Olumiant

(Baricitinib)

ApprovedSmall molecule

Baricitinib is used to treat rheumatoid arthritis, a condition where the immune system attacks joint tissues causing pain and inflammation. It can also be used to treat certain other inflammatory conditions and was studied for COVID-19 treatment.[2] Olumiant is currently approved and in use across 56 indications[4].[1]

Olumiant is one of 709 small molecule programs targeting Lupus. It is currently in Approved.

Indications

151

Total Trials

Active Trials

708

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

LupusApproved

MyalgiaApproved

Subarachnoid HemorrhageApproved

AlopeciaActive, not recruiting

Chronic Kidney DiseaseApproved

Sjogren SyndromeApproved

MyositisApproved

Aicardi-Goutieres SyndromeApproved

Brain InjuryApproved

MastitisApproved

LupusApproved

Approved

MyalgiaApproved

Approved

Subarachnoid HemorrhageApproved

Approved

AlopeciaApproved

Active, not recruiting

Chronic Kidney DiseaseApproved

Approved

Sjogren SyndromeApproved

Approved

MyositisApproved

Approved

Aicardi-Goutieres SyndromeApproved

Approved

Brain InjuryApproved

Approved

MastitisApproved

Approved

Showing 10 of 54 indications

Competition

Competitive Landscape

317 competitors in COVID-19

#DrugCompanyPhaseTrials

Olumiant

Eli Lilly

Approved

20 2

Stivarga

Bayer

Preclinical

1 3

Aimovig

Amgen

Preclinical

1 4

Aldactone

Pfizer

Preclinical

1 5

Nexavar

Bayer

Preclinical

1 6

Calciferol

Activella

Angiomax

BBaxter Healthcare Corporation

Preclinical

2 9

Tricor

JJagotec

Preclinical

1 10

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Systemic Juvenile Idiopathic Arthritis

NCT04088396

Post-ApprovalActive, not recruiting

Systemic Sclerosis

NCT05300932

Post-ApprovalNot yet recruiting

Rheumatoid Arthritis

NCT07357649

Recruiting

Efficacy and Safety

NCT06573593

Phase 2Not yet recruiting

Alopecia Areata

NCT06797310

Phase 2Recruiting

Intracerebral Hemorrhage

NCT06065046

Clinical

Trials by Indication[1]

COVID-1920 trials

Combination of Inhaled DNase, Baricitinib and Tocilizumab in Severe COVID-19

Unknown status·—·N/A·NCT05279391·150 enrolled

Randomised Evaluation of COVID-19 Therapy

Recruiting·UUniversity of Oxford·Phase 3·NCT04381936·70,000 enrolled

Safety and Efficacy of Baricitinib for COVID-19

Withdrawn·UUniversity of Colorado, Denver·Phase 2/3·NCT04340232

Show 17 more trials

Clinical-epidemiological Characterization of COVID-19 Disease in Hospitalized Older Adults

Completed·—··NCT04362943·576 enrolled

Clinical Trial to Evaluate the Efficacy of Different Treatments in Patients With COVID-19

Completed·IInstituto de Investigación Hospital Universitario La Paz·Phase 3·NCT04890626·356 enrolled

COVID-19 VaccinE Response in Rheumatology Patients

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

Tocilizumab Versus Baricitinib in Patients With Severe COVID-19

Completed·UUniversity Hospital of Patras·N/A·NCT05082714·251 enrolled

Baricitinib Compared to Standard Therapy in Patients With COVID-19

Unknown status·AAzienda Ospedaliero, Universitaria Pisana·Phase 2·NCT04393051·126 enrolled

Adaptive COVID-19 Treatment Trial 4 (ACTT-4)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT04640168·1,010 enrolled

A Study of Baricitinib (LY3009104) in Participants With COVID-19

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT04421027·1,525 enrolled

mulTi-Arm Therapeutic Study in Pre-ICu Patients Admitted With Covid-19 - Repurposed Drugs (TACTIC-R)

Unknown status·—·Phase 4·NCT04390464·1,167 enrolled

Efficacy and Safety of Baricitinib in Patients With Moderate and Severe COVID-19

Unknown status·IIncepta Pharmaceuticals Ltd·Phase 3·NCT05056558·480 enrolled

Adaptive COVID-19 Treatment Trial 2 (ACTT-2)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT04401579·1,033 enrolled

COVID-19 Study at the Russian Clinical and Research Center of Gerontology of the Pirogov RNRMU

Completed·PPirogov Russian National Research Medical University··NCT05302947·154 enrolled

Treatment of Moderate to Severe Coronavirus Disease (COVID-19) in Hospitalized Patients

Unknown status·LLisa Barrett·Phase 2·NCT04321993·363 enrolled

Factorial Randomized Trial of Rendesivir and Baricitinib Plus Dexamethasone for COVID-19 (the AMMURAVID Trial)

Unknown status·AASST Fatebenefratelli Sacco·Phase 3·NCT04832880·4,000 enrolled

Baricitinib Therapy in COVID-19

Completed·FFabrizio Cantini·Phase 2/3·NCT04358614·12 enrolled

Baricitinib in Symptomatic Patients Infected by COVID-19: an Open-label, Pilot Study.

Unknown status·—·Phase 2/3·NCT04320277·200 enrolled

Baricitinib, Placebo and Antiviral Therapy for the Treatment of Patients With Moderate and Severe COVID-19

Terminated·UUniversity of Southern California·Phase 2·NCT04373044·6 enrolled

A Multicenter, Open-Label, Pharmacokinetic and Safety Study of Baricitinib in Pediatric Patients From 1 Year to Less Than 18 Years Old Hospitalized With COVID-19

Terminated· Eli Lilly logo

Eli Lilly·Phase 3·NCT05074420·6 enrolled

Baricitinib19 trials

A Study of Baricitinib (LY3009104) in Healthy Chinese Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02758613·33 enrolled

A Study of Baricitinib (LY3009104) in Adult and Pediatric Japanese Participants With NNS/CANDLE, SAVI, and AGS

Terminated· Eli Lilly logo

Eli Lilly·Phase 2/3·NCT04517253·10 enrolled

A Study of Baricitinib in Healthy Japanese Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02263911·16 enrolled

Show 16 more trials

A Study to Measure Baricitinib (LY3009104) Absorption in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02340104·8 enrolled

A Study of Baricitinib and Simvastatin in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01960140·40 enrolled

A Study of Baricitinib and Ciclosporin in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01968057·18 enrolled

A Study of Baricitinib and Birth Control Pills in Healthy Females

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01896726·20 enrolled

Baricitinib in the Treatment of Intestinal Behçet's Syndrome

Recruiting·PPeking Union Medical College Hospital·Phase 2·NCT06849908·56 enrolled

A Study of Baricitinib and Omeprazole in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01925144·30 enrolled

Efficacy of Ramdicivir and Baricitinib for the Treatment of Severe COVID 19 Patients

Unknown status·—·Phase 3·NCT04693026·150 enrolled

A Study of Baricitinib When Administered With Ketoconazole or Fluconazole in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01924299·36 enrolled

Effect of Baricitinib Treatment on Peripheral Bone in RA

Unknown status·UUniversity of Erlangen-Nürnberg Medical School·Phase 3·NCT03701789·15 enrolled

Baricitinib for Reduction of HIV - CNS

Recruiting·WWilliam Tyor·Phase 2·NCT05452564·95 enrolled

Baricitinib in CPPD - the BAPTIST Study

Not yet recruiting·II.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio·Phase 2·NCT06768294·32 enrolled

BARIcitinib Cognitive Emotional and Neural signaTuRE

Terminated·AAssistance Publique - Hôpitaux de Paris·Phase 4·NCT05238896·5 enrolled

A Study of Baricitinib in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT03212638·42 enrolled

A Study of Baricitinib and Rifampicin in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01910311·18 enrolled

JAK 1/2 Inhibitor, Baricitinib, in the Treatment of Adult IIM

Completed·UUniversity of Manchester·Phase 2·NCT04208464·15 enrolled

A Study of Baricitinib and Probenecid in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01937026·18 enrolled

