Drugs / Mitomycin
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Mitomycin

Developed for
urinary bladder cancer · urothelial carcinoma · peritoneal carcinomatosis · infiltrating bladder urothelial carcinoma · metastatic malignant neoplasm · anal canal squamous cell carcinoma · anal margin squamous cell carcinoma · appendix carcinoma
+35 more · colorectal cancer · colorectal carcinoma · gastric cancer · hepatocellular carcinoma · liver cancer · non-small cell lung carcinoma · renal pelvis/ureter urothelial carcinoma · sarcoma · superficial urinary bladder carcinoma · anal canal cancer · anus basaloid carcinoma · bladder carcinoma in situ · bronchial neoplasm · cervical cancer · cloacogenic carcinoma · colon carcinoma · gastric adenocarcinoma · gastroesophageal junction adenocarcinoma · malignant pleural mesothelioma · metastasis from malignant tumor of colon · neoplasm · neoplasm of mediastinum · non-invasive bladder urothelial carcinoma · pancreatic adenocarcinoma · pleural neoplasm · pseudomyxoma peritonei · respiratory system cancer · transitional cell carcinoma · ureter cancer · urethra transitional cell carcinoma · anal squamous cell carcinoma · corneal disorder · glaucoma · optic nerve disorder · urinary bladder carcinoma
Investigated by
National Cancer Institute (NCI) · UroGen Pharma Ltd. · City of Hope Medical Center · Australian and New Zealand Urogenital and Prostate Cancer Trials Group · Mayo Clinic · NRG Oncology
+40 more · Seoul National University Hospital · University of Bern · University of Rome Tor Vergata · University of Sydney · Aktion Bronchialkarzinom e.V. · American College of Radiology Imaging Network · Astex Pharmaceuticals, Inc. · Azienda Ospedaliera "Sant'Andrea" · Cancer Australia · Carmel Medical Center · Centre Hospitalier Universitaire Vaudois · Copenhagen University Hospital at Herlev · ECOG-ACRIN Cancer Research Group · Eastern Cooperative Oncology Group · Gynecologic Oncology Group · Halozyme Therapeutics · Haruhiko Fukuda · Hospital Centre Biel/Bienne · Loma Linda University · M.D. Anderson Cancer Center · Maimónides Biomedical Research Institute of Córdoba · Mario Negri Institute for Pharmacological Research · Medical Research Council · Ministry of Health, Labour and Welfare, Japan · National Center for Advancing Translational Sciences (NCATS) · Nottingham University Hospitals NHS Trust · Radiation Therapy Oncology Group · Roland Seiler-Blarer · Rutgers, The State University of New Jersey · Second Affiliated Hospital, School of Medicine, Zhejiang University · Shahid Beheshti University of Medical Sciences · Sociedad Española de Oncología Quirúrgica · Spanish Association of Surgeons (AEC) · Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) · Spitalzentrum Biel · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · University of Bari · University of Chicago · University of L'Aquila · University of Southampton

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) MITOMYCIN — 2009-08-11 fda.gov ↗
Approved US (FDA) MUTAMYCIN — 1981-08-24 fda.gov ↗

Trials 48

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 trials
Phase 1 NCT07349043 Jan 2026 → Oct 2027 expected colorectal cancer, peritoneal carcinomatosis Second Affiliated Hospital, School of Medicine, Zhejiang University Recruiting No outcome recorded
Phase 1 NCT04329494 Aug 2020 → Jan 2028 expected appendix carcinoma, gastric carcinoma, metastatic malignant neoplasm, ovarian carcinoma +2 City of Hope Medical Center Recruiting No outcome recorded
Phase 1 NCT02672865 Feb 2016 → Oct 2018 gastric cancer Loma Linda University Completed No outcome recorded
Phase 1 NCT01017640 Oct 2009 → May 2016 neoplasm National Cancer Institute (NCI) Completed No outcome recorded
Phase 1 NCT00782587 Oct 2008 → Mar 2009 superficial urinary bladder carcinoma Halozyme Therapeutics Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT06704191 Apr 2025 → Dec 2026 expected bladder carcinoma in situ Mayo Clinic Recruiting No outcome recorded
Phase 220 trials · 3 met primary
Phase 2 NCT06822010 Mar 2026 → Apr 2028 expected renal pelvis/ureter urothelial carcinoma, urinary bladder cancer Rutgers, The State University of New Jersey Recruiting No outcome recorded
Phase 2 NCT04107077 Sep 2025 → Jun 2030 expected gastric cancer, peritoneal carcinomatosis University of Chicago Recruiting No outcome recorded
Phase 2 NCT06227065 Oct 2024 → Oct 2026 expected non-invasive bladder urothelial carcinoma University of Bern Not yet recruiting No outcome recorded
Phase 2 NCT05672108 May 2023 → Oct 2027 expected bronchial neoplasm, colon carcinoma, neoplasm of mediastinum, non-small cell lung carcinoma +2 City of Hope Medical Center Recruiting No outcome recorded
Phase 2 NCT05024734 Feb 2023 → Dec 2026 expected superficial urinary bladder carcinoma Roland Seiler-Blarer Active not recruiting No outcome recorded
Phase 2 NCT04845490 Sep 2022 → Sep 2023 overdue metastasis from malignant tumor of colon Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Not yet recruiting No outcome recorded
Phase 2 NCT04929028 Aug 2022 → Sep 2031 expected HIV infectious disease, anal canal cancer, anal margin squamous cell carcinoma National Cancer Institute (NCI) Active not recruiting No outcome recorded
Phase 2 NCT04166318 Jan 2020 → Dec 2029 expected anal canal squamous cell carcinoma, anal margin squamous cell carcinoma, anus basaloid carcinoma, cloacogenic carcinoma ECOG-ACRIN Cancer Research Group Active not recruiting No outcome recorded
Phase 2 NCT03558503 Oct 2018 → Jan 2020 urinary bladder cancer, urothelial carcinoma UroGen Pharma Ltd. Completed Met primary
Phase 2 NCT03617913 Sep 2018 → Nov 2019 infiltrating bladder urothelial carcinoma, ureter cancer, urethra transitional cell carcinoma Mayo Clinic Completed No outcome recorded
Phase 318 trials · 3 met primary · 1 missed
Phase 3 NCT07271355 Jul 2026 → Feb 2031 expected appendix carcinoma, peritoneal carcinomatosis City of Hope Medical Center Not yet recruiting No outcome recorded
Phase 3 NCT06783491 May 2026 → Jun 2030 expected colorectal carcinoma Maimónides Biomedical Research Institute of Córdoba Recruiting No outcome recorded
Phase 3 NCT07097142 Oct 2025 → May 2030 expected infiltrating bladder urothelial carcinoma NRG Oncology Recruiting No outcome recorded
Phase 3 NCT06774131 Aug 2025 → Mar 2027 expected renal pelvis/ureter urothelial carcinoma UroGen Pharma Ltd. Recruiting No outcome recorded
Phase 3 NCT06513065 Dec 2024 → Sep 2028 expected pseudomyxoma peritonei University of Southampton Recruiting No outcome recorded
Phase 3 NCT06331299 Aug 2024 → Sep 2025 overdue urinary bladder cancer, urothelial carcinoma UroGen Pharma Ltd. Active not recruiting No outcome recorded
Phase 3 NCT05243550 Mar 2022 → Apr 2023 overdue urinary bladder cancer, urothelial carcinoma UroGen Pharma Ltd. Active not recruiting Met primary
Phase 3 NCT05136898 Nov 2021 → Feb 2023 urinary bladder cancer, urothelial carcinoma UroGen Pharma Ltd. Completed No outcome recorded
Phase 3 NCT04688931 Feb 2021 → Mar 2023 urinary bladder cancer, urothelial carcinoma UroGen Pharma Ltd. Terminated Met primary
Phase 3 NCT06462001 Dec 2020 → Dec 2026 expected transitional cell carcinoma Nottingham University Hospitals NHS Trust Active not recruiting No outcome recorded
Phase 41 trial · 1 missed
Phase 4 NCT03790384 Jan → Sep 2019 urinary bladder cancer Azienda Ospedaliera "Sant'Andrea" Unknown Missed primary
Phase not applicable3 trials
— NCT06167057 Apr 2023 → Jan 2028 expected — Carmel Medical Center Recruiting No outcome recorded
— NCT03914820 Jun 2020 → Jun 2025 colorectal carcinoma Mario Negri Institute for Pharmacological Research Unknown No outcome recorded
— NCT00644215 Jun 2007 → Feb 2009 — Shahid Beheshti University of Medical Sciences Unknown No outcome recorded
Comparator or background therapy19 trials
Phase 0 NCT04493073 Comparator Dec 2020 → Dec 2021 — Asmaa Ahmed Ali Youssif Unknown No outcome recorded
Phase 0 NCT03766425 Comparator Jun 2017 → Jul 2019 glaucoma, optic nerve disorder Medical University of Lublin Completed No outcome recorded
Phase 1 NCT04073160 Background Jun 2020 → Jul 2021 urinary bladder cancer Daniel George, MD Withdrawn No outcome recorded Stop: Enrollment
Phase 1/2 NCT01581840 Background Jan 2016 → Sep 2018 anal carcinoma, squamous cell carcinoma Federation Francophone de Cancerologie Digestive Completed Missed primary
Phase 1/2 NCT02638857 Background Sep 2015 → Mar 2017 hepatocellular carcinoma Second Military Medical University Unknown No outcome recorded

