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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Jakafi, Opzelura
Drug Products
FDA
EMA
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| polycythemia vera | — | D011087 | D45 |
| primary myelofibrosis | — | D055728 | D47.4 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
RUXOLITINIB PHOSPHATE, JAKAFI, INCYTE CORP | |||
| 2029-03-22 | PED | ||
| 2028-09-22 | ODE-373 | ||
| 2026-11-24 | PED | ||
| 2026-06-19 | PED | ||
| 2026-05-24 | ODE-238 | ||
| 2025-12-19 | M-285 | ||
| 2025-03-22 | PED | ||
| 2024-09-22 | I-872 | ||
RUXOLITINIB PHOSPHATE, OPZELURA, INCYTE CORP | |||
| 2026-01-18 | PED | ||
| 2025-07-18 | I-896 | ||
| 2025-03-21 | PED | ||
| 2024-09-21 | NP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Ruxolitinib Phosphate, Opzelura, Incyte Corp | |||
| 11602536 | 2041-05-05 | U-3550 | |
| 11510923 | 2040-09-04 | U-3505 | |
| 11590137 | 2040-09-04 | U-3505 | |
| 11590138 | 2040-06-10 | U-3551 | |
| 10758543 | 2031-05-20 | DP | |
| 10869870 | 2031-05-20 | U-3229, U-3404 | |
| 11219624 | 2031-05-20 | DP | U-3229 |
| 11571425 | 2031-05-20 | DP | |
| 11590136 | 2031-05-20 | U-3229, U-3404 | |
| 10610530 | 2028-06-12 | U-3229, U-3404 | |
| 9974790 | 2026-12-12 | U-3229, U-3404 | |
| 10639310 | 2026-12-12 | U-3229 | |
| Ruxolitinib Phosphate, Jakafi, Incyte Corp | |||
| 8722693 | 2028-06-12 | DS, DP | |
| 8822481 | 2028-06-12 | U-1573, U-3226, U-3227, U-3228, U-3229, U-3230, U-3404 | |
| 8829013 | 2028-06-12 | U-1201, U-1622, U-3227, U-3228 | |
| 10016429 | 2028-06-12 | U-3226, U-3230 | |
| 7598257 | 2027-12-24 | DS, DP | U-3227, U-3228 |
| 8415362 | 2027-12-24 | DS, DP | |
| 9079912 | 2026-12-12 | U-3226, U-3227, U-3228, U-3229, U-3230, U-3404 | |
| 9814722 | 2026-12-12 | U-3226, U-3230 | |
HCPCS
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Clinical
Clinical Trials
399 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Primary myelofibrosis | D055728 | — | D47.4 | 38 | 61 | 17 | 3 | 12 | 115 |
| Polycythemia | D011086 | EFO_0005804 | D75.1 | 14 | 26 | 15 | 2 | 12 | 63 |
| Polycythemia vera | D011087 | — | D45 | 13 | 26 | 16 | 1 | 11 | 61 |
| Thrombocytosis | D013922 | HP_0001894 | D75.83 | 13 | 26 | 12 | 1 | 4 | 48 |
| Essential thrombocythemia | D013920 | — | D47.3 | 12 | 25 | 12 | 1 | 3 | 45 |
| Graft vs host disease | D006086 | — | D89.81 | 9 | 23 | 7 | 4 | 4 | 44 |
| Myeloid leukemia | D007951 | — | C92 | 13 | 14 | — | 1 | 1 | 24 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 10 | 12 | — | 1 | 1 | 20 |
| Eczema | D004485 | HP_0000964 | L30.9 | 4 | 4 | 7 | 1 | 2 | 18 |
| Syndrome | D013577 | — | — | 5 | 9 | 2 | 1 | 2 | 17 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 27 | 29 | 2 | — | 1 | 46 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 18 | 26 | 1 | — | 1 | 37 |
| Lymphoid leukemia | D007945 | — | C91 | 11 | 14 | 1 | — | 1 | 22 |
| Covid-19 | D000086382 | — | — | 2 | 11 | 4 | — | 8 | 22 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | — | 10 | 11 | 1 | — | 1 | 19 |
| Vitiligo | D014820 | EFO_0004208 | L80 | — | 6 | 4 | — | — | 10 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 3 | 2 | 2 | — | — | 7 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | 1 | 3 | 1 | — | 2 | 5 |
| Sars-cov-2 | D000086402 | — | — | 1 | 2 | 1 | — | 1 | 3 |
