Cyclophosphamide
Cytoxan, Neosar (cyclophosphamide) is a small molecule pharmaceutical. Cyclophosphamide was first approved as Cytoxan on 1982-01-01. It is used to treat b-cell chronic lymphocytic leukemia, BCR-ABL positive chronic myelogenous leukemia, breast neoplasms, burkitt lymphoma, and endometrial neoplasms amongst others in the USA.
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Drugs Approved for Childhood Cancers
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| neoplasms | D009369 |
| musculoskeletal diseases | D009140 |
| respiratory tract diseases | D012140 |
| nervous system diseases | D009422 |
| eye diseases | D005128 |
| urogenital diseases | D000091642 |
| cardiovascular diseases | D002318 |
| hemic and lymphatic diseases | D006425 |
| skin and connective tissue diseases | D017437 |
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Trade Name
FDA
EMA
Cytoxan (generic drugs available since 2008-05-21, discontinued: Cytoxan (lyophilized), Lyophilized cytoxan, Neosar)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Cyclophosphamide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CYTOXAN | Baxter | N-012141 RX | 1982-01-01 | 2 products, RLD |
| CYCLOPHOSPHAMIDE | Eugia Pharma Specialties | N-210735 RX | 2021-08-25 | 2 products, RLD, RS |
| CYCLOPHOSPHAMIDE | Hikma Pharmaceuticals | N-203856 RX | 2013-09-16 | 2 products, RLD, RS |
| CYCLOPHOSPHAMIDE | Ingenus | N-212501 RX | 2020-07-30 | 3 products, RLD, RS |
Show 6 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cyclophosphamide | ANDA | 2022-07-31 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| b-cell chronic lymphocytic leukemia | — | D015451 | C91.1 |
| bcr-abl positive chronic myelogenous leukemia | EFO_0000340 | D015464 | — |
| breast neoplasms | EFO_0003869 | D001943 | C50 |
| burkitt lymphoma | — | D002051 | C83.7 |
| endometrial neoplasms | EFO_0004230 | D016889 | — |
| ewing sarcoma | EFO_0000173 | D012512 | — |
| granulomatosis with polyangiitis | EFO_0005297 | D014890 | M31.3 |
| hemolytic anemia autoimmune | EFO_1001264 | D000744 | D59.10 |
| hemosiderosis | — | D006486 | — |
| hodgkin disease | — | D006689 | C81 |
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Agency Specific
FDA
EMA
No data
Clinical
Clinical Trials
3120 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 79 | 272 | 154 | 13 | 42 | 510 |
| Lymphoma | D008223 | C85.9 | 71 | 229 | 57 | 2 | 24 | 351 | |
| Leukemia | D007938 | C95 | 59 | 182 | 49 | 1 | 20 | 281 | |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 87 | 150 | 42 | 14 | 13 | 265 | |
| Multiple myeloma | D009101 | C90.0 | 79 | 129 | 25 | 2 | 7 | 212 | |
| Myelodysplastic syndromes | D009190 | D46 | 63 | 142 | 17 | 2 | 15 | 211 | |
| Non-hodgkin lymphoma | D008228 | C85.9 | 76 | 109 | 12 | 2 | 10 | 177 | |
| B-cell chronic lymphocytic leukemia | D015451 | C91.1 | 48 | 88 | 16 | 3 | 4 | 142 | |
| Large b-cell lymphoma diffuse | D016403 | C83.3 | 59 | 83 | 25 | 2 | 3 | 141 | |
| Plasma cell neoplasms | D054219 | 13 | 52 | 6 | 1 | 7 | 77 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloid leukemia acute | D015470 | C92.0 | 61 | 101 | 19 | — | 9 | 168 | |
| Neoplasms | D009369 | C80 | 95 | 67 | 6 | — | 5 | 141 | |
| Melanoma | D008545 | 62 | 65 | 1 | — | 2 | 106 | ||
| Neuroblastoma | D009447 | EFO_0000621 | 37 | 37 | 19 | — | 5 | 93 | |
