Overview

Mitomycin is an antineoplastic antibiotic first isolated by Japanese microbiologists in the 1950s from cultures of Streptomyces caespitosus. It is an alkylating agent that inhibits DNA synthesis (and, at higher concentrations, RNA and protein synthesis) by cross-linking the complementary strands of the DNA double helix. Few other antibiotics have been discovered that work via this alkylating mechanism, making mitomycin relatively unique in the space of microbiota-derived therapies. Mitomycin's cross-linking activity has resulted in its approval for the treatment of a variety of cancers - the most recent of which is an April 2020 approval for its use in low-grade Upper Tract Urothelial Cancer (LG-UTUC) - as well as adjunctly to ab externo glaucoma surgeries.

Indication

For treatment of malignant neoplasm of lip, oral cavity, pharynx, digestive organs, peritoneum, female breast, and urinary bladder. Also used as an adjunct to ab externo glaucoma surgery. Mitomycin is also indicated as a pyelocalyceal solution for the treatment of adults with low-grade upper tract urothelial cancer (LG-UTUC).

Associated Conditions

Anal Cancer
Bladder Cancer
Breast Cancer
Carcinoma of the Head and Neck
Cervical Cancer
Gastric Adenocarcinoma
Mesothelioma
Non-Small Cell Lung Cancer (NSCLC)
Pancreatic Adenocarcinoma
Ab externo surgery Glaucoma
Low-grade Upper Tract Urothelial Cancer (LG-UTUC)

Research Report

Published: Jul 23, 2025

Mitomycin (DB00305): A Comprehensive Monograph on its Pharmacology, Clinical Utility, and Evolving Therapeutic Landscape

Executive Summary

Mitomycin is a potent antineoplastic antibiotic belonging to the mitomycin family of natural products, first isolated from the bacterium Streptomyces caespitosus. As a prototypical bioreductive alkylating agent, its mechanism of action is contingent upon intracellular enzymatic reduction, a process that converts the relatively inert prodrug into a highly reactive bifunctional electrophile. This activated form, a mitosene, subsequently forms covalent interstrand cross-links within the DNA double helix, primarily at 5'-CpG-3' sequences. This action physically obstructs DNA replication and transcription, leading to cell cycle arrest and apoptosis, particularly in rapidly dividing cells.

The clinical trajectory of mitomycin is a compelling narrative of pharmaceutical evolution. Initially developed as a systemic agent for the palliative treatment of advanced gastrointestinal malignancies, such as stomach and pancreatic adenocarcinomas, its use was historically constrained by significant, dose-limiting toxicities, including cumulative myelosuppression and hemolytic uremic syndrome (HUS). This duality between profound efficacy and severe toxicity has been the central challenge and, paradoxically, the primary driver of innovation in its application. Over decades, the focus has shifted dramatically from systemic administration to highly specialized, localized therapies that maximize therapeutic benefit while minimizing systemic exposure.

Continue reading the full research report

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer	2025/04/09	NCT06919965	Phase 3	Not yet recruiting	Janssen Research & Development, LLC
Efficacy of the Use of Neoadjuvant With/without Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Colon Cancer	2025/01/20	NCT06783491	Phase 3	Not yet recruiting	Maimónides Biomedical Research Institute of Córdoba
Chemoablation or Bladder Resection with Adjuvant Chemotherapy in Recurrent Non-Muscle Invasive Bladder Cancer	2025/01/17	NCT06781879	Phase 4	Not yet recruiting	Jakob Kristian Jakobsen
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	2025/01/13	NCT06770582	Phase 2	Recruiting	National Cancer Institute (NCI)
In-home Intravesical Chemotherapy for the Treatment of Bladder Cancer, INVITE Trial	2024/11/26	NCT06704191	Phase 1	Recruiting	Mayo Clinic
Investigating the Efficacy and Safety of Neoadjuvant Intravesical Instillation of Mitomycin C in Treating High-risk NMIBC Patients	2024/11/20	NCT06696794	Phase 3	Recruiting	Shaogang Wang
Effect of Mitomycin-C on the Outcomes of Patients Receiving Ahmed Glaucoma Valve Implantation Surgery	2024/11/08	NCT06680245	Phase 3	Not yet recruiting	St. Joseph's Healthcare Hamilton
Study to Evaluate the Non-inferiority of Low-dose HIPEC Versus High-dose HIPEC in the Treatment of PMP (HIPEC-PMP)	2024/07/22	NCT06513065	Phase 3	Recruiting	University of Southampton
BCG + MMC: Adding Mitomycin C to BCG in High-risk, Non-muscle-invasive Bladder Cancer	2024/06/17	NCT06462001	Phase 3	Active, not recruiting	Nottingham University Hospitals NHS Trust
The Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy	2024/04/29	NCT06388720	Phase 2	Recruiting	National Cancer Center, Korea

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Mitomycin	Hikma Pharmaceuticals USA Inc.	0143-9280	INTRAVENOUS	40 mg in 80 mL	5/15/2023
Mitomycin	Accord Healthcare Inc	16729-116	INTRAVENOUS	40 mg in 80 mL	8/22/2023
Mitomycin	Hikma Pharmaceuticals USA Inc.	0143-9136	INTRAVENOUS	40 mg in 1 1	9/27/2022
MITOMYCIN	Eugia US LLC	55150-452	INTRAVENOUS	40 mg in 80 mL	4/12/2023
MITOMYCIN	Meitheal Pharmaceuticals Inc.	71288-138	INTRAVENOUS	20 mg in 40 mL	9/8/2022
MITOMYCIN	Fresenius Kabi USA, LLC	65219-568	INTRAVENOUS	40 mg in 80 mL	11/23/2022
MITOMYCIN	Gland Pharma Limited	68083-483	INTRAVENOUS	5 mg in 10 mL	10/22/2021
Mitomycin	Hikma Pharmaceuticals USA Inc.	0143-9135	INTRAVENOUS	20 mg in 1 1	9/27/2022
MITOMYCIN	Gland Pharma Limited	68083-484	INTRAVENOUS	20 mg in 40 mL	10/22/2021
MITOMYCIN	Gland Pharma Limited	68083-502	INTRAVENOUS	40 mg in 80 mL	11/23/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
MITOMYCIN ACCORD mitomycin powder for injection 20mg vial	243612	Omegapharm	Medicine	A	3/8/2016
MITOMYCIN ACCORD mitomycin powder for injection 2mg vial	243572	Omegapharm	Medicine	A	3/8/2016
MITOCIN mitomycin 20 mg powder for injection vial	370360	Echo Therapeutics Pty Ltd	Medicine	A	7/25/2022
MITOMYCIN OMEGAPHARM mitomycin powder for injection 10mg vial	243553	Omegapharm	Medicine	A	3/8/2016
MITOMYCIN OMEGAPHARM mitomycin powder for injection 20mg vial	243554	Omegapharm	Medicine	A	3/8/2016
MITOMYCIN OMEGAPHARM mitomycin powder for injection 2mg vial	243552	Omegapharm	Medicine	A	3/8/2016
MITOMYCIN ACCORD mitomycin powder for injection 10mg vial	243592	Omegapharm	Medicine	A	3/8/2016

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
MITOMYCIN FOR INJECTION, USP	hikma canada limited	02531941	Powder For Solution - Intravenous , Intravesical	20 MG / VIAL	2/27/2023
MUTAMYCIN INJ 5MG/VIAL	bristol-myers squibb canada	00381799	Powder For Solution - Intravenous , Intravesical	0.5 MG / ML	12/31/1977
MITOMYCIN FOR INJECTION	teva canada limited	02230450	Powder For Solution - Intravenous , Intravesical	5 MG / VIAL	10/22/1997
MITOMYCIN FOR INJECTION	teva canada limited	02230451	Powder For Solution - Intravenous , Intravesical	20 MG / VIAL	10/22/1997
MITOMYCIN FOR INJECTION USP	Accord Healthcare Inc	02464691	Powder For Solution - Intravenous , Intravesical	20 MG / VIAL	4/30/2018
MITOMYCIN FOR INJECTION USP	Pfizer Canada Ulc	02230729	Powder For Solution - Intravesical , Intravenous	20 MG / VIAL	3/12/1998
MITOMYCIN FOR INJECTION	eugia pharma inc.	02557762	Powder For Solution - Intravenous , Intravesicular	20 MG / VIAL	N/A
MUTAMYCIN INJ 20MG/VIAL	bristol-myers squibb canada	00587710	Powder For Solution - Intravenous , Intravesical	20 MG / VIAL	12/31/1984
MITOMYCIN FOR INJECTION USP	Pfizer Canada Ulc	02237745	Powder For Solution - Intravesical , Intravenous	5 MG / VIAL	7/15/1998

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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