Product Description
Mitomycin is used in combination with other medications to treat cancer of the stomach or pancreas that has spread to other parts of the body and has not improved or worsened after treatment with other medications, surgery, or radiation therapy. Mitomycin is a type of antibiotic that is only used in cancer chemotherapy. It slows or stops the growth of cancer cells in your body. (Sourced from: https://medlineplus.gov/druginfo/meds/a682415.html)
Mechanisms of Action: DNA Polymerase Inhibitor, Mitosis Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Intravenous, Topical
FDA Designation: *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Brazil | Bulgaria | Canada | Chile | China | Colombia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Ireland | Israel | Italy | Korea | Latvia | Lithuania | Malta | Mexico | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela
Approved Indications: None
Known Adverse Events: None
Company: UroGen Pharma
Company Location: RA'ANANA L3 4365007
Company CEO: Elizabeth Barrett
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Austria, Bulgaria, Estonia, France, Georgia, Germany, Hungary, Israel, Latvia, Lithuania, Netherlands, Poland, Romania, Serbia, Spain, United States
Active Clinical Trial Count: 21
Recent & Upcoming Milestones
- Clinical Outcomes Reported - UroGen Pharma presented P3 Bladder Cancer results on 2025-07-28 for Mitomycin
- Clinical Outcomes Reported - UroGen Pharma presented P2 Bladder Cancer|Muscle Cancer results on 2025-07-21 for Mitomycin
- Clinical Outcomes Reported - UroGen Pharma presented P3 Bladder Cancer results on 2025-06-02 for Mitomycin
Highest Development Phases
Phase 3: Bladder Cancer|Muscle Cancer|Squamous Cell Carcinoma|Transitional Cell Carcinoma
Phase 2: Adenocarcinoma|Anal Cancer|Anus Cancer|Head and Neck Cancer|Hepatocellular Carcinoma|Kidney Transplant|Ovarian Cancer|Pancreatic Cancer|Pancreatic Ductal Carcinoma
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
2021-000561-33 |
2021-000561-33 | P2 |
Active, not recruiting |
Kidney Transplant |
2026-03-08 |
|||
2017-000086-74 |
2017-000086-74 | P2 |
Completed |
Squamous Cell Carcinoma|Head and Neck Cancer |
2024-11-12 |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
2019-000922-23 |
TACE with Irinotecan and Mitomycin C in HCC | P2 |
Completed |
Hepatocellular Carcinoma |
2023-11-22 |
2025-06-23 |
Treatments |
|
NCT06331299 |
UTOPIA | P3 |
Recruiting |
Bladder Cancer|Transitional Cell Carcinoma|Muscle Cancer |
2025-08-01 |
48% |
2025-04-10 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT02701088 |
CANAL-IMRT-01 | P2 |
Active, not recruiting |
Anal Cancer|Anus Cancer |
2021-06-25 |
2% |
2022-12-09 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT06478862 |
PROM-2301 | P2 |
Active, not recruiting |
Adenocarcinoma|Ovarian Cancer|Pancreatic Cancer|Pancreatic Ductal Carcinoma |
2026-06-01 |
2% |
2025-05-08 |
|
2023-506680-34-00 |
BL011 | P3 |
Active, not recruiting |
Muscle Cancer|Bladder Cancer |
2028-07-17 |
2025-05-02 |
Treatments |
|
2023-503718-66-00 |
Study-AB03 | P3 |
Temporary halt |
Bladder Cancer |
2028-06-30 |
55% |
2025-05-02 |
Treatments |
2024-519343-15-00 |
UT002 | P3 |
Not yet recruiting |
Transitional Cell Carcinoma |
2027-09-30 |
16% |
||
2023-507261-25-00 |
BL013 | P3 |
Recruiting |
Muscle Cancer|Bladder Cancer |
2026-04-30 |
2025-05-02 |
||
NCT06774131 |
LG-UTUC | P3 |
Recruiting |
Transitional Cell Carcinoma |
2026-03-31 |
16% |
2025-07-24 |
Primary Endpoints|Start Date|Treatments|Trial Status |
2012-000559-15 |
FLUORESCENCE CYSTOSCOPY AND OPTIMIZED MMC IN RECURRENT BLADDER CANCER (FINNBLADDER 9) | P3 |
Completed |
Bladder Cancer|Transitional Cell Carcinoma |
2024-12-09 |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
2020-003541-11 |
A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer(ATLAS) | P3 |
Active, not recruiting |
Bladder Cancer|Muscle Cancer |
2024-04-15 |
2022-03-13 |
Treatments |
|
NCT05243550 |
ENVISION | P3 |
Active, not recruiting |
Muscle Cancer|Bladder Cancer|Transitional Cell Carcinoma |
2023-04-26 |
22% |
2024-11-05 |
Patient Enrollment|Primary Endpoints|Treatments |
NCT05136898 |
BL010 | P3 |
Completed |
Muscle Cancer|Bladder Cancer|Transitional Cell Carcinoma |
2023-02-02 |
33% |
2023-12-13 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
2016-002163-34 |
2016-002163-34 | P3 |
Active, not recruiting |
Squamous Cell Carcinoma |
2022-11-28 |
2022-03-13 |
Treatments |
|
2024-513446-12-00 |
TOL-2 | P2 |
Recruiting |
Kidney Transplant |
2028-11-01 |
2025-05-02 |
Treatments |
|
NCT03844256 |
CRIMI | P2 |
Recruiting |
Bladder Cancer |
2024-07-01 |
66% |
2022-08-13 |
Primary Endpoints |
2011-005436-26 |
2011-005436-26 | P2 |
Active, not recruiting |
Unknown |
2015-02-09 |
|||
NCT07097142 |
ARCHER | P3 |
Not yet recruiting |
Bladder Cancer |
2030-05-31 |
2025-08-01 |
Primary Endpoints|Treatments |
|
2018-003520-37 |
Rad-IO | P3 |
Unknown status |
Muscle Cancer|Bladder Cancer |
2030-02-07 |
2022-03-13 |
Treatments |