Fudr

(floxuridine)

ApprovedSmall molecule

Fudr is a small molecule that works as a Thymidylate Synthase Inhibitor.[2] It is being used across 9 indications, with its most advanced program in Approved.[1]

Fudr is one of 193 small molecule programs targeting Intrahepatic Cholangiocarcinoma. It is currently in Approved.

Indications

Total Trials

Active Trials

192

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Intrahepatic CholangiocarcinomaRecruiting

Hepatocellular CarcinomaApproved

Colorectal NeoplasmApproved

Colorectal AdenocarcinomaApproved

Metastatic Colorectal Cancer (mcrc)Recruiting

Pancreatic AdenocarcinomaActive, not recruiting

Metastatic Colorectal CarcinomaRecruiting

Colorectal Adenocarcinoma Metastatic in the LiverRecruiting

Colorectal CancerTerminated

Intrahepatic CholangiocarcinomaPhase 2

Recruiting

Hepatocellular CarcinomaApproved

Approved

Colorectal NeoplasmApproved

Approved

Colorectal AdenocarcinomaApproved

Approved

Metastatic Colorectal Cancer (mcrc)Phase 2

Recruiting

Pancreatic AdenocarcinomaPhase 2

Active, not recruiting

Metastatic Colorectal CarcinomaPhase 3

Recruiting

Colorectal Adenocarcinoma Metastatic in the LiverPhase 2

Recruiting

Colorectal CancerPhase 3

Terminated

Competition

Competitive Landscape

268 competitors in Colorectal Cancer

#DrugCompanyPhaseTrials

Fudr

Pfizer

Approved

16 2

Camptosar

Pfizer

Phase 3

34 3

Balstilimab

AAgenus Inc.

Phase 3

10 4

TAS 102

Taiho Oncology, Inc.

Phase 3

8 5

Calcium Folinate

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Phase 3

3 6

Serplulimab

Shanghai Henlius Biotech

Phase 3

2 7

PD-1 Monoclonal Antibody

SSichuan Baili Pharmaceutical Co., Ltd.

Phase 3

2 8

Folfirinox

PPhanes Therapeutics

Phase 3

1 9

Iron Isomaltoside

TThomas Jefferson University

Phase 3

3 10

Tucidinostat

CChipscreen Biosciences, Ltd.

Phase 3

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

Timeline

Expected Milestones

Q2 2027

Phase 2Recruiting

Intrahepatic Cholangiocarcinoma

NCT04891289

Q4 2028

Phase 2Active, not recruiting

Pancreatic Adenocarcinoma

NCT03856658

Phase 2Recruiting

Metastatic Colorectal Cancer (mcrc)

NCT05286814

Q1 2034

Phase 2Recruiting

Cholangiocarcinoma

NCT06313203

Q2 2034

Phase 3Recruiting

Metastatic Colorectal Carcinoma

NCT05863195

Clinical

Trials by Indication[1]

Colorectal Cancer16 trials

Isolated Hepatic Perfusion With Melphalan Followed By Chemotherapy in Treating Patients With Unresectable Colorectal Cancer That is Metastatic to the Liver

Completed·NNational Institutes of Health Clinical Center (CC)·Phase 2·NCT00019760

Hepatic Arterial Infusion With Floxuridine and Dexamethasone Combined With Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00492999·64 enrolled

Floxuridine, Dexamethasone, and Irinotecan After Surgery in Treating Patients With Liver Metastases From Colorectal Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00003753

Show 13 more trials

Liver Resection and Floxuridine Plus Fluorouracil and Leucovorin in Treating Patients With Liver Metastases From Colorectal Cancer

Completed·—·Phase 2·NCT00002842·49 enrolled

Radiofrequency Ablation Followed By Hepatic Artery Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00004142·40 enrolled

Oxaliplatin and Capecitabine With or Without an Hepatic Arterial Infusion With Floxuridine in Treating Patients Who Are Undergoing Surgery and/or Ablation for Liver Metastases Due to Colorectal Cancer

Terminated·NNSABP Foundation Inc·Phase 3·NCT00268463·22 enrolled

Hepatic Arterial Infusion With Floxuridine and Systemic Irinotecan After Surgery in Treating Patients With Hepatic (Liver) Metastases From Colorectal Cancer

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT00063960·94 enrolled

Adjuvant Hepatic Arterial Infusion and Combination Chemotherapy in Treating Patients With Resectable Hepatic Metastases From Colorectal Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT00059930·38 enrolled

Combination Chemotherapy in Treating Patients With Unresectable Liver Metastases From Colorectal Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT00008294

Chemotherapy and Internal Radiation in Treating Patients With Colorectal Cancer That Has Spread to the Liver

Unknown status·—·Phase 2·NCT00408551·20 enrolled

Combination Chemotherapy in Treating Patients With Liver Metastases From Colorectal Cancer

Completed·AAlliance for Clinical Trials in Oncology·Phase 3·NCT00002716·135 enrolled

Chemotherapy With or Without Isolated Hepatic Perfusion With Melphalan in Treating Patients With Colorectal Cancer That Has Spread to the Liver

