Mitomycin

Summary

Mitomycin (CHEMBL105) is an approved small-molecule antineoplastic agent (ATC L01DC03); indicated across 44 conditions including neoplasm and adenocarcinoma; with CIViC clinical evidence for 7 variant-indication associations (e.g. TP53 Overexpression in stomach cancer).

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Small molecule
• ATC class: L01DC03
• Indications: 44 conditions
• Clinical trials: 194
• Precision-oncology evidence (CIViC): 7 variant–indication associations
• Chemistry: 334.33 Da · C15H18N4O5

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL105
Name	Mitomycin
Type	Small molecule
Max phase	4
FDA approved	yes
PubChem CID	5746
ChEBI	CHEBI:27504
ATC	L01DC03
Molecular formula	C15H18N4O5
Molecular weight	334.33
InChIKey	NWIBSHFKIJFRCO-WUDYKRTCSA-N

SMILES: CC1=C(C(=O)C2=C(C1=O)N3C[C@H]4[C@@H]([C@@]3([C@@H]2COC(=O)N)OC)N4)N

IUPAC name: [(4S,6S,7R,8S)-11-amino-7-methoxy-12-methyl-10,13-dioxo-2,5-diazatetracyclo[7.4.0.02,7.04,6]trideca-1(9),11-dien-8-yl]methyl carbamate

Pharmacological roles (ChEBI): antineoplastic agent, alkylating agent.

Also known as: Ametycine, Jelmyto, Mitocin-c, Mitomicina, Mitomycin, Mitomycin c, Mitomycin-c, Mitomycine, Mitosol, Mitozytrex, Muamycin, Mutamycin

Patent coverage: 58,904 distinct patent families (233,273 SureChEMBL compound mentions), from 1 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

Broader ChEMBL bioactivity targets: 1 (assay-derived). Sample: Indoleamine 2,3-dioxygenase 1.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

44 indications (4 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
neoplasm	4	MONDO:0005070	EFO:0000616
adenocarcinoma	4	MONDO:0004970	EFO:0000228
glaucoma	4	MONDO:0005041	MONDO:0005041
urinary bladder neoplasm	3	MONDO:0004987	EFO:0000294
carcinoma	3	MONDO:0004993	EFO:0000313
hepatocellular carcinoma	3	MONDO:0007256	EFO:0000182
mesothelioma	3	MONDO:0005065	EFO:0000588
exocrine pancreatic carcinoma	3	MONDO:0005192	EFO:0002618
non-small cell lung carcinoma	3	MONDO:0005233	EFO:0003060
anus neoplasm	3	MONDO:0003046	EFO:0003835
transitional cell carcinoma	3	MONDO:0006474	EFO:1000601
urothelial carcinoma	3	MONDO:0040679	EFO:0008528
head and neck cancer	3	MONDO:0005627	EFO:0006859
gastric neoplasm	3	MONDO:0021085	MONDO:0001056
in situ carcinoma	3	MONDO:0004647	MONDO:0004647
breast neoplasm	3	MONDO:0021100	MONDO:0007254
lung neoplasm	3	MONDO:0021117	MONDO:0008903
colorectal neoplasm	3	MONDO:0005335	MONDO:0005575
nasopharyngeal carcinoma	3	MONDO:0015459	MONDO:0015459
pterygium	2	MONDO:0005085	EFO:0000678
sclerosing cholangitis	2	MONDO:0018646	EFO:0004268
head and neck squamous cell carcinoma	2	MONDO:0010150	EFO:0000181
sarcoma	2	MONDO:0005089	EFO:0000691
open-angle glaucoma	2	MONDO:0005338	EFO:0004190
cholangiocarcinoma	2	MONDO:0019087	EFO:0005221
neovascular glaucoma	2	MONDO:0019783	EFO:1001060
urethral stricture	2	MONDO:0002127	HP:0012227
appendiceal neoplasm	2	MONDO:0001236	MONDO:0001235
keratoconus	2	MONDO:0015486	MONDO:0015486
myopia	1	MONDO:0001384	HP:0000545
leukemia	1	MONDO:0005059	EFO:0000565
chronic kidney disease	1	MONDO:0005300	MONDO:0024327

12 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 194.

Phase distribution

Phase	Trials
PHASE2	65
PHASE3	57
PHASE1	20
Not specified	19
PHASE4	14
PHASE1/PHASE2	8
PHASE2/PHASE3	7
EARLY_PHASE1	4

Top trials by phase / activity

NCT	Phase	Status	Title
NCT06781879	PHASE4	RECRUITING	Chemoablation Or Bladder Resection With Adjuvant Chemotherapy in Recurrent Non-Muscle Invasive Bladder Cancer
NCT00346489	PHASE4	COMPLETED	Outcomes of Intraoperative 5-Fluorouracil Versus Mitomycin C
NCT00599950	PHASE4	TERMINATED	Anterior Stromal Changes After PRK by Using Intraoperative Mitomicin C
NCT00666237	PHASE4	COMPLETED	Primary Tube Versus Trabeculectomy Study
NCT02015650	PHASE4	TERMINATED	Cetuximab Compared to Mitomycin-C and 5-Fluorouracil for Locally Advanced Squamous Cell Carcinomas of the Head and Neck
NCT02199327	PHASE4	COMPLETED	Topical Interferon Alfa 2b and Mitomycin C in Conjunctival-Corneal Intraepithelial Neoplasia
NCT02641132	PHASE4	UNKNOWN	Pterygium Head Body MMC1: Two Different Surgical Procedures and Their Effect on Endothelial Cell Count.
NCT03101501	PHASE4	TERMINATED	A Prospective Study To Evaluate The Raindrop Near Vision Inlay In Presybopic or Pseudophakic Patients Treated With Mitomycin C Following Femtosecond Flap Creation.
NCT03126877	PHASE4	UNKNOWN	A Prospective Study to Evaluate the Raindrop Near Vision Inlay in Presbyopic Patients With Treatments to Optimize the Ocular Surface Before Implantation
NCT03242317	PHASE4	UNKNOWN	A Prospective Study to Evaluate the Raindrop Near Vision Inlay With Mitomycin C
NCT03348969	PHASE4	COMPLETED	Neoadjuvant Short-term Intensive Chemoresection Versus Standard Adjuvant Intravesical Instillations in NMIBC
NCT03790384	PHASE4	UNKNOWN	Sequential Combination Therapy in Bladder Cancer
NCT03875911	PHASE4	TERMINATED	Comparing Preoperative Injection of Mitomycin-C vs. Intraoperative Injection of Mitomycin-C vs. Topical Application of Mitomycin-C (Conventional Use) in Trabeculectomy
NCT04352660	PHASE4	COMPLETED	Subconjunctival Versus Direct Mitomycin C in Trabeculectomy
NCT03775265	PHASE3	ACTIVE_NOT_RECRUITING	Chemoradiotherapy With or Without Atezolizumab in Treating Patients With Localized Muscle Invasive Bladder Cancer
NCT04241185	PHASE3	ACTIVE_NOT_RECRUITING	Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992)
NCT05243550	PHASE3	ACTIVE_NOT_RECRUITING	A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
NCT05902533	PHASE2/PHASE3	ACTIVE_NOT_RECRUITING	REDEL Trial: Reduced Elective Nodal Dose for Anal Cancer Toxicity Mitigation
NCT06211764	PHASE3	ACTIVE_NOT_RECRUITING	A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)
NCT06319820	PHASE3	RECRUITING	A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer
NCT06462001	PHASE3	ACTIVE_NOT_RECRUITING	BCG + MMC: Adding Mitomycin C to BCG in High-risk, Non-muscle-invasive Bladder Cancer
NCT06513065	PHASE3	RECRUITING	Study to Evaluate the Non-inferiority of Low-dose HIPEC Versus High-dose HIPEC in the Treatment of PMP (HIPEC-PMP)
NCT06680245	PHASE3	NOT_YET_RECRUITING	Effect of Mitomycin-C on the Outcomes of Patients Receiving Ahmed Glaucoma Valve Implantation Surgery
NCT06696794	PHASE3	RECRUITING	Investigating the Efficacy and Safety of Neoadjuvant Intravesical Instillation of Mitomycin C in Treating High-risk NMIBC Patients
NCT06783491	PHASE3	NOT_YET_RECRUITING	Efficacy of the Use of Neoadjuvant With/Without Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Colon Cancer
NCT06919965	PHASE3	RECRUITING	A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer
NCT07097142	PHASE3	RECRUITING	Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients Receiving the Usual Chemotherapy Treatment for Bladder Cancer, ARCHER Study
NCT07271355	PHASE3	NOT_YET_RECRUITING	Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colorectal Cancer With Peritoneal Metastases, The IMPACT Trial
NCT07424287	PHASE3	NOT_YET_RECRUITING	A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC
NCT07566156	PHASE3	RECRUITING	Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer ( EV-309 )
NCT00002490	PHASE3	COMPLETED	Radiation Therapy, Chemotherapy, or Observation in Treating Patients With Bladder Cancer
NCT00002507	PHASE3	COMPLETED	Radiation Therapy and Chemotherapy in Treating Patients With Head and Neck Cancer
NCT00003159	PHASE3	COMPLETED	Surgery With or Without Preoperative Chemotherapy in Treating Patients With Resectable Non-small Cell Lung Cancer
NCT00003209	PHASE3	COMPLETED	Radiation Therapy With or Without Chemotherapy After Surgery in Treating Patients With Stage IB or Stage IIA Cervical Cancer
NCT00003240	PHASE3	UNKNOWN	Standard Therapy Given With or Without Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer
NCT00003596	PHASE3	COMPLETED	Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer
NCT00003893	PHASE3	COMPLETED	Adjuvant Chemotherapy Plus Radiation Therapy in Treating Women With Early-Stage Breast Cancer
NCT00004209	PHASE3	UNKNOWN	Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
NCT00004887	PHASE3	UNKNOWN	Paclitaxel and Carboplatin Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer That Cannot Be Removed During Surgery
NCT00005870	PHASE3	UNKNOWN	Nitrocamptothecin Compared With Other Chemotherapy in Treating Patients With Recurrent or Refractory Cancer of the Pancreas

Clinical evidence (CIViC)

Variant × indication × effect (7 predictive associations from 7 curated evidence items):

Variant	Indication	Effect	Therapy	Level	CIViC
TP53 Overexpression	Stomach Cancer	Sensitivity/Response	Cisplatin + Mitomycin + Etoposide	CIViC B	EID2799
PALB2 Biallelic Inactivation	Pancreatic Cancer	Sensitivity/Response	Mitomycin	CIViC C	EID1305
TP53 R273C	Stomach Carcinoma	Sensitivity/Response	Etoposide + Mitomycin + Cisplatin	CIViC C	EID2292
TP53 Y220C	Stomach Carcinoma	Sensitivity/Response	Mitomycin + Cisplatin + Etoposide	CIViC C	EID2306
BRCA2 Loss-of-function	Pancreatic Cancer	Sensitivity/Response	Mitomycin	CIViC D	EID1308
FANCC Loss-of-function	Pancreatic Cancer	Sensitivity/Response	Cisplatin + Melphalan + Chlorambucil + Mitomycin + Gemcitabine	CIViC D	EID1307
RB1 Overexpression	Pancreatic Adenocarcinoma	Resistance	Doxorubicin + Fluorouracil + Gemcitabine + Mitomycin	CIViC D	EID1324

Pharmacology

Pharmacogenomics

No CPIC/DPWG dosing guideline or drug-level clinical/variant annotations in PharmGKB for this molecule.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).