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
Therapeutic Areas
Trade Name
FDA
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Jelmyto, Mitomycin, Mitosol (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 |
|---|---|---|---|---|
| MITOSOL | Mobius Therapeutics | N-022572 RX | 2012-02-07 | 1 products, RLD, RS |
| JELMYTO | UroGen Pharma | N-211728 RX | 2020-04-15 | 1 products, RLD, RS |
Show 2 discontinued
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
MITOMYCIN, JELMYTO, UROGEN PHARMA | |||
| 2027-04-15 | ODE-289 | ||
Clinical
Clinical Trials
366 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Urinary bladder neoplasms | D001749 | — | C67 | 8 | 23 | 30 | 3 | 12 | 71 |
| Carcinoma | D002277 | — | C80.0 | 9 | 27 | 26 | 3 | 11 | 70 |
| Glaucoma | D005901 | EFO_0000516 | H40 | 5 | 10 | 11 | 11 | 36 | 67 |
| Neoplasms | D009369 | — | C80 | 8 | 12 | 10 | 1 | 5 | 34 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 5 | 14 | 5 | 1 | 4 | 25 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 4 | 10 | 8 | 1 | 3 | 24 |
| Open-angle glaucoma | D005902 | EFO_0004190 | H40.1 | 2 | 2 | 2 | 4 | 12 | 22 |
| Peritoneal neoplasms | D010534 | — | — | 2 | 10 | 3 | 1 | 3 | 18 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | 2 | 6 | 7 | 1 | 2 | 16 |
| Squamous cell carcinoma | D002294 | — | — | 2 | 9 | 2 | 1 | 2 | 14 |
Show 18 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | — | — | 3 | 13 | 7 | — | 7 | 27 |
| Anus neoplasms | D001005 | EFO_0003835 | C21 | 6 | 16 | 8 | — | 1 | 26 |
| Non-muscle invasive bladder neoplasms | D000093284 | — | — | 2 | 6 | 13 | — | 3 | 24 |
| Transitional cell carcinoma | D002295 | — | — | 2 | 4 | 9 | — | 3 | 17 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 3 | 6 | 4 | — | 3 | 16 |
| Hyperthermia | D000084462 | — | — | 3 | 7 | 4 | — | 1 | 14 |
| Urologic neoplasms | D014571 | — | C64-C68 | — | 3 | 6 | — | 3 | 12 |
| Fever | D005334 | HP_0001945 | R50.9 | 2 | 7 | 2 | — | 1 | 11 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | 7 | 1 | — | 1 | 10 |
| Pathologic constriction | D003251 | — | — | 1 | 3 | 1 | — | 6 | 9 |
Show 38 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Appendiceal neoplasms | D001063 | EFO_0003880 | C18.1 | 2 | 5 | — | — | 3 | 10 |
| Adenocarcinoma | D000230 | — | — | 2 | 3 | — | — | 1 | 6 |
| Sarcoma | D012509 | — | — | — | 4 | — | — | 1 | 5 |
| Esophageal stenosis | D004940 | HP_0010450 | K22.2 | — | 1 | — | — | 4 | 5 |
| Gastrointestinal neoplasms | D005770 | — | C26.9 | 2 | 3 | — | — | — | 4 |
| Pleural neoplasms | D010997 | — | — | 1 | 1 | — | — | 1 | 3 |
| Uterine neoplasms | D014594 | EFO_0003859 | C55 | 1 | 1 | — | — | 1 | 3 |
| Syndrome | D013577 | — | — | 1 | 1 | — | — | — | 2 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | 1 | — | — | — | 2 |
| Blister | D001768 | — | — | — | 1 | — | — | 1 | 2 |
Show 30 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Eye diseases | D005128 | EFO_0003966 | H44 | 1 | — | — | — | 2 | 3 |
| Autonomic nervous system diseases | D001342 | EFO_0009532 | G90 | 1 | — | — | — | — | 1 |
| Esophageal diseases | D004935 | EFO_0009544 | K22.9 | 1 | — | — | — | — | 1 |
| Optic nerve injuries | D020221 | — | S04.01 | 1 | — | — | — | — | 1 |
| Leukemia | D007938 | — | C95 | 1 | — | — | — | — | 1 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 1 | — | — | — | — | 1 |
| Myeloid leukemia | D007951 | — | C92 | 1 | — | — | — | — | 1 |
| Dermatitis | D003872 | HP_0011123 | L30.9 | 1 | — | — | — | — | 1 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.9 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hydrophthalmos | D006871 | EFO_1000968 | Q15.0 | — | — | — | — | 4 | 4 |
| Lacrimal duct obstruction | D007767 | — | — | — | — | — | — | 2 | 2 |
| Intraocular pressure | D007429 | — | — | — | — | — | — | 2 | 2 |
| Pleural effusion | D010996 | HP_0002202 | J90 | — | — | — | — | 1 | 1 |
| Gallbladder neoplasms | D005706 | EFO_0004606 | C23 | — | — | — | — | 1 | 1 |
| Corneal diseases | D003316 | — | H18.9 | — | — | — | — | 1 | 1 |
| Iris diseases | D007499 | — | — | — | — | — | — | 1 | 1 |
| Deglutition disorders | D003680 | HP_0002015 | R13.1 | — | — | — | — | 1 | 1 |
| Mucocele | D009078 | — | — | — | — | — | — | 1 | 1 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | — | — | — | 1 | 1 |
Show 15 more
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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Safety
Black-box Warning
Black-box warning for: Mitomycin
Adverse Events
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3,065 adverse events reported
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