Overview
Baricitinib is a Janus kinase (JAK) inhibitor. JAKs are tyrosine protein kinases that play an important role in pro-inflammatory signaling pathways. Overactive JAKs have been implicated in autoimmune disorders, such as rheumatoid arthritis. By inhibiting the actions of JAK1 and JAK2, baricitinib attenuates JAK-mediated inflammation and immune responses. Baricitinib was first approved by the European Commission (EC) in February 2017 for the treatment of rheumatoid arthritis in adults and was later approved by the FDA in 2018. The EC later approved baricitinib for the treatment of atopic dermatitis, making it the first JAK inhibitor used for this indication in Europe. While baricitinib was granted emergency use as a treatment for COVID-19 in combination with remdesivir under the Emergency Use Authorization (EUA) in November 2020, the FDA fully approved the use of baricitinib for the treatment of COVID-19 in May 2022.
Indication
In the US and Europe, baricitinib is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF blockers. Baricitinib may be used as monotherapy or in combination with methotrexate or other DMARDs. In Europe, baricitinib is indicated for the treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy. In the US, baricitinib is also indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation. Recently, it is also approved as the treatment for severe alopecia areata in adults.
Associated Conditions
- Alopecia Areata (AA)
- Coronavirus Disease 2019 (COVID‑19)
- Severe Atopic Dermatitis
- Moderate Atopic dermatitis
- Moderate, active Rheumatoid arthritis
- Severe, active Rheumatoid arthritis
Research Report
Baricitinib (Olumiant®): A Comprehensive Pharmacological and Clinical Review
Executive Summary
Baricitinib, marketed under the brand name Olumiant®, is an orally administered small molecule that functions as a selective and reversible inhibitor of Janus kinase (JAK) 1 and JAK2.[1] Developed by Incyte and licensed to Eli Lilly and Company, it represents a significant immunomodulatory agent in modern therapeutics.[3] The core mechanism of Baricitinib involves the targeted disruption of the JAK-Signal Transducer and Activator of Transcription (STAT) signaling pathway. This pathway is a critical conduit for numerous pro-inflammatory cytokines and growth factors implicated in the pathophysiology of various autoimmune diseases and the hyperinflammatory state observed in severe cases of Coronavirus Disease 2019 (COVID-19).[5]
The therapeutic applications of Baricitinib are diverse, with key approvals for moderately to severely active rheumatoid arthritis (RA), severe alopecia areata (AA), and for hospitalized patients with COVID-19 requiring supplemental oxygen or more advanced respiratory support.[2] Furthermore, it has received approval in Europe for atopic dermatitis and juvenile idiopathic arthritis (JIA).[5] Clinical trials have substantiated its efficacy, demonstrating significant improvements in patient-reported outcomes for RA, substantial hair regrowth in severe AA, and a noteworthy reduction in mortality for patients with severe COVID-19.[9]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/23 | Not Applicable | Not yet recruiting | |||
2025/06/04 | Phase 2 | Not yet recruiting | |||
2025/04/11 | Phase 2 | Recruiting | |||
2025/03/10 | Phase 2 | Not yet recruiting | |||
2025/02/27 | Phase 2 | Recruiting | |||
2025/01/28 | Phase 2 | Not yet recruiting | |||
2025/01/10 | Phase 2 | Not yet recruiting | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio | ||
2025/01/10 | Phase 2 | Recruiting | |||
2024/11/13 | Phase 4 | Not yet recruiting | |||
2024/10/29 | Phase 2 | Completed | Liu Tian |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Eli Lilly and Company | 0002-4479 | ORAL | 4 mg in 1 1 | 6/13/2022 | |
| Eli Lilly and Company | 0002-6885 | ORAL | 4 mg in 1 1 | 12/20/2021 | |
| Eli Lilly and Company | 0002-4732 | ORAL | 1 mg in 1 1 | 6/13/2022 | |
| Eli Lilly and Company | 0002-4182 | ORAL | 2 mg in 1 1 | 6/13/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 2/13/2017 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| OLUMIANT FILM-COATED TABLET 4MG | SIN15505P | TABLET, FILM COATED | 4.000mg | 6/18/2018 | |
| OLUMIANT FILM-COATED TABLET 2MG | SIN15504P | TABLET, FILM COATED | 2.000mg | 6/18/2018 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| OLUMIANT baricitinib 4 mg film-coated tablet blister pack | 277917 | Medicine | A | 1/23/2018 | |
| OLUMIANT baricitinib 2 mg film-coated tablet blister pack | 277905 | Medicine | A | 1/23/2018 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| OLUMIANT 2 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 1161170002 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized | |
| OLUMIANT 4 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 1161170010 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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