5-fluorouracil

Phase 3

5-fluorouracil is one of 248 therapeutic programs targeting Gastroesophageal Junction Adenocarcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

247

Competitors

Pipeline

Status by Indication[2][1]

Indication

Gastroesophageal Junction AdenocarcinomaCompleted

Esophageal Squamous Cell CarcinomaRecruiting

Colon AdenocarcinomaRecruiting

Esophageal CancerRecruiting

AdenocarcinomaRecruiting

Colorectal CancerNot yet recruiting

Pancreatic CancerRecruiting

Gastric CancerRecruiting

Gastroesophageal AdenocarcinomaRecruiting

Advanced Solid TumorsRecruiting

Gastroesophageal Junction AdenocarcinomaPhase 3

Completed

Esophageal Squamous Cell CarcinomaPreclinical

Recruiting

Colon AdenocarcinomaPhase 3

Recruiting

Esophageal CancerPhase 2

Recruiting

AdenocarcinomaPhase 2

Recruiting

Colorectal CancerPhase 2

Not yet recruiting

Pancreatic CancerPhase 3

Recruiting

Gastric CancerPhase 3

Recruiting

Gastroesophageal AdenocarcinomaPhase 2

Recruiting

Advanced Solid TumorsPhase 1

Recruiting

Showing 10 of 17 indications

Competition

Competitive Landscape

1063 competitors in Pancreatic Cancer

#DrugCompanyPhaseTrials

5-fluorouracil

Merck & Co.

Phase 3

1 2

Gemzar

GGynecologic Oncology Group

MS Contin

1 4

Medrol

Pfizer

Preclinical

1 5

Byetta

AstraZeneca

Preclinical

1 6

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 7

ABI-007

Bristol-Myers Squibb

Preclinical

2 8

Chemotherapy Agents

Takeda

Preclinical

1 9

Active Comparator

Moderna

Preclinical

1 10

LDE225

Novartis

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Colorectal Cancer

NCT05464030

Q3 2027

Phase 3Active, not recruiting

Gastric Neoplasms

NCT05152147

Phase 1Active, not recruiting

Malignant Solid Tumor

NCT06057038

Q4 2027

Phase 2Recruiting

Esophageal Cancer

NCT06123338

Q2 2028

Phase 3Recruiting

Metastatic Gastric Adenocarcinoma

NCT07043400

Clinical

Trials by Indication[1]

Colorectal Neoplasms3 trials

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

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

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

Colorectal Cancer2 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)

Recruiting· EMD Serono Research & Development Institute, Inc. logo

EMD Serono Research & Development Institute, Inc.·Phase 1·NCT05464030·200 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

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

Gastroesophageal Adenocarcinoma1 trial

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

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

12 more indications

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

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

Gastroesophageal Junction Adenocarcinoma1 trial

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

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

Esophageal Cancer1 trial

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

Esophageal Squamous Cell Carcinoma1 trial

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

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

Gastric Cancer1 trial

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

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

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

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

Advanced Solid Tumors1 trial

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

Sources

References

[1]
ClinicalTrials.gov — 20 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

Q3 2027

Q4 2027

Q2 2028

Trials by Indication[1]

Colorectal Neoplasms3 trials

Colorectal Cancer2 trials

Colon Adenocarcinoma1 trial

Gastroesophageal Adenocarcinoma1 trial

Advanced Unresectable Gastric Adenocarcinoma1 trial

Pancreatic Cancer1 trial

Peritoneal Mesothelioma1 trial

Gastroesophageal Junction Adenocarcinoma1 trial

Malignant Solid Tumor1 trial

Esophageal Cancer1 trial

Esophageal Squamous Cell Carcinoma1 trial

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

Gastric Cancer1 trial

Gastric Neoplasms1 trial

Adenocarcinoma1 trial

Metastatic Gastric Adenocarcinoma1 trial

Advanced Solid Tumors1 trial

References

Drug Info

Quick Facts

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