> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/ruxolitinib-phosphate-fce80c56-88a2-456a-bcb5-431e98979584
> Record changed: 2026-10-13

# Ruxolitinib phosphate

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1795071)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1795071)

First approval year

2011

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1795071)

## Development status

**First approval year**

2011

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1795071)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1795071)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1795071)

**Drug name**

Ruxolitinib phosphate

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1795071)

**Molecular weight**

404.37

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1795071)

**Structure (SMILES)**

N#CC\[C@H\](C1CCCC1)n1cc(-c2ncnc3\[nH\]ccc23)cn1.O=P(O)(O)O

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1795071)

### Brand names (6)

- jakafi
- Jakafi
- jakavi
- Jakavi
- opzelura
- Opzelura

### Other names (34)

- 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.

## Identifiers

**CAS registry numbers**

- 1092939-17-7

**ChEMBL ID**

CHEMBL1795071

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1795071)

**InChIKey**

JFMWPOCYMYGEDM-XFULWGLBSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1795071)

**PubChem compound IDs**

- 25127112

**RxNorm IDs (RxCUI)**

- 1193325

**FDA ingredient codes (UNII)**

- 436LRU32H5

## Regulatory information

### United States

**Applicant**

INCYTE CORP

**Approval date**

21 Sept 2021

**Application number**

NDA215309

### Other regulatory facts

**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

## Pharmacology

### Drug classification

**Drug name stem**

\-tinib

#### Administration routes

- Oral
- topical

### Mechanisms of action (2)

- **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

### Open Targets mechanisms (2)

- **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

### Investigated indications (16)

- **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

### Open Targets indications (36)

- **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

### Reported adverse events (22)

- **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

### Trial references (11)

- NCT00778700  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00778700)
- NCT00820950  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00820950)
- NCT02131584  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02131584)
- NCT03041636  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03041636)
- NCT02420717  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02420717)
- NCT02553330  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02553330)
- NCT02713386  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02713386)
- NCT02779283  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02779283)
- NCT03012230  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03012230)
- NCT03257644  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03257644)
- NCT04456634  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04456634)

## Chemical properties

**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

## National Drug Codes

- 50881-007

## Evidence counts

**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](https://trialight.com/data/condition/acquired-polycythemia-vera-5c3132a8-49a0-5b93-b3d6-cd5f1fa9e10e.md)
- Bone marrow neoplasm
- Graft versus host disease
- [Primary myelofibrosis](https://trialight.com/data/condition/primary-myelofibrosis-7777dc52-f40c-5e07-9d67-bcf779b7ff0e.md)
- Vitiligo

### In development for (11)

- Acute lymphoblastic leukemia Phase 1
- [Acute myeloid leukemia](https://trialight.com/data/condition/acute-myeloid-leukemia-b0971a7a-c18d-544e-bd7f-b1a13b9caa30.md) Phase 1
- [Alopecia areata](https://trialight.com/data/condition/alopecia-areata-8709d8ab-db3b-57e6-88fa-7d7ae93d4561.md) Phase 2
- [Atopic eczema](https://trialight.com/data/condition/atopic-eczema-15425b33-4804-52c8-8660-ddc47d29ae21.md) Phase 1
- [B-cell chronic lymphocytic leukemia](https://trialight.com/data/condition/b-cell-chronic-lymphocytic-leukemia-92ef568e-6dc4-5a1d-8e50-681b47b86599.md) Phase 2
- [Essential thrombocythemia](https://trialight.com/data/condition/essential-thrombocythemia-155250c9-5856-5b62-9d8b-794d484c4616.md) Phase 3
- [Fallopian tube cancer](https://trialight.com/data/condition/fallopian-tube-cancer-b95d05ee-41d5-565a-87e1-041170b88760.md) Phase 1
- [Leukemia](https://trialight.com/data/condition/leukemia-519aefcd-8521-5941-851b-5b77ca925ca5.md) Phase 2
- [Malaria](https://trialight.com/data/condition/malaria-54828cac-9b96-5833-93e2-e012d4505853.md) Phase 1
- [Psoriasis](https://trialight.com/data/condition/psoriasis-4340caf0-883c-54c7-886d-31e59b80dead.md) Phase 2
- [Triple-negative breast carcinoma](https://trialight.com/data/condition/triple-negative-breast-carcinoma-059174a2-9b5f-5234-90b9-4a4fee6eb9bb.md) Phase 1

### Other linked conditions (1)

- Myelofibrosis

### Targets (2)

- [JAK1](https://trialight.com/data/target/jak1-c22a6fc9-26d6-5daa-a0f4-71cd08b3c5e1.md) Tyrosine-protein kinase JAK1 inhibitor
- [JAK2](https://trialight.com/data/target/jak2-6d06f09e-903b-5a13-9d7a-79efa991190f.md) Tyrosine-protein kinase JAK2 inhibitor

---

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