Rheumatoid Arthritis15 trials

Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response

Recruiting·UUniversity of Nebraska·Phase 3·NCT03414502·400 enrolled

Combination of Baricitinib and Anti-TNF in Rheumatoid Arthritis

Active, not recruiting·UUniversity Hospital, Bordeaux·Phase 3·NCT04870203·160 enrolled

Oral Baricitinib (LY3009104)Treatment in Japanese Participants With Active Rheumatoid Arthritis on Background Methotrexate Therapy

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT01469013·145 enrolled

Show 12 more trials

A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis (RA)

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT02265705·290 enrolled

A Study in Moderate to Severe Rheumatoid Arthritis Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT01721057·684 enrolled

Baricitinib Effects on Procoagulant State in Rheumatoid Arthritis

Not yet recruiting·TTanta University·Phase 4·NCT07357649·100 enrolled

An Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT01885078·2,877 enrolled

A Study in Moderate to Severe Rheumatoid Arthritis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT01710358·1,307 enrolled

A Study in Participants With Moderate to Severe Rheumatoid Arthritis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT01711359·588 enrolled

A Moderate to Severe Rheumatoid Arthritis Study

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT01721044·527 enrolled

Efficacy and Safety of Baricitinib for the Treatment of Moderate to Severe Rheumatoid Arthritis

Completed·—·Phase 4·NCT05660655·94 enrolled

Baricitinib, Methotrexate as Monotherapy or Combination in the Treatment of Rheumatoid Arthritis - an Open Label Randomized Clinical Trial

Unknown status·—·Phase 4·NCT05827497·132 enrolled

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

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

A Randomized, Controlled Pragmatic Phase 3b/4 Study of Baricitinib in Patients With Rheumatoid Arthritis

Completed· Eli Lilly logo

Eli Lilly·Approved·NCT04086745·1,050 enrolled

A Randomized, Active-Controlled, Parallel-Group, Phase 3b/4 Study of Baricitinib in Patients With Rheumatoid Arthritis

Completed· Eli Lilly logo

Eli Lilly·Approved·NCT03915964·2,659 enrolled

Atopic Dermatitis11 trials

Atopic Dermatitis Treated With Dupilumab and JAK Inhibitors in Costa Rica

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

A Study of Baricitinib (LY3009104) in Participants With Moderate to Severe Atopic Dermatitis

Terminated· Eli Lilly logo

Eli Lilly·Phase 3·NCT03559270·374 enrolled

A Study of Long-term Baricitinib (LY3009104) Therapy in Atopic Dermatitis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT03334435·1,645 enrolled

Show 8 more trials

Study of Baricitinib (LY3009104) in Patients With Moderate to Severe Atopic Dermatitis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT03334422·615 enrolled

A Study of Baricitinib (LY3009104) in Adult Participants With Moderate to Severe Atopic Dermatitis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT03435081·440 enrolled

A Study of Baricitinib (LY3009104) in Combination With Topical Corticosteroids in Adults With Moderate to Severe Atopic Dermatitis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT03733301·329 enrolled

A Long-term Study of Baricitinib (LY3009104) With Topical Corticosteroids in Adults With Moderate to Severe Atopic Dermatitis That Are Not Controlled With Cyclosporine or for Those Who Cannot Take Oral Cyclosporine Because it is Not Medically Advisable

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT03428100·463 enrolled

Baricitinib Versus Azathioprine in Patients With Moderate-to-Severe Atopic Dermatitis

Completed·MMazandaran University of Medical Sciences·N/A·NCT05969730·40 enrolled

A Study of Baricitinib (LY3009104) in Participants With Moderate-to-Severe Atopic Dermatitis

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT02576938·124 enrolled

A Study of Baricitinib (LY3009104) in Patients With Moderate to Severe Atopic Dermatitis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT03334396·660 enrolled

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Outpatient Study Evaluating the Pharmacokinetics, Efficacy, and Safety of Baricitinib in Pediatric Patients With Moderate to Severe Atopic Dermatitis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT03952559·516 enrolled

Alopecia Areata4 trials

A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata

Completed· Eli Lilly logo

Eli Lilly·Phase 2/3·NCT03570749·764 enrolled

A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT03899259·546 enrolled

Evaluating the Effectiveness and Tolerance of Baricitinib in the Treatment of Acute Alopecia Areata With Active Hair Shedding: A Prospective Open-Label Study

Not yet recruiting·NNational Taiwan University Hospital·Phase 2·NCT06797310·30 enrolled

Show 1 more trial

Retinol Binding Protein 4 Protein in Alopecia Areata Treated With Barcitinib

Active, not recruiting·SSouth Valley University·Phase 1·NCT06545110·120 enrolled

65 more indications

Systemic Lupus Erythematosus4 trials

A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT02708095·314 enrolled

A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE)

Terminated· Eli Lilly logo

Eli Lilly·Phase 3·NCT03843125·1,147 enrolled

A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE-BRAVE II)

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT03616964·778 enrolled

Show 1 more trial

A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus

Terminated· Eli Lilly logo

Eli Lilly·Phase 3·NCT03616912·830 enrolled

Pneumonia4 trials

Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia

Recruiting·UUMC Utrecht·Phase 3·NCT02735707·20,000 enrolled

Clinical Trial to Evaluate Efficacy of 3 Types of Treatment in Patients With Pneumonia by COVID-19

Unknown status·HHospital Universitario de Fuenlabrada·Phase 2·NCT04346147·168 enrolled

"Baricitinib for Treating Hospital-acquired Pneumonia in Critically Ill Patients With a Proinflammatory Phenotype.

Unknown status·NNantes University Hospital·Phase 2/3·NCT05914584·450 enrolled

Show 1 more trial

Baricitinib for coRona Virus pnEumonia (COVID-19): a THerapeutic Trial

Unknown status·FFondazione IRCCS Policlinico San Matteo di Pavia·Phase 2·NCT04399798·13 enrolled

Vitiligo3 trials

Vitiligo, New Treatment and Serum s100B

Recruiting·SSouth Valley University·Phase 2/3·NCT06768840·50 enrolled

Evaluation Safety ,Efficacy Baricitinib Plus Excimer Light Versus Excimer Light Alone in Non Segmental Vitiligo

Unknown status·—··NCT05950542·30 enrolled

Evaluation of Effect and Tolerance of the Association of Baricitinib and Phototherapy Versus Phototherapy in Adults With Progressive Vitiligo

Completed·UUniversity Hospital, Bordeaux·Phase 2·NCT04822584·49 enrolled

Immune Thrombocytopenia3 trials

Low-dose Baricitinib Plus Danazol for Steroid-resistant/Relapse Immune Thrombocytopenia

Unknown status·PPeking University People's Hospital·Phase 2·NCT05852847·216 enrolled

Baricitinib for Steroid-resistant/Relapse Immune Thrombocytopenia

Unknown status·PPeking University People's Hospital·Phase 2·NCT05446831·35 enrolled

Low-dose Baricitinib Plus High-dose Dexamethasone for Patients With Newly Diagnosed Immune Thrombocytopenia

Unknown status·PPeking University People's Hospital·Phase 2·NCT05932524·132 enrolled

Intracerebral Hemorrhage2 trials

Efficacy and Safety of Baricitinib in the Post-intracerebral Hemorrhage Pulmonary Injury

Recruiting·TTianjin Medical University General Hospital·Phase 1/2·NCT06548802·100 enrolled

Baricitinib for Moderate and Severe Traumatic Intracerebral Hemorrhage/Contusions

