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 | unapproved drug for use in drug shortage | 2023-07-25 |
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
2325 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 | 405 | 547 | 99 | 16 | 60 | 951 |
| Lymphoma | D008223 | — | C85.9 | 281 | 318 | 36 | 3 | 41 | 578 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 178 | 248 | 57 | 6 | 26 | 443 |
| Myeloid leukemia | D007951 | — | C92 | 167 | 244 | 46 | 5 | 24 | 413 |
| Lymphoid leukemia | D007945 | — | C91 | 178 | 217 | 42 | 7 | 22 | 395 |
| Myelodysplastic syndromes | D009190 | — | D46 | 125 | 260 | 25 | 2 | 29 | 386 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 175 | 192 | 19 | 5 | 24 | 351 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 119 | 181 | 36 | 3 | 15 | 306 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 158 | 163 | 16 | 1 | 21 | 298 |
| Multiple myeloma | D009101 | — | C90.0 | 125 | 139 | 11 | 1 | 26 | 268 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 188 | 144 | 5 | — | 16 | 297 |
| Hematologic neoplasms | D019337 | — | — | 78 | 117 | 4 | — | 19 | 187 |
| Plasma cell neoplasms | D054219 | — | — | 93 | 77 | 9 | — | 16 | 175 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 32 | 111 | 7 | — | 11 | 141 |
| Hodgkin disease | D006689 | — | C81 | 46 | 83 | 3 | — | 13 | 125 |
| Melanoma | D008545 | — | — | 58 | 64 | 2 | — | 2 | 107 |
| Follicular lymphoma | D008224 | — | C82 | 38 | 55 | 12 | — | 5 | 99 |
| Mantle-cell lymphoma | D020522 | — | C83.1 | 41 | 54 | 9 | — | 6 | 94 |
| Anemia | D000740 | EFO_0004272 | D64.9 | 26 | 62 | 10 | — | 12 | 88 |
| Myelomonocytic leukemia juvenile | D054429 | — | C93.3 | 28 | 50 | 1 | — | 6 | 72 |
Show 47 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Carcinoma | D002277 | — | C80.0 | 59 | 27 | — | — | 4 | 72 |
| T-cell lymphoma | D016399 | — | — | 27 | 34 | — | — | 5 | 57 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 46 | 22 | — | — | — | 56 |
| Plasmacytoma | D010954 | — | C90.3 | 15 | 30 | — | — | 9 | 50 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 34 | 25 | — | — | — | 46 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 28 | 22 | — | — | 3 | 42 |
| Precursor t-cell lymphoblastic leukemia-lymphoma | D054218 | — | — | 36 | 16 | — | — | — | 39 |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | 10 | 21 | — | — | 9 | 37 |
| T-cell lymphoma peripheral | D016411 | — | — | 18 | 21 | — | — | 4 | 36 |
| Systemic lupus erythematosus | D008180 | EFO_0002690 | M32 | 35 | 8 | — | — | — | 36 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Rhabdoid tumor | D018335 | — | — | 4 | — | — | — | — | 4 |
| Female genital neoplasms | D005833 | — | — | 4 | — | — | — | — | 4 |
| Small cell lung carcinoma | D055752 | — | — | 3 | — | — | — | — | 3 |
| Wilms tumor | D009396 | EFO_0000212 | — | 3 | — | — | — | — | 3 |
| Nervous system diseases | D009422 | — | G00-G99 | 3 | — | — | — | — | 3 |
| Autoimmune diseases of the nervous system | D020274 | — | — | 3 | — | — | — | — | 3 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 3 | — | — | — | — | 3 |
| Chronic progressive multiple sclerosis | D020528 | EFO_0003840 | — | 3 | — | — | — | — | 3 |
| Ependymoma | D004806 | — | — | 2 | — | — | — | — | 2 |
| Gastrointestinal stromal tumors | D046152 | EFO_0000505 | C49.A | 2 | — | — | — | — | 2 |
Show 58 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Abnormal karyotype | D059786 | — | — | — | — | — | — | 1 | 1 |
| Hemoglobin c disease | D006445 | — | D58.2 | — | — | — | — | 1 | 1 |
| Mucositis | D052016 | EFO_1001898 | — | — | — | — | — | 1 | 1 |
| Type 1 hyper-igm immunodeficiency syndrome | D053307 | — | — | — | — | — | — | 1 | 1 |
| Hereditary congenital and neonatal diseases and abnormalities | D009358 | — | — | — | — | — | — | 1 | 1 |
| Blastic plasmacytoid dendritic cell neoplasm | D000099067 | — | C86.4 | — | — | — | — | 1 | 1 |
| Primary graft dysfunction | D055031 | — | — | — | — | — | — | 1 | 1 |
| Antiphospholipid syndrome | D016736 | EFO_0002689 | D68.61 | — | — | — | — | 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
Adverse Events
Top Adverse Reactions
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31,919 adverse events reported
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