Delving into the Latest Updates on Fluorouracil with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

5-fluoro-1H-pyrimidine-2,4-dione, 5-Fluoropyrimidine-2,4-dione, 5-Fluorouracil

+ [37]

Target

TYMS

Action

inhibitors

Mechanism

TYMS inhibitors(Thymidylate synthase inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [10]

Active Indication

Esophageal CarcinomaIntestinal NeoplasmsBiliary Tract Neoplasms+ [98]

Inactive Indication

adenocarcinoma of biliary tractAdenocarcinoma, metastaticAdvanced biliary tract cancer+ [112]

Originator Organization

Spectrum Pharmaceuticals, Inc.

Active Organization

The University of Texas MD Anderson Cancer Center

McGill University

Hill Dermaceuticals, Inc.

+ [26]

Inactive Organization

Hoffmann-La Roche, Inc.

University of Southern California

Sanofi

+ [44]

License Organization

Dr. Reddy's Laboratories Ltd.

Hill Dermaceuticals, Inc.

Extrovis AG

+ [1]

Drug Highest PhaseApproved

First Approval Date

United States (25 Apr 1962),

Breast CancerColorectal CancerPancreatic Cancer+ [1]

RegulationOrphan Drug (United States)

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Structure/Sequence

Molecular FormulaC4H3FN2O2

InChIKeyGHASVSINZRGABV-UHFFFAOYSA-N

CAS Registry51-21-8

This phase I trial studies the safety, side effects, and best dose of ADG126, in combination with ivonescimab alone, in combination with ivonescimab, leucovorin, and fluorouracil, or in combination with ivonescimab and leucovorin, fluorouracil, and irinotecan (FOLFIRI regimen) in treating patients with microsatellite stable (MSS) colorectal cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or has spread from where it first started (primary site) to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as ivonescimab and ADG126, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ivonescimab may also stop or slow the cancer by blocking the growth of new blood vessels necessary for tumor growth. Leucovorin calcium is a type of drug called a folic acid analog, which means it is similar to the vitamin folic acid. It is used in combination with certain chemotherapy drugs to enhance their ability to kill tumor cells or to lessen their harmful side effects. Fluorouracil is a type of chemotherapy called an antimetabolite, which is a drug that mimics a natural chemical and prevents its use in cells. It interferes with the production of a key component of deoxyribonucleic acid (DNA), which prevents the DNA from copying itself. This causes tumor cells and other rapidly dividing cells to die. Fluorouracil also gets incorporated into ribonucleic acid (RNA) and DNA, disrupting critical cell functions. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Giving ADG126 with ivonescimab, with or without leucovorin and fluorouracil or FOLFIRI regimen, may be safe in treating patients with MSS advanced/metastatic colorectal cancer.

Start Date21 Jul 2026

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT07271355

/ Not yet recruitingPhase 3IIT

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

This phase III trial studies how well pressurized intraperitoneal aerosolized chemotherapy (PIPAC) with mitomycin works versus (vs) standard chemotherapy (leucovorin calcium, fluorouracil, and irinotecan hydrochloride [FOLFIRI regimen] plus bevacizumab) in treating patients with appendix or colorectal cancer that cannot be removed by surgery (unresectable) and has spread from where it first started (primary site) to the abdominal cavity (peritoneal metastases). PIPAC is a new therapeutic approach that is minimally invasive, does not require surgery (laparotomy), and can be frequently repeated. Chemotherapy is delivered as a pressurized mist directly inside the abdominal cavity (peritoneum) during a minimally invasive surgery called a laparoscopy. The pressure helps the chemotherapy absorb into the cancer tissue and spread more evenly. Mitomycin is an antibiotic used as a chemotherapy drug. It stops or slows the growth of cancer cells and other rapidly growing cells by damaging their deoxyribonucleic acid (DNA). Standard chemotherapy drugs, such as those in the FOLFIRI regimen, are given via infusion into a vein (intravenously), and work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Another standard intravenous drug, bevacizumab, is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving mitomycin via PIPAC in combination with the standard FOLFIRI regimen, with or without bevacizumab, may work better than standard FOLFIRI plus bevacizumab alone in treating patients with unresectable appendix or colorectal cancer with peritoneal metastases.

