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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
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Primary completion date
Completion 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 Application2023-03-20
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
162 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ArthritisD001168HP_0001369M05-M1441481137
Rheumatoid arthritisD001172EFO_0000685M06.9141191035
Covid-19D0000863828181528
DermatitisD003872HP_0011123L30.91181617
Atopic dermatitisD003876EFO_0000274L20181616
EczemaD004485HP_0000964L30.9181313
Alopecia areataD000506EFO_0004192L63113116
AlopeciaD000505HP_0002293L64113116
Psoriatic arthritisD015535EFO_0003778L40.5123
SpondylarthritisD0252411113
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients1616
Allergic contact dermatitisD017449L2311
HypersensitivityD006967HP_0012393T78.4011
Contact dermatitisD003877L2511
Delayed hypersensitivityD00696811
Liver diseasesD008107HP_0002910K70-K7711
Liver failureD017093HP_0001399K72.911
Hepatic insufficiencyD04855011
Indications Without Phase
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
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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 9,423 documents
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Safety
Black-box Warning
Black-box warning for: Olumiant
Adverse Events
Top Adverse Reactions
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6,601 adverse events reported
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