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Last Updated: June 17, 2025

CLINICAL TRIALS PROFILE FOR FLUOROURACIL


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505(b)(2) Clinical Trials for Fluorouracil

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT01489865 ↗ ABT-888 With Modified FOLFOX6 in Patients With Metastatic Pancreatic Cancer Unknown status Abbott Phase 1/Phase 2 2011-02-01 People are being asked to participate in this study who have metastatic pancreatic cancer (cancer that has spread to other parts of the body). The purpose of this study is to test the efficacy (effectiveness) of a new combination of drugs, ABT-888 and mFOLFOX-6 (modified 5-Fluorouracil and Oxaliplatin) for patients with metastatic pancreatic cancer. ABT-888 inhibits an enzyme called "PARP" which helps to fix damaged DNA. By inhibiting this enzyme, ABT-888 prevents cancer cells from repairing the damage caused by the mFOLFOX-6, and will hopefully increase the killing of cancer cells, thus decreasing the tumors in your body.
New Combination NCT01489865 ↗ ABT-888 With Modified FOLFOX6 in Patients With Metastatic Pancreatic Cancer Unknown status Georgetown University Phase 1/Phase 2 2011-02-01 People are being asked to participate in this study who have metastatic pancreatic cancer (cancer that has spread to other parts of the body). The purpose of this study is to test the efficacy (effectiveness) of a new combination of drugs, ABT-888 and mFOLFOX-6 (modified 5-Fluorouracil and Oxaliplatin) for patients with metastatic pancreatic cancer. ABT-888 inhibits an enzyme called "PARP" which helps to fix damaged DNA. By inhibiting this enzyme, ABT-888 prevents cancer cells from repairing the damage caused by the mFOLFOX-6, and will hopefully increase the killing of cancer cells, thus decreasing the tumors in your body.
New Combination NCT01522989 ↗ PD-0332991, 5-FU, and Oxaliplatin for Advanced Solid Tumor Malignancies Unknown status Pfizer Phase 1 2011-12-01 This study is for patients with advanced solid tumor malignancies (cancer that has spread to other parts of the body). The purpose of this study is to test the safety and effectiveness of a new combination of drugs, PD-0332991 and 5-Fluorouracil and Oxaliplatin for patients with advanced solid tumor malignancies . PD-0332991 stops cells from dividing by blocking an enzyme called cyclin-dependent kinase (CDK), which cancer cells need to grow and divide. By inhibiting this enzyme, PD-0332991 prevent cancer cells from growing and dividing, while the 5-Fluorouracil and Oxaliplatin damage the cells, hopefully increasing the killing of cancer cells, thus decreasing the tumors in the body. PD-0332991 is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration for use in colorectal cancer. It is given as a pill which is taken once a day for one week followed by one week off. 5-Fluorouracil and Oxaliplatin are administered as an infusion into a vein once every 2 weeks and are approved for and used as chemotherapy for several cancers.
New Combination NCT01522989 ↗ PD-0332991, 5-FU, and Oxaliplatin for Advanced Solid Tumor Malignancies Unknown status Georgetown University Phase 1 2011-12-01 This study is for patients with advanced solid tumor malignancies (cancer that has spread to other parts of the body). The purpose of this study is to test the safety and effectiveness of a new combination of drugs, PD-0332991 and 5-Fluorouracil and Oxaliplatin for patients with advanced solid tumor malignancies . PD-0332991 stops cells from dividing by blocking an enzyme called cyclin-dependent kinase (CDK), which cancer cells need to grow and divide. By inhibiting this enzyme, PD-0332991 prevent cancer cells from growing and dividing, while the 5-Fluorouracil and Oxaliplatin damage the cells, hopefully increasing the killing of cancer cells, thus decreasing the tumors in the body. PD-0332991 is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration for use in colorectal cancer. It is given as a pill which is taken once a day for one week followed by one week off. 5-Fluorouracil and Oxaliplatin are administered as an infusion into a vein once every 2 weeks and are approved for and used as chemotherapy for several cancers.
New Combination NCT02019355 ↗ Actinic Keratosis Study Completed Washington University School of Medicine Early Phase 1 2013-10-01 The main purpose of this study is to determine the effectiveness of a new combination therapy for actinic keratosis. This study investigates a new indication for an FDA-approved topical medication, calcipotriol, for treatment of actinic keratosis, including how well it works and how safe it is when used in combination with the standard of care medication (5-fluorouracil) for the skin condition.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Fluorouracil

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000122 ↗ Fluorouracil Filtering Surgery Study (FFSS) Completed National Eye Institute (NEI) Phase 3 1985-09-01 To determine whether postoperative subconjunctival injections of 5-fluorouracil (5-FU) increase the success rate of filtering surgery in patients at high risk for failure after standard glaucoma filtering surgery.
NCT00000758 ↗ A Phase III Randomized Trial of Topical Vaginal Fluorouracil (5-Fluorouracil, 5-FU) Maintenance Therapy Versus Observation After Standard Treatment for High-Grade Cervical Dysplasia in HIV-Infected Women Completed Hoffmann-La Roche Phase 3 1969-12-31 To determine the efficacy and safety of intravaginal fluorouracil administered as prophylaxis in HIV-infected women who have received standard ablative therapy (surgery) for high-grade cervical dysplasia (pre-cancer of the cervix; cervical intraepithelial neoplasia). To correlate time to recurrence of cervical dysplasia with T-cell function. Women with HIV infection are at greater risk for cervical dysplasia. Because of the likelihood that untreated or recurrent cervical dysplasia may progress to invasive cancer, there is an urgent need to develop appropriate therapies.
NCT00000758 ↗ A Phase III Randomized Trial of Topical Vaginal Fluorouracil (5-Fluorouracil, 5-FU) Maintenance Therapy Versus Observation After Standard Treatment for High-Grade Cervical Dysplasia in HIV-Infected Women Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 1969-12-31 To determine the efficacy and safety of intravaginal fluorouracil administered as prophylaxis in HIV-infected women who have received standard ablative therapy (surgery) for high-grade cervical dysplasia (pre-cancer of the cervix; cervical intraepithelial neoplasia). To correlate time to recurrence of cervical dysplasia with T-cell function. Women with HIV infection are at greater risk for cervical dysplasia. Because of the likelihood that untreated or recurrent cervical dysplasia may progress to invasive cancer, there is an urgent need to develop appropriate therapies.
NCT00001165 ↗ Combination Chemotherapy in Patients With Zollinger-Ellison Syndrome and Tumors of the Pancreas Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 2 1978-09-01 Patients with Zollinger-Ellison Syndrome suffer from ulcers of the upper gastrointestinal tract, higher than normal levels of gastric acid, and tumors of the pancreas known as non-beta islet cell tumors. Prior to the use of drugs to cure the ulcers, patients typically died due to severe ulcers. Because of such effective drugs to treat the ulcers it is more common to see patients dying due to the pancreatic tumors. The study will observe patients suffering from Zollinger-Ellison Syndrome and non-beta islet cell tumors and determine the effectiveness of combined chemotherapy with streptozotocin, 5-fluorouracil, and doxorubicin.
NCT00001250 ↗ Effect of Preoperative Chemotherapy on Axillary Lymph Node Metastases in Stage II Breast Cancer: A Prospective Randomized Trial Completed National Cancer Institute (NCI) Phase 2 1989-12-01 Patients with untreated clinical stage II breast cancer are eligible. An excisional biopsy of the primary tumor is acceptable, but without definitive local therapy or prior chemotherapy. Histologic confirmation of invasive carcinoma is required. Patients are prospectively randomized to receive five 21-day cycles of dose-intense (5-fluorouracil, adriamycin, leucovorin, cytoxan, granuloctye-colony stimulating factor [FLAC/G-CSF]) chemotherapy either before (preoperative) or after (postoperative) local therapy. Chemotherapy is given as an outpatient. For patients receiving preoperative chemotherapy, local therapy (modified radical mastectomy, or breast segmentectomy/axillary dissection/breast radiotherapy according to patient preference) is performed 3-4 weeks after last chemotherapy. For patients receiving postoperative chemotherapy, chemotherapy will begin 2-3 weeks after local therapy. Immediate reconstruction for mastectomy is acceptable. Upon completion of local therapy and chemotherapy in either treatment group, all estrogen receptor positive patients receive tamoxifen for 5 years. Follow-up consists of history and physical examination each 3 months for first 3 years, each six months for years 4 and 5, and yearly thereafter. Mammogram, bone scan, chest x-ray and blood work are performed yearly.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Fluorouracil

