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.

health-canada-dpdRegulatory12 approval records from 2 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as MITOMYCIN FOR INJECTION, USP (DIN 02531941) under ATC L01DC03 MITOMYCIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Feb 27, 2023	health-canada-dpd
CA Health Canada	—	Marketed in Canada as MITOMYCIN FOR INJECTION USP (DIN 02464691) under ATC L01DC03 MITOMYCIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Apr 30, 2018	health-canada-dpd
CA Health Canada	—	Marketed in Canada as MITOMYCIN FOR INJECTION USP (DIN 02237745) under ATC L01DC03 MITOMYCIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Feb 28, 2020

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 20 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