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Drug ReportsMitoxantrone
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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Target
Variants
Financial
Trends
Safety
Events Timeline
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YTD
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2Y
5Y
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FDA approval date
EMA approval date
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Study first post date
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Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
nervous system diseasesD009422
urogenital diseasesD000091642
hemic and lymphatic diseasesD006425
skin and connective tissue diseasesD017437
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
psychological phenomenaD011579
musculoskeletal and neural physiological phenomenaD055687
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
NOVANTRONEEMD SeronoN-019297 DISCN1987-12-23
3 products, RLD
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FDA
EMA
Brand Name
Status
Last Update
mitoxantroneANDA2025-01-20
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01D: Cytotoxic antibiotics and related substances
— L01DB: Anthracyclines and related substances
— L01DB07: Mitoxantrone
HCPCS
Code
Description
J9293
Injection, mitoxantrone hydrochloride, per 5 mg
Clinical
Clinical Trials
398 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 diseasesD001327EFO_0000540M30-M36———1—1
Nervous system diseasesD009422—G00-G99———1—1
Autoimmune diseases of the nervous systemD020274—————1—1
Neuromyelitis opticaD009471EFO_0004256G36.0———1—1
Transverse myelitisD009188—G37.3———1—1
MyelitisD009187—G04.91———1—1
Cns demyelinating autoimmune diseasesD020278EFO_1000870G37———1—1
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple sclerosisD009103EFO_0003885G35————11
SclerosisD012598——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMitoxantrone
INNmitoxantrone
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 classantineoplastics, anthraquinone derivatives
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Structure (InChI/SMILES or Protein Sequence)
O=C1c2c(O)ccc(O)c2C(=O)c2c(NCCNCCO)ccc(NCCNCCO)c21
Identifiers
PDB—
CAS-ID65271-80-9
RxCUI—
ChEMBL IDCHEMBL58
ChEBI ID50729
PubChem CID4212
DrugBankDB01204
UNII IDBZ114NVM5P (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
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 20,145 documents
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Safety
Black-box Warning
Black-box warning for: Mitoxantrone
Adverse Events
Top Adverse Reactions
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7,623 adverse events reported
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