TheraRadar
Data updated: May 26, 2026

BARICITINIB

Immunology Approved 2024-07-22
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
1
Years on Market

Details

Status
Discontinued
First Approved
2024-07-22
Routes
ORAL
Dosage Forms
TABLET

Companies

Aurobindo Pharma
Active Ingredient: BARICITINIB

BARICITINIB Approval History

2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2024 to 2024
Jul 2024 ORIGINAL
Update
FDA Letter

What BARICITINIB Treats

1 FDA approvals

Originally approved for its first indication in 2024 .

  • Other (1)
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Clinical Trial Registry

91 trials
Trial Sponsor ID Phase Status Title
NCT07262983 10002176 002176-I Ph 1 recruiting Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
NCT03773965 JUVE-X 16278 I4V-MC-JAHX, 2017-004471-31 Ph 3 recruiting A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
NCT06631287 REVERSE-LC REVERSE-LC R01AG085873 Ph 3 recruiting Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID
NCT05237388 JUSTICE Pro00108755 R01MD016401-01 Ph 2 completed Janus Kinase-STAT Inhibition to Reduce APOL1 Associated Kidney Disease
NCT04088409 results posted 16277 I4V-MC-JAHW, 2019-000119-10 Ph 3 active not recruiting 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
NCT03952559 BREEZE-AD-PEDS results posted 16966 I4V-MC-JAIP, 2018-000349-38 Ph 3 active not recruiting A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis
NCT05524311 MYOCIT APHP211036 2022-000506-10 Ph 2 completed Baricitinib in the Treatment of New-onset Juvenile Dermatomyositis (MYOCIT)
NCT04381936 RECOVERY NDPHRECOVERY 2020-001113-21, ISRCTN50189673 Ph 3 recruiting Randomised Evaluation of COVID-19 Therapy
NCT07543458 DEN-HOST OxTREC 3271082 323061/Z/24/Z Ph 3 not yet recruiting Therapeutics for Moderate and Severe Dengue
NCT07535645 BAPT 2026PHD005-BAPT Ph 1, Ph 2 not yet recruiting Baricitinib for Post-HSCT Persistent Thrombocytopenia
NCT05723198 BRAVE-AA-PEDS 16875 I4V-MC-JAIO, 2022-502700-78-00 Ph 3 recruiting A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata
NCT07222137 BARICADE-DELAY 27404 2025-521797-34-00, I4V-MC-JAJJ Ph 3 recruiting A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults
NCT07222332 27405 2025-522170-36-00, I4V-MC-JAJK Ph 3 recruiting A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)
NCT03570749 BRAVE-AA1 results posted 16582 I4V-MC-JAHO Ph 2, Ph 3 completed A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata
NCT03899259 BRAVE-AA2 results posted 16978 I4V-MC-JAIR Ph 3 completed A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata
NCT06923072 10002416 002416-H Ph 2 recruiting Baricitinib in the Treatment of Kohlmeier-Degos Disease in Patients With Neurological Involvement
NCT05016297 PekingUMCH-HS-3023D Ph 2 completed Efficacy and Safety of Baricitinib in Sjogren's Syndrome
NCT04088396 16275 I4V-MC-JAHU, 2017-004495-60 Ph 3 recruiting A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis (sJIA)
NCT06381661 PALETTE APHP240385 Ph 2 not yet recruiting Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Exploratory, Bayesian Basket Trial
NCT05300932 TJ-SSc202203 Ph 4 active not recruiting A Study Evaluating the Efficacy and Safety of Baricitinib in Systemic Sclerosis
NCT07357649 BAR-RA BAR-RA-TANTA-2025 Ph 4 not yet recruiting Baricitinib Effects on Procoagulant State in Rheumatoid Arthritis
NCT05189106 NADALS NADALS Ph 1, Ph 2 completed Neurodegenerative Alzheimer's Disease and Amyotrophic Lateral Sclerosis (NADALS) Basket Trial
NCT03921554 results posted 18-015414 Ph 2 completed JAK Inhibitor Treatment in AGS
NCT06490757 JAKIH APHP220916 Ph 2 recruiting A Phase 2 Open-label Single-arm Trial of JAK1 Inhibitor for the Treatment of Large Inflammatory Hepatocellular Adenomas