Start Date01 Jul 2026

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT07041749

/ Not yet recruitingNot ApplicableIIT

Comparison of the Efficacy of Microneedling Alone Versus Microneedling Coupled With Either Bleomycin or 5flourouracil in the Treatment of Plantar Warts

To compare between the efficacy and safety of microneedling alone, microneedling with topical bleomycin and microneedling with 5-flurouracil in treatment of planter warts.
Microneedling will be performed on each wart using dermapen supplied with 12 needles arranged in rows. Topical anesthetic cream will be applied for 60 min before the procedures. Microneedling will be performed on each wart using dermapen. The penetration depth will be adjusted at 2-mm, endpoint is pinpoint bleeding and the dermapen will be held by the hand in a vertical direction on the warts.
Bleomycin is typically supplied in 15 U vials. The preparation will be diluted first with 7 mL normal saline ,double the amount taken from the vial by adding the same amount lidocaine (2%), so that the concentrations become 1 U/mL . The maximum total amount of bleomycin taken to each patient in one session will be 1 U/1 mL . Microneedling will be performed on the lesion using a microneedling pen type device with a 1-cm tip diameter at a 2-mm depth setting for 2-3 minutes until pinpoint bleebing occurs 1 mL of the prepared solution of bleomycin (1 U/1 mL) will be dropped on to the wart tissue using insulin syringe and occlusion will be applied for 3 hours.
5-FU is available in 10 mL vial: 500 mg/10 mL. Application of 5-FU solution will be done by dropping using an insulin syringe (1 mL)to help dropping of the solution on the warts surface. Then, the lesion will be occluded with a plaster for 3 h.
Sessions: Sessions will be performed every 2 weeks until complete cure or for maximum 6 sessions (total 3 month)

Start Date01 Jun 2026

Sponsor / Collaborator

Assiut University

100 Clinical Results associated with Fluorouracil

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100 Translational Medicine associated with Fluorouracil

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100 Patents (Medical) associated with Fluorouracil

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55,856

Literatures (Medical) associated with Fluorouracil

01 Dec 2026·JOURNAL OF BIOLOGICAL PHYSICS

Difference in cell death response between mitomycin C and 5-fluorouracil treatment studied using quartz crystal microbalance combined with simultaneous monitoring of viable cells

Article

Author: Muramatsu, Hiroshi ; Long, Hao ; Sugiyama, Tomoyasu

A quartz crystal microbalance (QCM) can be used to evaluate the physical properties of cells exposed to anticancer drugs. Mass-sensing techniques on electrodes detect subtle changes in adherent cells during drug treatment, providing insights into physiological, biochemical, and morphological events from a physical perspective. Although these methods have been established in many studies using living cells, their drug responses remain associated with cell viability. This study aimed to measure QCM response by simultaneously monitoring non-viable cell images. Treatment with mitomycin C (MMC) caused the resonant frequency to shift from a decrease to an increase, followed by a delayed rise in the proportion of non-viable cells. By contrast, treatment with 5-fluorouracil (5-FU) produced minimal frequency changes, accompanied by a shorter delay before cell death was observed. The fitting data to the model equations of the cumulative log-normal distribution curve showed a clear difference in parameter values between MMC and 5-FU, indicating distinct cell death processes. These results demonstrate that QCM-based monitoring of physical properties provides complementary information on drug responses and may serve as a useful tool in anticancer drug development.

01 Dec 2026·MOLECULAR BIOLOGY REPORTS

Non-Coding RNAs and cernas: emerging modulators of drug response in colorectal cancer

Review

Author: Abkenar, Elahe Daskar ; Sadeghi, Amir ; Mojarad, Ehsan Nazemalhosseini ; Nobili, Stefania ; Shams, Elahe ; Moghani, Mona Malekzadeh ; Sina, Negin ; Ebrahimi, Sara ; Fatemi, Nayeralsadat

Colorectal cancer (CRC) is still one of the most common cancers and a leading cause of cancer morbidity worldwide. A significant issue that should be paid much attention to is its resistance to anticancer agents. Non-coding RNAs (ncRNAs), such as microRNAs (miRNAs), long non-coding RNAs (lncRNAs), and circular RNAs (circRNAs), have been identified as important regulators of drug response and drug resistance in CRC. In this review, we provide a comprehensive assessment of the studies conducted in the field of investigating the role of ncRNAs in drug resistance to prominent anticancer agents used in CRC, including 5-fluorouracil (5-FU), oxaliplatin, cetuximab, bevacizumab, and regorafenib. We focussed specifically on the miRNAs, lncRNAs, and circRNAs associated with resistance to each drug individually, even within the context of combination therapies, such as FOLFOX. We also reviewed competing endogenous RNA (ceRNAs) networks and their relationship with drug sensitivity and resistance and new therapeutic strategies to manage drug resistance in CRC and also analyzed the role of ceRNA networks in modulating drug response and its implications for new approaches to overcome drug resistance in CRC. This article also discusses findings from human clinical trials, highlighting evidence from patient studies that validate the role of targeting ceRNA and ncRNA networks in improving drug sensitivity, overcoming resistance, and enhancing therapeutic outcomes in CRC. It supports the targeting of ncRNA and ceRNA networks as potential therapies to improve treatment outcomes and drug resistance in CRC.

01 Jun 2026·ACTA HISTOCHEMICA

Anticancer drug-treated fibroblasts modulate colon cancer cell behavior through lysophosphatidic acid (LPA) receptor-mediated signaling

Article

Author: Yamamoto, Mao ; Yashiro, Narumi ; Kusumoto, Yuka ; Shimomura, Nanami ; Tamura, Moemi ; Tsujiuchi, Toshifumi ; Nagano, Shion

Lysophosphatidic acid (LPA) receptor-mediated signaling contributes to the pathogenesis of cancer. The tumor microenvironment (TME), composed of cancer cells and surrounding stromal cells, plays a key role in promoting malignant traits, including resistance to anticancer drugs. In this study, we investigated the roles of LPA receptor-1 (LPA₁) and LPA₂ in colon cancer DLD-1 cell functions modulated by 3T3 fibroblasts chronically exposed to chemotherapy. 3T3 cells were treated long-term with fluorouracil (5-FU), irinotecan (CPT-11), or cisplatin (CDDP) to generate 3T3-5FU, 3T3-CPT11, and 3T3-CDDP cells, respectively. Co-culture with anticancer drug-treated 3T3 cells altered LPA receptor expression in DLD-1 cells, characterized by reduced LPAR1 and elevated LPAR2 levels, compared with co-culture with untreated fibroblasts (n = 3 independent experiments). Under these conditions, LPA stimulation enhanced DLD-1 cell proliferation and motility. Pharmacological modulation of LPA signaling further supported receptor-specific effects: the LPA₁ antagonist AM966 and the LPA₂ agonist GRI-977143 promoted DLD-1 cell growth, while AM966 suppressed and GRI-977143 enhanced cell motility in co-culture with drug-treated fibroblasts. These findings suggest that chemotherapy-conditioned fibroblasts reshape LPA receptor-dependent signaling in colon cancer cells, suggesting potential therapeutic relevance of distinct roles for LPA₁ and LPA₂ within the drug-modified TME.

883

News (Medical) associated with Fluorouracil

05 Feb 2026

·www.fda.gov

Safety labeling update for capecitabine and fluorouracil (5-FU) on risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency

The U.S. Food and Drug Administration (FDA) is providing this communication to increase awareness of recent updates to the product labeling of capecitabine (Xeloda) and fluorouracil (5-FU) related to risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency. All healthcare providers should be aware of the risks of DPD deficiency, inform patients prior to treatment about the potential for serious and life-threatening toxicities due to DPD deficiency, and test patients for genetic variants of DPYD prior to initiating treatment with capecitabine or 5-FU unless immediate treatment is necessary.The DPYD gene encodes the enzyme DPD, which breaks down >80% of fluorouracil. Patients with certain homozygous or compound heterozygous variants in the DPYD gene, known to result in complete or near complete absence of DPD activity (complete DPD deficiency), are at increased risk for acute early-onset toxicity and serious, including fatal, adverse reactions (e.g., mucositis, diarrhea, neutropenia, and neurotoxicity) when exposed to capecitabine or fluorouracil. Patients with partial DPD activity (partial DPD deficiency) may also have an increased risk of serious, including fatal, adverse reactions.The FDA recently approved revisions to the Xeloda (capecitabine) and 5-FU product labeling to provide further information on DPD deficiency. The following summarizes the key changes that were made to the labeling of both drugs:Boxed Warning: The Boxed Warning now highlights the risk of serious adverse reactions or death in patients with complete DPD deficiency. It also advises DPYD testing prior to initiating capecitabine or 5-FU, unless immediate treatment is necessary, and recommends avoiding use in patients with certain homozygous or compound heterozygous DYPD variants that result in complete DPD deficiency.Dosage and Administration: A new subsection, 2.1 Evaluation and Testing for DPD Deficiency Before Initiating capecitabine or 5-FU, has been added and instructs to avoid use of these drugs in patients known to have certain homozygous or compound heterozygous DYPD variants that result in complete DPD deficiency. For patients with partial DPD deficiency, dosing should be individualized.Warnings and Precautions: Reiterates that prior to initiating capecitabine or 5-FU, patients should be tested for genetic variants of the DPYD gene unless immediate treatment is necessary.See the full prescribing information for Xeloda (capecitabine) and 5-FU for additional information on DPD deficiency, located in the Boxed Warning and Sections 2, 5, 12, and 17.The FDA will continue to monitor this safety issue and evaluate the evolving landscape and impact of DPD deficiency on the safety of capecitabine and fluorouracil; additional regulatory actions may be considered. The FDA urges patients and healthcare providers to report side effects to the FDA MedWatch program.

