5-fluorouracil

Phase 3

5-fluorouracil is one of 374 therapeutic programs targeting Advanced Unresectable Gastric Adenocarcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

373

Competitors

Pipeline

Status by Indication[2][1]

Indication

Advanced Unresectable Gastric AdenocarcinomaRecruiting

AdenocarcinomaRecruiting

Esophageal Squamous Cell CarcinomaRecruiting

Gastric NeoplasmsActive, not recruiting

Gastric CancerRecruiting

Peritoneal MesotheliomaRecruiting

Colorectal NeoplasmsRecruiting

Gastroesophageal AdenocarcinomaRecruiting

Liver MetastasesRecruiting

Metastatic Solid TumorRecruiting

Advanced Unresectable Gastric AdenocarcinomaPhase 2

Recruiting

AdenocarcinomaPhase 2

Recruiting

Esophageal Squamous Cell CarcinomaPreclinical

Recruiting

Gastric NeoplasmsPhase 3

Active, not recruiting

Gastric CancerPhase 3

Recruiting

Peritoneal MesotheliomaPhase 1

Recruiting

Colorectal NeoplasmsPhase 3

Recruiting

Gastroesophageal AdenocarcinomaPhase 2

Recruiting

Liver MetastasesPhase 2

Recruiting

Metastatic Solid TumorPhase 1

Recruiting

Showing 10 of 24 indications

Competition

Competitive Landscape

348 competitors in Solid Tumor

#DrugCompanyPhaseTrials

5-fluorouracil

Merck & Co.

Phase 3

3 2

Nubeqa

Bayer

Preclinical

2 3

DATROWAY

Daiichi Sankyo

Preclinical

1 4

Fludara

Sanofi

Preclinical

1 5

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

2 6

Augtyro

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Preclinical

2 7

Zejula

GGlaxo Dba Glaxosmithkline

Preclinical

2 8

Paxil

SSebela Pharmaceuticals Development LLC

Preclinical

1 9

Navmi

SSummit Therapeutics

Preclinical

1 10

Tulmimetostat

Novartis

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Active, not recruiting

Colorectal Cancer

NCT05464030

Phase 2Active, not recruiting

Rectal Cancer

NCT02008656

Phase 2Active, not recruiting

Esophageal Cancer

NCT03764553

Q1 2027

Phase 2Recruiting

Liver Metastases

NCT05062317

Q2 2027

Phase 2Recruiting

Gastric Cancer

NCT06219941

Q3 2027

Phase 1Active, not recruiting

Malignant Solid Tumor

NCT06057038

Clinical

Trials by Indication[1]

Colorectal Neoplasms4 trials

A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Olomorasib in Combination With Cetuximab and mFOLFOX6 in Participants With KRAS G12C-Mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer

Not yet recruiting· Eli Lilly logo

Eli Lilly·Phase 2·NCT07814417·50 enrolled

A Randomized, Open-label Phase 3 Study of Amivantamab + FOLFIRI Versus Cetuximab/Bevacizumab + FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Recurrent, Unresectable or Metastatic Colorectal Cancer Who Have Received Prior Chemotherapy

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT06750094·700 enrolled

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

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT06662786·1,000 enrolled

Show 1 more trial

An Open-label Phase 1 Study to Investigate PF-08046050 (SGN-CEACAM5C) in Adults With Advanced Solid Tumors

Recruiting· Pfizer logo

Pfizer·Phase 1·NCT06131840·914 enrolled

Solid Tumor3 trials

A Phase 1, Open-label, Multicenter Study to Assess Safety, Tolerability, PK, and Efficacy of MK-1084 as Monotherapy and as Part of Various Combination Therapies in Participants With KRAS G12C Mutant Advanced Solid Tumors

Recruiting· Merck & Co. logo

Merck & Co.·Phase 1·NCT05067283·830 enrolled

Phase Ib Study of CBP-1019 in Combination With FOLFOX +/- Bevacizumab, Pembrolizumab, or Enzalutamide for Metastatic TRPV6-overexpressing Solid Tumors of Epithelial Origin

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT06576037·128 enrolled

A Phase 1/2 Study of ASP1570 as Monotherapy and in Combination With Pembrolizumab and/or Standard Therapies Including Chemotherapy and/or Immunotherapy in Participants With Locally Advanced or Metastatic Solid Tumors

Terminated· Astellas logo

Astellas·Phase 1·NCT05083481·226 enrolled

Colorectal Cancer3 trials

A Phase I, Multicenter, Open-Label First in Human Study of Anti-CEACAM5 Antibody Drug Conjugate M9140 in Participants With Advanced Solid Tumors (PROCEADE-CRC-01)

Active, not recruiting· EMD Serono Research & Development Institute, Inc. logo

EMD Serono Research & Development Institute, Inc.·Phase 1·NCT05464030·220 enrolled

A Randomized, Open Label, Multicenter, Phase 2 Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo® in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care for First-line Treatment of Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer

Recruiting· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 2·NCT06948448·144 enrolled

A Phase 2 Clinical Trial of Tovecimig Plus FOLFIRI in Second Line Metastatic Colorectal Cancer

Not yet recruiting·WWashington University School of Medicine·Phase 2·NCT07662031·25 enrolled

Esophageal Squamous Cell Carcinoma2 trials

A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy in Participants With 1L Locally Advanced Unresectable/Metastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06E

Recruiting· Merck & Co. logo

Merck & Co.·Preclinical·NCT06780111·298 enrolled

A Phase II/III Randomized Controlled Clinical Study of BL-B01D1 for Injection in Combination With Tislelizumab With or Without 5-Fluorouracil Versus Platinum-Based Chemotherapy Plus Tislelizumab as First-line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma(PANKU-Esophagus02)

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Preclinical·NCT07554456·90 enrolled

Gastric Cancer2 trials

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)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT07431281·2,130 enrolled

A Phase II, Open-label, Multi-centre Study to Evaluate Safety, Tolerability, Efficacy, PK, and Immunogenicity of AZD0901 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Tumours Expressing Claudin 18.2 (CLARITY-PanTumour01)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT06219941·226 enrolled

28 more indications

Gastroesophageal Adenocarcinoma2 trials

A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With 1L Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, and Esophageal Adenocarcinoma): Substudy 06C

Recruiting· Merck & Co. logo

Merck & Co.·Preclinical·NCT06469944·160 enrolled

A Master Protocol of an Open-Label, Multi-Drug, Multi-Center, Phase II Platform Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma (GEMINI-PeriOp GC)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT07069712·100 enrolled

Pancreatic Ductal Adenocarcinoma2 trials

An Open Labelled Phase III Adjuvant Trial of Disease-free Survival in Patients With Resected Pancreatic Ductal Adenocarcinoma Randomized to Allocation of Oxaliplatin- or Gemcitabine-based Chemotherapy by Standard Clinical Criteria or by a Transcriptomic Treatment Specific Stratification Signature

Recruiting·JJohn Neoptolemos·Phase 3·NCT05314998·394 enrolled

A Phase 1a/1b Trial of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors

Recruiting· Eli Lilly logo

Eli Lilly·Phase 1·NCT06586515·630 enrolled

Esophageal Cancer2 trials

Liposomal iRInotecan, Carboplatin or oXaliplatin in the First Line Treatment of Esophagogastric Cancer: a Randomized Phase 2 Study

Active, not recruiting·AAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)·Phase 2·NCT03764553·320 enrolled

A Single-Arm, Multicenter Phase 2 Study of Neoadjuvant Pembrolizumab With Trastuzumab and Chemotherapy in Resectable HER2+ Esophagogastric Tumors

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT06123338·49 enrolled

Gastroesophageal Junction Adenocarcinoma2 trials

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)

Terminated· Roche logo

Roche·Preclinical·NCT03281369·219 enrolled

RACE-trial: Neoadjuvant Radiochemotherapy Versus Chemotherapy for Patients With Locally Advanced, Potentially Resectable Adenocarcinoma of the Gastroesophageal Junction (GEJ) A Randomized Phase III Joint Study of the AIO, ARO and DGAV

Completed·UUniversitätsmedizin Mannheim·Phase 3·NCT04375605·342 enrolled

Locally Advanced or Metastatic Solid Tumors1 trial

A Phase 1b/2 Study of ASP388B as Monotherapy and in Combination With Standard Therapies in Participants With Locally Advanced Unresectable or Metastatic Solid Tumors

Recruiting· Astellas logo

Astellas·Preclinical·NCT07730021·392 enrolled

Advanced Esophageal Squamous Cell Carcinoma1 trial

A Phase 2 Study of Tislelizumab Administered With Alternative Dosing Schedules Plus Chemotherapy as First-line Treatment in Japanese Patients With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Recruiting·BBeOne Medicines·Phase 2·NCT07733180·30 enrolled

Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer1 trial

A Phase 3, Double-blind, Randomized Study of Zolbetuximab in Combination With Pembrolizumab and Chemotherapy (CAPOX or mFOLFOX6) in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in Participants Whose Tumors Are HER2-negative, Claudin (CLDN) 18.2-positive and Programmed Death-ligand 1 (PD-L1)-Positive

Recruiting· Astellas logo

Astellas·Phase 3·NCT06901531·500 enrolled

Colon Adenocarcinoma1 trial

A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084, Cetuximab, and mFOLFOX6 Versus mFOLFOX6 With or Without Bevacizumab as First-line Treatment of Participants With KRAS G12C-mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer (KANDLELIT-012)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT06997497·477 enrolled

Metastatic Gastric Adenocarcinoma1 trial

A Phase 3, Multi-Center, Randomized, Open-Label Clinical Study of Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Recruiting·BBeOne Medicines·Phase 3·NCT07043400·351 enrolled

HER2-positive Gastric Cancer1 trial

A Randomized, Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan Versus Trastuzumab, Chemotherapy, and Pembrolizumab for the First Line Treatment of HER2-positive Gastric Cancer (ARTEMIDE-Gastric01)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06764875·840 enrolled

Pancreatic Cancer1 trial

RASolute 305: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Investigator Choice of Chemotherapy (Modified FOLFIRINOX or Gemcitabine Plus Nab-Paclitaxel) With or Without Zoldonrasib (RMC-9805) as First-line Treatment in Patients With Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma

Recruiting· Revolution Medicines logo

Revolution Medicines·Phase 3·NCT07621718·670 enrolled

Malignant Solid Tumor1 trial

A Phase 1 Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of GEN1042 Monotherapy and in Combination With Pembrolizumab ± Chemotherapy in Japanese Subjects With Malignant Solid Tumors

Active, not recruiting· Genmab logo

Genmab·Phase 1·NCT06057038·8 enrolled

Metastatic Pancreatic Cancer1 trial

A Randomized, Controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of YL201 Versus Liposomal Irinotecan in Combination With 5-Fluorouracil/Leucovorin in Participants With Metastatic Pancreatic Ductal Adenocarcinoma Who Have Failed Prior Gemcitabine-based Systemic Therapy

Not yet recruiting·MMediLink Therapeutics (Suzhou) Co., Ltd.·Phase 3·NCT07803783·320 enrolled

Neoplasm Malignant1 trial

A Prospective, Open-label, Phase 4 Study to Evaluate the Safety of Pembrolizumab (KEYTRUDA®) in Combination With Indication-specific Chemotherapy or Chemoradiotherapy in Participants Across Multiple Indications in India (KEYNOTE-G44)

Not yet recruiting· Merck & Co. logo

Merck & Co.·Approved·NCT07801027·150 enrolled

Stage II Rectal Cancer AJCC v81 trial

The Janus Rectal Cancer Trial: A Randomized Phase II/III Trial Testing the Efficacy of Triplet Versus Doublet Chemotherapy Regarding Clinical Complete Response and Disease-free Survival in Patients With Locally Advanced Rectal Cancer

Active, not recruiting·AAlliance for Clinical Trials in Oncology·Preclinical·NCT05610163·760 enrolled

Gastric Neoplasms1 trial

A Randomized, Multicenter, Phase 3 Study of Zanidatamab in Combination With Chemotherapy With or Without Tislelizumab in Subjects With HER2-positive Unresectable Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma (GEA)

Active, not recruiting· Jazz Pharmaceuticals logo

Jazz Pharmaceuticals·Phase 3·NCT05152147·920 enrolled

Malignant Neoplam1 trial

A Phase 2, Open-label Clinical Study to Evaluate the Safety and Efficacy of MK-2010 as Monotherapy and in Combination

Not yet recruiting· Merck & Co. logo

Merck & Co.·Phase 2·NCT07793942·480 enrolled

Gastric Carcinoma1 trial

A Single-Arm, Phase II Study of Ivonescimab in Combination With FOLFOX in Advanced HER2 Negative Gastroesophageal Adenocarcinomas

Recruiting·MMassachusetts General Hospital·Phase 2·NCT07070466·40 enrolled

Peritoneal Mesothelioma1 trial

Individualized Response Assessment to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for the Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Primaries

Recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT04847063·60 enrolled

Advanced Unresectable Gastric Adenocarcinoma1 trial

An Open-Label, Single-Arm, Phase 2 Study to Evaluate the Efficacy and Safety of Tislelizumab Plus Chemotherapy in a First-Line Setting for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma in US Racial and Ethnic Minority Patients

Recruiting·BBeOne Medicines·Phase 2·NCT07554521·30 enrolled

Rectal Cancer1 trial

A Phase II Multicenter Randomized Trial Evaluating 3-year Disease Free Survival in Patients With Locally Advanced Rectal Cancer Treated With Chemoradiation Plus Induction or Consolidation Chemotherapy and Total Mesorectal Excision or Non-operative Management

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT02008656·358 enrolled

Endometrial Cancer1 trial

A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced/Metastatic Solid Tumours

Recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT05489211·454 enrolled

Advanced Colorectal Cancer1 trial

Phase Ib/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of MRG007 Combination Therapy in Patients With Advanced Colorectal Cancer

Not yet recruiting·LLepu Biopharma Co., Ltd.·Preclinical·NCT07737600·316 enrolled

Adenocarcinoma1 trial

Phase II Study of NALIRIFOX (Nanoliposomal Irinotecan + Oxaliplatin With Fluorouracil and Folinic Acid) in Advanced Unresectable Small Bowel Tumors

Recruiting·TTiago Biachi de Castria·Phase 2·NCT06835387·36 enrolled

Locally-advanced Rectal Cancer1 trial

Phase II Study of Short-course Radiotherapy Followed by Consolidation Chemotherapy With the Triplet FOLFOXIRI as Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer: the ShorTrip Study

Active, not recruiting·GGruppo Oncologico del Nord-Ovest·Phase 2·NCT05253846·63 enrolled

Liver Metastases From Colorectal Cancer (mCRC)1 trial

Abemaciclib Combined With FOLFOX/FOLFIRI Regimen in Patients With Advanced Colorectal Liver Metastases Cancer Who Failed Standard Two or Three-line Therapy

Enrolling by invitation·FFudan University·Phase 2·NCT07441369·16 enrolled

Metastatic Solid Tumor1 trial

A Phase 1B, Multicenter, Open-Label Study of the Safety and Efficacy of CHS-114 in Combination With Toripalimab With or Without Other Treatments in Participants With Advanced or Metastatic Solid Tumors (TREGCHECK 102)

Recruiting·CCoherus Oncology, Inc.·Phase 1·NCT06657144·154 enrolled

Liver Metastases1 trial

Risk-Stratified Adjuvant Therapy: ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05062317·120 enrolled

Sources

References

[1]
ClinicalTrials.gov — 46 trial records for 5-fluorouracil. U.S. National Library of Medicine, National Institutes of Health.
[2]
Open Targets Platform — Drug–disease associations for 5-fluorouracil. EMBL-EBI & Wellcome Sanger Institute.
[3]
SEC EDGAR — Merck & Co. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Highest Phase: Phase 3[1]
Company: Merck & Co.

5-fluorouracil

Status by Indication[2][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q3 2027

Trials by Indication[1]

Colorectal Neoplasms4 trials

Solid Tumor3 trials

Colorectal Cancer3 trials

Esophageal Squamous Cell Carcinoma2 trials

Gastric Cancer2 trials

Gastroesophageal Adenocarcinoma2 trials

Pancreatic Ductal Adenocarcinoma2 trials

Esophageal Cancer2 trials

Gastroesophageal Junction Adenocarcinoma2 trials

Locally Advanced or Metastatic Solid Tumors1 trial

Advanced Esophageal Squamous Cell Carcinoma1 trial

Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer1 trial

Colon Adenocarcinoma1 trial

Metastatic Gastric Adenocarcinoma1 trial

HER2-positive Gastric Cancer1 trial

Pancreatic Cancer1 trial

Malignant Solid Tumor1 trial

Metastatic Pancreatic Cancer1 trial

Neoplasm Malignant1 trial

Stage II Rectal Cancer AJCC v81 trial

Gastric Neoplasms1 trial

Malignant Neoplam1 trial

Gastric Carcinoma1 trial

Peritoneal Mesothelioma1 trial

Advanced Unresectable Gastric Adenocarcinoma1 trial

Rectal Cancer1 trial

Endometrial Cancer1 trial

Advanced Colorectal Cancer1 trial

Adenocarcinoma1 trial

Locally-advanced Rectal Cancer1 trial

Liver Metastases From Colorectal Cancer (mCRC)1 trial

Metastatic Solid Tumor1 trial

Liver Metastases1 trial

References

Drug Info

Quick Facts

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