Recruiting·TTang-Du Hospital·Phase 2·NCT06065046·100 enrolled

Dermatomyositis2 trials

Baricitinib for Cutaneous Dermatomyositis

Withdrawn·UUniversity of Washington·Phase 2·NCT05361109

Baricitinib in Patients With Relapsing or naïve Dermatomyositis

Recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT04972760·62 enrolled

Efficacy and Safety2 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

Efficacy and Safety of Baricitinib in Sjogren's Syndrome

Completed·PPeking Union Medical College Hospital·Phase 2·NCT05016297·87 enrolled

JAK Inhibitor2 trials

JAK Inhibitor Treatment in AGS

Completed·—·Phase 2·NCT03921554·54 enrolled

Effect of JAK Inhibitor on Erosion Healing in RA

Recruiting·—·Phase 4·NCT05955066·60 enrolled

Kidney Disease2 trials

A Study to Test Safety and Efficacy of Baricitinib in Participants With Diabetic Kidney Disease

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT01683409·130 enrolled

Janus Kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease

Recruiting·—·Phase 2·NCT05237388·75 enrolled

Juvenile Idiopathic Arthritis2 trials

A Study of Baricitinib in Participants From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT03773978·220 enrolled

A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients From 1 Year to <18 Years of Age With Juvenile Idiopathic Arthritis (JIA)

Recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT03773965·190 enrolled

Diabetes Mellitus, Type 12 trials

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Preserve Beta Cell Function in Participants Newly Diagnosed With Type 1 Diabetes Aged ≥1 to <36 Years

Recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT07222332·300 enrolled

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Delay Stage 3 Type 1 Diabetes in At-risk Participants Aged ≥1 to <36 Years

Recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT07222137·150 enrolled

Uveitis1 trial

A Study of Baricitinib (LY3009104) in Participants From 2 Years to Less Than 18 Years Old With Active JIA-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT04088409·30 enrolled

Glucocorticoid1 trial

Baricitinib Plus Glucocorticoid for Eosinophilia in IgG4-RD

Unknown status·WWen Zhang·N/A·NCT05781516·74 enrolled

Adenoma1 trial

A Phase 2 Open-label Single-arm Trial of JAK1 Inhibitor for the Treatment of Large Inflammatory Hepatocellular Adenomas

Recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT06490757·25 enrolled

Skin Disease1 trial

Molecular Signatures in Inflammatory Skin Disease

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

Primary Biliary Cholangitis1 trial

A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCA

Terminated· Eli Lilly logo

Eli Lilly·Phase 2·NCT03742973·2 enrolled

Allogeneic Hematopoietic Stem Cell Transplantation1 trial

Study of Baricitinib, a JAK1/2 Inhibitor, in Chronic Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT02759731·24 enrolled

Double-blind1 trial

Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID

Recruiting·WWes Ely·Phase 3·NCT06631287·550 enrolled

Liver Disease1 trial

A Pharmacokinetic Study of Baricitinib in Participants With Liver Disease

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01870388·16 enrolled

Inflammation1 trial

Inflammation and Depression in People With HIV

Recruiting·EEmory University·Phase 2·NCT05849038·60 enrolled

Giant Cell Arteritis1 trial

Baricitinib in Relapsing Giant Cell Arteritis

Completed·MMatthew J Koster·Phase 2·NCT03026504·15 enrolled

Treatment1 trial

Compassionate Use Protocol for the Treatment of Autoinflammatory Syndromes

Approved for marketing· Eli Lilly logo

Eli Lilly··NCT01724580

Interaction1 trial

A Drug Drug Interaction (DDI) Study of Baricitinib (LY3009104) and Digoxin in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01859078·28 enrolled

Depression1 trial

JAK Signaling in Depression

Recruiting·EEmory University·Phase 2·NCT07003997·100 enrolled

Pyoderma Gangrenosum1 trial

Baricitinib in the Treatment of Adults With Pyoderma Gangrenosum (PG)

Completed·OOregon Health and Science University·Phase 2·NCT04901325·5 enrolled

Systemic Sclerosis1 trial

A Study Evaluating the Efficacy and Safety of Baricitinib in Systemic Sclerosis

Active, not recruiting·TTongji Hospital·Phase 4·NCT05300932·60 enrolled

Hypersensitivity1 trial

Efficacy of Baricitinib In Treatment of Delayed-Type Hypersensitivity Versus Irritant Skin Reactions in Healthy Adult Male Subjects