Press releases naming this drug 81 releases

DateIssuerRelease
2026-06-02 UroGen Pharma Ltd. UroGen Announces Agreement Resolving Patent Litigation Relating to JELMYTO® (mitomycin) for pyelocalyceal solution urogen.com ↗
2025-06-12 UroGen Pharma Ltd. U.S. FDA Approves UroGen’s ZUSDURI™ (mitomycin) for Intravesical Solution as the First and Only Medication for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC) urogen.com ↗
2025-06-02 UroGen Pharma Ltd. UroGen Presents uTRACT Registry at ASCO 2025 Annual Meeting Designed to Study Real-World Use of JELMYTO in Low-Grade Upper Tract Urothelial Cancer urogen.com ↗
2025-06-02 UroGen Pharma Ltd. UroGen Announces Data at ASCO 2025 Annual Meeting on UGN-102, an Investigational Treatment for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC) urogen.com ↗
2025-05-21 UroGen Pharma Ltd. UroGen Announces Outcome of Oncologic Drugs Advisory Committee for UGN-102 for the Treatment of Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC) urogen.com ↗
2025-05-07 UroGen Pharma Ltd. UroGen Announces FDA Advisory Committee for UGN-102, an Investigational Treatment for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer urogen.com ↗
2025-04-27 UroGen Pharma Ltd. OLYMPUS Long-Term Follow-Up Study Reports Nearly Four-Year Duration of Response in Subset of Patients with Low-Grade Upper Tract Urothelial Cancer Who Achieved a Complete Response to Initial JELMYTO Treatment urogen.com ↗
2025-04-27 UroGen Pharma Ltd. New Patient-Reported Outcomes from UGN-102 Clinical Trials Show the Investigational Treatment Did Not Adversely Affect Functionality, Symptom Burden, and Quality of Life in Patients with LG-IR-NMIBC urogen.com ↗
2025-04-27 UroGen Pharma Ltd. New Long-Term Follow-Up Data from OPTIMA II Study of UGN-102 Demonstrates Median Duration of Response of Two Years in Patients with LG-IR-NMIBC urogen.com ↗
2025-04-26 UroGen Pharma Ltd. UroGen Announces Updated 18-Month Duration of Response (DOR) of 80.6% from the Phase 3 ENVISION Trial of UGN-102, an Investigational Treatment for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC) urogen.com ↗
2025-03-10 UroGen Pharma Ltd. UroGen Pharma Reports Fourth Quarter and Full Year 2024 Financial Results and Announces Updated 18-Month Duration of Response (DOR) of 80.6% from the Phase 3 ENVISION Trial of UGN-102 urogen.com ↗
2025-02-14 UroGen Pharma Ltd. UroGen Announces Results from Subgroup Analyses of the Pivotal ENVISION Trial Evaluating Impact of Baseline Tumor Burden and Focality on Response to UGN-102 urogen.com ↗

Evidence & citations 11 cited values

Every value below carries the sentence it was read from. 70 sources stand behind the page.

FieldValueCited text
Known as Mitomycin “standard infusion chemotherapy (including gemcitabine, mitomycin, epirubicin, etc.), dissolved in 50 mL of normal saline or glucose, and intravesical infusion chemotherapy for...” NCT05547516 ↗
65

“Intravesicular therapy will consist of BCG, gemcitabine, mitomycin or a similar drug, depending on institutional standards and treating provider's discretion.” NCT04073160 ↗

“UGN-102 consists of mitomycin and sterile hydrogel (a proprietary thermally responsive gel) that is used to reconstitute mitomycin before instillation.” NCT03558503 ↗

“UGN-103 consists of mitomycin and sterile hydrogel (a proprietary thermally responsive gel) that is used to reconstitute mitomycin before instillation.” NCT06331299 ↗

“UGN-104 consists of mitomycin and sterile hydrogel (a proprietary thermally responsive gel) that is used to reconstitute mitomycin before instillation.” NCT06774131 ↗

“UGN-102 consists of mitomycin and sterile hydrogel (a proprietary thermally responsive gel) that is used to reconstitute mitomycin before instillation.” NCT05243550 ↗

“UGN-102 consists of mitomycin and sterile hydrogel (a proprietary thermally responsive gel) that is used to reconstitute mitomycin before instillation.” NCT05136898 ↗

“Patients will be treated with HIPEC using a single dose of Mitomycin 15mg/m2 and Cisplatin 50mg/m2 at 41-42 C for 90 minutes.” NCT02672865 ↗

“5FU 1000 mg/m2/day as 96 hour infusion days 1-5 and 29-33; Mitomycin 10mg/m2 days 1 and 29” NCT03018418 ↗

“40 mg mitomycin with 800,000 U rHuPH20 total volume of 40 mL instilled” NCT00782587 ↗

“Chemotherapy : 5Fu (400 to 1000 mg/m²) mitomycin : 10 mg/m²” NCT01581840 ↗

Show 55 more sources

Known as JELMYTO “This study will evaluate the efficacy and safety of UGN-104, a new formulation of UGN-101 (approved in the United States and Israel as JELMYTO \[mitomycin\] for pyelocalyceal...” NCT06774131 ↗
Known as Mitomycin C “This study therefore aims to evaluate the non-inferiority of HIPEC with mitomycin C 10 mg/m2 for 60 minutes versus HIEPC with mitomycin C 35 mg/m2 for 90 minutes.” NCT06513065 ↗
5

“Standard treatment of squamous cell carcinoma of the anus (SCCA)is 5-fluorouracil (5FU) and mitomycin C (MMC) based chemoradiotherapy (CRT).” PMID 37315583 ↗ Jun 2023

“compare concentrations of mitomycin C (MMC) in the human bladder wall after either passive delivery or electromotive administration (EMDA)” PMID 9041189 ↗ Mar 1997

“Comparison of Subconjunctival 5-FU Injection and Mitomycin C for Treatment of Early Bleb Failure” NCT00644215 ↗

“Mitomycin C (MMC) and Bacillus Calmette-Guérin (BCG)” PMID 38842053 ↗ Jun 2024

“Mitomycin C will be used as 20mg dry powder.” NCT05024734 ↗

Known as MMC “Standard treatment of squamous cell carcinoma of the anus (SCCA)is 5-fluorouracil (5FU) and mitomycin C (MMC) based chemoradiotherapy (CRT).” PMID 37315583 ↗ Jun 2023
6

“compare concentrations of mitomycin C (MMC) in the human bladder wall after either passive delivery or electromotive administration (EMDA)” PMID 9041189 ↗ Mar 1997

“doses of mitomycin C (MMC) for the treatment of pseudomyxoma peritonei.” NCT06513065 ↗

“mitomycin (MMC) in the treatment of superficial bladder cancer” NCT00782587 ↗

“Mitomycin C (MMC) and Bacillus Calmette-Guérin (BCG)” PMID 38842053 ↗ Jun 2024

“Mitomycin (MMC)” NCT02638857 ↗

“Mitomycin (MMC)” NCT07692152 ↗

Known as MMS “The MTD of PIPAC combined with mitomycin (MMS) in the treatment of CRCPM” NCT07349043 ↗
Known as UGN-101 “This study will evaluate the efficacy and safety of UGN-104, a new formulation of UGN-101 (approved in the United States and Israel as JELMYTO \[mitomycin\] for pyelocalyceal...” NCT06774131 ↗
Known as UGN-102 ClinicalTrials.gov intervention name — accepted as the source's own label NCT04688931 ↗
Known as UGN-102 (mitomycin) for intravesical solution “UGN-102 (mitomycin) for intravesical solution” NCT04688931 ↗
2

“UGN-102 (mitomycin) for intravesical solution” NCT05243550 ↗

“UGN-102 (mitomycin) for intravesical solution” NCT03558503 ↗

Known as UGN-104 (mitomycin) for pyelocalyceal solution “UGN-104 (mitomycin) for pyelocalyceal solution” NCT06774131 ↗
Action Inhibit “causing cross-linking of DNA and inhibition of DNA synthesis” NCT03766425 ↗
Route Intravenous “Patients receive IV doxorubicin, mitomycin, and cisplatin over 3 hours once every 3 weeks” NCT00002993 ↗