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Last Updated: March 13, 2025

CLINICAL TRIALS PROFILE FOR MITOMYCIN


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505(b)(2) Clinical Trials for mitomycin

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial TypeTrial IDTitleStatusSponsorPhaseStart DateSummary
New Formulation NCT03268499 ↗ TACE Emulsion Versus Suspension Recruiting Chinese University of Hong Kong Phase 2 2016-09-01 The aim of the study was to evaluate the safety and efficacy of using the new formulation (Lipiodol-cisplatin suspension) for TACE in the treatment of HCC as compared to the conventional formulation (Lipiodol-cisplatin emulsion). This is a prospective, parallel-group, open-label randomized, phase II study that is conducted in accordance to the Declaration of Helsinki and international standards of Good Clinical Practice, and approved by the institutional review board. Eligible patients were randomized into either a treatment arm of Lipiodol-cisplatin suspension or a control arm of Lipiodol-cisplatin emulsion with a 1:1 ratio.
New Dosage NCT00974818 ↗ Mitomycin C Versus Bacillus Calmette-Guerin in the Intravesical Treatment of Non-Muscle-Invasive Bladder Cancer Patients Terminated New York Presbyterian Hospital Phase 3 2009-09-01 The purpose of this study is to compare the bladder cancer treatments, Mitomycin C (MMC) and Bacillus Calmette Guerin (BCG), to find out which is better. In this study, the patient will get either the Mitomycin C (MMC) or the Bacillus Calmette Guerin (BCG). They will not get both. The patient had a Transurethral Resection (TUR) or an in office cystoscopy to make the diagnosis of bladder cancer. A biopsy was done and removed any tumors the doctor saw. Even after the doctor removes the tumors, the cancer can return. In this case, the doctor will put medicine into the bladder to destroy cancer cell. This is called intravesical therapy. The two most commonly used drugs for this purpose are MMC and BCG. Both drugs have been studied for many years. They both show good results when compared to other treatments. They have not been studied using the schedule that will be used in the study. The doctor does not know if these two drugs are equally effective in treating the cancer and preventing recurrence. BCG has been studied more often than MMC. The studies have shown that a long schedule of BCG is better than a short schedule of MMC. They have also shown that the side effects of BCG are more intense than with MMC. A recent study showed that a new dose of MMC is better than the old standard dose. Since the side effects of MMC occur less often, it is important to learn whether the two drugs are equally effective. That could help us decide between the treatments. In this study, the doctor will compare MMC and BCG when given for the same amount of time. The doctor hopes the study will tell us which drug is more effective in preventing the return of the cancer.
New Dosage NCT00974818 ↗ Mitomycin C Versus Bacillus Calmette-Guerin in the Intravesical Treatment of Non-Muscle-Invasive Bladder Cancer Patients Terminated Weill Medical College of Cornell University Phase 3 2009-09-01 The purpose of this study is to compare the bladder cancer treatments, Mitomycin C (MMC) and Bacillus Calmette Guerin (BCG), to find out which is better. In this study, the patient will get either the Mitomycin C (MMC) or the Bacillus Calmette Guerin (BCG). They will not get both. The patient had a Transurethral Resection (TUR) or an in office cystoscopy to make the diagnosis of bladder cancer. A biopsy was done and removed any tumors the doctor saw. Even after the doctor removes the tumors, the cancer can return. In this case, the doctor will put medicine into the bladder to destroy cancer cell. This is called intravesical therapy. The two most commonly used drugs for this purpose are MMC and BCG. Both drugs have been studied for many years. They both show good results when compared to other treatments. They have not been studied using the schedule that will be used in the study. The doctor does not know if these two drugs are equally effective in treating the cancer and preventing recurrence. BCG has been studied more often than MMC. The studies have shown that a long schedule of BCG is better than a short schedule of MMC. They have also shown that the side effects of BCG are more intense than with MMC. A recent study showed that a new dose of MMC is better than the old standard dose. Since the side effects of MMC occur less often, it is important to learn whether the two drugs are equally effective. That could help us decide between the treatments. In this study, the doctor will compare MMC and BCG when given for the same amount of time. The doctor hopes the study will tell us which drug is more effective in preventing the return of the cancer.
New Dosage NCT00974818 ↗ Mitomycin C Versus Bacillus Calmette-Guerin in the Intravesical Treatment of Non-Muscle-Invasive Bladder Cancer Patients Terminated Memorial Sloan Kettering Cancer Center Phase 3 2009-09-01 The purpose of this study is to compare the bladder cancer treatments, Mitomycin C (MMC) and Bacillus Calmette Guerin (BCG), to find out which is better. In this study, the patient will get either the Mitomycin C (MMC) or the Bacillus Calmette Guerin (BCG). They will not get both. The patient had a Transurethral Resection (TUR) or an in office cystoscopy to make the diagnosis of bladder cancer. A biopsy was done and removed any tumors the doctor saw. Even after the doctor removes the tumors, the cancer can return. In this case, the doctor will put medicine into the bladder to destroy cancer cell. This is called intravesical therapy. The two most commonly used drugs for this purpose are MMC and BCG. Both drugs have been studied for many years. They both show good results when compared to other treatments. They have not been studied using the schedule that will be used in the study. The doctor does not know if these two drugs are equally effective in treating the cancer and preventing recurrence. BCG has been studied more often than MMC. The studies have shown that a long schedule of BCG is better than a short schedule of MMC. They have also shown that the side effects of BCG are more intense than with MMC. A recent study showed that a new dose of MMC is better than the old standard dose. Since the side effects of MMC occur less often, it is important to learn whether the two drugs are equally effective. That could help us decide between the treatments. In this study, the doctor will compare MMC and BCG when given for the same amount of time. The doctor hopes the study will tell us which drug is more effective in preventing the return of the cancer.
>Trial Type>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 4 of 4 entries

All Clinical Trials for mitomycin

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00002993 ↗ Combination Chemotherapy in Treating Patients With Recurrent or Advanced Cancer of the Uterus Terminated National Cancer Institute (NCI) Phase 2 1997-08-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with mitomycin, doxorubicin, and cisplatin in treating patients with recurrent or advanced cancer of the uterus.
NCT00002993 ↗ Combination Chemotherapy in Treating Patients With Recurrent or Advanced Cancer of the Uterus Terminated Gynecologic Oncology Group Phase 2 1997-08-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with mitomycin, doxorubicin, and cisplatin in treating patients with recurrent or advanced cancer of the uterus.
NCT00002507 ↗ Radiation Therapy and Chemotherapy in Treating Patients With Head and Neck Cancer Completed Yale University Phase 3 1992-11-01 RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether combining mitomycin or porfiromycin with radiation therapy is more effective in treating patients with head and neck cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus either mitomycin or porfiromycin in treating patients with head and neck cancer.
NCT00002490 ↗ Radiation Therapy, Chemotherapy, or Observation in Treating Patients With Bladder Cancer Completed Medical Research Council Phase 3 1991-09-01 RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not known whether receiving either radiation therapy, chemotherapy, or observation is more effective for cancer of the bladder. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy, chemotherapy, or observation following tumor surgery in treating patients who have bladder cancer.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 4 of 4 entries

Clinical Trial Conditions for mitomycin

Condition Name

261812900510152025Bladder CancerGlaucomaColorectal CancerAnal Cancer[disabled in preview]
Condition Name for mitomycin
Intervention Trials
Bladder Cancer 26
Glaucoma 18
Colorectal Cancer 12
Anal Cancer 9
[disabled in preview] 0
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Condition MeSH

46442822005101520253035404550Urinary Bladder NeoplasmsCarcinomaGlaucomaAnus Neoplasms[disabled in preview]
Condition MeSH for mitomycin
Intervention Trials
Urinary Bladder Neoplasms 46
Carcinoma 44
Glaucoma 28
Anus Neoplasms 22
[disabled in preview] 0
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Clinical Trial Locations for mitomycin

Trials by Country

+
Trials by Country for mitomycin
Location Trials
United States 488
United Kingdom 58
China 21
Spain 19
Italy 15
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Trials by US State

+
Trials by US State for mitomycin
Location Trials
California 29
Maryland 25
Texas 25
New York 24
Pennsylvania 23
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Clinical Trial Progress for mitomycin

Clinical Trial Phase

11.9%29.5%6.8%51.7%0102030405060708090Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for mitomycin
Clinical Trial Phase Trials
Phase 4 21
Phase 3 52
Phase 2/Phase 3 12
[disabled in preview] 91
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Clinical Trial Status

50.0%22.1%15.2%12.7%02030405060708090100CompletedUnknown statusRecruiting[disabled in preview]
Clinical Trial Status for mitomycin
Clinical Trial Phase Trials
Completed 102
Unknown status 45
Recruiting 31
[disabled in preview] 26
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Clinical Trial Sponsors for mitomycin

Sponsor Name

trials0510152025303540National Cancer Institute (NCI)UroGen Pharma Ltd.Medical Research Council[disabled in preview]
Sponsor Name for mitomycin
Sponsor Trials
National Cancer Institute (NCI) 38
UroGen Pharma Ltd. 6
Medical Research Council 5
[disabled in preview] 5
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Sponsor Type

78.7%11.2%9.5%0050100150200250300350OtherIndustryNIH[disabled in preview]
Sponsor Type for mitomycin
Sponsor Trials
Other 322
Industry 46
NIH 39
[disabled in preview] 2
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Mitomycin: Clinical Trials, Market Analysis, and Projections

Introduction to Mitomycin

Mitomycin is a potent chemotherapeutic agent used in the treatment of various types of cancer, including bladder cancer, gastric cancer, pancreatic cancer, and more. Its mechanism involves inhibiting DNA synthesis, thereby preventing the division of rapidly dividing cancer cells. Here, we will delve into the current clinical trials, market analysis, and future projections for mitomycin.

Clinical Trials Update

Intravesical Mitomycin for Non-Muscle-Invasive Bladder Cancer (NMIBC)

A significant development in the clinical trials of mitomycin is its application in treating low-grade, intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC). The FDA has accepted the New Drug Application (NDA) for intravesical mitomycin, with a target action date set for June 13, 2025[1].

  • ENVISION Trial: This trial has shown promising results, with a 79.6% complete response rate at 3 months after the first instillation of intravesical mitomycin. Additionally, the trial revealed an 82.3% 12-month duration of response in patients who achieved a complete response at 3 months[1].

UGN-103 and UGN-104 Trials

UroGen Pharma is currently conducting Phase 3 trials for UGN-103, a next-generation mitomycin-based formulation, under the UTOPIA trial. This trial aims to enroll 87 patients with LG-IR-NMIBC to assess the safety and efficacy of UGN-103. The anticipated advantages of UGN-103 include a shorter manufacturing process and a simplified reconstitution procedure[4].

  • License and Supply Agreement: UroGen has entered into a license and supply agreement with medac GmbH to develop UGN-103 and UGN-104, combining UroGen’s RTGel® technology with medac’s licensed mitomycin formulation. This agreement is expected to extend the patent protection on UroGen’s urothelial cancer franchise until December 2041[3].

Market Analysis

Global Mitomycin Market Size and Growth

The global mitomycin market has been experiencing significant growth driven by the increasing incidence of cancer worldwide.

  • Current Market Size: As of 2023, the global mitomycin market was valued at USD 175.7 million. It is projected to grow to USD 384.76 million by 2032, at a Compound Annual Growth Rate (CAGR) of 9.1% during the forecast period (2025-2032)[2].

  • Segmentation: The mitomycin market is segmented based on component, type, application, and region. Cancer treatment dominates the global market, with mitomycin being effective in various types of cancers such as gastric, pancreatic, breast, non-small cell lung, cervical, prostate, and bladder cancer[2].

