Mitoxantrone
Mitoxantrone (mitoxantrone) is a small molecule pharmaceutical. Mitoxantrone was first approved as Novantrone on 1987-12-23. It is used to treat breast neoplasms, lymphoma, multiple sclerosis, myeloid leukemia acute, and pain amongst others in the USA. It is known to target DNA topoisomerase 2-alpha.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Mitoxantrone (discontinued: Mitoxantrone, Novantrone)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Mitoxantrone hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| NOVANTRONE | EMD Serono | N-019297 DISCN | 1987-12-23 | 3 products, RLD |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| mitoxantrone | ANDA | 2025-07-14 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J9293 | Injection, mitoxantrone hydrochloride, per 5 mg |
Clinical
Clinical Trials
407 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 | 58 | 71 | 37 | 8 | 8 | 158 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 53 | 65 | 36 | 4 | 8 | 146 |
| Myeloid leukemia | D007951 | — | C92 | 46 | 44 | 22 | 2 | 6 | 104 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 13 | 21 | 6 | 3 | 1 | 39 |
| Lymphoid leukemia | D007945 | — | C91 | 5 | 17 | 4 | 3 | 1 | 27 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | 3 | 2 | 1 | 5 | 11 |
| Promyelocytic leukemia acute | D015473 | — | C92.4 | — | 1 | 4 | 3 | — | 8 |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | — | 3 | — | 1 | 2 | 6 |
| Philadelphia chromosome | D010677 | — | — | 1 | 1 | — | 1 | — | 3 |
| Neuromyelitis optica | D009471 | EFO_0004256 | G36.0 | — | 1 | — | 2 | — | 3 |
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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 | 16 | 48 | 19 | — | 7 | 80 |
| Prostatic neoplasms | D011471 | — | C61 | 7 | 21 | 8 | — | — | 32 |
| Myelodysplastic syndromes | D009190 | — | D46 | 12 | 14 | 8 | — | 1 | 31 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 4 | 14 | 8 | — | — | 25 |
| Recurrence | D012008 | — | — | 9 | 13 | 1 | — | 3 | 24 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 4 | 13 | 2 | — | 3 | 19 |
| T-cell lymphoma peripheral | D016411 | — | — | 7 | 12 | 2 | — | 3 | 19 |
| Monocytic leukemia acute | D007948 | — | — | 9 | 7 | 2 | — | — | 16 |
| Neoplasms | D009369 | — | C80 | 11 | 6 | 1 | — | — | 16 |
| T-cell lymphoma | D016399 | — | — | 6 | 10 | 1 | — | 3 | 16 |
Show 38 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mantle-cell lymphoma | D020522 | — | C83.1 | — | 6 | — | — | — | 6 |
| Carcinoma | D002277 | — | C80.0 | 2 | 3 | — | — | — | 5 |
| Biphenotypic leukemia acute | D015456 | — | C95.0 | 3 | 4 | — | — | 1 | 5 |
| Multiple myeloma | D009101 | — | C90.0 | 3 | 4 | — | — | — | 5 |
| Sarcoma | D012509 | — | — | 2 | 3 | — | — | — | 5 |
| Plasma cell neoplasms | D054219 | — | — | 3 | 3 | — | — | — | 4 |
| Hypereosinophilic syndrome | D017681 | EFO_1001467 | D72.11 | 2 | 1 | — | — | — | 3 |
| Precursor t-cell lymphoblastic leukemia-lymphoma | D054218 | — | — | 1 | 3 | — | — | — | 3 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | — | 3 | — | — | — | 3 |
| Blast crisis | D001752 | — | — | — | 2 | — | — | — | 2 |
Show 30 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | 1 | — | — | — | — | 1 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 1 | — | — | — | — | 1 |
| Central nervous system neoplasms | D016543 | — | — | 1 | — | — | — | — | 1 |
| Head and neck neoplasms | D006258 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hematopoietic stem cell transplantation | D018380 | — | — | — | — | — | — | 4 | 4 |
| Classical conditioning | D003214 | — | — | — | — | — | — | 3 | 3 |
| Drug therapy | D004358 | — | — | — | — | — | — | 1 | 1 |
| Malignant mesothelioma | D000086002 | — | — | — | — | — | — | 1 | 1 |
| Mesothelioma | D008654 | — | C45 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Mitoxantrone |
| INN | mitoxantrone |
| Description | Mitoxantrone is a dihydroxyanthraquinone that is 1,4-dihydroxy-9,10-anthraquinone which is substituted by 6-hydroxy-1,4-diazahexyl groups at positions 5 and 8. It has a role as an antineoplastic agent and an analgesic. |
| Classification | Small molecule |
| Drug class | antineoplastics, anthraquinone derivatives |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C1c2c(O)ccc(O)c2C(=O)c2c(NCCNCCO)ccc(NCCNCCO)c21 |
Identifiers
| PDB | — |
| CAS-ID | 65271-80-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL58 |
| ChEBI ID | 50729 |
| PubChem CID | 4212 |
| DrugBank | DB01204 |
| UNII ID | BZ114NVM5P (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
TOP2A
TOP2A
Organism
Homo sapiens
Gene name
TOP2A
Gene synonyms
TOP2
NCBI Gene ID
Protein name
DNA topoisomerase 2-alpha
Protein synonyms
DNA gyrase, DNA topoisomerase (ATP-hydrolyzing), DNA topoisomerase II, 170 kD, DNA topoisomerase II, alpha isozyme, topoisomerase (DNA) II alpha 170kDa
Uniprot ID
Mouse ortholog
Top2a (21973)
DNA topoisomerase 2-alpha (Q01320)
Variants
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Financial
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Trends
PubMed Central
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Additional graphs summarizing 21,156 documents
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Safety
Black-box Warning
Black-box warning for: Mitoxantrone
Adverse Events
Top Adverse Reactions
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7,779 adverse events reported
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