Drug

Fluorouracil

In clinical development

ClassThymidylate synthase inhibitorActively researchedLate-stage developmentSteady momentum

Also known as 5 FU, 5 Fluorouracil, 5- Fluorouracil, 5-FU+23 more

5 FU, 5 Fluorouracil, 5- Fluorouracil, 5-FU, 5-Fluoracil, 5-Fluorouracil, 5-Fluorouracile, 5-Fluoruracil, 5-Fluracil, 5FU, 5Fluorouracil, 5Fluorouracile, Adrucil, Carac, Efudex, Favlyxa, Fluoroplex, Fluorouracil Topical, Tolak, Fluoro Uracil, Fluoro-uracil, Fluorouracilo, Fluouracil, fluorouracile, flurouracil, 5-Fluoropyrimidine-2,4-dione, Fluorouracilum.

RxNorm4492 ChEMBLCHEMBL185 ATCL01BC02 ATCL01BC52UNIIU3P01618RT

Research papers

Active clinical trials

Thymidylate synthase

Primary target

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Randomized, Open-Label, Multicenter Phase 3 Trial of Domvanalimab, Zimberelimab, and Chemotherapy Versus Nivolumab and Chemotherapy in Participants With Previously Untreated Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

Randomized Phase II Trial of Pembrolizumab and Radiation vs. Radiation and Concurrent Chemotherapy for High-Grade T1 Bladder Cancer (PARRC Trial)

Clinical trial2026-07-31Results expected Q1 2032 · ClinicalTrials.gov

A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of ASP3082 in Combination With mFOLFIRINOX or NALIRIFOX as First-line Treatment in Participants With KRAS G12D Mutated Metastatic Pancreatic Adenocarcinoma

Clinical trial2026-07-27Results expected Q3 2029 · ClinicalTrials.gov

A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) + Lenvatinib (E7080/MK-7902) + Chemotherapy Compared With Standard of Care as First-line Intervention in Participants With Metastatic Esophageal Carcinoma.

Clinical trial2026-07-20Results posted · ClinicalTrials.gov

Clinical trial2026-07-20Status changed to Completed · ClinicalTrials.gov

Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)

Clinical trial2026-07-16Results expected Q4 2026 · ClinicalTrials.gov

A Phase 1b Study of Neoadjuvant ASP2138 Monotherapy and Investigator's Choice of Adjuvant Chemotherapy in Participants With Resectable Pancreatic Ductal Adenocarcinoma Whose Tumors Have Claudin (CLDN) 18.2 Expression

Clinical trial2026-07-15Results expected Q1 2028 · ClinicalTrials.gov

A Phase 1b/2 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Trastuzumab Deruxtecan (T-DXd) Monotherapy and Combinations in Adult Participants With HER2-expressing Gastric Cancer (DESTINY-Gastric-03)

Clinical trial2026-07-10Results expected Q2 2027 · ClinicalTrials.gov

Encorafenib, Cetuximab, and mFOLFOX6 in <i>BRAF</i>-Mutated Colorectal Cancer.

Research2025-05-30The New England journal of medicine

Encorafenib, cetuximab and chemotherapy in BRAF-mutant colorectal cancer: a randomized phase 3 trial.

Research2025-01-25Nature medicine

Glucose-dependent insulinotropic polypeptide receptor signaling alleviates gut inflammation in mice.

Research2024-12-26JCI insight

MOUNTAINEER-03 phase III study design: first-line mFOLFOX6 + tucatinib + trastuzumab for HER2+ metastatic colorectal cancer.

Research2024-12-26Future oncology (London, England)

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Fluorouracil

Aliases & brands

5 FU5 Fluorouracil5- Fluorouracil5-FU5-Fluoracil5-Fluorouracil5-Fluorouracile5-Fluoruracil5-Fluracil5FU5Fluorouracil5FluorouracileAdrucilCaracEfudexFavlyxaFluoroplexFluorouracil TopicalTolakFluoro UracilFluoro-uracilFluorouraciloFluouracilfluorouracileflurouracil5-Fluoropyrimidine-2,4-dioneFluorouracilum

RxNorm CUI

4492

ChEMBL ID

CHEMBL185

ATC codes

L01BC02L01BC52

UNII

U3P01618RT

Primary mechanism

Thymidylate synthase inhibitor

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Thymidylate synthase

TYMS · P04818

INHIBITORThymidylate synthase inhibitor

Clinical trials

193 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

193

registered trials across all phases

LATEST COMPLETION 2026

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 193

Early Phase 11Phase 117Phase 1 / 222Phase 289Phase 2 / 37Phase 354Phase 41Phase N / A2

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Prospective Case-controlled Study Comparing 5-Fluorouracil vs 5-Fluorouracil With Viscoelastic (Hyaluronic Acid) Formulation for the Prevention of Subconjunctival Scarring Post-trabeculectomy

CompletedPH IVSingapore National Eye Centren=502010

A Randomized, Open-label Phase 3 Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer

RecruitingPH IIIKey trialJanssen Research & Development, LLCn=1,0002032

A Phase 3, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Participants With Muscle-invasive Bladder Cancer (MIBC) (KEYNOTE-992)

Active, not recruitingPH IIIMerck Sharp & Dohme LLCn=5202031

A Phase III, Multicentre, Randomised Controlled Study of Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in First-Line Claudin18.2-Positive, HER2-Negative, Advanced/Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (CLARITY-Gastric 02)

RecruitingPH IIIKey trialAstraZenecan=2,1302031

A Phase 3, Global, Multi-center, Double-blind, Randomized Study of ASP2138 Plus Chemotherapy (CAPOX or mFOLFOX6) With Pembrolizumab vs Placebo Plus Chemotherapy With or Without Pembrolizumab in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma in Participants Whose Tumors Are HER2-negative and Claudin (CLDN) 18.2-positive

Not yet recruitingPH IIIAstellas Pharma Global Development, Inc.n=5702031

Recent completions

Trials that read out recently, adding to the completed evidence base.

CompletedPH IIIMerck Sharp & Dohme LLCn=8632026

Treatment of Children With All Stages of Hepatoblastoma With Temsirolimus (NSC#683864) Added to High Risk Stratum Treatment

CompletedPH IIINational Cancer Institute (NCI)n=2362026

A Phase Ib/II, Open-Label, Multicenter, Randomized, Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer)

CompletedPH I/IIHoffmann-La Rochen=2142025

A Multi-centre, Randomised, Parallel Group, Open-label, Phase II, Single-stage Selection Trial of Liposomal Irinotecan (Nal-IRI) and 5-fluorouracil (5-FU)/Folinic Acid or Docetaxel as Second-line Therapy in Patients With Progressive Poorly Differentiated Extra-pulmonary Neuroendocrine Carcinoma (NEC))

CompletedPH IIThe Christie NHS Foundation Trustn=582024

An Exploratory Pilot Study of Nab-paclitaxel Based Induction Chemotherapy Followed by Response-Stratified Locoregional Therapy for Patients With Stage III and IV HPV-Related Oropharyngeal Cancer - the OPTIMA HPV Trial

CompletedPH IIUniversity of Chicagon=622024

A Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First-Line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

CompletedPH IIIBeiGenen=6492024

Research activity

47 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

19992025

Most influential

Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer.

The New England journal of medicine · 2009 · 2,738 cites

Platinum-based chemotherapy plus cetuximab in head and neck cancer.

The New England journal of medicine · 2008 · 2,492 cites

Pembrolizumab in Microsatellite-Instability-High Advanced Colorectal Cancer.

The New England journal of medicine · 2020 · 2,216 cites

FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer.

The New England journal of medicine · 2018 · 2,091 cites

Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group.

The New England journal of medicine · 2000 · 2,062 cites

Concurrent chemotherapy and radiotherapy for organ preservation in advanced laryngeal cancer.

The New England journal of medicine · 2003 · 2,008 cites

Related diseases

12 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Active research areas

Colorectal Neoplasms19 Neoplasm Metastasis10 Pancreatic Neoplasms5 Stomach Neoplasms5 Adenocarcinoma4 Colonic Neoplasms3 Neoplasm Recurrence, Local3 Rectal Neoplasms3 Carcinoma, Pancreatic Ductal2 Carcinoma, Squamous Cell2 Disease Models, Animal2 Esophageal Neoplasms2

Related drugs

8 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Leucovorin

Studied across 15 of the same disease areas as Fluorouracil in the shared literature.

16 shared papers15 shared diseases

Cisplatin

Studied across 17 of the same disease areas as Fluorouracil in the shared literature.

17 shared diseases8 shared papers

Oxaliplatin

Studied across 10 of the same disease areas as Fluorouracil in the shared literature.

10 shared papers10 shared diseases

Irinotecan

Studied across 17 of the same disease areas as Fluorouracil in the shared literature.

17 shared diseases7 shared papers

Capecitabine

Acts on the same molecular target as Fluorouracil, with 5 overlapping disease areas.

Shared target5 shared diseases3 shared papers

Camptothecin

Studied across 14 of the same disease areas as Fluorouracil in the shared literature.

14 shared diseases6 shared papers

Pembrolizumab

Studied across 18 of the same disease areas as Fluorouracil in the shared literature.

18 shared diseases2 shared papers

Deoxycytidine

Studied across 9 of the same disease areas as Fluorouracil in the shared literature.

9 shared diseases4 shared papers

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials