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AboutPricing
Drug ReportsMitomycin
Mitomycin
Jelmyto, Mitomycin, 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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Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
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
digestive system diseasesD004066
urogenital diseasesD000091642
endocrine system diseasesD004700
Trade Name
FDA
EMA
Jelmyto, Mitomycin, Mitosol, Zusduri (discontinued: Mitomycin, 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
MITOSOLGlaukosN-022572 RX2012-02-07
1 products, RLD, RS
JELMYTOUroGen PharmaN-211728 RX2020-04-15
1 products, RLD, RS
ZUSDURIUroGen PharmaN-215793 RX2025-06-12
1 products, RLD, RS
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
jelmytoNew Drug Application2025-07-09
mitomycinANDA2025-04-22
mitosolNew Drug Application2025-04-23
mutamycinANDA2025-03-12
zusduriNew Drug Application2025-06-20
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
colorectal neoplasms—D015179—
pancreatic neoplasmsEFO_0003860D010190C25
stomach neoplasmsEFO_0003897D013274C16
urinary bladder neoplasms—D001749C67
adenocarcinoma—D000230—
Agency Specific
FDA
EMA
Expiration
Code
MITOMYCIN, JELMYTO, UROGEN PHARMA
2027-04-15ODE-289
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
388 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CarcinomaD002277—C80.0—17—311
Urinary bladder neoplasmsD001749—C67—24—410
Transitional cell carcinomaD002295———17—210
Urologic neoplasmsD014571—C64-C68—15—39
Non-muscle invasive bladder neoplasmsD000093284———14—16
NeoplasmsD009369—C80—11—13
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Urologic diseasesD014570—N39.9—1——12
Urinary bladder diseasesD001745—N32.9—1——12
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Invasive hydatidiform moleD002820—D39.2————22
RecurrenceD012008——————22
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)
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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
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Jelmyto – UroGen Pharma
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 51,134 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,471 adverse events reported
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