baricitinib
Trade name: olumiant
Approved
May 31, 2018
Baricitinib (trade name Olumiant) is an investigational drug for rheumatoid arthritis (RA), being developed by Incyte and Eli Lilly. Baricitinib is a selective JAK1 and JAK2 inhibitor with IC50 of 5.9 nM and 5.7 nM in cell-free assays. In February 2017 Baricitinib was approved for use in the European Union as a second-line therapy for moderate to severe active rheumatoid arthritis in adults, either alone or in combination with methotrexate. On 31 May 2018 FDA approved Barictinib for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies. — NCATS
Clinical trial activity
148 trials · 97 clinical orgs · 3 marketing orgs
Earliest trial started May 1, 2009 (NCT00902486)
Timeline
2000s
- Jan 1, 2009
Earliest Phase 2 Sponsor(trial)
2010s
2020s
- Jul 22, 2024
Aurobindo Pharma — Marketing Organization
- Aug 8, 2025
MSN Laboratories — Marketing Organization
Indications
Approved for
Studied for
- Acute Lung Injury · Phase 2
- Adenoma, Liver Cell · Phase 2
- Alopecia · Phase 4
- Alopecia Areata · Phase 3
- Alzheimer Disease · Phase 1/Phase 2
- Amyotrophic Lateral Sclerosis · Phase 1/Phase 2
- Anhedonia · Phase 2
- Arthritis, Juvenile · Phase 3
- Arthritis, Rheumatoid · Phase 4
- Axial Spondyloarthritis · Phase 2
- Behcet Syndrome · Phase 2
- Bone Density · Phase 3
- Brain Injuries, Traumatic · Phase 2
- Cerebral Hemorrhage · Phase 2
- Chondrocalcinosis · Phase 2
- Cognitive Dysfunction · Phase 1/Phase 2
- Communicable Diseases, Emerging · Phase 2/Phase 3
- Conjunctivitis · Phase 2
- Coronavirus Infections · Phase 3
- COVID-19 · Phase 4
- Depression · Phase 2
- Dermatitis, Allergic Contact · Early Phase 1
- Dermatitis, Atopic · Phase 3
- Dermatomyositis · Phase 3
- Diabetes Mellitus, Type 1 · Phase 3
- Diabetic Nephropathies · Phase 2
- Finger Joint · Phase 3
- Giant Cell Arteritis · Phase 2
- Gout · Phase 2/Phase 3
- Graft vs Host Disease · Phase 1/Phase 2
- Granulomatous Mastitis · Phase 2
- Hair Diseases · Phase 3
- Healthcare-Associated Pneumonia · Phase 2/Phase 3
- Healthy Volunteers · Phase 1
- Heart Diseases · Phase 2
- Hepatic Insufficiency · Phase 1
- Hereditary Autoinflammatory Diseases · Phase 2/Phase 3
- HIV · Phase 2
- HIV Infections · Phase 2
- Hypotrichosis · Phase 3
- Inflammation · Phase 1
- Inosine Triphosphate · Phase 2
- Leukemia, Biphenotypic, Acute · Phase 2/Phase 3
- Leukemia, Myeloid, Acute · Phase 2/Phase 3
- Lichen Planus · Phase 2
- Lichen Planus, Oral · Phase 2
- Lipodystrophy · Phase 2/Phase 3
- Livedoid Vasculopathy · Phase 2/Phase 3
- Liver Cirrhosis, Biliary · Phase 2
- Liver Diseases · Phase 1
- Lupus Erythematosus, Systemic · Phase 3
- Lupus Nephritis · Phase 2/Phase 3
- Lymphoma · Phase 2/Phase 3
- Major Depressive Disorder · Phase 2
- Malignant Atrophic Papulosis · Phase 2
- Mastitis · Phase 2
- Membranes · Phase 2
- Myalgia · Phase 2
- Myelodysplastic Syndromes · Phase 2/Phase 3
- Myositis · Phase 2
- Nephritis · Phase 2/Phase 3
- Neuromyelitis Optica · Phase 1/Phase 2
- Pathological Conditions, Anatomical · Phase 3
- Pharmacology · Phase 3
- Pneumonia · Phase 2/Phase 3
- Pneumonia, Viral · Phase 3
- Precursor Cell Lymphoblastic Leukemia-Lymphoma · Phase 2/Phase 3
- Psoriasis · Phase 2
- Purpura, Thrombocytopenic, Idiopathic · Phase 2
- Pyoderma · Phase 2
