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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Commercial
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Trade Name
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Jelmyto, Mitomycin, Mitosol, Zusduri (discontinued: Mitomycin, Mitozytrex, Mutamycin)
Drug Products
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New Drug Application (NDA)
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Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Mitomycin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| MITOSOL | Glaukos | N-022572 RX | 2012-02-07 | 1 products, RLD, RS |
| JELMYTO | UroGen Pharma | N-211728 RX | 2020-04-15 | 1 products, RLD, RS |
| ZUSDURI | UroGen Pharma | N-215793 RX | 2025-06-12 | 1 products, RLD, RS |
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| colorectal neoplasms | — | D015179 | — |
| pancreatic neoplasms | EFO_0003860 | D010190 | C25 |
| stomach neoplasms | EFO_0003897 | D013274 | C16 |
| urinary bladder neoplasms | — | D001749 | C67 |
| adenocarcinoma | — | D000230 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
MITOMYCIN, JELMYTO, UROGEN PHARMA | |||
| 2027-04-15 | ODE-289 | ||
Clinical
Clinical Trials
388 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Urinary bladder neoplasms | D001749 | — | C67 | 1 | 1 | — | — | — | 1 |
| Invasive hydatidiform mole | D002820 | — | D39.2 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
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Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Mitomycin |
| INN | mitomycin |
| 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 class | antibiotics (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-ID | 50-07-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL105 |
| ChEBI ID | 27504 |
| PubChem CID | 5746 |
| DrugBank | DB00305 |
| UNII ID | 50SG953SK6 (ChemIDplus, GSRS) |
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Jelmyto – UroGen Pharma
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Zusduri – UroGen Pharma
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Safety
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3,471 adverse events reported
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