Cytarabine, Depocyte(cytarabine)
Cytarabine, DepoCyte, Vyxeos (cytarabine) is a small molecule pharmaceutical. Cytarabine was first approved as Cytarabine on 1982-01-01. It is used to treat leukemia, lymphoma, and meningeal neoplasms in the USA. It has been approved in Europe to treat meningeal neoplasms and myeloid leukemia acute.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Cytarabine (discontinued: Cytarabine, Cytosar-u, Depocyt)
CombinationsVyxeos
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Cytarabine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DEPOCYT | Pacira BioSciences | N-021041 DISCN | 1999-04-01 | 1 products, RLD |
| CYTARABINE | Teva | N-016793 DISCN | 1982-01-01 | 4 products, RLD |
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Cytarabine
+
Daunorubicin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VYXEOS | Jazz Pharmaceuticals | N-209401 RX | 2017-08-03 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| byun rak | unapproved drug other | 2019-03-21 |
| cytarabine | ANDA | 2025-08-13 |
| vyxeos | New Drug Application | 2025-07-01 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
CYTARABINE / DAUNORUBICIN, VYXEOS, CELATOR PHARMS | |||
| 2028-03-30 | ODE-350 | ||
| 2024-08-03 | ODE-287 | ||
| 2024-03-30 | NPP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Cytarabine / Daunorubicin, Vyxeos, Celator Pharms | |||
| 10028912 | 2032-10-15 | DP | U-3149, U-3150 |
| 10166184 | 2032-10-15 | DP | U-3149 |
| 10835492 | 2032-10-15 | U-3150 | |
| 8092828 | 2029-04-01 | U-3147 | |
| 8022279 | 2027-09-14 | DP | U-3147 |
| 7850990 | 2027-01-23 | DP | U-3147 |
| 9271931 | 2027-01-23 | DP | |
| 8518437 | 2026-06-07 | DP | |
| 8431806 | 2025-04-22 | DP | U-3147 |
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01B: Antimetabolites
— L01BC: Pyrimidine analogues, antineoplastic antimetabolites
— L01BC01: Cytarabine
— L01X: Other antineoplastic agents in atc
— L01XY: Combinations of antineoplastic agents
— L01XY01: Cytarabine and daunorubicin
Clinical
Clinical Trials
1716 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 266 | 438 | 173 | 30 | 65 | 833 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 297 | 405 | 145 | 14 | 56 | 780 |
| Myeloid leukemia | D007951 | — | C92 | 179 | 260 | 87 | 9 | 41 | 487 |
| Lymphoma | D008223 | — | C85.9 | 60 | 230 | 65 | 9 | 31 | 361 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 78 | 170 | 69 | 22 | 26 | 322 |
| Myelodysplastic syndromes | D009190 | — | D46 | 91 | 134 | 23 | 2 | 12 | 212 |
| Lymphoid leukemia | D007945 | — | C91 | 32 | 88 | 35 | 16 | 13 | 168 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 37 | 82 | 26 | 4 | 9 | 139 |
| Preleukemia | D011289 | — | — | 48 | 76 | 14 | 1 | 7 | 113 |
| Syndrome | D013577 | — | — | 38 | 58 | 12 | 1 | 7 | 91 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myelomonocytic leukemia acute | D015479 | — | C92.5 | 26 | 28 | 10 | — | 3 | 61 |
| Monocytic leukemia acute | D007948 | — | — | 23 | 26 | 11 | — | 3 | 58 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 19 | 38 | 7 | — | 1 | 57 |
| Hodgkin disease | D006689 | — | C81 | 16 | 31 | 9 | — | 7 | 53 |
| Erythroblastic leukemia acute | D004915 | EFO_1001257 | C94.0 | 21 | 22 | 10 | — | 3 | 52 |
| Megakaryoblastic leukemia acute | D007947 | — | C94.2 | 20 | 21 | 10 | — | 3 | 50 |
| Neoplasms | D009369 | — | C80 | 23 | 23 | 1 | — | 5 | 46 |
| Precursor t-cell lymphoblastic leukemia-lymphoma | D054218 | — | — | 15 | 27 | 7 | — | 3 | 40 |
| Hematologic neoplasms | D019337 | — | — | 25 | 16 | 2 | — | 4 | 40 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 15 | 19 | 6 | — | 5 | 39 |
Show 58 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Blast crisis | D001752 | — | — | 8 | 18 | — | — | 1 | 25 |
| Myeloid leukemia accelerated phase | D015465 | — | — | 5 | 5 | — | — | 1 | 10 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | 2 | 8 | — | — | 2 | 10 |