- Pyoderma Gangrenosum · Phase 2
- Renal Insufficiency, Chronic · Phase 2
- Scleroderma, Diffuse · Phase 3
- Scleroderma, Systemic · Phase 4
- Sjogren's Syndrome · Phase 2
- Skin Diseases · Phase 3
- Skin Diseases, Papulosquamous · Phase 2
- Skin Ulcer · Phase 2
- Subarachnoid Hemorrhage · Phase 2
- Takayasu Arteritis · Phase 2
- Uveitis · Phase 3
- Vitiligo · Phase 2/Phase 3
- Wound Healing · Phase 2
Mechanism of action
- Tyrosine-protein kinase JAK1INHIBITOR
JAK1 inhibitor
- Tyrosine-protein kinase JAK2INHIBITOR
JAK2 inhibitor
Approval history
- approvedMay 31, 2018
Chemistry & pharmacology
SMILES
CCS(=O)(=O)N1CC(CC#N)(C1)N2C=C(C=N2)C3=C4C=CNC4=NC=N3- Mol. weight
- 371.417 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- WikipediaBaricitinib ↗
- NCATSISP4442I3Y ↗
- ChEMBLCHEMBL2105759 ↗
Also known as
- baricitinib
- baricitinib
- baricitinib
- baricitinib
- baricitinib
- baricitinib
- baricitinib
- baricitinib
- incb028050
- incb028050
- incb028050
- incb-028050
- incb-028050
- incb-28050
- incb-28050
- ly3009104
- ly3009104
- ly3009104
- ly-3009104
- ly-3009104
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07081763 | Phase 2 | May 31, 2026 | Government of France |
| NCT07268534 | Phase 2 | Apr 1, 2026 | Assistance Publique - Hôpitaux de Paris |
| NCT07222332 | Phase 3 | Mar 31, 2026 | Eli Lilly |
| NCT07222137 | Phase 3 | Jan 31, 2026 | Eli Lilly |
| NCT07262983 | Phase 1 | Dec 14, 2025 | National Institute of Allergy and Infectious Diseases (NIAID) |
| NCT07279688 | Phase 3 | Dec 12, 2025 | Eli Lilly, University of Western Brittany |
| NCT06923072 | Phase 2 | Dec 2, 2025 | National Heart, Lung, and Blood Institute (NHLBI) |
| NCT07209267 | Phase 2 | Nov 30, 2025 | Eli Lilly, Emory University |
| NCT07028385 | Phase 2 | Sep 30, 2025 | Badalona Hospital Germans Trias i Pujol, FUNDACIÓN FLS DE LUCHA CONTRA EL SIDA, LAS ENFERMEDADES INFECCIOSAS Y LA PROMOCIÓN DE LA SALUD Y LA CIENCIA, IrsiCaixa, Universidad Carlos III Madrid, University of Turin |
| NCT07003997 | Phase 2 | Sep 3, 2025 | Emory University, National Institute of Mental Health (NIMH) |
| NCT06868381 | Phase 2 | Apr 1, 2025 | Eli Lilly, Stanford University |
| NCT06768294 | Phase 2 | Jan 31, 2025 | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio |
| NCT06797310 | Phase 2 | Jan 23, 2025 | Eli Lilly, National Taiwan University |
| NCT06687551 | Phase 4 | Jan 1, 2025 | University of Toulouse |
| NCT06737705 | Phase 2 | Dec 18, 2024 | Fujian Medical University, Tianjin Medical University |
| NCT06849908 | Phase 2 | Nov 8, 2024 | Chinese Academy of Medical Sciences |
| NCT06631287 | Phase 3 | Oct 11, 2024 | National Institute on Aging (NIA), National Institutes of Health (NIH), Vanderbilt University |
| NCT06768840 | Phase 2/Phase 3 (Phase 3) | Oct 2, 2024 | South Valley University |
| NCT06490757 | Phase 2 | Sep 2, 2024 | Assistance Publique - Hôpitaux de Paris |
| NCT06439615 | Phase 2 | Aug 1, 2024 | People's Liberation Army of China, Tangdu Hospital |
Organizations
Research & Development (97)
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Aurobindo Pharma | For profit | MKTG | Jul 22, 2024 |
| Eli Lilly | For profit | NDA2 | May 31, 2018 |
| Eli Lilly | For profit | NDA | May 31, 2018 |
| MSN Laboratories | For profit | MKTG | Aug 8, 2025 |