Completed·WWright State Physicians·Phase 1·NCT03945760·23 enrolled

Diabetes Mellitus1 trial

Baricitinib in Hospitalized Covid-19 Patients With Diabetes Mellitus

Withdrawn·—·Phase 3·NCT04970719

Folliculitis1 trial

Biologics in Folliculitis Decalvans : an Adaptative Trial Research

Not yet recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT07268534·120 enrolled

Type 1 Diabetes1 trial

Baricitinib in New-onset Type 1 Diabetes

Completed·—·Phase 2·NCT04774224·91 enrolled

Psoriasis1 trial

A Phase 2b Study of Baricitinib in Participants With Moderate to Severe Psoriasis

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT01490632·271 enrolled

Infection1 trial

EU SolidAct: An Adaptive Pandemic and Emerging Infection Platform Trial

Terminated·OOslo University Hospital·Phase 2/3·NCT04891133·290 enrolled

Hematopoietic Cell Transplantation1 trial

Baricitinib for the Prophylaxis of Graft-Versus-Host Disease After Peripheral Blood Hematopoietic Cell Transplantation

Completed·WWashington University School of Medicine·Phase 1·NCT04131738·26 enrolled

Mucous Membrane Pemphigoid1 trial

Baricitinib for the Treatment of Ocular Mucous Membrane Pemphigoid

Terminated·WWashington University School of Medicine·Phase 2·NCT05263505·2 enrolled

Large Vessel Occlusion1 trial

Safety and Efficacy of Baricitinib After Endovascular Treatment in Acute Anterior Circulation Large Vessel Occlusion: A Multicenter, Randomized Controlled Clinical Trial

Not yet recruiting·TThe First Affiliated Hospital of University of Science and Technology of China·Phase 2/3·NCT07449910·750 enrolled

Arthritis1 trial

Baricitinib in the Treatment of Refractory Axial Spondyloarthritis Patients: A Comparison With Tofacitinib

Unknown status·—·Phase 2·NCT06114407·184 enrolled

Remission1 trial

Use of Baricitenib to Maintain of Remission

Unknown status·—·Phase 2/3·NCT05686746·80 enrolled

Cardiac Sarcoidosis1 trial

A Trial of Baricitinib in Patients With Cardiac Sarcoidosis

Not yet recruiting·SStanford University·Phase 2·NCT06868381·10 enrolled

Lichen Planus1 trial

Baricitinib (LY3009104) in the Treatment of Cutaneous Lichen Planus

Completed·—·Phase 2·NCT05188521·12 enrolled

Injury1 trial

Baricitinib for the Lung Injury Following Spontaneous SAH

Not yet recruiting·TTang-Du Hospital·Phase 2·NCT06439615·100 enrolled

Primary Sjogren's Syndrome1 trial

A Prospective Pilot Study to Explore Efficacy and Safety of Baricitinib in Active Primary Sjogren's Syndrome Patients

Completed·PPeking Union Medical College Hospital·Phase 1/2·NCT04916756·11 enrolled

Antiretroviral Treatment1 trial

Immunotherapy With Baricitinib and Sirolimus, Alone and in Combination, for the Control of HIV-1 Replication After Antiretroviral Treatment Interruption

Not yet recruiting·AANRS, Emerging Infectious Diseases·Phase 2·NCT07081763·191 enrolled

Anterior Uveitis1 trial

Efficacy and Tolerance of Baricitinib, a JAK Inhibitor, in the Treatment of Refractory Non-infectious Non-anterior Uveitis

Not yet recruiting·UUniversity Hospital, Rouen·Phase 3·NCT05651880·33 enrolled

Takayasu arteritis1 trial

Baricitinib for Refractory Takayasu Arteritis

Completed·LLiu Tian·Phase 2·NCT06662721·10 enrolled

Granuloma1 trial

Baricitinib in Idiopathic Granulomatous Mastitis

Active, not recruiting·FFirst Affiliated Hospital of Zhejiang University·Phase 2·NCT05852171·20 enrolled

Juvenile Dermatomyositis1 trial

Baricitinib in the Treatment of New-onset Juvenile Dermatomyositis (MYOCIT)