| Severe acute respiratory syndrome | D045169 | EFO_0000694 | J12.81 | 1 | 2 | 1 | — | 1 | 3 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 19 | 19 | — | — | 1 | 32 |
| Myelodysplastic syndromes | D009190 | — | D46 | 9 | 8 | — | — | — | 16 |
| Bronchiolitis obliterans syndrome | D000092122 | — | — | 3 | 10 | — | — | 1 | 14 |
| Hematologic neoplasms | D019337 | — | — | 7 | 7 | — | — | — | 12 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 7 | 6 | — | — | — | 11 |
| Recurrence | D012008 | — | — | 6 | 5 | — | — | 1 | 10 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 5 | 7 | — | — | — | 10 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 5 | 6 | — | — | 1 | 10 |
| Myelodysplastic-myeloproliferative diseases | D054437 | — | — | 5 | 5 | — | — | — | 8 |
| Preleukemia | D011289 | — | — | 6 | 3 | — | — | — | 8 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Triple negative breast neoplasms | D064726 | — | — | 2 | — | — | — | — | 2 |
| Residual neoplasm | D018365 | — | — | 1 | — | — | — | — | 1 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 1 | — | — | — | — | 1 |
| Carcinosarcoma | D002296 | — | — | 1 | — | — | — | — | 1 |
| Mycoses | D009181 | — | B35-B49 | 1 | — | — | — | — | 1 |
| Large-cell lymphoma anaplastic | D017728 | — | C84.6 | 1 | — | — | — | — | 1 |
| Immunoblastic lymphadenopathy | D007119 | EFO_1001350 | C86.5 | 1 | — | — | — | — | 1 |
| Mycosis fungoides | D009182 | — | C84.0 | 1 | — | — | — | — | 1 |
| T-cell lymphoma cutaneous | D016410 | — | — | 1 | — | — | — | — | 1 |
| Melanoma | D008545 | — | — | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pregnancy rate | D018873 | — | — | — | — | — | — | 2 | 2 |
| Acute disease | D000208 | — | — | — | — | — | — | 1 | 1 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 1 | 1 |
| Heart failure | D006333 | HP_0001635 | I50 | — | — | — | — | 1 | 1 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 1 | 1 |
| Menorrhagia | D008595 | EFO_0003945 | N92.0 | — | — | — | — | 1 | 1 |
| Hemophilia a | D006467 | EFO_0007267 | D66 | — | — | — | — | 1 | 1 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | — | 1 | 1 |
| Down syndrome | D004314 | EFO_0001064 | Q90 | — | — | — | — | 1 | 1 |
| Mucocutaneous lymph node syndrome | D009080 | EFO_0004246 | M30.3 | — | — | — | — | 1 | 1 |
Show 26 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Ruxolitinib |
| INN | ruxolitinib |
| 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 class | deuterated 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
| PDB | — |
| CAS-ID | 941678-49-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1789941 |
| ChEBI ID | 66919 |
| PubChem CID | 25126798 |
| DrugBank | DB08877 |
| UNII ID | 82S8X8XX8H (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
JAK3
JAK3
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Jakavi – Incyte
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Jakavi – Novartis
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Opzelura – Incyte
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Jakafi – Incyte
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Opzelura
Adverse Events
Top Adverse Reactions
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61,746 adverse events reported
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