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Last Updated: June 14, 2025

Investigational Drug Information for Fluoropyrimidine


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What is the development status for investigational drug Fluoropyrimidine?

Fluoropyrimidine is an investigational drug.

There have been 333 clinical trials for Fluoropyrimidine. The most recent clinical trial was a Phase 3 trial, which was initiated on September 1st 2016.

The most common disease conditions in clinical trials are Colorectal Neoplasms, Stomach Neoplasms, and Adenocarcinoma. The leading clinical trial sponsors are National Cancer Institute (NCI), Eli Lilly and Company, and Hoffmann-La Roche.

There are six hundred and eighty-one US patents protecting this investigational drug and zero international patents.

Recent Clinical Trials for Fluoropyrimidine
TitleSponsorPhase
Trastuzumab Deruxtecan(T-DXd) and Afatinib Combination in HER2-low Advanced Gastric CancerJeeyun LeePhase 1/Phase 2
PD-1 Inhibitor Plus Chemotherapy With or Without Radiotherapy in Patients With Metastatic Esophageal CancerAffiliated Hospital of North Sichuan Medical CollegePhase 3
PD-1 Inhibitor Plus Chemotherapy With or Without Radiotherapy in Patients With Metastatic Esophageal CancerAnyang Tumor HospitalPhase 3

See all Fluoropyrimidine clinical trials

Clinical Trial Summary for Fluoropyrimidine

Top disease conditions for Fluoropyrimidine
Top clinical trial sponsors for Fluoropyrimidine

See all Fluoropyrimidine clinical trials

US Patents for Fluoropyrimidine

Drugname Patent Number Patent Title Patent Assignee Estimated Expiration
Fluoropyrimidine ⤷  Try for Free Lin28/let-7 crystal structures, purification protocols, and molecular probes suitable for screening assays and therapeutics PRESIDENT AND FELLOWS OF HARVARD COLLEGE (Cambridge, MA) ⤷  Try for Free
Fluoropyrimidine ⤷  Try for Free Tapered looped suture Covidien LP (Mansfield, MA) ⤷  Try for Free
Fluoropyrimidine ⤷  Try for Free Dosing regimens for echinocandin class compounds Cidara Therapeutics, Inc. (San Diego, CA) ⤷  Try for Free
Fluoropyrimidine ⤷  Try for Free Phosphoramidate derivatives of 5-fluoro-2'-deoxyuridine for use in the treatment of cancer NuCana plc (GB) ⤷  Try for Free
Fluoropyrimidine ⤷  Try for Free Antibody drug conjugates (ADCs) with kinesin spindel protein (KSP) BAYER PHARMA AKTIENGESELLSCHAFT (Berlin, DE) ⤷  Try for Free
Fluoropyrimidine ⤷  Try for Free Nuclear localization of GLP-1 stimulates myocardial regeneration and reverses heart failure Baylor Research Institute (Dallas, TX) ⤷  Try for Free
Fluoropyrimidine ⤷  Try for Free 2,3-disubstituted 1 -acyl-4-amino-1,2,3,4-tetrahydroquinoline derivatives and their use as bromodomain inhibitors GlaxoSmithKline Intellectual Property (No. 2) Limited (Brentford, Middlesex, GB) ⤷  Try for Free
>Drugname >Patent Number >Patent Title >Patent Assignee >Estimated Expiration

International Patents for Fluoropyrimidine

Drugname Country Document Number Estimated Expiration Related US Patent
Fluoropyrimidine World Intellectual Property Organization (WIPO) WO2013071079 2031-11-09 ⤷  Try for Free
Fluoropyrimidine Australia AU2009212980 2028-09-11 ⤷  Try for Free
Fluoropyrimidine Australia AU2011201113 2028-09-11 ⤷  Try for Free
Fluoropyrimidine Canada CA2678277 2028-09-11 ⤷  Try for Free
Fluoropyrimidine Canada CA2733493 2028-09-11 ⤷  Try for Free
Fluoropyrimidine China CN101683278 2028-09-11 ⤷  Try for Free
Fluoropyrimidine European Patent Office EP2163207 2028-09-11 ⤷  Try for Free
>Drugname >Country >Document Number >Estimated Expiration >Related US Patent

Fluoropyrimidine Drugs: Development Updates and Market Projections

Introduction to Fluoropyrimidines

Fluoropyrimidines are a class of chemotherapy drugs that include fluorouracil (5-FU) and capecitabine (Xeloda), among others. These drugs are widely used in the treatment of various cancers, including colorectal, breast, and gastric cancers. Here, we will delve into the recent development updates and market projections for these critical oncology drugs.

Recent Development Updates

FDA Labeling Changes for Fluorouracil

In a significant development, the FDA approved safety labeling changes for fluorouracil injection products on March 21, 2024. These changes were made to highlight the risks associated with the use of fluorouracil in patients with dihydropyrimidine dehydrogenase (DPD) deficiency. The revisions include updates to the Highlights of Prescribing Information, Warnings and Precautions, and Patient Counseling Information sections. A new subsection on Pharmacogenomics has also been added to the Clinical Pharmacology section, aligning with similar changes made for capecitabine (Xeloda) in December 2022[1].

