Ruxolitinib phosphate
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2011
- First approval year
- 2011
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Ruxolitinib phosphate
- Molecular weight
- 404.37
- Structure (SMILES)
- N#CC[C@H](C1CCCC1)n1cc(-c2ncnc3[nH]ccc23)cn1.O=P(O)(O)O
- jakafi
- Jakafi
- jakavi
- Jakavi
- opzelura
- Opzelura
- 1 5 ruxolitinib phosphate cream opzelura
- 1.5% Ruxolitinib Phosphate Cream (Opzelura)
- incb 018424 phosphate
- incb 018424 salt
- incb 18424 phosphate
- INCB-018424 PHOSPHATE
- INCB-018424 SALT
- INCB-18424 PHOSPHATE
- incb018424 phosphate
- INCB018424 PHOSPHATE
- incb018424 salt
- INCB018424 SALT
- jakafi xr
- JAKAFI XR
- opzelura
- Opzelura
- Ruxolitinib (as phosphate)
- Ruxolitinib (as phosphate) [EMA EPAR]
- ruxolitinib as phosphate
- ruxolitinib as phosphate ema epar
- ruxolitinib monophosphate
- Ruxolitinib monophosphate
- ruxolitinib phosphate
- Ruxolitinib phosphate
- Ruxolitinib phosphate [JAN]
And 9 more, listed on the interactive page.
- CAS registry numbers
- 1092939-17-7
- ChEMBL ID
- CHEMBL1795071
- InChIKey
- JFMWPOCYMYGEDM-XFULWGLBSA-N
- PubChem compound IDs
- 25127112
- RxNorm IDs (RxCUI)
- 1193325
- FDA ingredient codes (UNII)
- 436LRU32H5
- Applicant
- INCYTE CORP
- Approval date
- 21 Sept 2021
- Application number
- NDA215309
- Patents
- 49
- Designations
- 2
- Earliest recorded loss of exclusivity
- 5 May 2041
- First in class
- Yes
- Fast track
- No
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- Drug name stem
- -tinib
Administration routes
- Oral
- topical
- Mechanism
- Tyrosine-protein kinase JAK1 inhibitor
- Action type
- Inhibitor
- Target
- Tyrosine-protein kinase JAK1
- Protein identifier
- P23458
- Mechanism
- Tyrosine-protein kinase JAK2 inhibitor
- Action type
- Inhibitor
- Target
- Tyrosine-protein kinase JAK2
- Protein identifier
- O60674
- Mechanism
- Tyrosine-protein kinase JAK1 inhibitor
- Action type
- Inhibitor
- Target
- Tyrosine-protein kinase JAK1
- Mechanism
- Tyrosine-protein kinase JAK2 inhibitor
- Action type
- Inhibitor
- Target
- Tyrosine-protein kinase JAK2
- Condition
- Leukemia, Lymphocytic, Chronic, B-Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000095
- Subject identifier
- D015451
- Condition
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000220
- Subject identifier
- D054198
- Condition
- Leukemia, Myeloid, Acute
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000222
- Subject identifier
- D015470
- Condition
- Dermatitis, Atopic
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000274
- Subject identifier
- D003876
- Condition
- Leukemia
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000565
- Subject identifier
- D007938
- Condition
- Psoriasis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000676
- Subject identifier
- D011565
- Condition
- Malaria
- Highest recorded phase
- 1
- Condition identifier
- EFO:0001068
- Subject identifier
- D008288
- Condition
- Polycythemia Vera
- Highest recorded phase
- 4
- Condition identifier
- EFO:0002429
- Subject identifier
- D011087
- Condition
- Primary Myelofibrosis
- Highest recorded phase
- 4
- Condition identifier
- EFO:0002430
- Subject identifier
- D055728
- Condition
- Alopecia Areata
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004192
- Subject identifier
- D000506
- Condition
- Vitiligo
- Highest recorded phase
- 4
- Condition identifier
- EFO:0004208
- Subject identifier
- D014820
- Condition
- Myeloproliferative Disorders
- Highest recorded phase
- 4
- Condition identifier
- EFO:0004251
- Subject identifier
- D009196
- Condition
- Triple Negative Breast Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0005537
- Subject identifier
- D064726
- Condition
- Primary Myelofibrosis
- Highest recorded phase
- 4
- Condition identifier
- HP:0011974
- Subject identifier
- D055728
- Condition
- Fallopian Tube Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- MONDO:0002158
- Subject identifier
- D005185
- Condition
- Graft vs Host Disease
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0013730
- Subject identifier
- D006086
- Condition identifier
- EFO_0000095
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000274
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000479
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000676
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001068
- Highest recorded phase
- 1
- Condition identifier
- EFO_0002429
- Condition identifier
- EFO_0002430
- Condition identifier
- EFO_0004192
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004251
- Condition identifier
- EFO_1001494
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0000430
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002158
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0002280
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004653
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004948
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004967
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004980
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005029
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005140
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005340
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0008661
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0009692
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0009891
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0011962
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0013730
And 11 more, listed on the interactive page.
Warnings
- Warning
- Black Box Warning
- Effect
- infectious disease
Open Targets warnings
- Warning
- Black Box Warning
- Effect
- infectious disease
- Country
- United States
- Event
- acute myeloid leukaemia
- Reports
- 168
- Reporting signal score
- 310.905
- Event
- anaemia
- Reports
- 1,106
- Reporting signal score
- 975.893
- Event
- blast cell count increased
- Reports
- 82
- Reporting signal score
- 279.93
- Event
- blood count abnormal
- Reports
- 305
- Reporting signal score
- 609.097
- Event
- contusion
- Reports
- 343
- Reporting signal score
- 307.01
- Event
- drug hypersensitivity
- Reports
- 13
- Reporting signal score
- 187.578
- Event
- fatigue
- Reports
- 1,089
- Reporting signal score
- 240.507
- Event
- haematocrit decreased
- Reports
- 175
- Reporting signal score
- 202.572
- Event
- haemoglobin decreased
- Reports
- 919
- Reporting signal score
- 1,143.33
- Event
- injection site pain
- Reports
- 2
- Reporting signal score
- 176.557
- Event
- myelofibrosis
- Reports
- 226
- Reporting signal score
- 807.304
- Event
- night sweats
- Reports
- 176
- Reporting signal score
- 212.906
- Event
- platelet count decreased
- Reports
- 944
- Reporting signal score
- 1,246.55
- Event
- platelet count increased
- Reports
- 416
- Reporting signal score
- 1,053.06
- Event
- primary myelofibrosis
- Reports
- 43
- Reporting signal score
- 181.893
- Event
- red blood cell count decreased
- Reports
- 257
- Reporting signal score
- 374.766
- Event
- second primary malignancy
- Reports
- 282
- Reporting signal score
- 716.037
- Event
- splenomegaly
- Reports
- 524
- Reporting signal score
- 1,504.29
- Event
- squamous cell carcinoma
- Reports
- 139
- Reporting signal score
- 224.455
- Event
- thrombocytopenia
- Reports
- 530
- Reporting signal score
- 320.284
- Event
- weight increased
- Reports
- 513
- Reporting signal score
- 331.154
- Event
- white blood cell count increased
- Reports
- 399
- Reporting signal score
- 554.582
- NCT00778700
- NCT00820950
- NCT02131584
- NCT03041636
- NCT02420717
- NCT02553330
- NCT02713386
- NCT02779283
- NCT03012230
- NCT03257644
- NCT04456634
- Hydrogen bond acceptors
- 5
- Hydrogen bond donors
- 1
- Polar surface area
- 83.18
- Calculated partition coefficient (ALogP)
- 3.47
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 4
- Heavy atoms
- 28
- Molecular formula
- C17H21N6O4P
- Monoisotopic mass
- 404.13619017
- Natural product
- No
- 50881-007
- Recorded assays
- 8
- Active assays
- 8
Active assay types
- Confirmatory
Related records
Trials (368)
- A Clinical Study of Ruxolitinib in Patients With Primary Myelofibrosis (PM), Post-polycythemia Vera (PV) Myelofibrosis, or Post-essential Thrombocythemia (ET) Myelofibrosis
- A Clinical Study to Test the Effects of Ruxolitinib And Thalidomide Combination for Patients With Myelofibrosis
- A Clinical Trial of Bomedemstat in Participants With Polycythemia Vera (MK-3543-025)
- A Clinical Trial of Flonoltinib Maleate for Intermediate or High-Risk Myelofibrosis
- A Dose Ranging Study of the Effect of Ruxolitinib Phosphate Cream When Applied to Participants With Plaque Psoriasis
- A Maximum Use Trial of Ruxolitinib Cream in Adolescent and Adult Participants With Atopic Dermatitis
- A New Prognostic Stratification-based Safety and Efficacy Study of Ruxolitinib in Myelofibrosis
- A Pharmacokinetic Study of Ruxolitinib Phosphate Cream in Pediatric Subjects With Atopic Dermatitis
- A Phase 1/2 Study of CPI-0610 With and Without Ruxolitinib in Patients With Hematologic and Myeloproliferative Malignancies
- A Phase 2 Study of INCB57643 (BET Inhibitor) in Combination With Ruxolitinib in JAK Inhibitor-naïve Patients With Myelofibrosis
- A Phase 2 Study of RO7490677 In Participants With Myelofibrosis
- A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia
- A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
- A Phase I Study to Evaluate the Safety and Efficacy of L19IL2 in Combination With Ruxolitinib in Patients With Advanced Solid Tumors
- A Phase II Clinical Trial of Flonoltinib Maleate Tablet in Intermediate-High Risk Myelofibrosis
- A Phase II Study of Oral JAK1/JAK2 Inhibitor INC424 in Adult Patients With Relapsed/Refractory Classical Hodgkin's Lymphoma
- A Phase II Study of Re-treatment of Myelofibrosis Patients With Ruxolitinib/Jakavi After Treatment Interruption Due to Loss of Response and/or Adverse Event (ReTreatment Trial)
- A Pilot Study of Ruxolitinib in Secondary Hemophagocytic Syndrome
- A Prospective Clinical Study of Ruxolitinib and Etoposide Combined With DDGP Regimen (RUE-DDGP) in Induction Therapy of T/NK Cell Lymphoma-associated Hemophagocytic Syndrome.
- A Randomized Study to Compare Post-transplant Cyclophosphamide, Sirolimus, Ruxolitinib and Post-transplant Cyclophosphamide, Sirolimus, Mycophenolate Mofetil to Prevent Graft Versus Host Disease
Approved for (5)
- Acquired polycythemia vera
- Bone marrow neoplasm
- Graft versus host disease
- Primary myelofibrosis
- Vitiligo
In development for (11)
- Acute lymphoblastic leukemia Phase 1
- Acute myeloid leukemia Phase 1
- Alopecia areata Phase 2
- Atopic eczema Phase 1
- B-cell chronic lymphocytic leukemia Phase 2
- Essential thrombocythemia Phase 3
- Fallopian tube cancer Phase 1
- Leukemia Phase 2
- Malaria Phase 1
- Psoriasis Phase 2
- Triple-negative breast carcinoma Phase 1
Other linked conditions (1)
- Myelofibrosis