| Hodgkin disease | D006689 | C81 | 23 | 60 | 13 | — | 7 | 91 | |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 41 | 45 | 5 | — | 2 | 76 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | 18 | 59 | 5 | — | 4 | 75 | |
| Triple negative breast neoplasms | D064726 | 22 | 50 | 11 | — | 1 | 70 | ||
| B-cell lymphoma | D016393 | 41 | 27 | 3 | — | 2 | 65 | ||
| Sarcoma | D012509 | 24 | 27 | 12 | — | 1 | 59 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 21 | 27 | — | — | 3 | 38 |
| Colorectal neoplasms | D015179 | 16 | 17 | — | — | 1 | 26 | ||
| Fallopian tube neoplasms | D005185 | 15 | 12 | — | — | 1 | 25 | ||
| B-cell lymphoma marginal zone | D018442 | C88.4 | 7 | 13 | — | — | 2 | 20 | |
| Myeloid leukemia chronic-phase | D015466 | 5 | 15 | — | — | — | 18 | ||
| Prostatic neoplasms | D011471 | C61 | 14 | 7 | — | — | — | 18 | |
| Osteosarcoma | D012516 | 11 | 5 | — | — | — | 15 | ||
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 13 | 8 | — | — | — | 14 |
| Prolymphocytic leukemia | D015463 | 3 | 11 | — | — | 1 | 14 | ||
| Skin neoplasms | D012878 | EFO_0004198 | C44 | 3 | 12 | — | — | — | 13 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Primitive neuroectodermal tumors | D018242 | 2 | — | — | — | 1 | 3 | ||
| Clear cell sarcoma | D018227 | 3 | — | — | — | — | 3 | ||
| Hepatoblastoma | D018197 | C22.2 | 3 | — | — | — | — | 3 | |
| Liposarcoma | D008080 | 3 | — | — | — | — | 3 | ||
| Myasthenia gravis | D009157 | EFO_0004991 | G70.0 | 2 | — | — | — | — | 2 |
| Endodermal sinus tumor | D018240 | 2 | — | — | — | — | 2 | ||
| Adrenocortical carcinoma | D018268 | 2 | — | — | — | — | 2 | ||
| Nausea | D009325 | HP_0002018 | R11.0 | 1 | — | — | — | — | 1 |
| Pinealoma | D010871 | 1 | — | — | — | — | 1 | ||
| Deltaretrovirus infections | D006800 | EFO_1001303 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chediak-higashi syndrome | D002609 | Orphanet_167 | D72.0 | — | — | — | — | 3 | 3 |
| Hemoglobin sc disease | D006450 | EFO_1001797 | D57.2 | — | — | — | — | 2 | 2 |
| Cognitive dysfunction | D060825 | G31.84 | — | — | — | — | 2 | 2 | |
| Pure red-cell aplasia | D012010 | HP_0012410 | — | — | — | — | 2 | 2 | |
| Trophoblastic neoplasms | D014328 | — | — | — | — | 1 | 1 | ||
| Fatigue | D005221 | HP_0012378 | R53.83 | — | — | — | — | 1 | 1 |
| Ataxia telangiectasia | D001260 | Orphanet_100 | G11.3 | — | — | — | — | 1 | 1 |
| Hyper-igm immunodeficiency syndrome | D053306 | Orphanet_101088 | D80.5 | — | — | — | — | 1 | 1 |
| Proteinuria | D011507 | HP_0000093 | R80 | — | — | — | — | 1 | 1 |
| Ototoxicity | D000081015 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | CYCLOPHOSPHAMIDE |
| INN | cyclophosphamide |
| Description | Cyclophosphamide is a phosphorodiamide that is 1,3,2-oxazaphosphinan-2-amine 2-oxide substituted by two 2-chloroethyl groups at the amino nitrogen atom. It has a role as a carcinogenic agent, an alkylating agent, an immunosuppressive agent, an antineoplastic agent, an antirheumatic drug, an environmental contaminant, a xenobiotic and a drug allergen. It is a phosphorodiamide, a nitrogen mustard and an organochlorine compound. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | O.O=P1(N(CCCl)CCCl)NCCCO1 |
Identifiers
| PDB | — |
| CAS-ID | 6055-19-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1200796 |
| ChEBI ID | 4026 |
| PubChem CID | 2907 |
| DrugBank | DB00531 |
| UNII ID | 6UXW23996M (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
0 adverse events reported
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