Completed·NNational Institutes of Health Clinical Center (CC)·Phase 3·NCT00020501

Combination Chemotherapy and Bevacizumab in Treating Patients With Stage IV Colorectal Cancer

Terminated·UUniversity of Miami·Phase 2·NCT00449163·25 enrolled

A Phase I Study of Isolated Hepatic Perfusion With Escalating Dose Melphalan Followed by Postoperative Hepatic Arterial Floxuridine and Leucovorin for Metastatic Unresectable Colorectal Cancers of the Liver

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00001576·28 enrolled

Hepatic Arterial Infusion Plus Chemotherapy in Treating Patients With Colorectal Cancer Metastatic to the Liver

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00026234·75 enrolled

A Single-Arm Phase II Study of Hepatic Artery Infusion Pump Chemotherapy With Floxuridine and Dexamethasone in Combination With Systemic Chemotherapy for Patients With Colorectal Cancer Metastatic to the Liver

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT03366155·24 enrolled

Chemotherapy4 trials

FUDR/Oxaliplatin HAI Plus Irinotecan vs. FOLFOXIRI Chemotherapy in Treating Initially Unresectable CRCLM

Terminated·SSun Yat-sen University·Phase 3·NCT03678428·92 enrolled

Preoperative Hepatic Arterial Infusion Chemotherapy

Unknown status·IIRCCS San Raffaele··NCT00522509

A Study of Systemic Chemotherapy With CPT-11 Plus HAI (FUDR+L-OHP) in Patients With Initially Unresectable CRCLM

Completed·SSun Yat-sen University·Phase 2·NCT03493061·60 enrolled

Show 1 more trial

Hepatic Arterial Infusion Pump Chemotherapy Combined With Systemic Chemotherapy (PUMP-IT)

Unknown status·TThe Netherlands Cancer Institute·Phase 2/3·NCT04552093·31 enrolled

Intrahepatic Cholangiocarcinoma3 trials

Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Gemcitabine as Adjuvant Treatment After Resection of Intrahepatic Cholangiocarcinoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT01938729·8 enrolled

A Randomized Phase II Study of Systemic Chemotherapy With or Without HAI FUDR/Dexamethasone in Patients With Unresectable Intrahepatic Cholangiocarcinoma

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT04891289·164 enrolled

A Phase II Study of Hepatic Arterial Infusion (HAI) With Floxuridine (FUDR) and Dexamethasone (Dex) Combined With Systemic Gemcitabine and Oxaliplatin in Patients With Unresectable Intrahepatic Cholangiocarcinoma (ICC)

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT01862315·56 enrolled

Stomach Cancer2 trials

Combination Chemotherapy Followed by Surgery in Treating Patients With Stomach Cancer

Completed·NNYU Langone Health·Phase 2·NCT00004103

Combination Chemotherapy Before and After Surgery in Treating Patients With Stomach Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00002783·50 enrolled

Liver Metastases2 trials

Hepatic Artery Infusion Pump for NPC Liver Metastases

Completed·XXiangya Hospital of Central South University·Phase 1·NCT03876574·16 enrolled

HAI-Floxuridine, or Liver-Tx, Combined With 2nd Line Chemotherapy Versus 2nd Line Chemotherapy Alone for Patients With Colorectal Liver Metastases and Heavy Tumour Burden.

Active, not recruiting·OOslo University Hospital·Phase 2·NCT04898504·45 enrolled

18 more indications

Metastatic Colorectal Cancer2 trials

Study of Chemotherapy With or Without Hepatic Arterial Infusion for Patients With Unresectable Metastatic Colorectal Cancer to the Liver

Withdrawn·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT03069950

Hepatic Arterial Infusion of Floxuridine, Gemcitabine Hydrochloride, and Radiolabeled Monoclonal Antibody Therapy in Treating Liver Metastases in Patients With Metastatic Colorectal Cancer Previously Treated With Surgery

Completed·—·Phase 1/2·NCT00645710·16 enrolled

Cholangiocarcinoma2 trials

HAI-Floxuridine, or SIRT, Combined With Gemox For Patients With Intra-Hepatic Cholangiocarcinoma Not Amenable to Resection (TOMCAT)

Recruiting·OOslo University Hospital·Phase 2·NCT06313203·39 enrolled

Hepatic Arterial Infusion in Treating Patients With Locally Advanced, Non-Metastatic Cholangiocarcinoma

Terminated·WWashington University School of Medicine·Phase 1·NCT01525069·27 enrolled

Colorectal Carcinoma2 trials

A Study of the Use of the Medtronic Pump and Codman Catheter to Give Chemotherapy to Patients With Colorectal Carcinoma or Cholangiocarcinoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT03693807·35 enrolled

A Study of the Use of the Medtronic Pump and Codman Catheter to Give Chemotherapy to Patients With Colorectal Carcinoma or Cholangiocarcinoma

Unknown status·—·Phase 2·NCT04668976·100 enrolled

Esophageal Cancer1 trial

Combination Chemotherapy in Treating Patients With Previously Untreated Stage II or Stage III Esophageal Cancer That Can Be Removed By Surgery

Completed·UUniversity of Miami·Phase 2·NCT00448760·29 enrolled

Fallopian Tube Cancer1 trial

Veliparib and Floxuridine in Treating Patients With Metastatic Epithelial Ovarian, Primary Peritoneal Cavity, or Fallopian Tube Cancer

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT01749397·29 enrolled

Intestinal Cancer1 trial

Combination Chemotherapy in Treating Patients With Stage III Ovarian Epithelial Cancer or Gastrointestinal Cancer

Completed·NNYU Langone Health·Phase 2·NCT00005049·45 enrolled

Dexamethasone1 trial

A Phase II Study of Continuous Hepatic Arterial Infusion With Floxuridine (FUDR) and Dexamethasone (DEX) in Patients With Unresectable Primary Hepatic Malignancy

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00587067·34 enrolled

Metastatic Cancer1 trial

Oxaliplatin With Or Without Floxuridine and Leucovorin in Treating Patients With Metastatic Cancer of the Peritoneum

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT00005860

GastroEsophageal Junction (GEJ) Cancer1 trial

Irinotecan/Cisplatin, Potentially Curative Surgery With or Without Floxuridine, Followed by Capecitabine for Stomach and Gastro-esophageal Junction (GEJ) Cancers

Terminated·NNYU Langone Health·Phase 2·NCT00848783·8 enrolled

Gastric Cancer1 trial

Combination Chemotherapy as First-Line Therapy in Treating Patients With Stage IV Gastric Cancer That Cannot Be Removed By Surgery

Terminated·UUniversity of Miami·Phase 2·NCT00448682·25 enrolled

Intraperitoneal Chemotherapy1 trial

Combination Chemotherapy Followed by Surgery and Intraperitoneal Chemotherapy in Treating Patients With Locally Advanced Stomach Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00006038

Intraperitoneal1 trial

Adjuvant Intraperitoneal Floxuridine Added to Chemoradiation for Fully Resected Advanced Stomach Cancer

Completed·NNYU Langone Health·Phase 2·NCT00858338·28 enrolled

Liver Cancer1 trial

Floxuridine and Dexamethasone as a Hepatic Arterial Infusion and Bevacizumab in Treating Patients With Primary Liver Cancer That Cannot be Removed by Surgery

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00410956·22 enrolled

Metastatic Colorectal Cancer (mCRC)1 trial

Phase II Study Evaluating the Efficacy of PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05286814·70 enrolled

Metastatic Colorectal Carcinoma1 trial

A Randomized Phase III Study of Systemic Therapy With or Without Hepatic Arterial Infusion for Unresectable Colorectal Liver Metastases: The PUMP Trial

Recruiting·EECOG-ACRIN Cancer Research Group·Phase 3·NCT05863195·408 enrolled

Colorectal Adenocarcinoma Metastatic in the Liver1 trial

A Phase II Study of Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Best Systemic Chemotherapy in Patients With Inoperable Hepatic Metastasis From Colorectal Cancer

Recruiting·SSunnybrook Health Sciences Centre·Phase 2·NCT07764497·200 enrolled

Pancreatic Adenocarcinoma1 trial

A Phase II Trial of Hepatic Artery Infusional Floxuridine With Systemic Chemotherapy in the Treatment of Pancreatic Cancer Liver Metastases

Active, not recruiting·CCorewell Health West·Phase 2·NCT03856658·14 enrolled

Liver and Intrahepatic Bile Duct Carcinoma1 trial

A Phase II Study of Induction Systemic mFOLFIRINOX Followed by Hepatic Arterial Infusion of Floxuridine and Dexamethasone Given Concurrently With Systemic mFOLFIRI as a First-Line Therapy in Patients With Unresectable Liver-Dominant Intrahepatic Cholangiocarcinoma

Terminated·OOHSU Knight Cancer Institute·Phase 2·NCT04251715·5 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

FUDR

NDA NDA016929

Sources

References

[1]
ClinicalTrials.gov — 48 trial records for floxuridine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — floxuridine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for floxuridine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA016929). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Thymidylate Synthase Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Pfizer

Fudr

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q4 2028

Q1 2034

Q2 2034

Trials by Indication[1]

Colorectal Cancer16 trials

Chemotherapy4 trials

Intrahepatic Cholangiocarcinoma3 trials

Stomach Cancer2 trials

Liver Metastases2 trials

Metastatic Colorectal Cancer2 trials

Cholangiocarcinoma2 trials

Colorectal Carcinoma2 trials

Esophageal Cancer1 trial

Fallopian Tube Cancer1 trial

Intestinal Cancer1 trial

Dexamethasone1 trial

Metastatic Cancer1 trial

GastroEsophageal Junction (GEJ) Cancer1 trial

Gastric Cancer1 trial

Intraperitoneal Chemotherapy1 trial

Intraperitoneal1 trial

Liver Cancer1 trial

Metastatic Colorectal Cancer (mCRC)1 trial

Metastatic Colorectal Carcinoma1 trial

Colorectal Adenocarcinoma Metastatic in the Liver1 trial

Pancreatic Adenocarcinoma1 trial

Liver and Intrahepatic Bile Duct Carcinoma1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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