CLINICAL TRIALS PROFILE FOR ADRUCIL

All Clinical Trials for Adrucil

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002524 ↗	Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma	Completed	National Cancer Institute (NCI)	Phase 2	1993-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with AIDS-related lymphoma.
NCT00002524 ↗	Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma	Completed	M.D. Anderson Cancer Center	Phase 2	1993-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with AIDS-related lymphoma.
NCT00002525 ↗	Perioperative Chemotherapy in Treating Patients With Colon Cancer That Can Be Surgically Removed	Terminated	American College of Surgeons	Phase 3	1993-08-01	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 and giving drugs in different ways may kill more tumor cells. It is not yet known if surgery is more effective with or without chemotherapy for colon cancer. PURPOSE: Randomized phase III trial to evaluate whether perioperative 5-Fluorouracil (5-FU) chemotherapy after curative resection could improve overall survival and disease-free survival in patients with Duke's B3 or C colon cancer.
NCT00002525 ↗	Perioperative Chemotherapy in Treating Patients With Colon Cancer That Can Be Surgically Removed	Terminated	Cancer and Leukemia Group B	Phase 3	1993-08-01	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 and giving drugs in different ways may kill more tumor cells. It is not yet known if surgery is more effective with or without chemotherapy for colon cancer. PURPOSE: Randomized phase III trial to evaluate whether perioperative 5-Fluorouracil (5-FU) chemotherapy after curative resection could improve overall survival and disease-free survival in patients with Duke's B3 or C colon cancer.
NCT00002525 ↗	Perioperative Chemotherapy in Treating Patients With Colon Cancer That Can Be Surgically Removed	Terminated	National Cancer Institute (NCI)	Phase 3	1993-08-01	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 and giving drugs in different ways may kill more tumor cells. It is not yet known if surgery is more effective with or without chemotherapy for colon cancer. PURPOSE: Randomized phase III trial to evaluate whether perioperative 5-Fluorouracil (5-FU) chemotherapy after curative resection could improve overall survival and disease-free survival in patients with Duke's B3 or C colon cancer.
NCT00002525 ↗	Perioperative Chemotherapy in Treating Patients With Colon Cancer That Can Be Surgically Removed	Terminated	NSABP Foundation Inc	Phase 3	1993-08-01	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 and giving drugs in different ways may kill more tumor cells. It is not yet known if surgery is more effective with or without chemotherapy for colon cancer. PURPOSE: Randomized phase III trial to evaluate whether perioperative 5-Fluorouracil (5-FU) chemotherapy after curative resection could improve overall survival and disease-free survival in patients with Duke's B3 or C colon cancer.

Clinical Trial Conditions for Adrucil

Condition Name

Condition Name for Adrucil
Intervention	Trials
Breast Cancer	8
Pancreatic Cancer	6
Colorectal Cancer	6
Metastatic Pancreatic Adenocarcinoma	5

Condition MeSH

Condition MeSH for Adrucil
Intervention	Trials
Adenocarcinoma	19
Pancreatic Neoplasms	15
Colorectal Neoplasms	14
Carcinoma	10

Clinical Trial Locations for Adrucil

Trials by Country

Trials by Country for Adrucil
Location	Trials
United States	341
Spain	29
Japan	18
Australia	16
Canada	15

Trials by US State

Trials by US State for Adrucil
Location	Trials
Texas	34
California	20
Michigan	14
Illinois	14
Ohio	14

Clinical Trial Progress for Adrucil

Clinical Trial Phase

Clinical Trial Phase for Adrucil
Clinical Trial Phase	Trials
Phase 3	8
Phase 2/Phase 3	3
Phase 2	41

Clinical Trial Status

Clinical Trial Status for Adrucil
Clinical Trial Phase	Trials
Completed	37
Recruiting	13
Terminated	12

Clinical Trial Sponsors for Adrucil

Sponsor Name

Sponsor Name for Adrucil
Sponsor	Trials
National Cancer Institute (NCI)	30
M.D. Anderson Cancer Center	25
Genentech, Inc.	6

Sponsor Type

Sponsor Type for Adrucil
Sponsor	Trials
Other	76
Industry	52
NIH	30

Adrucil (5-Fluorouracil): Clinical Trials, Market Analysis, and Projections

Introduction to Adrucil (5-Fluorouracil)

Adrucil, commonly known as 5-fluorouracil (5-FU), is a chemotherapeutic agent used to treat various types of cancer, including colon, esophageal, stomach, pancreatic, breast, and cervical cancers. Here, we will delve into the current clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Recent Developments

Ongoing and Completed Trials

Several clinical trials have been conducted or are ongoing to evaluate the efficacy and safety of 5-fluorouracil in different cancer types. For instance, the NIFTY trial, a randomized, multicenter, open-label, phase 2b clinical trial, investigated the addition of liposomal irinotecan to fluorouracil and leucovorin for patients with advanced biliary tract cancer (BTC). The trial showed significant improvement in progression-free survival (PFS) with the combination therapy compared to fluorouracil and leucovorin alone[4].

Combination Therapies

5-Fluorouracil is often used in combination with other drugs to enhance its therapeutic effects. For example, the combination of 5-FU with leucovorin and liposomal irinotecan has shown promising results in treating advanced BTC. Such combination therapies are a focus area in current clinical trials to optimize treatment outcomes[4].

Market Analysis

Market Size and Growth

The global 5-fluorouracil market is expected to register a significant compound annual growth rate (CAGR) by 2031. The market size in 2023 was valued at several million dollars and is projected to increase substantially over the forecast period. This growth is driven by the increasing prevalence of chronic diseases and cancer, along with rising demand for cell therapies and government initiatives to enhance healthcare facilities[2][5].

Regional Market Insights

The 5-fluorouracil market is segmented into several regions, including North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA), and South & Central America. The APAC region is expected to exhibit the highest growth rate during the forecast period due to growing awareness, increasing investments in R&D, and the competitive pricing of 5-FU in this region[2][5].

Competitive Landscape

The global 5-fluorouracil market is highly competitive, with key players such as VHB Lifesciences Inc., Cadila Pharmaceuticals Ltd., Celon Labs, Neon Laboratories Ltd, Samarth Pharma Pvt. Ltd., and Alkem Laboratories Ltd. These companies are focusing on developing their technological expertise, product line extensions, and innovations to strengthen their market presence[5].

Market Dynamics

Drivers

• Increasing Prevalence of Cancer: The rising incidence of various types of cancer globally is a major driver for the 5-fluorouracil market[2][5].
• Government Initiatives: Government efforts to improve healthcare facilities and increase research funding are fueling the market growth[2].
• Demand for Cell Therapies: The growing demand for advanced cell therapies in cancer treatment is another significant driver[2].

Restraints

• Side Effects and Toxicity: 5-Fluorouracil is associated with several side effects and toxicity issues, which can limit its adoption in some cases[4].
• Competition from Alternative Treatments: The emergence of new cancer treatments and therapies can pose a competitive challenge to 5-FU[5].

End-Use Insights

Treatment Settings

The hospitals segment captures a significant revenue share in the 5-fluorouracil market. Factors such as treatment accessibility, high penetration of surgery, and increasing photodynamic therapy procedures performed in hospitals support this segment's growth. Physician-assisted therapies like cryotherapy, photodynamic therapy (PDT), and laser therapy also contribute to the segment's expansion[3].

Product Insights

Efficacy and Adoption

5-Fluorouracil remains a leading segment in the treatment of actinic keratosis, with a high efficacy rate of up to 74% and significant therapeutic results. Its reliability and lower chances of non-response make it a preferred choice for treating various skin conditions and cancers[3].

Future Projections

Market Forecast

The global 5-fluorouracil market is expected to continue its steady growth through 2031. The market size is projected to increase from its current value to several million dollars by the end of the forecast period, driven by the factors mentioned above[2][5].

Emerging Trends

• Precision Medicine: There is a growing focus on precision medicine approaches, which could further enhance the efficacy of 5-fluorouracil by tailoring treatments to individual patient profiles[1].
• Combination Therapies: Continued research into combination therapies involving 5-FU is expected to yield more effective treatment options for various cancers[4].

Key Takeaways

• Clinical Trials: Ongoing and completed trials, such as the NIFTY trial, highlight the potential of 5-fluorouracil in combination therapies.
• Market Growth: The global 5-fluorouracil market is expected to grow significantly, driven by increasing cancer prevalence and government initiatives.
• Regional Insights: The Asia-Pacific region is anticipated to exhibit the highest growth rate due to competitive pricing and growing awareness.
• Competitive Landscape: The market is highly competitive, with key players focusing on technological advancements and product innovations.
• End-Use: Hospitals remain a major segment due to treatment accessibility and increasing use of physician-assisted therapies.

FAQs

What is 5-fluorouracil used for?

5-Fluorouracil (Adrucil) is used to treat various types of cancer, including colon, esophageal, stomach, pancreatic, breast, and cervical cancers.

What are the key drivers of the 5-fluorouracil market?

The key drivers include the increasing prevalence of cancer, government initiatives to enhance healthcare facilities, and the growing demand for cell therapies.

Which region is expected to exhibit the highest growth rate in the 5-fluorouracil market?

The Asia-Pacific region is expected to exhibit the highest growth rate due to competitive pricing, growing awareness, and increasing investments in R&D.

What are the common side effects of 5-fluorouracil?

5-Fluorouracil is associated with several side effects, including nausea, vomiting, diarrhea, and toxicity issues.

What is the current market size of 5-fluorouracil, and what is its projected growth?

The current market size is valued at several million dollars, and it is projected to increase substantially by 2031, driven by various market dynamics.

Sources

1. AstraZeneca, "Clinical trials appendix H1 2022 results update," [PDF].
2. The Insight Partners, "5-Fluorouracil Market Key Findings by 2031."
3. BioSpace, "U.S. Actinic Keratosis Treatment Market Size Industry Analysis 2033."
4. JAMA Oncology, "Treatment With Liposomal Irinotecan Plus Fluorouracil and Leucovorin for Patients With Advanced Biliary Tract Cancer."
5. Reports and Data, "Fluorouracil Market Size, Share | Industry Report, 2016-2027."

Last updated: 2025-01-02