Mitosol

(Mitomycin)

ApprovedSmall molecule

UUroGen Pharma Ltd.

Mitosol is one of 471 small molecule programs targeting Colorectal Neoplasm. It is currently in Approved.

Indications

Total Trials

Active Trials

470

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Colorectal NeoplasmActive, not recruiting

Breast CancerActive, not recruiting

AdenocarcinomaActive, not recruiting

Corneal DiseaseActive, not recruiting

Pancreatic CancerApproved

PterygiumApproved

Metastatic Malignant NeoplasmApproved

Metastatic Colorectal CancerApproved

Nasopharyngeal CarcinomaApproved

Pseudomyxoma PeritoneiApproved

Colorectal NeoplasmPreclinical

Active, not recruiting

Breast CancerApproved

Active, not recruiting

AdenocarcinomaApproved

Active, not recruiting

Corneal DiseasePreclinical

Active, not recruiting

Pancreatic CancerApproved

Approved

PterygiumApproved

Approved

Metastatic Malignant NeoplasmApproved

Approved

Metastatic Colorectal CancerApproved

Approved

Nasopharyngeal CarcinomaApproved

Approved

Pseudomyxoma PeritoneiApproved

Approved

Showing 10 of 39 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Mitosol

UUroGen Pharma Ltd.

Approved

38 2

Adenocard

Astellas

Preclinical

2 3

Zolymbus

AbbVie

Preclinical

1 4

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 5

Nubain

AAultman Health Foundation

Preclinical

1 6

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 7

Acupan

YYonsei University

Preclinical

1 8

Paracetamol

GSK

Preclinical

1 9

Ablavar

LLantheus Medical Imaging

Preclinical

2 10

Diuretic

RReprieve Cardiovascular, Inc

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Bladder Cancer

NCT06462001

Phase 2Recruiting

Gastric Cancer

NCT04107077

Q2 2027

Phase 3Active, not recruiting

Bladder Urothelial Carcinoma

NCT03775265

Q4 2027

Phase 2Recruiting

Phase II

NCT05672108

Q1 2028

Phase 1Recruiting

Clinical Stage IV Gastric Cancer AJCC V8

NCT04329494

Clinical

Trials by Indication[1]

Bladder Cancer9 trials

BCG + MMC: Adding Mitomycin C to BCG in High-risk, Non-muscle-invasive Bladder Cancer

Active, not recruiting·NNottingham University Hospitals NHS Trust·Phase 3·NCT06462001·500 enrolled

In-home Intravesical Chemotherapy for the Treatment of Bladder Cancer, INVITE Trial

Recruiting·MMayo Clinic·Phase 1/2·NCT06704191·40 enrolled

Radiation Therapy and Chemotherapy in Treating Patients With Stage I Bladder Cancer

Completed· Radiation Therapy Oncology Group logo

Radiation Therapy Oncology Group·Phase 2·NCT00981656·37 enrolled

Show 6 more trials

Avelumab in Combination With Fluorouracil and Mitomycin or Cisplatin and Radiation Therapy in Treating Participants With Muscle-Invasive Bladder Cancer

Completed·MMayo Clinic·Phase 2·NCT03617913·2 enrolled

A Study of Chemotherapy and Radiation Therapy Compared to Chemotherapy and Radiation Therapy Plus MEDI4736 (Durvalumab) Immunotherapy for Bladder Cancer Which Has Spread to the Lymph Nodes, INSPIRE Trial

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04216290·95 enrolled

Adding Mitomycin to BCG as Adjuvant Intravesical Therapy for High-risk Non-Muscle-invasive Bladder Cancer

Unknown status·UUniversity of Sydney·Phase 3·NCT02948543·501 enrolled

Sequential Combination Therapy in Bladder Cancer

Unknown status·AAzienda Ospedaliera "Sant'Andrea"·Phase 4·NCT03790384·140 enrolled

POLO-Trial. Precise Neoadjuvant Chemoresection of Low-grade NMIBC Guided by Drug Sceens in Patient-derived Or-ganoids. An Open-label, Phase II Trial.

Not yet recruiting·UUniversity of Bern·Phase 2·NCT06227065·28 enrolled

Guidance of Adjuvant Instillation in Intermediate Risk Non-muscle Invasive Bladder Cancer by Drug Screens in Patient Derived Organoids. A Single Center, Open-label, Phase II Trial With a Feasibility Endpoint. (GAIN-INST-TRIAL)

Active, not recruiting·RRoland Seiler-Blarer·Phase 2·NCT05024734·31 enrolled

Hepatocellular Carcinoma3 trials

The Efficacy of 5-fluorouracil/Mitomycin for the Patients With Pulmonary Metastasis of Hepatocellular Carcinoma

Withdrawn·SSeoul National University Hospital·Phase 2·NCT01953406

Comparison Study of Sorafenib and 5-fluorouracil/Mitomycin for Metastatic Hepatocellular Carcinoma

Terminated·SSeoul National University Hospital·Phase 2·NCT01171482·5 enrolled

Immunotherapy Using Precision T Cells Specific to Multiple Common Tumor-Associated Antigen Combined With Transcatheter Arterial Chemoembolization for the Treatment of Advanced Hepatocellular Carcinoma

Unknown status·SSecond Military Medical University·Phase 1/2·NCT02638857·60 enrolled

Liver Cancer2 trials

Chemoembolization in Treating Patients With Primary Liver Cancer or Metastases to the Liver

Completed·EEastern Cooperative Oncology Group·Phase 2·NCT00003907·50 enrolled

Chemoembolization With or Without Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

Completed·NNational Cancer Institute (NCI)·Phase 3·NCT01004978·235 enrolled

Muscle-Invasive Bladder Carcinoma2 trials

A Pilot Study of Bladder Preservation or Cystectomy for Muscle-invasive Bladder Cancer Guided by Multi-omics: the B-PRECISE Study

Active, not recruiting·DDana-Farber Cancer Institute·Phase 1·NCT07821177·20 enrolled

Consolidative Radiation Therapy or Cystectomy After Initial Favorable Response Succeeding Enfortumab Vedotin Plus Pembrolizumab (REINFORCE)--- A Pilot Feasibility Trial

Recruiting·UUniversity of Washington·Preclinical·NCT07579195·12 enrolled

Colorectal Carcinoma1 trial

Prophylactic Surgery Plus HIPEC With CO2 in Patients Affected by Colorectal Carcinoma. CHECK Study.

Unknown status· Mario Negri Institute for Pharmacological Research logo

Mario Negri Institute for Pharmacological Research·N/A·NCT03914820·330 enrolled

21 more indications

Efficacy and Safety1 trial

Comparison of Efficacy and Safety of Mitomycin and Aflibercept Used to Support Primary Trabeculectomy.

Completed·MMedical University of Lublin·Phase 1·NCT03766425·64 enrolled

Intensity-modulated Radiotherapy1 trial

Phase II Study of Concomitant Intensity-modulated Radiotherapy Combined to Capecitabine, Mitomycin and Panitumumab in Patients With Stage II-IIIB Squamous-cell Carcinoma of the Anal Canal

Terminated·—·Phase 2·NCT01843452·8 enrolled

Esophageal Cancer1 trial

Heated Mitomycin and Cisplatin During Surgery in Treating Patients With Stomach or Gastroesophageal Cancer

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT02891447·24 enrolled

LAM1 trial

Automated Lamellar Keratectomy in Symptomatic Patients With Bullous Keratopathy

Completed·FFederal University of São Paulo·N/A·NCT00654888·28 enrolled

Phase II1 trial

Phase II Trial of Lung Chemoemobolization

Recruiting·—·Phase 2·NCT05672108·30 enrolled

Fluorouracil1 trial

A Phase I/II Evaluation of ADXS11-001, Mitomycin, 5-fluorouracil (5-FU) and IMRT for Anal Cancer

Terminated·—·Phase 1/2·NCT01671488·11 enrolled

Solid Tumors1 trial

Veliparib With or Without Mitomycin C in Treating Patients With Metastatic, Unresectable, or Recurrent Solid Tumors

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT01017640·20 enrolled

Locally Advanced Colon Cancer1 trial

Efficacy of the Use of Neoadjuvant With/Without Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Colon Cancer

Not yet recruiting·MMaimónides Biomedical Research Institute of Córdoba·Phase 3·NCT06783491·1,083 enrolled

Glaucoma1 trial

Lucentis Versus Mitomycin C During Glaucoma Surgery

Completed·WWills Eye·Phase 2/3·NCT00626782·24 enrolled

Lung Cancer1 trial

Randomized Phase III-Study in Stage IIIb and IV Non-Small-Cell Lung Cancer. Sequential Single-Agent vs. Double-Agent vs. Triple-Agent Therapy.

Completed·AAktion Bronchialkarzinom e.V.·Phase 3·NCT00148395·280 enrolled

Colorectal Cancer1 trial

Comparative Study of Mitomycin and Lobaplatin in Advanced Colorectal Cancer Patients With Radical Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy

Not yet recruiting·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology·Phase 2·NCT04845490·201 enrolled

Anal Cancer1 trial

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04929028·40 enrolled

Anal Basaloid Carcinoma1 trial

A Randomized Phase II Study of De-Intensified ChemoRadiation for Early-Stage Anal Squamous Cell Carcinoma (DECREASE)

Active, not recruiting·EECOG-ACRIN Cancer Research Group·Phase 2·NCT04166318·252 enrolled

Gastric Cancer1 trial

A Phase IIa Study of Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and PD-L1 Expression in Gastric Cancer With Peritoneal Metastases

Recruiting·UUniversity of Chicago·Phase 2·NCT04107077·21 enrolled

Non-Muscle Invasive Bladder Urothelial Carcinoma1 trial

Randomized Phase II Trial of Pembrolizumab and Radiation vs. Radiation and Concurrent Chemotherapy for High-Grade T1 Bladder Cancer (PARRC Trial)

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06770582·160 enrolled

Bladder Urothelial Carcinoma1 trial

Phase III Randomized Trial of Concurrent Chemoradiotherapy With or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT03775265·475 enrolled

Clinical Stage IV Gastric Cancer AJCC v81 trial

Safety and Efficacy of Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Ovarian, Uterine, Appendiceal, Colorectal, and Gastric Cancer Patients With Peritoneal Carcinomatosis (PC)

Recruiting·CCity of Hope Medical Center·Phase 1·NCT04329494·49 enrolled

Appendix Cancer1 trial

Investigation of Mitomycin C PIPAC - FOLFIRI Combination for Unresectable Appendiceal or Colorectal Peritoneal Metastases Treatment (IMPACT): A Multicenter, Randomized, Open-Label, Phase 3 Trial

Not yet recruiting·CCity of Hope Medical Center·Phase 3·NCT07271355·129 enrolled

Muscle Invasive Bladder Urothelial Carcinoma1 trial

The Phase III Adaptive Radiation and Chemotherapy for Muscle Invasive Bladder Cancer Trial (ARCHER)

Recruiting·NNRG Oncology·Phase 3·NCT07097142·486 enrolled

Anal Squamous Cell Carcinoma, Limited-stage1 trial

A Multicenter, Phase III, Randomized Controlled Clinical Trial of Sintilimab Versus Mitomycin in Combination With Capecitabine and Intensity-Modulated Radiotherapy in the Treatment of Limited-stage Anal Squamous Cell Carcinoma

Recruiting·CCancer Institute and Hospital, Chinese Academy of Medical Sciences·Phase 3·NCT07692152·350 enrolled

Unspecified1 trial

Conjunctival Vascularity Changes Usnig OCTA After Trabeculectomy

Unknown status·AAsmaa Ahmed Ali Youssif·Phase 1·NCT04493073·100 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

MUTAMYCIN

NDA NDA050450

Nov 14, 2002

MITOZYTREX

NDA NDA050763

Feb 7, 2012

MITOSOL

NDA NDA022572

Apr 15, 2020

JELMYTO

NDA NDA211728

Jun 12, 2025

ZUSDURI

NDA NDA215793

Sources

References

[1]
ClinicalTrials.gov — 38 trial records for Mitomycin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Mitomycin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Mitomycin. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA215793). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Mitosol. U.S. Food & Drug Administration.
[6]
SEC EDGAR — UroGen Pharma Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: UUroGen Pharma Ltd.

Patent Landscape[5]

Patent Cliff

Jan 2, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8186511Jul 19, 2026

9205075Jul 19, 2026

9539241Jan 2, 2028

7806265Feb 1, 2029

9649428May 21, 2029

5 more patents

12268745Jan 20, 2031

12440568Jan 20, 2031

9040074Jan 20, 2031

9950069Jan 20, 2031

10039832Jan 20, 2031

Mitosol

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q4 2027

Q1 2028

Trials by Indication[1]

Bladder Cancer9 trials

Hepatocellular Carcinoma3 trials

Liver Cancer2 trials

Muscle-Invasive Bladder Carcinoma2 trials

Colorectal Carcinoma1 trial

Efficacy and Safety1 trial

Intensity-modulated Radiotherapy1 trial

Esophageal Cancer1 trial

LAM1 trial

Phase II1 trial

Fluorouracil1 trial

Solid Tumors1 trial

Locally Advanced Colon Cancer1 trial

Glaucoma1 trial

Lung Cancer1 trial

Colorectal Cancer1 trial

Anal Cancer1 trial

Anal Basaloid Carcinoma1 trial

Gastric Cancer1 trial

Non-Muscle Invasive Bladder Urothelial Carcinoma1 trial

Bladder Urothelial Carcinoma1 trial

Clinical Stage IV Gastric Cancer AJCC v81 trial

Appendix Cancer1 trial

Muscle Invasive Bladder Urothelial Carcinoma1 trial

Anal Squamous Cell Carcinoma, Limited-stage1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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