| Graft vs host disease | D006086 | — | D89.81 | 1 | 7 | — | — | — | 7 |
| Plasmacytoma | D010954 | — | C90.3 | 2 | 5 | — | — | — | 7 |
| Prolymphocytic leukemia | D015463 | — | — | 5 | 3 | — | — | — | 5 |
| Primary myelofibrosis | D055728 | — | D47.4 | 3 | 3 | — | — | — | 5 |
| Neuroblastoma | D009447 | EFO_0000621 | — | 4 | 1 | — | — | — | 4 |
| Adult t-cell leukemia-lymphoma | D015459 | — | C91.5 | 1 | 2 | — | — | 1 | 4 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 1 | 1 | — | — | 2 | 4 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| T-cell lymphoma cutaneous | D016410 | — | C84.A | 1 | — | — | — | 2 | 3 |
| Pain | D010146 | EFO_0003843 | R52 | 1 | — | — | — | 1 | 2 |
| Chromosome aberrations | D002869 | Orphanet_68335 | — | 1 | — | — | — | 1 | 2 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | 1 | — | — | — | — | 1 |
| Neutrophilic leukemia chronic | D015467 | — | D47.1 | 1 | — | — | — | — | 1 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 1 | — | — | — | — | 1 |
| Esophageal neoplasms | D004938 | — | C15 | 1 | — | — | — | — | 1 |
| Rectal neoplasms | D012004 | — | — | 1 | — | — | — | — | 1 |
| Neoplasms by histologic type | D009370 | — | — | 1 | — | — | — | — | 1 |
| Germ cell and embryonal neoplasms | D009373 | — | — | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Extranodal nk-t-cell lymphoma | D054391 | — | C86.0 | — | — | — | — | 3 | 3 |
| Thalassemia | D013789 | EFO_1001996 | D56 | — | — | — | — | 2 | 2 |
| Sezary syndrome | D012751 | — | C84.1 | — | — | — | — | 2 | 2 |
| Mycosis fungoides | D009182 | — | C84.0 | — | — | — | — | 2 | 2 |
| Mucositis | D052016 | EFO_1001898 | — | — | — | — | — | 2 | 2 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | — | — | 2 | 2 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | — | — | — | — | 1 | 1 |
| Hemoglobin sc disease | D006450 | EFO_1001797 | D57.2 | — | — | — | — | 1 | 1 |
| Hemoglobin c disease | D006445 | — | D58.2 | — | — | — | — | 1 | 1 |
| Paroxysmal hemoglobinuria | D006457 | Orphanet_447 | D59.12 | — | — | — | — | 1 | 1 |
Show 37 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Cytarabine |
| INN | cytarabine |
| Description | Cytarabine is a pyrimidine nucleoside in which cytosine is attached to D-arabinofuranose via a beta-N(1)-glycosidic bond. Used mainly in the treatment of leukaemia, especially acute non-lymphoblastic leukaemia, cytarabine is an antimetabolite antineoplastic agent that inhibits the synthesis of DNA. It also has antiviral and immunosuppressant properties. It has a role as an antineoplastic agent, an antimetabolite, an antiviral agent and an immunosuppressive agent. It is a beta-D-arabinoside, a pyrimidine nucleoside and a monosaccharide derivative. It is functionally related to a cytosine. |
| Classification | Small molecule |
| Drug class | antineoplastics (arabinofuranosyl derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Nc1ccn([C@@H]2O[C@H](CO)[C@@H](O)[C@@H]2O)c(=O)n1 |
Identifiers
| PDB | — |
| CAS-ID | 147-94-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL803 |
| ChEBI ID | 28680 |
| PubChem CID | 6253 |
| DrugBank | DB00987 |
| UNII ID | 04079A1RDZ (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Depocyte – Pacira BioSciences
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Vyxeos – Jazz Pharmaceuticals
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Estimated US medical usage
Cytarabine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Trends
PubMed Central
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Additional graphs summarizing 46,252 documents
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Safety
Black-box Warning
Black-box warning for: Cytarabine, Vyxeos
Adverse Events
Top Adverse Reactions
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59,925 adverse events reported
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