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT05524311·16 enrolled

Transplantation1 trial

Preventing of GVHD With Post-transplantation Cyclophosphamide, Abatacept, Vedolizumab and Baricitinib at Children and Young Adults With Hemoblastosis

Active, not recruiting·FFederal Research Institute of Pediatric Hematology, Oncology and Immunology·Phase 2/3·NCT06475820·150 enrolled

Polymyalgia Rheumatica1 trial

BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica

Completed·UUniversity Hospital, Brest·Phase 2·NCT04027101·34 enrolled

Recruiting·PPeking University People's Hospital·Preclinical·NCT07535645·28 enrolled

Post-Acute COVID-19 Syndrome1 trial

REVERSE-Long COVID: A Multicenter Randomized, Placebo-Controlled Clinical Trial of Immunomodulation (With Baricitinib) for Long COVID Related Cognitive Impairment and ADRD (Alzheimer's Disease and Related Dementias)

Withdrawn·VVanderbilt University Medical Center·Phase 3·NCT05858515

Areata Alopecia1 trial

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of Baricitinib in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata

Recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT05723198·595 enrolled

Lichen Planus, Oral1 trial

Efficacy and Safety of Baricitinib for the Treatment of Oral Lichen Planus: A Proof-of-Concept Study

Active, not recruiting·UUniversity of North Carolina, Chapel Hill·Phase 2·NCT06158113·10 enrolled

ARDS (Acute Respiratory Distress Syndrome)1 trial

Precision Medicine Adaptive Network Platform Trial in Hypoxemic Acute Respiratory Failure

Not yet recruiting·UUniversity of Colorado, Denver·Phase 2·NCT07779642·300 enrolled

Polymyalgia Rheumatica (PMR)1 trial

Justification And Evaluation of Baricitinib Plus Corticosteroids Versus corticosteroiDs Alone in pOlymyalgia RhEumatica - JADORE-BARI Study

Recruiting·UUniversity Hospital, Brest·Phase 3·NCT07279688·140 enrolled

Sepsis1 trial

PALETTE- Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Exploratory, Bayesian Basket Trial

Recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT06381661·2,000 enrolled

Depressive Symptoms1 trial

JAK Signaling in Depression and Cognition in Male Football Players

Not yet recruiting·EEmory University·Phase 2·NCT07608796·30 enrolled

HIV infection1 trial

Baricitinib Curative Repression of HIV-1

Not yet recruiting·EEmory University·Phase 2·NCT07209267·35 enrolled

NMO Spectrum Disorder1 trial

Efficacy and Safety of Baricitinib in Neuromyelitis Optica Spectrum Disorders

Active, not recruiting·TTianjin Medical University General Hospital·Phase 1·NCT05792462·11 enrolled

Systemic Juvenile Idiopathic Arthritis1 trial

Open-Label, Randomized Study With a Tocilizumab Reference Arm to Evaluate Safety, Efficacy and Pharmacokinetics of Baricitinib in Children From 1 to Less Than 18 Years of Age With Systemic Juvenile Idiopathic Arthritis.

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT04088396·58 enrolled

Frontal Fibrosing Alopecia1 trial

A Pilot Study to Evaluate the Safety and Efficacy of Baricitinib in the Treatment of Frontal Fibrosing Alopecia (FFA)

Active, not recruiting·UUniversity of Alabama at Birmingham·Approved·NCT06240351·15 enrolled

Amyotrophic Lateral Sclerosis1 trial

Neurodegenerative Alzheimer's Disease and Amyotrophic Lateral Sclerosis (NADALS) Basket Proof of Concept Trial Including Asymptomatic Individuals Using Baricitinib

Completed·MMassachusetts General Hospital·Preclinical·NCT05189106·17 enrolled

ITP - Immune Thrombocytopenia1 trial

TPO-RA Plus Baricitinib vs. TPO-RA in Patients With ITP : A Randomized, Open-label Trial

Not yet recruiting·PPeking University People's Hospital·Phase 2·NCT07669675·100 enrolled

