OLUMIANT (baricitinib)
Olumiant is indicated for adults with moderate to severe rheumatoid arthritis who have had an inadequate response to one or more TNF blockers. It is also indicated for hospitalized adults with COVID-19 requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO, as well as for adults with severe alopecia areata. It is not recommended for use in combination with other JAK inhibitors, biologic DMARDs/immunomodulators, or potent immunosuppressants such as azathioprine and cyclosporine.
How OLUMIANT Works
Baricitinib is a Janus kinase (JAK) inhibitor that selectively inhibits JAK1, JAK2, and TYK2. These intracellular enzymes transmit signals from cytokine and growth factor receptors to influence hematopoiesis and immune cell function. By inhibiting JAKs, baricitinib prevents the phosphorylation and activation of Signal Transducers and Activators of Transcription (STATs), thereby modulating gene expression and the signaling pathways involved in the inflammatory response.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2018-05-31
- Patent Cliff
- 2032
- Routes
- ORAL
- Dosage Forms
- TABLET
OLUMIANT Approval History
What OLUMIANT Treats
3 indicationsOLUMIANT is approved for 3 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Rheumatoid Arthritis
- COVID-19
- Alopecia Areata
OLUMIANT Boxed Warning
SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS See full prescribing information for complete boxed warning. Increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Interrupt treatment with OLUMIANT if serious infection occurs until the infectio...
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS See full prescribing information for complete boxed warning. Increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Interrupt treatment with OLUMIANT if serious infection occurs until the infection is controlled. OLUMIANT should not be given to patients with active tuberculosis. Test for latent TB before and during therapy, except for COVID-19; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test. ( 5.1 ) Higher rate of all-cause mortality, including sudden cardiovascular death with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. ( 5.2 ) Malignancies have occurred in patients treated with OLUMIANT. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients. ( 5.3 ) Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another JAK inhibitor vs. TNF blockers in RA patients. ( 5.4 ) Thrombosis has occurred in patients treated with OLUMIANT. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs. TNF blockers. ( 5.5 ) SERIOUS INFECTIONS Patients treated with OLUMIANT are at risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )] . Most patients with rheumatoid arthritis who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt OLUMIANT until the infection is controlled. Reported infections include: Active tuberculosis,
OLUMIANT Target & Pathway
ProTarget
A member of the JAK family involved in signaling for interferons and several interleukins. JAK1 inhibition is effective in rheumatoid arthritis, atopic dermatitis, and other inflammatory conditions by blocking multiple cytokine pathways.
OLUMIANT Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in OLUMIANT's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications OLUMIANT treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to OLUMIANT
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
97 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 97 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
OLUMIANT FDA Label Details
Indications & Usage
FDA Label (PDF)OLUMIANT is indicated for the treatment of Rheumatoid Arthritis; COVID-19; Alopecia Areata.
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS See full prescribing information for complete boxed warning. Increased risk of...
OLUMIANT Patents & Exclusivity
Patents (6 active)
Pro Intelligence Preview
Deep insights for OLUMIANT
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2032
- • 51 active patents
Trial Analysis
- • 102 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment