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
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.
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. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| MITOMYCIN ACCORD mitomycin powder for injection 20mg vial | 243612 | Medicine | A | 3/8/2016 | |
| MITOMYCIN ACCORD mitomycin powder for injection 2mg vial | 243572 | Medicine | A | 3/8/2016 | |
| MITOCIN mitomycin 20 mg powder for injection vial | 370360 | Medicine | A | 7/25/2022 | |
| MITOMYCIN OMEGAPHARM mitomycin powder for injection 10mg vial | 243553 | Medicine | A | 3/8/2016 | |
| MITOMYCIN OMEGAPHARM mitomycin powder for injection 20mg vial | 243554 | Medicine | A | 3/8/2016 | |
| MITOMYCIN OMEGAPHARM mitomycin powder for injection 2mg vial | 243552 | Medicine | A | 3/8/2016 | |
| MITOMYCIN ACCORD mitomycin powder for injection 10mg vial | 243592 | 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 | 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. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.