT06630715·178 enrolled

Early Changes in Pain, Disease Activity, and Ultrasound Evidence of Inflammatory Synovitis in Patients Receiving JAK-inhibitor vs. TNF-inhibitor Therapy for Active Rheumatoid Arthritis: A Feasibility Study.

Unknown status·OOttawa Hospital Research Institute·Phase 4·NCT05153200·40 enrolled

A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate

Active, not recruiting· AbbVie logo

AbbVie·Phase 3·NCT02629159·1,629 enrolled

A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate

Completed· AbbVie logo

AbbVie·Phase 3·NCT02706873·1,002 enrolled

A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)

Completed· AbbVie logo

AbbVie·Phase 3·NCT02706951·648 enrolled

A Study Investigating the Efficacy and Safety of Upadacitinib (ABT-494) Given With Methotrexate (MTX) in Adults With Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone

Completed· AbbVie logo

AbbVie·Phase 2·NCT02066389·300 enrolled

Discontinuation of Methotrexate in Rheumatoid Arthritis Patients Achieving Clinical Remission by Treatment With Upadacitinib Plus Methotrexate

Unknown status·AAtsushi Kawakami·Phase 3·NCT05121298·155 enrolled

A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs

Completed· AbbVie logo

AbbVie·Phase 3·NCT03086343·657 enrolled

A Study With Upadacitinib (ABT-494) in Subjects From China and Selected Countries With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs)

Completed· AbbVie logo

AbbVie·Phase 3·NCT02955212·338 enrolled

A Phase 3b/4 Randomized, Double-Blind, Double Dummy, Active Comparator-Controlled Study, Comparing the Efficacy and Safety of Upadacitinib Versus Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis on a Stable Background of MTX and Who Had an Inadequate Response or Intolerance to a Single TNF Inhibitor (SELECT- SWITCH)

Completed· AbbVie logo

AbbVie·Phase 3·NCT05814627·487 enrolled

JAK Inhibitor Dose TAPering Strategy Study in Low Disease Activity Rheumatoid Arthritis Patients

Recruiting·UUniversity Hospital, Toulouse·Approved·NCT06687551·308 enrolled

Atopic Dermatitis17 trials

A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis

Completed· AbbVie logo

AbbVie·Phase 3·NCT03738397·673 enrolled

A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

Completed· AbbVie logo

AbbVie·Phase 3·NCT05601882·920 enrolled

A Study of Oral Upadacitinib Tablets to Assess Change in Disease State in Participants Aged 12-75 Years With Moderate to Severe Atopic Dermatitis in Brazil

Withdrawn· AbbVie logo

AbbVie·Phase 3·NCT04666675

Show 14 more trials

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

Active, not recruiting· AbbVie logo

AbbVie·Phase 3·NCT06701331·99 enrolled

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

Not yet recruiting·UUniversity of California, San Francisco·Phase 4·NCT07352566·10 enrolled

Atopic Dermatitis Treated With Dupilumab and JAK Inhibitors in Costa Rica

Not yet recruiting·CCaja Costarricense de Seguro Social··NCT07448363·50 enrolled

A Study to Assess the Effect of Upadacitinib in Atopic Dermatitis-induced Sleep Disturbance in Adults With Moderate to Severe Atopic Dermatitis

Withdrawn· AbbVie logo

AbbVie·Phase 3·NCT06390722

A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Upadacitinib in Pediatric Participants With Severe Atopic Dermatitis

Completed· AbbVie logo

AbbVie·Phase 1·NCT03646604·35 enrolled

A Study to Assess Treat-to-Target and Dosing Flexibility of Oral Upadacitinib Tablets in Adult Participants With Moderate to Severe Atopic Dermatitis

Completed· AbbVie logo

AbbVie·Phase 4·NCT05507580·461 enrolled

A Study to Evaluate Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis (Measure Up 2)

Completed· AbbVie logo

AbbVie·Phase 3·NCT03607422·912 enrolled

Open-Label Extension Study of Upadacitinib in Adult Participants With Moderate to Severe Atopic Dermatitis

Completed· AbbVie logo

AbbVie·Phase 3·NCT04195698·475 enrolled

A Study to Evaluate Safety of Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

Completed· AbbVie logo

AbbVie·Phase 3·NCT03661138·272 enrolled

A Study to Evaluate ABT-494 (Upadacitinib) in Adults With Moderate to Severe Atopic Dermatitis