Unspecified1 trial

ConsideRAte Study - Splenic Stimulation for RA

Recruiting·GGalvani Bioelectronics·N/A·NCT05003310·28 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 8, 2019

OLUMIANT

NDA NDA207924

Oct 8, 2019

OLUMIANT

NDA NDA207924

Jul 8, 2020

OLUMIANT

NDA NDA207924

Dec 2, 2021

OLUMIANT

NDA NDA207924

May 10, 2022

OLUMIANT

NDA NDA207924

Jun 13, 2022

OLUMIANT

NDA NDA207924

Jun 30, 2026

OLUMIANT

NDA NDA207924

Sources

References

[1]
ClinicalTrials.gov — 151 trial records for Baricitinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Olumiant drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Baricitinib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Baricitinib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA207924). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Olumiant. U.S. Food & Drug Administration.
[7]
PubMed — 1 publication indexed for Baricitinib. U.S. National Library of Medicine.
[8]
SEC EDGAR — Eli Lilly company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: JAK1/2 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Eli Lilly

Patent Landscape[6]

Patent Cliff

Mar 10, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8420629Mar 10, 2029

9737469Nov 2, 2031

11806555Nov 2, 2031

8158616May 31, 2032

9089574Nov 30, 2032

1 more patents

11045474Nov 30, 2032

Key Publications[7]

Baricitinib in Severe Alopecia Areata: BRAVE-AA1 52-Week Results

N Engl J MedMar 26, 2022DOI: 10.1056/NEJMoa2110343

Olumiant

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

COVID-1920 trials

Baricitinib19 trials

Rheumatoid Arthritis15 trials

Atopic Dermatitis11 trials

Alopecia Areata4 trials

Systemic Lupus Erythematosus4 trials

Pneumonia4 trials

Vitiligo3 trials

Immune Thrombocytopenia3 trials

Intracerebral Hemorrhage2 trials

Dermatomyositis2 trials

Efficacy and Safety2 trials

JAK Inhibitor2 trials

Kidney Disease2 trials

Juvenile Idiopathic Arthritis2 trials

Diabetes Mellitus, Type 12 trials

Uveitis1 trial

Glucocorticoid1 trial

Adenoma1 trial

Skin Disease1 trial

Primary Biliary Cholangitis1 trial

Allogeneic Hematopoietic Stem Cell Transplantation1 trial

Double-blind1 trial

Liver Disease1 trial

Inflammation1 trial

Giant Cell Arteritis1 trial

Treatment1 trial

Interaction1 trial

Depression1 trial

Pyoderma Gangrenosum1 trial

Systemic Sclerosis1 trial

Hypersensitivity1 trial

Diabetes Mellitus1 trial

Folliculitis1 trial

Type 1 Diabetes1 trial

Psoriasis1 trial

Infection1 trial

Hematopoietic Cell Transplantation1 trial

Mucous Membrane Pemphigoid1 trial

Large Vessel Occlusion1 trial

Arthritis1 trial

Remission1 trial

Cardiac Sarcoidosis1 trial

Lichen Planus1 trial

Injury1 trial

Primary Sjogren's Syndrome1 trial

Antiretroviral Treatment1 trial

Anterior Uveitis1 trial

Takayasu arteritis1 trial

Granuloma1 trial

Juvenile Dermatomyositis1 trial

Transplantation1 trial

Polymyalgia Rheumatica1 trial

Hyper IgE Syndrome From STAT3 Mutation1 trial

Kohlmeier-Degos Disease1 trial

Thrombocytopenia1 trial

Post-Acute COVID-19 Syndrome1 trial

Areata Alopecia1 trial

Lichen Planus, Oral1 trial

ARDS (Acute Respiratory Distress Syndrome)1 trial

Polymyalgia Rheumatica (PMR)1 trial

Sepsis1 trial

Depressive Symptoms1 trial

HIV infection1 trial

NMO Spectrum Disorder1 trial

Systemic Juvenile Idiopathic Arthritis1 trial

Frontal Fibrosing Alopecia1 trial

Amyotrophic Lateral Sclerosis1 trial

ITP - Immune Thrombocytopenia1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts