Overview
A pyrimidine nucleoside analog that is used mainly in the treatment of leukemia, especially acute non-lymphoblastic leukemia. Cytarabine is an antimetabolite antineoplastic agent that inhibits the synthesis of DNA. Its actions are specific for the S phase of the cell cycle. It also has antiviral and immunosuppressant properties. (From Martindale, The Extra Pharmacopoeia, 30th ed, p472)
Indication
For the treatment of acute non-lymphocytic leukemia, acute lymphocytic leukemia and blast phase of chronic myelocytic leukemia. Cytarabine is indicated in combination with daunorubicin for the treatment of newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older.
Associated Conditions
- Acute Lymphoblastic Leukemia (ALL)
- Acute Myeloid Leukemia
- Acute Myeloid Leukemia With Myelodysplasia-Related Changes
- Acute Promyelocytic Leukemia
- Meningeal leukemia
- Metastatic Malignant Neoplasm to the Leptomeninges
- Non-Hodgkin's Lymphoma (NHL)
- Treatment-Related Acute Myeloid Leukemia
- Blast phase Chronic myeloid leukemia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/22 | Not Applicable | Recruiting | Beijing 302 Hospital | ||
2025/07/18 | Not Applicable | Not yet recruiting | |||
2025/07/11 | Not Applicable | Not yet recruiting | |||
2025/07/11 | Not Applicable | Not yet recruiting | Joanna Yi | ||
2025/07/08 | Not Applicable | Not yet recruiting | |||
2025/07/01 | Not Applicable | Not yet recruiting | |||
2025/06/24 | Phase 2 | Not yet recruiting | |||
2025/06/15 | Phase 3 | Not yet recruiting | |||
2025/06/10 | Phase 2 | Recruiting | yuejun Liu | ||
2025/06/06 | Phase 1 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Meitheal Pharmaceuticals Inc. | 71288-109 | INTRAVENOUS, INTRATHECAL, SUBCUTANEOUS | 2 g in 20 mL | 7/27/2020 | |
| Gland Pharma Limited | 68083-343 | INTRAVENOUS, INTRATHECAL, SUBCUTANEOUS | 20 mg in 1 mL | 7/13/2020 | |
| Sagent Pharmaceuticals | 25021-223 | INTRAVENOUS, INTRATHECAL, SUBCUTANEOUS | 100 mg in 1 mL | 5/22/2023 | |
| Hospira, Inc. | 61703-304 | INTRAVENOUS, SUBCUTANEOUS | 20 mg in 1 mL | 3/3/2023 | |
| Hospira, Inc. | 61703-305 | INTRAVENOUS, INTRATHECAL, SUBCUTANEOUS | 20 mg in 1 mL | 12/9/2022 | |
| Gland Pharma Limited | 68083-337 | INTRAVENOUS, INTRATHECAL, SUBCUTANEOUS | 100 mg in 1 mL | 7/14/2020 | |
| Hospira, Inc. | 61703-155 | INTRAVENOUS, INTRATHECAL, SUBCUTANEOUS | 100 mg in 1 mL | 4/7/2025 | |
| Hospira, Inc. | 61703-303 | INTRAVENOUS | 20 mg in 1 mL | 12/9/2022 | |
| Meitheal Pharmaceuticals Inc. | 71288-168 | INTRAVENOUS, SUBCUTANEOUS | 20 mg in 1 mL | 1/11/2022 | |
| Hospira, Inc. | 61703-319 | INTRAVENOUS, INTRATHECAL, SUBCUTANEOUS | 100 mg in 1 mL | 8/25/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 8/23/2018 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| CYBIN INJECTION 100mg/ml | Mylan Laboratories Limited [OTL] | SIN14293P | INJECTION, SOLUTION, CONCENTRATE | 100mg/ml | 1/16/2013 |
| CYTARABINE CS INJECTION 100 mg/ml | SIN05521P | INJECTION | 100 mg/ml | 3/5/1991 | |
| CYTARINE KABI SOLUTION FOR INJECTION OR INFUSION 100MG/ML | SIN17149P | INJECTION, SOLUTION | 100 mg/ml | 12/18/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| CYTARABINE KABI SOLUTION FOR INJECTION OR INFUSION 100MG/1ML | N/A | N/A | N/A | 4/29/2019 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| CYTARABINE ACCORD cytarabine 100 mg/1 mL injection vial | 297536 | Medicine | A | 4/16/2019 | |
| CYTARABINE ACCORD cytarabine 5000 mg/50 mL injection vial | 297543 | Medicine | A | 4/16/2019 | |
| Cytarabine Injection 100 mg/5 mL (8) | 405776 | Medicine | A | 3/6/2023 | |
| Cytarabine Injection 2 g/20 mL (6) | 405696 | Medicine | A | 3/3/2023 | |
| Cytarabine Injection 1 g/10 mL (7) | 405010 | Medicine | A | 2/17/2023 | |
| Pfizer (Australia) CYTARABINE 100mg/5mL injection vial | 11351 | Medicine | A | 8/13/1991 | |
| Cytarabine Injection 100 mg/5 mL (1) | 283424 | Medicine | A | 12/12/2016 | |
| Cytarabine Injection 100 mg/5 mL (4) | 405190 | Medicine | A | 2/21/2023 | |
| Cytarabine Injection 500 mg/25 mL (2) | 404972 | Medicine | A | 2/17/2023 | |
| Cytarabine Injection 2 g/20 mL (1) | 283859 | Medicine | A | 12/20/2016 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| PMS-CYTARABINE | 02406764 | Solution - Intravenous
,
Subcutaneous
,
Intrathecal | 20 MG / ML | 1/16/2014 | |
| CYTARABINE INJECTION BP | 02394901 | Solution - Intravenous
,
Intrathecal
,
Subcutaneous | 100 MG / ML | N/A | |
| VYXEOS | 02515490 | Powder - Intravenous | 100 MG | 7/6/2021 | |
| CYTARABINE INJ 100MG/ML | david bull laboratories (pty) ltd. | 00885797 | Liquid - Subcutaneous
,
Intravenous | 100 MG / ML | 12/31/1992 |
| CYTARABINE - PWS 2GM/VIAL | novopharm limited | 02167891 | Powder For Solution - Subcutaneous
,
Intrathecal
,
Intravenous | 2 G / VIAL | 12/31/1995 |
| PMS-CYTARABINE | 02406772 | Solution - Subcutaneous
,
Intravenous
,
Intrathecal | 100 MG / ML | 1/16/2014 | |
| CYTARABINE INJECTION | Sterimax Inc | 02515296 | Solution - Subcutaneous
,
Intrathecal
,
Intravenous | 100 MG / ML | 4/21/2022 |
| CYTOSAR | 00646296 | Powder For Solution - Intrathecal
,
Intravenous
,
Subcutaneous | 1 G / VIAL | 12/31/1986 | |
| CYTOSAR | 02403811 | Solution - Subcutaneous
,
Intrathecal
,
Intravenous | 20 MG / ML | N/A | |
| CYTOSAR | 02403838 | Solution - Subcutaneous
,
Intrathecal
,
Intravenous | 100 MG / ML | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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