Completed· AbbVie logo

AbbVie·Phase 2·NCT02925117·167 enrolled

Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)

Completed· AbbVie logo

AbbVie·Phase 3·NCT03569293·912 enrolled

Pragmatic Replication of the Heads Up Head-to-head Study of Upadacitinib and Dupilumab With TREATgermany Registry Data

Terminated·TTechnische Universität Dresden··NCT06937788·210 enrolled

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

Recruiting· AbbVie logo

AbbVie·Phase 3·NCT06461897·675 enrolled

A Phase 3b/4 Randomized, Open-label, Efficacy Assessor-Blinded Study, to Evaluate the Efficacy and Safety of Upadacitinib for the Treatment of Adult Subjects With Moderate to Severe Atopic Dermatitis and Inadequate Response to Dupilumab (SWITCH-UP)

Recruiting· AbbVie logo

AbbVie·Phase 3·NCT06389136·200 enrolled

Ulcerative Colitis8 trials

Efficacy and Safety of Vedolizumab Combined With Upadacitinib in Patients With Ulcerative Colitis

Recruiting·SSixth Affiliated Hospital, Sun Yat-sen University·N/A·NCT06095596·334 enrolled

Comparison of Medical RESCUE Strategies for Patients With Steroid-refractory Acute Severe Ulcerative Colitis

Recruiting·MMcMaster University·Phase 3·NCT06660693·134 enrolled

A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)

Completed· AbbVie logo

AbbVie·Phase 2/3·NCT02819635·1,302 enrolled

Show 5 more trials

Study to Assess Adverse Events, Change in Disease Activity, and How Oral Upadacitinib Moves Through the Body of Pediatric Participants With Moderately to Severely Active Ulcerative Colitis.

Active, not recruiting· AbbVie logo

AbbVie·Phase 3·NCT05782907·122 enrolled

Upadacitinib Combined With Corticosteroids vs Corticosteroid Monotherapy Induction for Inpatients and Outpatients With Acute Severe Ulcerative Colitis

Recruiting·BBerinstein, Jeffrey·Phase 4·NCT07258771·110 enrolled

A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC)

Active, not recruiting· AbbVie logo

AbbVie·Phase 3·NCT03006068·950 enrolled

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis

Completed· AbbVie logo

AbbVie·Phase 3·NCT03653026·522 enrolled

Effectiveness and Safety of Upadacitinib for Acute Severe Ulcerative Colitis

Completed·XXijing Hospital of Digestive Diseases··NCT07472309·81 enrolled

Efficacy and Safety4 trials

Efficacy and Safety of JAK Inhibitors in Patients With AA: RWE Study

Recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University··NCT06573593·150 enrolled

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy

Completed· AbbVie logo

AbbVie·Phase 3·NCT03345836·624 enrolled

A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433

Active, not recruiting· AbbVie logo

AbbVie·Phase 3·NCT03345823·747 enrolled

Show 1 more trial

A Study of the Efficacy and Safety of Upadacitinib in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies

Completed· AbbVie logo

AbbVie·Phase 3·NCT03345849·526 enrolled

Psoriatic Arthritis4 trials

A Study to Evaluate the Impact of Upadacitinib on Spondyloarthritis Outcomes in Patients With Active Psoriatic Arthritis

Recruiting·CCARE ARTHRITIS LTD.·Phase 4·NCT06454188·100 enrolled

A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD)

Completed· AbbVie logo

AbbVie·Phase 3·NCT03104400·1,705 enrolled

A Study Comparing Upadacitinib (ABT-494) to Placebo in Participants With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug

Completed· AbbVie logo

AbbVie·Phase 3·NCT03104374·642 enrolled

Show 1 more trial

Response to Upadacitinib of Enthesitis Evaluated by Ultrasound in Patients With Psoriatic Arthritis

Not yet recruiting·IInstituto de Investigación Sanitaria de la Fundación Jiménez Díaz··NCT06144567·19 enrolled

41 more indications

Systemic Lupus Erythematosus3 trials

Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus

Recruiting· AbbVie logo

AbbVie·Phase 3·NCT05843643·1,000 enrolled

A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)

Completed· AbbVie logo

AbbVie·Phase 2·NCT03978520·341 enrolled

A Study of the Safety of Oral Elsubrutinib Capsules and Oral Upadacitinib Tablets Given Alone or in Combination (ABBV-599) for Adult Participants With Moderately to Severely Active Systemic Lupus Erythematosus to Assess Change in Disease State

