MedPath

Mitomycins

Generic Name
Mitomycins
Brand Names
Jelmyto, Mitosol, Mutamycin
Drug Type
Small Molecule
Chemical Formula
C15H18N4O5
CAS Number
50-07-7
Unique Ingredient Identifier
50SG953SK6

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
2025/04/09
Phase 3
Not yet recruiting
2025/01/20
Phase 3
Not yet recruiting
Maimónides Biomedical Research Institute of Córdoba
2025/01/17
Phase 4
Not yet recruiting
Jakob Kristian Jakobsen
2025/01/13
Phase 2
Recruiting
2024/11/26
Phase 1
Recruiting
2024/11/20
Phase 3
Recruiting
Shaogang Wang
2024/11/08
Phase 3
Not yet recruiting
2024/07/22
Phase 3
Recruiting
2024/06/17
Phase 3
Active, not recruiting
2024/04/29
Phase 2
Recruiting

FDA Drug Approvals

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

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
02464691
Powder For Solution - Intravenous ,  Intravesical
20 MG / VIAL
4/30/2018
MITOMYCIN FOR INJECTION USP
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
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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