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Mitomycin
Jelmyto, Mitosol (mitomycin) is a small molecule pharmaceutical. Mitomycin was first approved as Mutamycin on 1982-01-01. It is used to treat adenocarcinoma, colorectal neoplasms, pancreatic neoplasms, stomach neoplasms, and urinary bladder neoplasms in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
digestive system diseasesD004066
urogenital diseasesD000091642
endocrine system diseasesD004700
Trade Name
FDA
EMA
Jelmyto, Mitosol (generic drugs available since 1995-04-19, discontinued: Mitozytrex, Mutamycin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Mitomycin
Tradename
Company
Number
Date
Products
MITOSOLMobius TherapeuticsN-022572 RX2012-02-07
1 products, RLD, RS
JELMYTOUroGen PharmaN-211728 RX2020-04-15
1 products, RLD, RS
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
jelmytoNew Drug Application2021-01-27
mitomycinANDA2023-05-24
mitosolNew Drug Application2021-04-23
mutamycinANDA2017-08-01
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
adenocarcinoma—D000230—
colorectal neoplasms—D015179—
pancreatic neoplasmsEFO_0003860D010190C25
stomach neoplasmsEFO_0003897D013274C16
urinary bladder neoplasms—D001749C67
Agency Specific
FDA
EMA
Expiration
Code
MITOMYCIN, JELMYTO, UROGEN PHARMA
2027-04-15ODE-289
2023-04-15NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Mitomycin, Jelmyto, Urogen Pharma
90400742031-01-20DP
99500692031-01-20DP
Mitomycin, Mitosol, Mobius Therap
96494282029-05-21U-2095
78062652029-02-01DP
95392412028-01-02DS, DPU-2095
81865112026-07-19DP
92050752026-07-19DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01D: Cytotoxic antibiotics and related substances
— L01DC: Other cytotoxic antibiotics in atc
— L01DC03: Mitomycin
HCPCS
Code
Description
J7315
Mitomycin, ophthalmic, 0.2 mg
J9280
Injection, mitomycin, 5 mg
J9281
Mitomycin pyelocalyceal instillation, 1 mg
Clinical
Clinical Trials
4 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Digeorge syndromeD004062D82.1—1———1
Psychotic disordersD011618F20.81—1———1
SarcomaD012509—1———1
Ewing sarcomaD012512EFO_0000173—1———1
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Feeding and eating disordersD001068F50————11
Bulimia nervosaD052018EFO_0005204F50.2————11
RewardD012201————11
Cocaine-related disordersD019970F14————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMITOMYCIN
INNmitomycin
Description
Mitomycin C is a mitomycin. It has a role as an antineoplastic agent and an alkylating agent. It is a conjugate acid of a mitomycin C(1-).
Classification
Small molecule
Drug classantibiotics (Streptomyces strain)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CO[C@@]12[C@H](COC(N)=O)C3=C(C(=O)C(C)=C(N)C3=O)N1C[C@@H]1N[C@@H]12
Identifiers
PDB—
CAS-ID50-07-7
RxCUI—
ChEMBL IDCHEMBL105
ChEBI ID27504
PubChem CID5746
DrugBankDB00305
UNII ID50SG953SK6 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Jelmyto - UroGen Pharma
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 43,002 documents
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Safety
Black-box Warning
Black-box warning for: Mitomycin
Adverse Events
Top Adverse Reactions
Mock data
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30 adverse events reported
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