Last reviewed 2026-05-31 · How we verify

Mitomycin-C/ 5-Fluorouracil

Mitomycin-C/ 5-Fluorouracil is a Chemotherapy combination (alkylating agent + antimetabolite) Small molecule drug developed by Medical University Innsbruck. It is currently FDA-approved for Colorectal cancer, Gastric cancer, Pancreatic cancer.

This combination of mitomycin-C and 5-fluorouracil works by inhibiting DNA synthesis and cell division through complementary mechanisms of alkylating damage and antimetabolite activity.

Mitomycin-C and 5-Fluorouracil are used in combination with other treatments, such as radiation and chemoradiation, for conditions including muscle invasive bladder cancer and stage II bladder cancer. The exact mechanism of action of these drugs is not specified in the provided facts, but they are studied in clinical trials for various cancer indications.

At a glance

Mechanism of action

Mitomycin-C is an alkylating agent that cross-links DNA strands, preventing replication and transcription. 5-Fluorouracil (5-FU) is a pyrimidine antimetabolite that inhibits thymidylate synthase and gets incorporated into RNA and DNA, disrupting nucleotide synthesis. Together, they provide synergistic cytotoxic effects against rapidly dividing cancer cells.

Approved indications

• Colorectal cancer
• Gastric cancer
• Pancreatic cancer
• Biliary tract cancer

Common side effects

• Myelosuppression (neutropenia, thrombocytopenia)
• Nausea and vomiting
• Diarrhea
• Mucositis
• Anemia
• Hand-foot syndrome
• Cardiotoxicity

Key clinical trials

• Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer (PHASE2)
• Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies (PHASE1)
• 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 (PHASE2)
• Chemoradiotherapy With or Without Atezolizumab in Treating Patients With Localized Muscle Invasive Bladder Cancer (PHASE3)
• Perioperative Systemic Therapy for Isolated Resectable Colorectal Peritoneal Metastases (PHASE2, PHASE3)
• Lower-Dose Chemoradiation in Treating Patients With Early-Stage Anal Cancer, the DECREASE Study (PHASE2)
• HPV ctDNA Response-Adapted Chemoradiation +/- Retifanlimab Treatment in Advanced-Stage Anal Cancer (PHASE2)
• Concurrent Chemoradiation + 5-FU + Mitomycin-C in Anal Carcinoma (EARLY_PHASE1)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Mitomycin-C/ 5-Fluorouracil CI brief — competitive landscape report
• Mitomycin-C/ 5-Fluorouracil updates RSS · CI watch RSS
• Medical University Innsbruck portfolio CI

Frequently asked questions about Mitomycin-C/ 5-Fluorouracil

Related

• Drug class: All Chemotherapy combination (alkylating agent + antimetabolite) drugs
• Manufacturer: Medical University Innsbruck — full pipeline
• Therapeutic area: All drugs in Oncology
• Indication: Drugs for Colorectal cancer
• Indication: Drugs for Gastric cancer
• Indication: Drugs for Pancreatic cancer

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing