Fludarabine phosphate
Fludarabine (fludarabine phosphate) is a small molecule pharmaceutical. Fludarabine phosphate was first approved as Fludara on 1991-04-18. It is used to treat b-cell chronic lymphocytic leukemia and non-hodgkin lymphoma in the USA.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Fludarabine (discontinued: Fludara, Fludarabine, Oforta)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| fludarabine | ANDA | 2024-10-14 |
| fludarabine phosphate | ANDA | 2023-02-14 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| non-hodgkin lymphoma | — | D008228 | C85.9 |
| b-cell chronic lymphocytic leukemia | — | D015451 | C91.1 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
Clinical
Clinical Trials
2497 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 | 7 | 8 | 1 | 1 | 1 | 13 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 2 | 4 | 1 | 1 | 2 | 8 |
| Lymphoid leukemia | D007945 | — | C91 | 1 | — | — | 1 | — | 2 |
| Thrombocytopenia | D013921 | HP_0001873 | D69.6 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloid leukemia acute | D015470 | — | C92.0 | 7 | 8 | 1 | — | — | 12 |
| Myelodysplastic syndromes | D009190 | — | D46 | 6 | 8 | 1 | — | — | 10 |
| Graft vs host disease | D006086 | — | D89.81 | 1 | 1 | 1 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 1 | 3 | — | — | — | 4 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 2 | 3 | — | — | — | 4 |
| Prolymphocytic leukemia | D015463 | — | — | 2 | 3 | — | — | 1 | 4 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 1 | 3 | — | — | — | 4 |
| Myeloid leukemia | D007951 | — | C92 | 3 | 3 | — | — | — | 4 |
| Preleukemia | D011289 | — | — | 3 | 2 | — | — | — | 3 |
| Hodgkin disease | D006689 | — | C81 | 1 | 2 | — | — | — | 2 |
| Syndrome | D013577 | — | — | 2 | 2 | — | — | — | 2 |
| Neoplasms | D009369 | — | C80 | 1 | 1 | — | — | — | 1 |
| Myelomonocytic leukemia chronic | D015477 | — | C93.1 | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| B-cell lymphoma | D016393 | — | — | 1 | — | — | — | — | 1 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | 1 | — | — | — | — | 1 |
| Diffuse scleroderma | D045743 | EFO_0000404 | — | 1 | — | — | — | — | 1 |
| Sclerosis | D012598 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| B-cell leukemia | D015448 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Fludarabine phosphate |
| INN | fludarabine |
| Description | (2R,3S,4S,5R)-2-(6-amino-2-fluoro-9-purinyl)-5-(hydroxymethyl)oxolane-3,4-diol is a purine nucleoside. |
| Classification | Small molecule |
| Drug class | antineoplastics (arabinofuranosyl derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Nc1nc(F)nc2c1ncn2[C@@H]1O[C@H](COP(=O)(O)O)[C@@H](O)[C@@H]1O |
Identifiers
| PDB | — |
| CAS-ID | 75607-67-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1096882 |
| ChEBI ID | 63599 |
| PubChem CID | 657237 |
| DrugBank | DB01073 |
| UNII ID | P2K93U8740 (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Trends
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Safety
Black-box Warning
Black-box warning for: Fludarabine, Fludarabine phosphate
Adverse Events
Top Adverse Reactions
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35,061 adverse events reported
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