Regional Market Insights

  • Asia Pacific: This region is emerging as a lucrative market for mitomycin, with Japan being a leading supplier. India is also increasing its production, contributing to the growth of the Asia Pacific market. Leading manufacturers are expanding their operations in this region, which is expected to boost its prominence in the global market[2].

  • US Market: The US mitomycin market is also poised to grow at a sustainable CAGR, driven by the increasing demand for cancer treatments[2].

Market Drivers and Restraints

Drivers

  • Increasing Cancer Cases: The global rise in cancer cases has significantly increased the demand for mitomycin, driving market growth[2].
  • Ophthalmology Utilization: Mitomycin's use in ophthalmology, particularly in procedures like pterygium surgery, creates additional market opportunities[2].

Restraints

  • Increasing Costs: One of the major restraints for the mitomycin market is the increasing cost associated with the drug, which can limit its accessibility in some regions[2].

Projections and Future Outlook

Market Growth Projections

  • Forecast Period: The global mitomycin market is expected to continue its growth trajectory, reaching USD 384.76 million by 2032. This growth is driven by the expanding application of mitomycin in cancer treatment and other medical fields[2].

  • CAGR: The market is projected to grow at a CAGR of 9.1% during the forecast period (2025-2032)[2].

Competitive Landscape

  • Key Players: The global mitomycin market is dominated by players such as Teva, Bristol-Myers Squibb, Aspen, Contura, Alkem Laboratories, Varifarma, and APOGEPHA. These companies hold a significant share of the market and are continuously innovating to maintain their competitive edge[5].

Key Takeaways

  • Clinical Trials: Intravesical mitomycin is under review for FDA approval for LG-IR-NMIBC, with promising results from the ENVISION trial and ongoing Phase 3 trials for UGN-103.
  • Market Growth: The global mitomycin market is expected to grow from USD 175.7 million in 2023 to USD 384.76 million by 2032, driven by increasing cancer cases and expanding medical applications.
  • Regional Insights: Asia Pacific, particularly Japan and India, is emerging as a key region for mitomycin production and consumption.
  • Market Drivers: Increasing cancer cases and ophthalmology utilization are driving market growth, while increasing costs are a significant restraint.

FAQs

Q: What is the current status of the FDA approval for intravesical mitomycin?

A: The FDA has accepted the NDA for intravesical mitomycin, with a target action date set for June 13, 2025[1].

Q: What are the key findings from the ENVISION trial for intravesical mitomycin?

A: The ENVISION trial showed a 79.6% complete response rate at 3 months and an 82.3% 12-month duration of response in patients who achieved a complete response at 3 months[1].

Q: What is UGN-103, and what is its significance in the treatment of NMIBC?

A: UGN-103 is a next-generation mitomycin-based formulation under development for LG-IR-NMIBC. It is anticipated to shorten the manufacturing process and simplify the reconstitution procedure[4].

Q: How is the global mitomycin market projected to grow in the coming years?

A: The global mitomycin market is projected to grow from USD 175.7 million in 2023 to USD 384.76 million by 2032, at a CAGR of 9.1% during the forecast period (2025-2032)[2].

Q: Which region is emerging as a key market for mitomycin production and consumption?

A: The Asia Pacific region, particularly Japan and India, is emerging as a key market for mitomycin production and consumption[2].

Sources

  1. FDA Clears NDA of Intravesical Mitomycin in Non–Muscle-Invasive Bladder Cancer. Targeted Oncology.
  2. Mitomycin Market Size, Growth & Trends Report | 2032. SkyQuest.
  3. UroGen Pharma Delivers Double Digit JELMYTO® Growth and Prepares for Future Launches. UroGen Pharma.
  4. Phase 3 trial launches of UGN-103 in low-grade, intermediate-risk NMIBC. Urology Times.
  5. Global Mitomycin C Market Insights, Forecast to 2030. Valuates Reports.

More… ↓

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