Combination Therapies

The FDA has also approved the use of pembrolizumab (Keytruda) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. This approval, granted on November 16, 2023, is based on the KEYNOTE-859 trial, which showed statistically significant improvements in overall survival, progression-free survival, and overall response rate[4].

Market Projections

Global Market Size and Growth

The global fluorouracil (5-FU) market is projected to experience significant growth. As of 2023, the market size was valued at USD 2.45 billion and is expected to reach USD 4.34 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 7.7% from 2024 to 2030[2].

Key Drivers of Market Growth

Several factors are driving the growth of the fluoropyrimidine market:

Rising Cancer Incidence

The increasing incidence of cancer worldwide is a major driver. Fluorouracil is a first-line treatment for various cancers, including pancreatic, colon, cervical, and breast cancers[2].

Advancements in Cancer Treatment

Advancements in cancer treatment options, including combination therapies and new formulations, are contributing to market growth. For example, the approval of pembrolizumab with fluoropyrimidine-based chemotherapy highlights the evolving landscape of cancer treatment[4].

Increasing Healthcare Access

As more people gain access to healthcare, especially in emerging economies, the demand for cancer treatments like fluorouracil is increasing. Early detection programs are also becoming more common, leading to an increase in the number of patients seeking these treatments[5].

Government and Private Sector Investments

Government and private sector investments in oncology research and development are further fueling market growth. Pharmaceutical companies are investing heavily in research to develop new formulations and biosimilars of fluoropyrimidine drugs[5].

Market Segmentation

By Route of Administration

The fluorouracil market is segmented by route of administration, including:

  • Parenteral: This is the most common route for fluorouracil administration, particularly for treating advanced cancers.
  • Oral: Capecitabine, an oral fluoropyrimidine, is used for treating certain types of cancer, offering an alternative to parenteral administration[2].

By Geography

The market is also segmented geographically, with key regions including:

  • North America: The U.S., Canada, and Mexico are significant markets due to high cancer incidence and advanced healthcare systems.
  • Europe: Countries like Germany, the U.K., and France have a substantial market share.
  • Asia Pacific: China, Japan, and India are emerging as major markets due to increasing healthcare access and a growing population[2].

Competitive Landscape

The fluoropyrimidine market is competitive, with several key players:

  • Nantong Haier’s Pharmaceutical Co. Ltd.: One of the companies involved in the production and distribution of fluorouracil products[2].
  • Other Pharmaceutical Companies: Companies like Shire plc and Accord Healthcare are also active in the market, with recent approvals and launches of fluorouracil-based products[2].

Future Outlook

Biosimilars and Combination Therapies

The future of the fluoropyrimidine market looks promising, driven by the increasing demand for biosimilars and advancements in combination therapies. Biosimilars of fluorouracil are expected to play a significant role in expanding market access, especially in regions with limited healthcare resources[5].

Innovations in Drug Formulations

Innovations in drug formulations, such as new delivery systems and combination therapies, are expected to continue driving market growth. The integration of immunotherapies like pembrolizumab with fluoropyrimidine-based chemotherapies is a notable trend that is likely to shape the future of cancer treatment[4].

Key Takeaways

  • FDA Labeling Changes: Recent labeling changes for fluorouracil highlight the importance of pharmacogenomics in patient care.
  • Market Growth: The global fluorouracil market is projected to grow significantly, driven by rising cancer incidence, advancements in treatment options, and increasing healthcare access.
  • Combination Therapies: Approvals for combination therapies, such as pembrolizumab with fluoropyrimidine-based chemotherapy, are enhancing treatment outcomes.
  • Biosimilars and Innovations: The market is expected to benefit from the development of biosimilars and innovative drug formulations.

FAQs

What is the current market size of the fluorouracil market?

The global fluorouracil market size was valued at USD 2.45 billion in 2023[2].

What is the projected growth rate of the fluorouracil market?

The market is projected to grow at a CAGR of 7.7% from 2024 to 2030[2].

What are the key drivers of the fluorouracil market growth?

Key drivers include rising cancer incidence, advancements in cancer treatment options, and increasing healthcare access[2][5].

What recent FDA approvals are significant for fluoropyrimidine drugs?

The FDA approved safety labeling changes for fluorouracil injection products and approved pembrolizumab with fluoropyrimidine-based chemotherapy for HER2-negative gastric or GEJ adenocarcinoma[1][4].

What role do biosimilars play in the fluoropyrimidine market?

Biosimilars are expected to expand market access, especially in regions with limited healthcare resources, and drive market growth[5].

Sources

  1. FDA: FDA approves safety labeling changes regarding DPD deficiency for fluorouracil injection products[1].
  2. Verified Market Research: In-Depth Industry Outlook: Fluorouracil (5FU) Market Size & Forecast[2].
  3. CITELINE: Key Potential Drug Launches in 2025[3].
  4. FDA: FDA approves pembrolizumab with chemotherapy for HER2-negative gastric or gastroesophageal junction adenocarcinoma[4].
  5. Market Research Intellect: 5 fluorouracil Market Size And Projection[5].
Last updated: 2024-12-30

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