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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
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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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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Labels
FDA
EMA
Brand Name
Status
Last Update
mitoxantroneANDA2024-10-15
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
397 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938—C95728847109197
Myeloid leukemia acuteD015470—C92.0545936410144
Myeloid leukemiaD007951—C9254573039135
Precursor cell lymphoblastic leukemia-lymphomaD054198——132163139
Lymphoid leukemiaD007945—C91102263137
Multiple sclerosisD009103EFO_0003885G35—421512
SclerosisD012598———421512
Promyelocytic leukemia acuteD015473—C92.4—143—8
Relapsing-remitting multiple sclerosisD020529EFO_0003929——3—126
Philadelphia chromosomeD010677——11—1—3
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223—C85.9195518—990
Myelodysplastic syndromesD009190—D4612149—132
Prostatic neoplasmsD011471—C617218——32
Non-hodgkin lymphomaD008228—C85.94158——26
PreleukemiaD011289——10109——25
SyndromeD013577——8117——22
RecurrenceD012008——982—219
NeoplasmsD009369—C801281——19
Large b-cell lymphoma diffuseD016403—C83.34121—317
T-cell lymphoma peripheralD016411——6101—316
Show 24 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
T-cell lymphomaD016399——69——415
Myelomonocytic leukemia acuteD015479—C92.595———13
Erythroblastic leukemia acuteD004915EFO_1001257C94.085———12
Megakaryoblastic leukemia acuteD007947—C94.284———11
Mantle-cell lymphomaD020522———6———6
Precursor t-cell lymphoblastic leukemia-lymphomaD054218——23———4
Biphenotypic leukemia acuteD015456—C95.033———4
Multiple myelomaD009101—C90.033———4
Plasma cell neoplasmsD054219——33———4
SarcomaD012509——22———4
Show 37 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hematologic diseasesD006402EFO_0005803D75.91————1
Stomach neoplasmsD013274EFO_0003897C161————1
Central nervous system neoplasmsD016543——1————1
Head and neck neoplasmsD006258——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hematopoietic stem cell transplantationD018380——————44
Classical conditioningD003214——————33
Large-cell lymphoma anaplasticD017728—C84.6————11
Drug therapyD004358——————11
Malignant mesotheliomaD000086002——————11
MesotheliomaD008654—C45————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
Image (chem structure or protein)Loading
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 19,806 documents
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Safety
Black-box Warning
Black-box warning for: Mitoxantrone
Adverse Events
Top Adverse Reactions
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7,548 adverse events reported
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