Drug · Small Molecule

Mitomycin

CI-DRUG-00000381Explore in graph →NCIt C1820 CHEMBL105 CIViC Approved

Regulatory

Approvals (12)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

openfdaRegulatory3 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	Non-Muscle Invasive Bladder Carcinoma	ZUSDURI™ is indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). ZUSDURI is an alkylating drug indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). ( 1 )	approved	Jun 12, 2025	openfda
US FDA	—	JELMYTO ® is indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC). JELMYTO is an alkylating drug indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC). ( 1 )	approved	Apr 15, 2020	openfda
US FDA	—	Mitosol ® is an antimetabolite indicated for use as an adjunct to ab externo glaucoma surgery. Mitosol ® is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery. ( 1 )	approved	Feb 7, 2012	openfda

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 18 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	37	22	47	128	12	CA, US	Oct 22, 1997	1991-09
Malignant Bladder Neoplasm	Approved	Phase 4	16	8	17	36	1	US	Jun 12, 2025	1991-09
Malignant Anal Neoplasm	Phase3	Phase 3	5	2	6	15	0	—	—	1998-10
Malignant Breast Neoplasm	Phase3	Phase 3	1	0	1	2	0

Curated evidence

Clinical evidence (7)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–7 of 7 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
TP53 R273C1
Cisplatin + Etoposide

Clinical trials

Trials with this intervention (129)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 129 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT06770582	Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial	recruiting	Phase 2	160	National Cancer Institute (NCI)NIH	2	Sep 28, 2026	clinicaltrials
NCT06919965	A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer

Molecule

Record

Kind: Small Molecule
Mechanism: DNA inhibitor
UNII: 50SG953SK6
Aliases: [1aS-(1a Alpha,8beta,8a Alpha,8b Alpha)]-6-amino-8-[[(aminocarbonyl)oxy]methyl]-1,1a,2,8,8a,8b-hexahydro-8a-methoxy-5-methylazirino[2',3':3,4]pyrrolo[1,2-a]indole-4,7-dione, (1aS,8S,8aR,8bS)-6-Amino-8-[[(aminocarbonyl)oxy]methyl]-1,1a,2,8,8a,8b-hexahydro-8a-methoxy-5-methylazirino[2',3':3,4]pyrrolo[1,2-a]indole-4,7-dione, Ametycine, Jelmyto, JELMYTO, MITO, MITO-C, Mitocin, Mitocin-C, Mitolem, Mito-Medac, Mitomicina, Mitomycin, Mitomycin c, MITOMYCIN C, Mitomycine, Mitomycine C, Mitomycin Pyelocalyceal, Mitomycin-X, Mitosol, MITOSOL, Mitozytrex, Muamycin, Mutamycin, MUTAMYCIN, Mutamycine, Mytozytrex, NCI-C04706, NSC-26980, UGN-101 … (+3)

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (19)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01DC03	MITOMYCIN
DIN (Health Canada)	00381799