Completed· AbbVie logo

AbbVie·Phase 2·NCT04451772·185 enrolled

Vitiligo3 trials

Study to Evaluate Adverse Events and Change in Disease Activity With Oral Tablets of Upadacitinib in Adult Participants With Non-Segmental Vitiligo

Completed· AbbVie logo

AbbVie·Phase 2·NCT04927975·185 enrolled

Efficacy of Upadacitinib After NECS in Vitiligo

Recruiting·JJilin University·N/A·NCT06454461·60 enrolled

A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo

Active, not recruiting· AbbVie logo

AbbVie·Phase 3·NCT06118411·614 enrolled

Crohn's Disease2 trials

A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease

Recruiting· Takeda logo

Takeda·Phase 3·NCT06227910·396 enrolled

A Phase 3 Multicenter Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Upadacitinib With Open-Label Induction, Randomized, Double-Blind Maintenance and Open-Label Long-Term Extension in Pediatric Subjects With Moderately to Severely Active Crohn's Disease and Inadequate Response, Intolerance, or Medical Contraindications to Corticosteroids, Immunosuppressants, and/or Biologic Therapy

Recruiting· AbbVie logo

AbbVie·Phase 3·NCT06332534·110 enrolled

Inflammatory Bowel Disease2 trials

Efficacy and Safety Analysis of Upadacitinib in Inflammatory Bowel Disease

Completed·SSixth Affiliated Hospital, Sun Yat-sen University··NCT06274996·81 enrolled

Efficacy and Safety of Upadacitinib in Inflammatory Bowel Disease

Recruiting·XXiang Gao··NCT06780683·174 enrolled

Hidradenitis Suppurativa2 trials

A Study of Oral Upadacitinib Tablet Compared to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa to Assess Change in Disease Symptoms

Completed· AbbVie logo

AbbVie·Phase 2·NCT04430855·68 enrolled

A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy

Active, not recruiting· AbbVie logo

AbbVie·Phase 3·NCT05889182·1,328 enrolled

Arthritis2 trials

A Study to Assess Disease Activity in Adult Participants With Axial Spondyloarthritis Who Receive Upadacitinib in a Real-world Setting

Recruiting· AbbVie logo

AbbVie··NCT05094128·352 enrolled

A Study to Evaluate Efficacy and Safety of Upadacitinib in Adults With Axial Spondyloarthritis

Completed· AbbVie logo

AbbVie·Phase 3·NCT04169373·734 enrolled

Upadacitinib2 trials

Upadacitinib for Refractory IBD in Asian Children and Elderly: Age-Stratified Analysis

Completed·SSixth Affiliated Hospital, Sun Yat-sen University··NCT06922331·21 enrolled

Active Pharmacovigilance Study of the Medicine Rinvoq™ (Upadacitinib)

Recruiting·UUniversidade do Porto··NCT06498167·150 enrolled

Alopecia Areata2 trials

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

Recruiting· AbbVie logo

AbbVie·Phase 3·NCT06012240·1,500 enrolled

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

Active, not recruiting· AbbVie logo

AbbVie·Phase 3·NCT07023302·125 enrolled

Ulcerative Colitis (UC)2 trials

Real-World Comparative Effectiveness and Safety of Upadacitinib Plus Vedolizumab Versus Upadacitinib Monotherapy During Induction in Moderate-to-Severe Ulcerative Colitis: A Multicenter Retrospective Cohort Study

Recruiting·SSixth Affiliated Hospital, Sun Yat-sen University··NCT07442045·150 enrolled

A Single Arm, Multicenter Open-Label Interventional to Evaluate the Efficacy of Upadacitinib Re-induction Therapy in Patients With Ulcerative Colitis Who Lost Response to 30 mg Maintenance Dose

Not yet recruiting·GGroupe d'Etude Therapeutique des Affections Inflammatoires Digestives·Approved·NCT07700446·100 enrolled

Adult Subject1 trial

Drug-Drug Interaction (DDI) Study of Leramistat in Healthy Adult Subjects

Recruiting·MModern Biosciences Ltd·Phase 1·NCT06379958·48 enrolled

Ankylosing Spondylitis1 trial

A Study Evaluating the Safety and Efficacy of Upadacitinib in Adults With Active Ankylosing Spondylitis

Completed· AbbVie logo

AbbVie·Phase 2·NCT03178487·187 enrolled

Anal fistula1 trial

Efficacy and Safety of Upatinib in the Treatment of Active Anal Fistulas in Crohn's Disease

Recruiting·SSixth Affiliated Hospital, Sun Yat-sen University·Phase 1·NCT06902987·27 enrolled

Skin Disease1 trial

Molecular Signatures in Inflammatory Skin Disease

Recruiting·PProf. Dr. Stephan Weidinger··NCT03358693·300 enrolled

Prurigo Nodularis1 trial

Upadacitinib for Prurigo Nodularis

Recruiting·PPsoriasis Treatment Center of Central New Jersey·Phase 4·NCT06773403·25 enrolled

Primary Sjögren's Syndrome1 trial

Therapeutic Effect of Upadacitinib in Primary Sjögren's Syndrome

Not yet recruiting·PPeking University People's Hospital·Phase 2·NCT06862284·30 enrolled

Systemic Sclerosis1 trial

Use of Selective JAK Inhibitor in ILD and Skin Tightness of Systemic Sclerosis Versus MMF

Completed·—·Phase 3·NCT06758947·60 enrolled

Anterior Uveitis1 trial

Impact Of Upadacitinib On The Frequency Of Acute Recurrent Anterior Uveitis In Patients With Axial Spondyloarthritis

Not yet recruiting·CCARE ARTHRITIS LTD.·Phase 4·NCT07018206·200 enrolled

Behcet's syndrome1 trial

Upadacitinib for Refractory Behcet's Syndrome

Completed·LLiu Tian·Phase 2·NCT07080346·27 enrolled

Dermatitis1 trial

Upadacitinib As a Novel Treatment for Refractory Eyelid Dermatitis

Not yet recruiting·NNorthwestern University·Phase 1·NCT06684522·10 enrolled

Maintenance Therapy1 trial

Ustekinumab and Upadacitinib for Induction and Maintenance Therapy in Patients With Refractory Crohn's Disease: A Multicenter, Randomized, Parallel-Controlled Study

Not yet recruiting·SSixth Affiliated Hospital, Sun Yat-sen University·Phase 3·NCT07149467·454 enrolled

Immune Thrombocytopenia1 trial

The Combination of Upadacitinib and High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia

Not yet recruiting·PPeking University People's Hospital·Phase 2·NCT07064889·132 enrolled

Takayasu arteritis1 trial

A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants With Takayasu Arteritis (TAK)

Active, not recruiting· AbbVie logo

AbbVie·Phase 3·NCT04161898·56 enrolled

Giant Cell Arteritis1 trial

A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis

Completed· AbbVie logo

AbbVie·Phase 3·NCT03725202·429 enrolled

Long COVID1 trial

Long Covid (LC)-REVITALIZE - A Long Covid Repurposed Drug Study

Recruiting·—·Phase 3·NCT06928272·348 enrolled

COVID-191 trial

COVID-19 VaccinE Response in Rheumatology Patients

Completed·JJeffrey Curtis·Phase 4·NCT05080218·841 enrolled

Relapsing Polychondritis1 trial

Efficacy, Safety and Immunological Evaluation of Upadacitinib for Relapsing Polychondritis

Recruiting·PPeking University People's Hospital·Phase 1/2·NCT06873100·30 enrolled

Lichen Planopilaris1 trial

Upadacitinib in Adult Patients With Erosive Mucosal Lichen Planus and Lichen Planopilaris: a Prospective Multicenter Randomized Placebo-controlled Study.

Not yet recruiting·—·Phase 2·NCT07492251·56 enrolled

Severe Alopecia Areata1 trial

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

Recruiting· AbbVie logo

AbbVie·Phase 3·NCT07772492·300 enrolled

Juvenile Idiopathic Arthritis1 trial

A Multicenter, Randomized Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Upadacitinib With a Tocilizumab Reference Arm in Subjects From 1 Year to Less Than 18 Years Old With Active Systemic Juvenile Idiopathic Arthritis

Recruiting· AbbVie logo

AbbVie·Phase 3·NCT05609630·90 enrolled

Axial Spondyloarthritis1 trial

A Pragmatic Randomized Pilot Trial of Interleukin-17 Inhibition Versus Janus Kinase Inhibition After Tumor Necrosis Factor-alpha Inhibitor Failure in Axial Spondyloarthritis

Not yet recruiting·TThe University of Texas Health Science Center, Houston·Approved·NCT07770646·40 enrolled

JAK1 GOF1 trial

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

Not yet recruiting·LLisa Satter·Preclinical·NCT07670156·30 enrolled

Crohn Disease1 trial

Expanded Access to Upadacitinib

Available· AbbVie logo

AbbVie··NCT04159597

Ulcerative Colitis Acute1 trial

A Sequential Multiple Assignment Randomized Trial (SMART) Feasibility Pilot Developing and Optimizing Patient-Tailored Adaptive Treatment Strategies (ATS) for Acute Severe Ulcerative Colitis (ASUC)

Recruiting·BBerinstein, Jeffrey·Approved·NCT05867329·700 enrolled

Juvenile Idiopathic Arthritis (JIA)1 trial

An Open-Label Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis

Active, not recruiting· AbbVie logo

AbbVie·Phase 1·NCT03725007·124 enrolled

Hidradenitis Suppurativa (Acne Inversa)1 trial

A Single-Center, Prospective, Open-Label, Exploratory, Single-Arm Real-World Study of Upadacitinib in Patients With Moderate-to-Severe Hidradenitis Suppurativa

Active, not recruiting·PPeking Union Medical College·Phase 2·NCT07727889·50 enrolled

Arthritis, Rheumatoid1 trial

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

Not yet recruiting·TTufts Medical Center··NCT06016517·18 enrolled

Inflammatory Bowel Disease (IBD)1 trial

Efficacy and Safety of Low-Dose Upadacitinib Combined With Ustekinumab in the Treatment of Refractory Crohn's Disease

Completed·SShanghai 10th People's Hospital··NCT07697547·84 enrolled

Rheumatic Disease1 trial

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Recruiting·NNYU Langone Health·Phase 2·NCT07138898·80 enrolled

Primary Biliary Cholangitis (PBC)1 trial

Evaluation of the Safety and Efficacy of Upadacitinib in the Treatment of Atopic Dermatitis With Moderate to Severe Itching and Refractory Autoimmune Related Cholangitis: a Single Arm, Exploratory Clinical Study

Not yet recruiting·RRenJi Hospital·Phase 2·NCT07678645·44 enrolled

Multiple Sclerosis1 trial

OCEAN: Ocrelizumab in Primary Progressive MS

Active, not recruiting· Roche logo

Roche·Phase 3·NCT03568318·730 enrolled

Unspecified1 trial

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

Completed· AbbVie logo

AbbVie·Phase 1·NCT07425899·16 enrolled

Regulatory

FDA Approval Timeline[5]

Aug 16, 2019

RINVOQ

NDA NDA211675

Aug 16, 2019

RINVOQ

NDA NDA211675

Dec 2, 2021

RINVOQ

NDA NDA211675

Dec 14, 2021

RINVOQ

NDA NDA211675

Dec 14, 2021

RINVOQ

NDA NDA211675

Jan 14, 2022

RINVOQ

NDA NDA211675

Mar 16, 2022

RINVOQ

NDA NDA211675

Apr 29, 2022

RINVOQ

NDA NDA211675

Oct 21, 2022

RINVOQ

NDA NDA211675

Apr 10, 2023

RINVOQ

NDA NDA211675

May 18, 2023

RINVOQ

NDA NDA211675

Jun 22, 2023

RINVOQ

NDA NDA211675

Nov 14, 2023

RINVOQ

NDA NDA211675

Apr 26, 2024

RINVOQ

NDA NDA211675

Apr 26, 2024

RINVOQ LQ

NDA NDA218347

Apr 26, 2024

RINVOQ

NDA NDA211675

Apr 26, 2024

RINVOQ LQ

NDA NDA218347

Mar 26, 2025

RINVOQ LQ

NDA NDA218347

Mar 26, 2025

RINVOQ

NDA NDA211675

Apr 28, 2025

RINVOQ

NDA NDA211675

Aug 12, 2025

RINVOQ

NDA NDA211675

Aug 19, 2025

RINVOQ LQ

NDA NDA218347

Oct 10, 2025

RINVOQ

NDA NDA211675

Oct 10, 2025

RINVOQ LQ

NDA NDA218347

Jun 30, 2026

RINVOQ LQ

NDA NDA218347

Jun 30, 2026

RINVOQ

NDA NDA211675

Sources

References

[1]
ClinicalTrials.gov — 103 trial records for Upadacitinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Rinvoq drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Upadacitinib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Upadacitinib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA218347). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Rinvoq. U.S. Food & Drug Administration.
[7]
PubMed — 4 publications indexed for Upadacitinib. U.S. National Library of Medicine.
[8]
SEC EDGAR — AbbVie company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: JAK1 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AbbVie

Patent Landscape[6]

Patent Cliff

Jan 15, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8962629Jan 15, 2031

RE47221Aug 16, 2033

11512092Oct 17, 2036

11365198Oct 17, 2036

11773106Oct 17, 2036

40 more patents

11976077Oct 17, 2036

11524964Oct 17, 2036

11795175Oct 17, 2036

11535624Oct 17, 2036

11535625Oct 17, 2036

11535626Oct 17, 2036

12365689Oct 17, 2036

11993605Oct 17, 2036

11993606Oct 17, 2036

11767326Oct 17, 2036

10995095Oct 17, 2036

10597400Oct 17, 2036

11780848Oct 17, 2036

9951080Oct 17, 2036

12570664Oct 17, 2036

10550126Oct 17, 2036

12110297Oct 17, 2036

10519164Oct 17, 2036

10981923Oct 17, 2036

12110298Oct 17, 2036

11661425Oct 17, 2036

12091415Oct 17, 2036

11680069Oct 17, 2036

10981924Oct 17, 2036

11198697Oct 17, 2036

12103933Oct 17, 2036

11718627Oct 17, 2036

10344036Oct 17, 2036

11186584Oct 17, 2036

11773105Oct 17, 2036

10202393Oct 17, 2036

12134621Oct 17, 2036

12077545Oct 17, 2036

11787815Oct 17, 2036

11780847Oct 17, 2036

9963459Oct 17, 2036

12116373Oct 17, 2036

10730883Oct 17, 2036

11564922Mar 9, 2038

11607411Mar 9, 2038

Key Publications[7]

Matching-Adjusted Indirect Comparison of Risankizumab Versus Icotrokinra in Adult Patients with Moderate-to-Severe Plaque Psoriasis.

Dermatol Ther (Heidelb)Jul 2, 2026DOI: 10.1007/s13555-026-01839-2

Movement Disorders in Children: Treatment Algorithm and Surgical Options.

Adv Tech Stand NeurosurgJan 1, 2026DOI: 10.1007/978-3-032-22008-0_15

Upadacitinib in Moderately to Severely Active Ulcerative Colitis: U-ACHIEVE

LancetFeb 9, 2023DOI: 10.1016/S0140-6736(23)00176-7

Upadacitinib Versus Adalimumab in Rheumatoid Arthritis: SELECT-COMPARE

N Engl J MedApr 28, 2022DOI: 10.1056/NEJMoa2202556

Rinvoq

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Rheumatoid Arthritis18 trials

Atopic Dermatitis17 trials

Ulcerative Colitis8 trials

Efficacy and Safety4 trials

Psoriatic Arthritis4 trials

Systemic Lupus Erythematosus3 trials

Vitiligo3 trials

Crohn's Disease2 trials

Inflammatory Bowel Disease2 trials

Hidradenitis Suppurativa2 trials

Arthritis2 trials

Upadacitinib2 trials

Alopecia Areata2 trials

Ulcerative Colitis (UC)2 trials

Adult Subject1 trial

Ankylosing Spondylitis1 trial

Anal fistula1 trial

Skin Disease1 trial

Prurigo Nodularis1 trial

Primary Sjögren's Syndrome1 trial

Systemic Sclerosis1 trial

Anterior Uveitis1 trial

Behcet's syndrome1 trial

Dermatitis1 trial

Maintenance Therapy1 trial

Immune Thrombocytopenia1 trial

Takayasu arteritis1 trial

Giant Cell Arteritis1 trial

Long COVID1 trial

COVID-191 trial

Relapsing Polychondritis1 trial

Lichen Planopilaris1 trial

Severe Alopecia Areata1 trial

Juvenile Idiopathic Arthritis1 trial

Axial Spondyloarthritis1 trial

JAK1 GOF1 trial

Crohn Disease1 trial

Ulcerative Colitis Acute1 trial

Juvenile Idiopathic Arthritis (JIA)1 trial

Hidradenitis Suppurativa (Acne Inversa)1 trial

Arthritis, Rheumatoid1 trial

Inflammatory Bowel Disease (IBD)1 trial

Rheumatic Disease1 trial

Primary Biliary Cholangitis (PBC)1 trial

Multiple Sclerosis1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

Key Publications[7]

Related News