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
411 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Autoimmune diseases | D001327 | EFO_0000540 | M30-M36 | — | — | — | 1 | — | 1 |
| Nervous system diseases | D009422 | — | G00-G99 | — | — | — | 1 | — | 1 |
| Autoimmune diseases of the nervous system | D020274 | — | — | — | — | — | 1 | — | 1 |
| Neuromyelitis optica | D009471 | EFO_0004256 | G36.0 | — | — | — | 1 | — | 1 |
| Transverse myelitis | D009188 | — | G37.3 | — | — | — | 1 | — | 1 |
| Myelitis | D009187 | — | G04.91 | — | — | — | 1 | — | 1 |
| Cns demyelinating autoimmune diseases | D020278 | EFO_1000870 | G37 | — | — | — | 1 | — | 1 |
Indications Phases 3
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Indications Phases 2
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Indications Phases 1
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | — | — | — | 1 | 1 |
| Sclerosis | D012598 | — | — | — | — | — | — | 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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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Mitoxantrone
Adverse Events
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7,851 adverse events reported
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