Cytarabine, Depocyte(cytarabine)
Cytosar-u, DepoCyte, Depocyt, 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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Drugs Approved for Childhood Cancers
Commercial
Trade Name
FDA
EMA
Combinations
Vyxeos
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Cytarabine
Cytarabine
+
Daunorubicin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VYXEOS | Celator Pharmaceuticals | N-209401 RX | 2017-08-03 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cytarabine | ANDA | 2023-05-31 |
| vyxeos | New Drug Application | 2021-04-13 |
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
1112 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloid leukemia acute | D015470 | C92.0 | 187 | 232 | 74 | 11 | 14 | 438 | |
| Leukemia | D007938 | C95 | 57 | 118 | 63 | 2 | 9 | 220 | |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 49 | 88 | 37 | 18 | 8 | 175 | |
| Myelodysplastic syndromes | D009190 | D46 | 58 | 89 | 17 | 1 | 6 | 140 | |
| Non-hodgkin lymphoma | D008228 | C85.9 | 15 | 32 | 2 | 1 | 5 | 46 | |
| Large b-cell lymphoma diffuse | D016403 | C83.3 | 8 | 23 | 5 | 1 | 1 | 33 | |
| Mantle-cell lymphoma | D020522 | C83.1 | 8 | 23 | 2 | 1 | 1 | 29 | |
| Burkitt lymphoma | D002051 | C83.7 | 6 | 13 | — | 2 | 1 | 17 | |
| Promyelocytic leukemia acute | D015473 | C92.4 | 4 | 2 | 5 | 3 | — | 13 | |
| Hematologic neoplasms | D019337 | 4 | 3 | — | 1 | — | 7 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | C85.9 | 17 | 80 | 26 | — | 10 | 129 | |
| Myeloid leukemia | D007951 | C92 | 17 | 16 | 7 | — | 2 | 38 | |
| Monocytic leukemia acute | D007948 | 15 | 15 | 6 | — | 2 | 35 | ||
| Myelomonocytic leukemia acute | D015479 | C92.5 | 15 | 14 | 5 | — | 2 | 34 | |
| Erythroblastic leukemia acute | D004915 | EFO_1001257 | C94.0 | 15 | 12 | 5 | — | 2 | 32 |
| Megakaryoblastic leukemia acute | D007947 | C94.2 | 14 | 12 | 5 | — | 2 | 31 | |
| Hodgkin disease | D006689 | C81 | 8 | 13 | 4 | — | 4 | 24 | |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | 9 | 13 | 2 | — | — | 21 | |
| Myelomonocytic leukemia chronic | D015477 | C93.1 | 10 | 8 | 1 | — | 2 | 18 | |
| Philadelphia chromosome | D010677 | 3 | 9 | 2 | — | — | 12 |
Show 18 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Biphenotypic leukemia acute | D015456 | C95.0 | 8 | 10 | — | — | 1 | 15 | |
| Plasma cell neoplasms | D054219 | 2 | 6 | — | — | 1 | 9 | ||
| Neoplasms | D009369 | C80 | 5 | 4 | — | — | 1 | 8 | |
| Follicular lymphoma | D008224 | C82 | 4 | 7 | — | — | 1 | 8 | |
| B-cell lymphoma | D016393 | 4 | 3 | — | — | — | 7 | ||
| B-cell chronic lymphocytic leukemia | D015451 | C91.1 | 1 | 5 | — | — | 1 | 6 | |
| Myeloproliferative disorders | D009196 | D47.1 | 2 | 4 | — | — | 1 | 6 | |
| Precursor t-cell lymphoblastic leukemia-lymphoma | D054218 | 4 | 2 | — | — | — | 5 | ||
| Primary myelofibrosis | D055728 | D47.4 | 3 | 2 | — | — | — | 4 | |
| Myeloid leukemia chronic-phase | D015466 | — | 4 | — | — | — | 4 |
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Indications Phases 1
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | — | — | — | — | 1 | 1 |
| Hemoglobin sc disease | D006450 | EFO_1001797 | D57.2 | — | — | — | — | 1 | 1 |
| Extranodal nk-t-cell lymphoma | D054391 | C86.0 | — | — | — | — | 1 | 1 | |
| B-cell lymphoma marginal zone | D018442 | C88.4 | — | — | — | — | 1 | 1 | |
| Adult t-cell leukemia-lymphoma | D015459 | C91.5 | — | — | — | — | 1 | 1 | |
| Hairy cell leukemia | D007943 | C91.4 | — | — | — | — | 1 | 1 | |
| Intraocular lymphoma | D064090 | — | — | — | — | 1 | 1 | ||
| Large granular lymphocytic leukemia | D054066 | — | — | — | — | 1 | 1 | ||
| Large-cell lymphoma immunoblastic | D016400 | — | — | — | — | 1 | 1 | ||
| Lymphomatoid granulomatosis | D008230 | C83.8 | — | — | — | — | 1 | 1 |
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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 | 3041 |
| ChEMBL ID | CHEMBL803 |
| ChEBI ID | 28680 |
| PubChem CID | 6253 |
| DrugBank | DB00987 |
| UNII ID | 04079A1RDZ (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Depocyte - Pacira BioSciences
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Vyxeos - Jazz Pharmaceuticals
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Trends
PubMed Central
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Additional graphs summarizing 25,743 documents
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Safety
Black-box Warning
Black-box warning for: Cytarabine, Vyxeos
Adverse Events
Top Adverse Reactions
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2,329 adverse events reported
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