Condition Name

Condition Name for Fluorouracil
Intervention Trials
Colorectal Cancer 285
Breast Cancer 123
Gastric Cancer 108
Pancreatic Cancer 99
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Condition MeSH

Condition MeSH for Fluorouracil
Intervention Trials
Colorectal Neoplasms 509
Adenocarcinoma 269
Carcinoma 250
Pancreatic Neoplasms 184
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Clinical Trial Locations for Fluorouracil

Trials by Country

Trials by Country for Fluorouracil
Location Trials
China 529
United States 5,729
Canada 372
Japan 341
Italy 321
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Trials by US State

Trials by US State for Fluorouracil
Location Trials
California 264
New York 261
Illinois 219
Texas 217
Florida 201
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Clinical Trial Progress for Fluorouracil

Clinical Trial Phase

Clinical Trial Phase for Fluorouracil
Clinical Trial Phase Trials
Phase 4 33
Phase 3 430
Phase 2/Phase 3 56
[disabled in preview] 1035
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Clinical Trial Status

Clinical Trial Status for Fluorouracil
Clinical Trial Phase Trials
Completed 848
Recruiting 285
Unknown status 238
[disabled in preview] 306
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Clinical Trial Sponsors for Fluorouracil

Sponsor Name

Sponsor Name for Fluorouracil
Sponsor Trials
National Cancer Institute (NCI) 374
Sanofi 65
Sun Yat-sen University 64
[disabled in preview] 78
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Sponsor Type

Sponsor Type for Fluorouracil
Sponsor Trials
Other 2224
Industry 730
NIH 383
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Fluorouracil: Clinical Trials, Market Analysis, and Projections

Introduction to Fluorouracil

Fluorouracil, commonly known as 5-FU, is a chemotherapeutic agent widely used in the treatment of various types of cancer, including colon, stomach, esophageal, breast, cervical, and pancreatic cancers. It is also used to treat skin conditions such as actinic keratosis and basal cell carcinoma.

Clinical Trials and Efficacy

Pharmacokinetically Guided Dosing

Clinical trials have highlighted the importance of pharmacokinetically guided dosing for fluorouracil. A study by Gamelin et al. (2008) demonstrated that patients with metastatic colorectal cancer who received fluorouracil doses adjusted based on pharmacokinetic monitoring had a significantly improved objective response rate, a trend towards higher survival rates, and fewer severe toxicities compared to those receiving conventional dosing[4].

Another study by Macaire et al. (2019) showed that pharmacokinetic-guided dosing algorithms reduced the incidence of severe 5-FU related toxicity, particularly in patients older than 75 years. This approach led to a significant decrease in diarrhea and oral mucositis, improving the tolerability of the treatment[4].

DPD Deficiency Screening

DPD (dihydropyrimidine dehydrogenase) deficiency is a critical factor in the metabolism of fluorouracil. Screening for DPD deficiency before initiating fluoropyrimidine-based chemotherapy can reduce the negative side effects associated with 5-FU treatment. French recommendations advocate for plasma uracil quantification to identify DPD deficiency, which has been shown to minimize toxicity in patients undergoing 5-FU therapy[4].

Market Analysis

Current Market Size and Growth

The global fluorouracil market was valued at USD 2.45 billion in 2023 and is projected to reach USD 4.34 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 7.7% from 2024 to 2030[3].

Market Drivers

  • Increasing Incidence of Cancer: The rising prevalence of cancer globally is a major driver for the fluorouracil market. According to the World Health Organization (WHO), cancer caused over 3.7 million new cases and 1.9 million deaths in Europe in 2012 alone[3].
  • Research and Development: Pharmaceutical companies are investing heavily in research and development to enhance fluorouracil-based treatments. For example, the European Commission approved ONIVYDE for the treatment of metastatic pancreatic adenocarcinoma in combination with 5-fluorouracil and leucovorin in adults[3].

Market Restraints

  • COVID-19 Impact: The COVID-19 pandemic has limited the growth of the fluorouracil market, as chemotherapy treatments like 5-FU can weaken patients' immune systems, making them more susceptible to the virus[3].
  • High Cost and Toxicity: The high cost of fluorouracil, particularly in the form of topical creams, and its associated toxicities, such as gastrointestinal dysfunction and enteric neurotoxicity, are significant restraints on market growth[3].

Geographical Distribution

The global fluorouracil market is segmented geographically into North America, Europe, Asia Pacific, and the Rest of the world. North America dominates the market due to the high burden of cancer and non-communicable diseases in the region. The Asia Pacific is expected to exhibit the highest growth rate during the forecast period due to increasing cancer incidence and improving healthcare infrastructure[3].

Key Players

The market is highly competitive, with key players including:

  • Nantong Haier’s Pharmaceutical Co. Ltd
  • Jinghua Pharmaceutical Co., Ltd
  • DCS Pharma AG
  • Glaxo Smith Kline Pharmaceuticals Ltd
  • Dabur Pharmaceuticals Ltd
  • Taj Pharmaceuticals Limited
  • Neon Laboratories Ltd
  • Cadila Pharmaceuticals Ltd[3].

Market Projections

Future Growth

The fluorouracil market is projected to grow steadily, driven by increasing cancer incidence, advancements in treatment technologies, and investments in research and development. The Asia Pacific region is expected to be a significant growth area due to its large population and rising healthcare needs[3].

Technological Advancements

Vendors are focusing on developing their technological expertise and expanding their product lines. Innovations such as fluorouracil-based conjugate treatments and improved dosing algorithms are expected to enhance the market's growth potential[2][3].

Regulatory Approvals

Recent and upcoming regulatory approvals for new indications and formulations of fluorouracil will also contribute to market growth. For instance, the approval of ONIVYDE for metastatic pancreatic adenocarcinoma in combination with 5-fluorouracil and leucovorin has expanded treatment options for patients[3].

Key Takeaways

  • Clinical Efficacy: Pharmacokinetically guided dosing and DPD deficiency screening are crucial for optimizing the efficacy and reducing the toxicity of fluorouracil.
  • Market Growth: The global fluorouracil market is expected to grow at a CAGR of 7.7% from 2024 to 2030.
  • Geographical Trends: North America currently dominates the market, but the Asia Pacific region is expected to show the highest growth rate.
  • Market Drivers: Increasing cancer incidence and investments in R&D are key drivers.
  • Market Restraints: High costs, toxicity, and the impact of COVID-19 are significant restraints.

FAQs

What is the primary use of fluorouracil in medical treatment?

Fluorouracil is primarily used as a chemotherapeutic agent to treat various types of cancer, including colon, stomach, esophageal, breast, cervical, and pancreatic cancers.

How does pharmacokinetically guided dosing improve fluorouracil treatment?

Pharmacokinetically guided dosing adjusts the dose of fluorouracil based on individual patient pharmacokinetics, leading to improved response rates, higher survival rates, and reduced toxicity.

What is the impact of DPD deficiency on fluorouracil treatment?

DPD deficiency can lead to increased toxicity from fluorouracil. Screening for DPD deficiency before treatment can help minimize these adverse effects.

Which region is expected to show the highest growth rate in the fluorouracil market?

The Asia Pacific region is expected to exhibit the highest growth rate in the fluorouracil market due to its large population and rising healthcare needs.

What are the major restraints on the fluorouracil market?

The major restraints include the high cost of the medication, associated toxicities, and the impact of the COVID-19 pandemic on cancer treatment.

Sources

  1. Clinical Trials Appendix | AstraZeneca - Q1 2024 Results Update.
  2. Fluorouracil Market Size, Share | Industry Report, 2016-2027 - Reports and Data.
  3. In-Depth Industry Outlook: Fluorouracil (5FU) Market Size & Forecast - Verified Market Research.
  4. Therapeutic Drug Monitoring for 5-Fluorouracil - South Carolina Blues.
Last updated: 2025-01-01

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