Adrucil
(fluorouracil)ApprovedSmall molecule
Fluorouracil is used to treat certain types of cancer, including colorectal cancer and breast cancer, by stopping cancer cells from growing and dividing. It is also used as a topical cream to treat precancerous skin lesions and certain types of skin cancer.[2] Adrucil is currently approved and in use across 101 indications[4].[1]
Adrucil is one of 1050 small molecule programs targeting Colorectal Cancer. It is currently in Approved.
101
Indications
743
Total Trials
9
Active Trials
1,049
Competitors
8
FDA Applications
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 101 indications
Competition
Competitive Landscape
348 competitors in Solid Tumor
#DrugCompanyPhaseTrials
1Adrucil
EElorac, Inc.
Approved
Yervoy
Bristol-Myers SquibbPreclinical
Fludara
SanofiPreclinical
Augtyro
KKaruna Therapeutics, Inc., a Bristol Myers Squibb company
Preclinical
Zejula
GGlaxo Dba Glaxosmithkline
Preclinical
Navmi
SSummit Therapeutics
Preclinical
Epivir
GGlaxo Dba Glaxosmithkline
Preclinical
PD-1 Inhibitor
Johnson & JohnsonPreclinical
Tulmimetostat
NovartisPreclinical
Ifinatamab Deruxtecan
Daiichi SankyoPreclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Colorectal Cancer34 trials
Show 31 more trials
Ursodiol, Combination Chemotherapy, and Bevacizumab in Treating Patients With Stage IV Colorectal Cancer
Completed·—·Phase 1·NCT00873275·11 enrolled
Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer With Liver Metastases or Lung Metastases That Are Potentially Removable by Surgery
Unknown status·—·Phase 2·NCT00513266·35 enrolled
Metastatic Colorectal Cancer18 trials
Show 15 more trials
Combination Chemotherapy With or Without Celecoxib in Treating Patients With Metastatic Colorectal Cancer
Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00064181·86 enrolled
Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer
Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00003287·554 enrolled
Breast Cancer16 trials
Show 13 more trials
Combination Chemotherapy in Treating Women With Stage II or Stage III Breast Cancer
Unknown status·IIRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy·Phase 3·NCT00005581·1,000 enrolled
Biomarker (p53 Gene) Analysis and Combination Chemotherapy Followed by Radiation Therapy and Surgery in Treating Women With Large Operable or Locally Advanced or Inflammatory Breast Cancer
Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00017095·1,856 enrolled
Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Nonmetastatic Breast Cancer
Unknown status·—·Phase 3·NCT01093235·800 enrolled
Radiation Therapy12 trials
Radiation Therapy Plus Fluorouracil With or Without Additional Chemotherapy in Treating Patients With Primary Anal Cancer
Completed·—·Phase 3·NCT00025090·600 enrolled
Show 9 more trials
Oxaliplatin, Leucovorin, and Fluorouracil Before and After Radiation Therapy and Surgery in Treating Patients With Rectal Cancer That Can Be Removed by Surgery
Completed·—·Phase 2·NCT01263171·60 enrolled
Esophageal Cancer10 trials
Show 7 more trials
Molecular Phenotyping in Predicting Response in Patients With Stage IB-III Esophageal Cancer Receiving Combination Chemotherapy
Terminated·—·Phase 2·NCT02392377·1 enrolled
63 more indications
Pancreatic Cancer9 trials
Bevacizumab, Combination Chemotherapy, and Radiation Therapy in Treating Patients Undergoing Surgery For Locally Advanced Pancreatic Cancer
Completed·—·Phase 2·NCT00602602·19 enrolled
Show 6 more trials
Cancer of the Esophagus7 trials
Show 4 more trials
Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus
Unknown status·—·Phase 3·NCT00002884·326 enrolled
Cancer of the Pancreas5 trials
Fluorouracil With or Without Cisplatin in Treating Patients With Advanced or Metastatic Cancer of the Pancreas
Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00003029·200 enrolled
Head and Neck Cancer4 trials
Stage III Colon Cancer4 trials
Colon Cancer3 trials
Patients With Advanced Solid Tumors3 trials
Gastroesophageal Junction3 trials
Cervical Cancer3 trials
Whole Body Hyperthermia Combined With Chemotherapy in Treating Patients With Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer
Unknown status·TThe University of Texas Health Science Center, Houston·Phase 2·NCT00003135·34 enrolled
Adenocarcinoma3 trials
Stomach Cancer3 trials
Advanced Head and Neck Cancer2 trials
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer
Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00003888·359 enrolled
Gastric Cancer2 trials
Unresectable Solid Tumor2 trials
Chemotherapy2 trials
A Pilot, Prospective, Non-randomized Evaluation of the Safety of Anakinra Plus Standard Chemotherapy
Completed·—·Phase 1·NCT02021422·13 enrolled
Rectal Cancer2 trials
Kidney Cancer2 trials
Stage III Rectal Cancer2 trials
Recurrent Head and Neck Cancer2 trials
Intestinal Cancer2 trials
Gastroesophageal Junction Cancer2 trials
Adjuvant Chemotherapy1 trial
Immunoscore As Decision Guidance for Adjuvant Chemotherapy in Colon Cancer
Withdrawn·—·Phase 3·NCT04488159
Patients With Solid Tumors1 trial
Squamous Cell Carcinoma1 trial
Cancer of Unknown Primary1 trial
Pancreatic Ductal Adenocarcinoma1 trial
Pancreatic Adenocarcinoma1 trial
Fluorouracil1 trial
Induction Chemotherapy1 trial
Gastroesophageal Junction Adenocarcinoma1 trial
Unresectable1 trial
Safety and Efficacy1 trial
Locally-advanced Rectal Cancer1 trial
Metastatic Cancer1 trial
Bladder Cancer1 trial
Intraperitoneal Chemotherapy1 trial
Colorectal Adenocarcinoma1 trial
Cancer of the Stomach1 trial
Combination Chemotherapy in Treating Patients With Metastatic or Recurrent Cancer of the Stomach or Esophagus
Unknown status·—·Phase 2·NCT00005607
Nasopharyngeal Cancer1 trial
Fluorouracil, Cisplatin, and Radiation Therapy in Treating Patients With Stage II, Stage III, or Stage IV Nasopharyngeal Cancer
Unknown status·—·Phase 2·NCT00093665·90 enrolled
Bevacizumab1 trial
Bone Marrow Transplantation1 trial
Repeated Bone Marrow Transplantation in Treating Women With Advanced Breast Cancer
Terminated·LLouisiana State University Health Sciences Center Shreveport·Phase 1/2·NCT00003086·12 enrolled
Thyroid Cancer1 trial
Oral Cavity Cancer1 trial
Anal Cancer1 trial
Ovarian Cancer1 trial
Cancer of the Head and Neck1 trial
First-line Treatment1 trial
Locally Advanced Cancer1 trial
Refractory Solid Tumors1 trial
Neuroendocrine Carcinoma1 trial
Gastric Adenocarcinoma1 trial
Non-Small Cell Lung Cancer1 trial
Lymphoma1 trial
Regulatory
FDA Approval Timeline[5]
Jan 1, 1982
FLUOROPLEX
NDA NDA016765
Jan 1, 1982
EFUDEX
NDA NDA016831
Jan 1, 1982
FLUOROPLEX
NDA NDA016988
Jan 1, 1982
ADRUCIL
NDA NDA017959
Oct 27, 2000
CARAC
NDA NDA020985
Sep 18, 2015
TOLAK
NDA NDA022259
Jul 29, 2016
FLUOROURACIL
NDA NDA012209
Feb 20, 2026
FAVLYXA
NDA NDA220201
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Adrucil drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for fluorouracil. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Thymidylate Synthase Inhibitor[3]
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company
- EElorac, Inc.