NCT05074420 COV-BARRIER 18253 I4V-MC-KHAB, 2021-001338-21 Ph 3 terminated A Study of Baricitinib (LY3009104) in Children With COVID-19
NCT07268534 BOOSTERS APHP230831 2024-514848-88-00 Ph 2 not yet recruiting Biologics in Folliculitis Decalvans : an Adaptative Trial Research
NCT07003997 STUDY00009295 1R01MH140180-01 Ph 2 recruiting JAK Signaling in Depression
NCT04972760 BIRD APHP180612 2020-004987-24 Ph 3 recruiting Baricitinib in Patients With Relapsing or naïve Dermatomyositis
NCT03915964 RA-BRIDGE 17172 I4V-MC-JAJA, 2018-003351-37 Ph 4 completed A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis
NCT04086745 RA-BRANCH 17363 I4V-MC-JAJD Ph 4 completed A Study of Baricitinib in Participants With Rheumatoid Arthritis
NCT04517253 results posted 17571 I4V-JE-JAJE, 2025-000001-16 Ph 2, Ph 3 terminated A Study of Baricitinib (LY3009104) in Adult and Pediatric Japanese Participants With NNS/CANDLE, SAVI, and AGS
NCT05849038 STUDY00005526 5R01MH128872-03 Ph 2 recruiting Inflammation and Depression in People With HIV
NCT05852171 B-IGM ZYYY-IGM-001 Ph 2 active not recruiting Baricitinib in Idiopathic Granulomatous Mastitis
NCT04901325 Baricitinib for PG Treatment Ph 2 completed Baricitinib in the Treatment of Adults With Pyoderma Gangrenosum (PG)
NCT05080218 COVER COVER-Main Ph 4 completed COVID-19 VaccinE Response in Rheumatology Patients
NCT06849908 Baricitinib-IBS-PUMCH Ph 2 recruiting Baricitinib in the Treatment of Intestinal Behçet's Syndrome
NCT06797310 MQ7422 202401193MIPB Ph 2 not yet recruiting Evaluating the Effectiveness and Tolerance of Baricitinib in the Treatment of Acute Alopecia Areata With Active Hair Shedding: A Prospective Open-Label Study
NCT06768840 EAOsman Ph 2, Ph 3 recruiting Vitiligo, New Treatment and Serum s100B
NCT04774224 BANDIT SVI-BARI-01 Ph 2 completed Baricitinib in New-onset Type 1 Diabetes
NCT05792462 IRB2023-YX-012-01 Ph 1, Ph 2 recruiting Efficacy and Safety of Baricitinib in Neuromyelitis Optica Spectrum Disorders
NCT02759731 results posted 160094 16-C-0094 Ph 1, Ph 2 completed Study of Baricitinib, a JAK1/2 Inhibitor, in Chronic Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation
NCT03334435 BREEZE-AD3 results posted 16587 I4V-MC-JAHN, 2017-000873-35 Ph 3 completed A Study of Long-term Baricitinib (LY3009104) Therapy in Atopic Dermatitis
NCT06475820 NCHPOI-2023-07 Ph 2, Ph 3 active not recruiting Preventing of GVHD With Post-transplantation Cyclophosphamide, Abatacept, Vedolizumab and Baricitinib at Children and Young Adults With Hemoblastosis
NCT06548802 BRIGHT IRB2024-YX-067-01 Ph 1, Ph 2 recruiting Efficacy and Safety of Baricitinib in the Post-intracerebral Hemorrhage Pulmonary Injury
NCT02735707 REMAP-CAP U1111-1189-1653 2015-002340-14, 602525 Ph 3 recruiting Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
NCT03428100 BREEZE-AD4 results posted 16841 I4V-MC-JAIN, 2017-004574-34 Ph 3 completed 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
NCT04970719 BADAS-ERC/EC/21/00311 Ph 3 withdrawn Baricitinib in Hospitalized Covid-19 Patients With Diabetes Mellitus
NCT04027101 BACHELOR BACHELOR (29BRC18.0144) Ph 2 completed BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica
NCT04208464 MYOJAK R123899 Ph 2 completed JAK 1/2 Inhibitor, Baricitinib, in the Treatment of Adult IIM
NCT05361109 STUDY00014444 CUDM001 Ph 2 withdrawn Baricitinib for Cutaneous Dermatomyositis

Showing 50 of 91 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

BARICITINIB FDA Label Details

Looking for the branded version?

OLUMIANT

Full clinical data, patents, trials, and competitive landscape for baricitinib.

See OLUMIANT

Data Sources

FDA Approval: ANDA217542 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.