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Drug ReportsBaricitinib
Olumiant(baricitinib)
Baricitinib, Olumiant (baricitinib) is a small molecule pharmaceutical. Baricitinib was first approved as Olumiant on 2017-02-13. It is used to treat rheumatoid arthritis in the USA. It has been approved in Europe to treat rheumatoid arthritis. The pharmaceutical is active against tyrosine-protein kinase JAK1 and tyrosine-protein kinase JAK2. In addition, it is known to target cyclin-G-associated kinase, non-receptor tyrosine-protein kinase TYK2, BMP-2-inducible protein kinase, AP2-associated protein kinase 1, and tyrosine-protein kinase JAK3.
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Events Timeline
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3M
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FDA approval date
EMA approval date
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Study first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
skin and connective tissue diseasesD017437
immune system diseasesD007154
Trade Name
FDA
EMA
Olumiant (discontinued: Baricitinib)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Baricitinib
Tradename
Company
Number
Date
Products
OLUMIANTEli LillyN-207924 RX2018-05-31
3 products, RLD
Labels
FDA
EMA
Brand Name
Status
Last Update
baricitinibUse Authorization2022-05-10
olumiantNew Drug Application2026-06-30
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration
Code
BARICITINIB, OLUMIANT, ELI LILLY AND CO
2025-06-13I-890
2025-05-10I-891
2023-05-31NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Baricitinib, Olumiant, Eli Lilly And Co
90895742032-11-30U-3372
110454742032-11-30U-3372
97374692031-11-02U-3500
81586162030-06-08DS, DP
84206292029-03-10U-247
ATC Codes
L: Antineoplastic and immunomodulating agents
— L04: Immunosuppressants
— L04A: Immunosuppressants
— L04AA: Selective immunosuppressants
— L04AA37: Baricitinib
HCPCS
No data
Clinical
Clinical Trials
196 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Rheumatoid arthritisD001172EFO_0000685M06.91411101238
Covid-19D000086382—U07.1—8171527
ArthritisD001168EFO_0005856M05-M14—374721
Atopic dermatitisD003876EFO_0000274L201181718
EczemaD004485—L30.9—181313
DermatitisD003872—L30.91151311
Psoriatic arthritisD015535EFO_0003778L40.5———112
SpondylarthritisD025241———1—1—2
SpondylitisD013166—M46.9—1—1—2
Systemic sclerodermaD012595EFO_0000717M34———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PneumoniaD011014EFO_0003106J18—55——8
Alopecia areataD000506EFO_0004192L63223—28
AlopeciaD000505—L64131—16
Systemic lupus erythematosusD008180EFO_0002690M32113——5
Skin diseasesD012871—L00-L99—32—15
SyndromeD013577——131—25
Coronavirus infectionsD018352EFO_0007224B34.2—22——4
DermatomyositisD003882EFO_0000398M33—21—14
Juvenile arthritisD001171EFO_1002007M08——3——3
VitiligoD014820EFO_0004208L80—21—13
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———18————18
Allergic contact dermatitisD017449—L231————1
HypersensitivityD006967EFO_0003785T78.401————1
Contact dermatitisD003877—L251————1
Delayed hypersensitivityD006968——1————1
Liver diseasesD008107EFO_0001421K70-K771————1
Liver failureD017093—K72.91————1
Hepatic insufficiencyD048550——1————1
SarcomaD012509——1————1
ChondrosarcomaD002813——1————1
Show 6 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Joint diseasesD007592—M12.9————11
Musculoskeletal diseasesD009140——————11
PainD010146EFO_0003843R52————11
Brain diseasesD001927—G93.40————11
FatigueD005221—R53.83————11
Rheumatic diseasesD012216—M79.0————11
Ankylosing spondylitisD013167EFO_0003898M45————11
EosinophiliaD004802—D72.1————11
Immunoglobulin g4-related diseaseD000077733—D89.84————11
Autoimmune diseases of the nervous systemD020274——————11
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBaricitinib
INNbaricitinib
Description
Baricitinib is a pyrrolopyrimidine that is 7H-pyrrolo[2,3-d]pyrimidine substituted by a 1-[3-(cyanomethyl)-1-(ethanesulfonyl)azetidin-3-yl]-1H-pyrazol-4-yl group at position 5. It is an FDA approved selective Janus Kinase 1 and 2 (JAK1 and JAK2) inhibitor used for the treatment of rheumatoid arthritis. It has a role as an antirheumatic drug, an EC 2.7.10.2 (non-specific protein-tyrosine kinase) inhibitor, an anti-inflammatory agent, an immunosuppressive agent and an antiviral agent. It is a pyrrolopyrimidine, a member of pyrazoles, a member of azetidines, a sulfonamide and a nitrile.
Classification
Small molecule
Drug classtyrosine kinase inhibitors: tyrosine kinase inhibitors; janus kinase inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CCS(=O)(=O)N1CC(CC#N)(n2cc(-c3ncnc4[nH]ccc34)cn2)C1
Identifiers
PDB—
CAS-ID1187594-09-7
RxCUI—
ChEMBL IDCHEMBL2105759
ChEBI ID—
PubChem CID44205240
DrugBankDB11817
UNII IDISP4442I3Y (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
GAK
GAK
AAK1
AAK1
JAK3
JAK3
Organism
Homo sapiens
Gene name
GAK
Gene synonyms
NCBI Gene ID
Protein name
cyclin-G-associated kinase
Protein synonyms
auxilin-2
Uniprot ID
Mouse ortholog
Gak (231580)
cyclin-G-associated kinase (Q99KY4)
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Olumiant – Eli Lilly
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Olumiant – Incyte
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,999 documents
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Safety
Black-box Warning
Black-box warning for: Olumiant
Adverse Events
Top Adverse Reactions
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8,660 adverse events reported
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