04 Feb 2026

·pmlive.com

AstraZeneca’s Imfinzi regimen receives positive CHMP opinion for early gastric and gastroesophageal cancer

AstraZeneca has announced that Imfinzi (durvalumab), in combination with standard of care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin and docetaxel), has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for adults with resectable, early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers. Imfinzi and FLOT form a perioperative regimen that includes neoadjuvant Imfinzi and chemotherapy prior to surgery, adjuvant Imfinzi and chemotherapy, and finally Imfinzi as a monotherapy. The CHMP’s positive opinion is based on results from the phase 3 MATTERHORN trial. The trial showed that the Imfinzi-FLOT regimen reduced risk of death by 22% compared to chemotherapy alone. Around 69% of Imfinzi-FLOT-treated patients were alive at three years, compared to 62% of patients in the comparator arm of the study. The safety profile of the combination treatment was consistent with the established safety profiles of each component, and the rate of Grade 3 or higher adverse events was consistent across both arms. Results from the trial were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine. Gastric cancer is the fifth highest cause of cancer deaths worldwide, and almost a million people are diagnosed with it each year. There were around 43,000 patients treated for early-stage and locally advanced gastric or GEJ cancer in the US, EU and Japan in 2024. By 2030, around 62,000 patients across these regions are expected to be newly diagnosed with early-stage and locally advanced gastric or GEJ cancer. Imfinzi is approved in the US and various other countries for the same indication, with approval following the MATTERHORN data. Additionally, Japan and other countries are currently reviewing regulatory applications for Imfinzi. Susan Galbraith, executive vice president, oncology haematology R&D at AstraZeneca, said: “The CHMP recommendation marks further progress toward our goal to offer novel approaches in early-stage cancers where there is the greatest chance for cure and brings us closer to providing the third perioperative Imfinzi-based regimen in the EU.”

Clinical ResultASCOPhase 3Drug Approval

04 Feb 2026

·oncolyticsbiotech.com

Oncolytics Biotech® Receives FDA Fast Track Designation for Pelareorep in 2L KRAS-Mutant MSS Metastatic Colorectal Cancer

Strong efficacy signals showing 33% ORR, 16.6-month PFS, and 27-month OS, improving on the SOC by 2-3X in a difficult-to-treat population Company to launch controlled study in second-line KRAS-mutant MSS mCRC with interim data expected by the end of 2026 Pelareorep now has Fast Track Designation for two gastrointestinal cancers, solidifying its potential as an immunotherapeutic platform therapy in gastrointestinal cancers SAN DIEGO, Feb. 04, 2026 (GLOBE NEWSWIRE) — Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track Designation to pelareorep in combination with bevacizumab (Avastin®) and leucovorin, fluorouracil, irinotecan (“FOLFIRI”) for the treatment of patients with KRAS (“Kirsten rat sarcoma”)-mutant, microsatellite-stable (“MSS”) metastatic colorectal cancer (“mCRC”) in the second-line (“2L”) setting. As part of the Company’s increased focus on gastrointestinal cancer and analysis of the existing colorectal data set in the fall, the Company applied for and has now received Fast Track Designation. The Fast Track Designation is supported by clinical data demonstrating a 33% objective response rate (“ORR”) for pelareorep-based therapy compared to approximately 10% ORR with standard-of-care (“SOC”) in this patient population.1-2 In addition, pelareorep combination therapy was associated with a median progression-free survival (“PFS”) of 16.6 months, compared to 5.7 months with SOC, and a median overall survival (“OS”) of 27 months, compared to 11.2 months with SOC.1 KRAS-mutant MSS metastatic colorectal cancer represents one of the most challenging diseases in gastrointestinal oncology, as few effective treatment options exist following first-line progression, and available immune-based therapies provide little benefit. There are an estimated 2 million new colorectal cancer cases each year globally, with an annual total addressable market of approximately $3-5 billion for the 2L KRAS-mutant MSS mCRC subgroup.3-7 “This designation is an important validation of our focus on pelareorep’s potential as a platform immunotherapy for gastrointestinal cancers like colorectal cancer,” said Jared Kelly, Chief Executive Officer of Oncolytics. “Adding pelareorep to the standard-of-care in this underserved segment of colorectal cancer patients results in a doubling or tripling of critical clinical endpoints, including overall survival, progression-free survival, and objective response rate in a market that is estimated to be worth several billion dollars. Pelareorep offers the potential to help a meaningful number of patients, and I look forward to continuing to collaborate with the FDA to address this treatment gap as expeditiously as possible.” Oncolytics expects to initiate a controlled clinical study in second-line KRAS-mutant MSS mCRC comparing standard-of-care therapy alone versus standard-of-care plus pelareorep. The first clinical site is expected to be activated in March, with up to 10 additional sites anticipated to open shortly thereafter. Interim data from the study are expected by year-end. Further details regarding the study design and milestones are forthcoming. The Fast Track Designation enables more frequent meetings and communication with the FDA to ensure alignment on development plans and the collection of clinical data needed to support approval. Furthermore, clinical programs with Fast Track Designation may be eligible for Accelerated Approval and Priority Review if relevant criteria are met. For conditions where an available treatment exists, a candidate therapy regimen must show some advantage over the available treatment, such as superior effectiveness, to be granted Fast Track Designation. References Bennouna J. Lancet Oncol (14):29-37, 2013 Iwamoto S. Ann Oncol. Jul;26(7):1427-33, 2015 International Agency for Research on Cancer. (n.d.). Colorectal cancer. World Health Organization – IARC. https://www.iarc.who.int/cancer-type/colorectal-cancer/ Amado RG, et al. Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer. J Clin Oncol. 2008 Apr 1;26(10):1626-34. doi: 10.1200/JCO.2007.14.7116. Epub 2008 Mar 3. PMID: 18316791 Cohen R, et al. Association of Primary Resistance to Immune Checkpoint Inhibitors in Metastatic Colorectal Cancer With Misdiagnosis of Microsatellite Instability or Mismatch Repair Deficiency Status. JAMA Oncol. 2019 Apr 1;5(4):551-555. doi: 10.1001/jamaoncol.2018.4942. PMID: 30452494; PMCID: PMC6459114. Snider J, et al. Metastatic colorectal cancer (mCRC) treatment patterns in the Medicare population. J Clin Oncol. 2018;36(4_suppl):823. https://doi.org/10.1200/JCO.2018.36.4_suppl.823 American Health & Drug Benefits. (2013). Metastatic colorectal cancer: Treatment patterns and costs. https://ahdbonline.com/issues/2013/february-2013-vol-6-no-1-special-issue/article-1294 About Oncolytics Biotech Inc.Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically “cold” tumors “hot” through the activation of innate and adaptive immune responses. The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic gastrointestinal cancers, where pelareorep has received Fast Track designation from the FDA for colorectal and pancreatic cancer. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: www.oncolyticsbiotech.com or follow the Company on social media on LinkedIn and on X @oncolytics. Forward-looking statementsThis press release contains forward-looking statements, within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; the anticipated design, timelines, milestones, and outcomes of current and future studies; the estimated size of the total addressable market of the 2L KRAS-mutant MSS mCRC subgroup; expected benefits of the Fast Track Designation, including increased collaboration with regulatory bodies; the Company’s goals, strategies, and objectives; and its belief in the clinical promise of pelareorep in colorectal and other gastrointestinal cancers. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics’ public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law. Company Contact Jon PattonDirector of IR & Communicationjpatton@oncolytics.ca Investor Relations for OncolyticsMike MoyerLifeSci Advisors+1-617-308-4306mmoyer@lifesciadvisors.com Media Contact for OncolyticsOwen BlaschakLifeSci Communicationsoblaschak@lifescicomms.com

ImmunotherapyFast TrackClinical ResultPhase 2

100 Deals associated with Fluorouracil

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KEGG	Wiki	ATC	Drug Bank
D00584	Fluorouracil	L01BC02	DB00544

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Esophageal Carcinoma	Japan	Kyowa Kirin Co., Ltd.	25 Nov 2021
Intestinal Neoplasms	Japan	Kyowa Kirin Co., Ltd.	21 Sep 2018
Biliary Tract Neoplasms	Brazil	Libbs Farmacêutica Ltda.	22 Jan 2007
Bladder Cancer	Brazil	Libbs Farmacêutica Ltda.	22 Jan 2007
Colonic Cancer	Brazil	Libbs Farmacêutica Ltda.	22 Jan 2007
Gallbladder Neoplasms	Brazil	Libbs Farmacêutica Ltda.	22 Jan 2007
Hepatocellular Carcinoma	Brazil	Libbs Farmacêutica Ltda.	22 Jan 2007
Rectal Cancer	Brazil	Libbs Farmacêutica Ltda.	22 Jan 2007
Head and Neck Neoplasms	Japan	Kyowa Kirin Co., Ltd.	14 Feb 2005
Bowen's Disease	Australia	iNova Pharmaceuticals (Australia) Pty Ltd.	23 Aug 1991
Neoplasms	China	Grand Pharmaceutical (China) Co., Ltd.	01 Jan 1981
Skin Neoplasms	Japan	Kyowa Kirin Co., Ltd.	26 Aug 1972
Actinic Keratosis	United States	Extrovis AG	29 Jul 1970
Advanced gastric carcinoma	Japan	Kyowa Kirin Co., Ltd.	24 Jul 1967
Endometrial Carcinoma	Japan	Kyowa Kirin Co., Ltd.	24 Jul 1967
Liver Cancer	Japan	Kyowa Kirin Co., Ltd.	24 Jul 1967
Lung Cancer	Japan	Kyowa Kirin Co., Ltd.	24 Jul 1967
Ovarian Cancer	Japan	Kyowa Kirin Co., Ltd.	24 Jul 1967
recurrent gastric cancer	Japan	Kyowa Kirin Co., Ltd.	24 Jul 1967
Stomach Cancer	Japan	Kyowa Kirin Co., Ltd.	24 Jul 1967

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
RAS/BRAF Wild Type Colorectal Cancer	Phase 3	Italy	National Cancer Institute	12 Jun 2024
Cutaneous Squamous Cell Carcinoma	Phase 3	United States	ECOG-ACRIN Medical Research Foundation, Inc.	08 Jun 2023
Hypopharyngeal Carcinoma	Phase 3	United States	ECOG-ACRIN Medical Research Foundation, Inc.	08 Jun 2023
Squamous cell carcinoma of head and neck metastatic	Phase 3	United States	ECOG-ACRIN Medical Research Foundation, Inc.	08 Jun 2023
Squamous cell carcinoma of the hypopharynx	Phase 3	United States	ECOG-ACRIN Medical Research Foundation, Inc.	08 Jun 2023
Squamous Cell Carcinoma of the Larynx	Phase 3	United States	ECOG-ACRIN Medical Research Foundation, Inc.	08 Jun 2023
Squamous cell carcinoma of the oral cavity	Phase 3	United States	ECOG-ACRIN Medical Research Foundation, Inc.	08 Jun 2023
Advanced Gastroesophageal Junction Adenocarcinoma	Phase 3	United States	Alliance for Clinical Trials in Oncology	31 Jan 2023
Metastatic gastroesophageal adenocarcinoma	Phase 3	United States	Alliance for Clinical Trials in Oncology	31 Jan 2023
Metastatic Gastroesophageal Junction Adenocarcinoma	Phase 3	United States	Alliance for Clinical Trials in Oncology	31 Jan 2023

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03693807 (CTgov)	Phase 2	Colorectal Liver Metastases \| Colorectal Cancer \| Bile Duct Neoplasms	35	Cetuximab+Gemcitabine+Floxuridine (FUDR)+Oxaliplatin+Irinotecan (CPT-11)+Panitumumab+Fluorouracil (Group 1: Unresectable Liver Metastases From Colorectal Cancer)	ppiudpuhzu(acprpczlmn) = rbckkymedn pqbiuldpum (ndzlflvkjk, dmelbzsybr - rkxkzcehez) View more	-	06 Feb 2026
				Cetuximab+Gemcitabine+Floxuridine (FUDR)+Oxaliplatin+Irinotecan (CPT-11)+Panitumumab+Fluorouracil (Group 2: Resectable Liver Metastases From Colorectal Cancer)	ppiudpuhzu(acprpczlmn) = tejawlubvl pqbiuldpum (ndzlflvkjk, grivluasyw - wveeelejoi) View more
NCT05047991 (Pubmed \| NEWS) Manual	Phase 2	Advanced Pancreatic Adenocarcinoma	117	NALIRIFOX (liposomal irinotecan+ 5-FU+leucovorin+oxaliplatin)	eqisvticuq(ousoinasfc) = tvwrgwusey embwjvuajf (hrzaamkaia, 5.52 - 9.23) View more	Positive	16 Jan 2026
				gemcitabine + nab-paclitaxel	eqisvticuq(ousoinasfc) = cruofmunsa embwjvuajf (hrzaamkaia, 3.38 - 5.32) View more
NCT04539808 (NeoOPTIMIZE, CTgov)	Phase 2	Pancreatic adenocarcinoma \| Pancreatic Ductal Adenocarcinoma	42	mFOLFIRINOX+nab-paclitaxel+leucovorin calcium+gemcitabine hydrochloride+potassium+losartan+Oxaliplatin+irinotecan hydrochloride+capecitabine+fluorouracil	mjgfsxecnl = eezfnpcrla tigvjpjajh (agsrkkgcth, owfzfrhfrk - yyjbccpvtk) View more	-	14 Jan 2026
JPRN-jRCTs031200094 (ASCO_GI2026)	Phase 2	Esophageal Squamous Cell Carcinoma Neoadjuvant	53	Neoadjuvant fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy	oyrarpwkhi(soucujzchu) = iwrmfolhoq afrgnewyib (fcmvufujpc ) View more	Positive	08 Jan 2026
				Neoadjuvant fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy (without SCLN metastasis)	oyrarpwkhi(soucujzchu) = izdpejyyba afrgnewyib (fcmvufujpc ) View more
ASCO_GI2026	Not Applicable	Esophageal Squamous Cell Carcinoma	104	IC-DCF+Nivo	wvjzjjgbfm(gqberyhkxj) = oxozzzsoiv iebytywqgf (jzkiapdmfr ) View more	Positive	08 Jan 2026
				IC-DCF	ujcalugwdp(xwuwrfnyjh) = jnscdzvdep yusyzsujoy (oiysyyaiww ) View more
SABCS2025	Not Applicable	Triple Negative Breast Cancer Neoadjuvant	10	Neoadjuvant CMF and pembrolizumab	xvuzzxftar(umlyzbijtd) = wtjsaxxhdq thndihivej (ofpmjavlkh )	Positive	11 Dec 2025
ESMO_ASIA2025	Not Applicable	Esophageal Carcinoma	43	Induction m-DCF followed by definitive chemoradiation	tdtuierzwi(nwocfuhgar) = neutropenia (25.6%) dbbnyprjxf (dzmfmpcfvz )	Positive	05 Dec 2025
ESMO_ASIA2025	Not Applicable	Solid tumor	114	CAPOX	risqhjzauv(lhomdcvntf) = umartbdmto yyocfbofzy (jyefeelpia ) View more	Positive	05 Dec 2025
ESMO_ASIA2025	Not Applicable	squamous cell carcinoma of the anus	48	Capecitabine plus Mitomycin	vkaqtiwpxw(ydbsmvbcbd) = bxgiiwpigg maroqgodfr (abtvylizsx ) View more	Positive	05 Dec 2025
				5-Fluorouracil plus Mitomycin	vkaqtiwpxw(ydbsmvbcbd) = wjnfhnlqls maroqgodfr (abtvylizsx ) View more
NCT02688803 (OTT15-04, CTgov)	Phase 4	Triple Negative Breast Cancer	2	Dose dense AC-P (Dose Dense AC-P)	jnznljongd = ncnvcukdcz vdnwnazeiz (ajxnapaphl, lxwooukhby - nxovryizuq) View more	-	04 Dec 2025
				Dose dense AC (Dose Dense AC)	bnugitmpoc = ggtftxhhpj gtzsagfrlf (oyitofkxuo, ecmrngotow - usrfghqiyx) View more