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Drug ReportsRuxolitinib
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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Novartis Pharmaceuticals
Top 200 Pharmaceuticals by Retail Sales
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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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 Application2025-06-24
opzeluraNew Drug Application2025-11-11
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
443 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Atopic dermatitisD003876EFO_0000274L203361215
PruritusD011537—L29——1124
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Primary myelofibrosisD055728—D47.411213—131
Myeloproliferative disordersD009196—D47.16142——19
EczemaD004485—L30.9347—216
DermatitisD003872—L30.9456——14
LeukemiaD007938—C95791——13
Graft vs host diseaseD006086—D89.81252—211
Polycythemia veraD011087—D45274——11
PolycythemiaD011086EFO_0005804D75.1263—111
Essential thrombocythemiaD013920—D47.3571——11
ThrombocytosisD013922—D75.83171——8
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myelodysplastic syndromesD009190—D4655———9
NeoplasmsD009369—C8046———7
Breast neoplasmsD001943EFO_0003869C5036———6
Myeloid leukemia acuteD015470—C92.034———6
Multiple myelomaD009101—C90.043———5
Non-small-cell lung carcinomaD002289——33———4
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340—13———4
Plasma cell neoplasmsD054219——32———4
Myelomonocytic leukemia chronicD015477—C93.114———4
Prostatic neoplasmsD011471—C6123———3
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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———2————2
Philadelphia chromosomeD010677——1————1
Wasting syndromeD019282——1————1
CachexiaD002100—R641————1
Pancreatic ductal carcinomaD021441——1————1
Disease progressionD018450——1————1
NeurodermatitisD009450—L28.01————1
Biphenotypic leukemia acuteD015456—C95.01————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pregnancy rateD018873——————22
EmergenciesD004630——————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)Loading
Structure (InChI/SMILES or Protein Sequence)
N#CC[C@H](C1CCCC1)n1cc(-c2ncnc3[nH]ccc23)cn1
Identifiers
PDB—
CAS-ID941678-49-5
RxCUI—
ChEMBL IDCHEMBL1789941
ChEBI ID66919
PubChem CID25126798
DrugBankDB08877
UNII ID82S8X8XX8H (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
JAK3
JAK3
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
No data
Financial
Revenue by drug
$
€
£
₣
Jakafi – Incyte
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Opzelura – Incyte
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Jakavi – Incyte
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Jakavi – Novartis
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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 15,827 documents
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Safety
Black-box Warning
Black-box warning for: Opzelura
Adverse Events
Top Adverse Reactions
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67,354 adverse events reported
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