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Jakafi, Jakavi(ruxolitinib)
Jakafi, Jakavi, Opzelura (ruxolitinib) is a small molecule pharmaceutical. Ruxolitinib was first approved as Jakafi on 2011-11-16. It is used to treat polycythemia vera and primary myelofibrosis in the USA. It has been approved in Europe to treat graft vs host disease, myeloproliferative disorders, polycythemia vera, and vitiligo. The pharmaceutical is active against tyrosine-protein kinase JAK1 and tyrosine-protein kinase JAK2. In addition, it is known to target tyrosine-protein kinase JAK3 and non-receptor tyrosine-protein kinase TYK2.
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COVID-19
Novartis Pharmaceuticals
Top 200 Pharmaceuticals by Retail Sales
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
skin and connective tissue diseasesD017437
immune system diseasesD007154
Trade Name
FDA
EMA
Jakafi, Opzelura
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ruxolitinib phosphate
Tradename
Company
Number
Date
Products
JAKAFIIncyteN-202192 RX2011-11-16
5 products, RLD, RS
OPZELURAIncyteN-215309 RX2021-09-21
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
jakafiNew Drug Application2020-02-26
opzeluraNew Drug Application2021-09-21
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
polycythemia vera—D011087D45
primary myelofibrosis—D055728D47.4
Agency Specific
FDA
EMA
Expiration
Code
RUXOLITINIB PHOSPHATE, JAKAFI, INCYTE CORP
2029-03-22PED
2028-09-22ODE-373
2026-11-24PED
2026-06-19PED
2026-05-24ODE-238
2025-12-19M-285
2025-03-22PED
2024-09-22I-872
RUXOLITINIB PHOSPHATE, OPZELURA, INCYTE CORP
2026-01-18PED
2025-07-18I-896
2025-03-21PED
2024-09-21NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Ruxolitinib Phosphate, Opzelura, Incyte Corp
116025362041-05-05U-3550
115109232040-09-04U-3505
115901372040-09-04U-3505
115901382040-06-10U-3551
107585432031-05-20DP
108698702031-05-20U-3229, U-3404
112196242031-05-20DPU-3229
115714252031-05-20DP
115901362031-05-20U-3229, U-3404
106105302028-06-12U-3229, U-3404
99747902026-12-12U-3229, U-3404
106393102026-12-12U-3229
Ruxolitinib Phosphate, Jakafi, Incyte Corp
87226932028-06-12DS, DP
88224812028-06-12U-1573, U-3226, U-3227, U-3228, U-3229, U-3230, U-3404
88290132028-06-12U-1201, U-1622, U-3227, U-3228
100164292028-06-12U-3226, U-3230
75982572027-12-24DS, DPU-3227, U-3228
84153622027-12-24DS, DP
90799122026-12-12U-3226, U-3227, U-3228, U-3229, U-3230, U-3404
98147222026-12-12U-3226, U-3230
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EJ: Janus-associated kinase (jak) inhibitors
— L01EJ01: Ruxolitinib
HCPCS
No data
Clinical
Clinical Trials
299 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Primary myelofibrosisD055728D47.43236103673
Polycythemia veraD011087D454851419
Graft vs host diseaseD006086D89.812912316
Myeloid leukemia acuteD015470C92.079—1—14
Atopic dermatitisD003876EFO_0000274L203341—11
Hemophagocytic lymphohistiocytosisD051359D76.12312—6
Healthy volunteers/patients—1——2—3
Beta-thalassemiaD017086Orphanet_848D56.1—1—1—2
Cytokine release syndromeD000080424D89.83—1—1—2
T-cell lymphomaD0163991——1—2
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Covid-19D000086382U07.12104—316
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.0661——11
Pancreatic neoplasmsD010190EFO_0003860C25322——7
Essential thrombocythemiaD013920D47.3271——7
VitiligoD014820EFO_0004208L80—41——5
Sars-cov-2D000086402121—13
Severe acute respiratory syndrome-related coronavirusD045473NCBITaxon_227859—11——1
Macrophage activation syndromeD055501EFO_1001806——1——1
EczemaD004485HP_0000964L30.9——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myelodysplastic syndromesD009190D4655———9
NeoplasmsD009369C8066———9
Breast neoplasmsD001943EFO_0003869C5046———8
Hodgkin diseaseD006689C8143———6
LeukemiaD007938C9544———6
B-cell chronic lymphocytic leukemiaD015451C91.134———5
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_000034042———5
Myeloid leukemia chronic-phaseD01546633———5
Myeloproliferative disordersD009196D47.154———5
Hematologic neoplasmsD01933713———4
Show 57 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Castration-resistant prostatic neoplasmsD0641291————1
Residual neoplasmD0183651————1
Endometrial neoplasmsD016889EFO_00042301————1
Uveal neoplasmsD014604EFO_10012301————1
Triple negative breast neoplasmsD0647261————1
Bone neoplasmsD001859EFO_0003820D161————1
MalariaD008288EFO_0001068B541————1
GlioblastomaD005909EFO_00005151————1
GliomaD005910EFO_00005201————1
CachexiaD002100HP_0004326R641————1
Show 2 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Bone marrow neoplasmsD019046————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameRUXOLITINIB
INNruxolitinib
Description
Ruxolitinib is a pyrazole substituted at position 1 by a 2-cyano-1-cyclopentylethyl group and at position 3 by a pyrrolo[2,3-d]pyrimidin-4-yl group. Used as the phosphate salt for the treatment of patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis. It has a role as an antineoplastic agent and an EC 2.7.10.2 (non-specific protein-tyrosine kinase) inhibitor. It is a nitrile, a pyrrolopyrimidine and a member of pyrazoles.
Classification
Small molecule
Drug classdeuterated compounds; tyrosine kinase inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
N#CC[C@H](C1CCCC1)n1cc(-c2ncnc3[nH]ccc23)cn1
Identifiers
PDB4U5J
CAS-ID941678-49-5
RxCUI1193326
ChEMBL IDCHEMBL1789941
ChEBI ID66919
PubChem CID25126798
DrugBankDB08877
UNII ID82S8X8XX8H (ChemIDplus, GSRS)
Target
Agency Approved
JAK1
JAK1
JAK2
JAK2
Organism
Homo sapiens
Gene name
JAK1
Gene synonyms
JAK1A, JAK1B
NCBI Gene ID
3716
Protein name
tyrosine-protein kinase JAK1
Protein synonyms
JAK-1, Janus kinase 1
Uniprot ID
Q9UD26
Mouse ortholog
Jak1 (16451)
tyrosine-protein kinase JAK1 (P52332)
Alternate
JAK3
JAK3
TYK2
TYK2
Organism
Homo sapiens
Gene name
JAK3
Gene synonyms
NCBI Gene ID
3718
Protein name
tyrosine-protein kinase JAK3
Protein synonyms
JAK-3, Janus kinase 3, Janus kinase 3 (a protein tyrosine kinase, leukocyte), L-JAK, Leukocyte janus kinase
Uniprot ID
Q9Y6S2
Mouse ortholog
Jak3 (16453)
tyrosine-protein kinase JAK3 (Q62137)
Variants
Clinical Variant
No data
Financial
Opzelura - Incyte
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Jakafi - Incyte
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Jakavi - Incyte
$
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Jakavi - Novartis
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,811 documents
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Safety
Black-box Warning
Black-box warning for: Opzelura
Adverse Events
Top Adverse Reactions
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6,496 adverse events reported
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