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 113 indications[4].[1]
Adrucil is one of 1304 small molecule programs targeting Ependymoma. It is currently in Approved.
113
Indications
728
Total Trials
26
Active Trials
1,303
Competitors
8
FDA Applications
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 113 indications
Competition
Competitive Landscape
2828 competitors in Breast Cancer
#DrugCompanyPhaseTrials
1Adrucil
EElorac, Inc.
Approved
Halaven
EisaiPreclinical
Megace
Bristol-Myers SquibbPreclinical
Lexiscan
AstellasPreclinical
Adenocard
AstellasPreclinical
Spravato
WWim Janssens
Preclinical
Feraheme
AAzurity Pharmaceuticals
Preclinical
Sporanox
SSebela Pharmaceuticals Development LLC
Preclinical
Systemic Therapy
Bristol-Myers SquibbPreclinical
Aquasol E
NNational Eye Institute (NEI)
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Metastatic Colorectal Cancer32 trials
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FOLFIRI and Panitumumab in Treating Patients With RAS and BRAF Wild-Type Metastatic Colorectal Cancer
Terminated·—·Phase 2·NCT02508077·1 enrolled
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
Radiolabeled Monoclonal Antibody Therapy, Combination Chemotherapy, and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer
Completed·—·Phase 1·NCT01205022·3 enrolled
MEK Inhibitor MEK162 in Combination With Leucovorin Calcium, Fluorouracil, and Oxaliplatin in Treating Patients With Advanced Metastatic Colorectal Cancer
Completed·—·Phase 1·NCT02041481·26 enrolled
Ivonescimab and ADG126, Alone, and in Combination With Leucovorin and Fluorouracil or FOLFIRI Regimen for the Treatment of Microsatellite Stable Advanced/Metastatic Colorectal Cancer
Not yet recruiting·—·Phase 1·NCT07363408·30 enrolled
Colorectal Cancer23 trials
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Chemotherapy and Internal Radiation in Treating Patients With Colorectal Cancer That Has Spread to the Liver
Unknown status·—·Phase 2·NCT00408551·20 enrolled
Pancreatic Cancer21 trials
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Breast Cancer11 trials
Combination Chemotherapy With Trastuzumab in Treating Women With Metastatic Breast Cancer
Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT00036868·90 enrolled
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
Show 8 more trials
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
Radiation Therapy9 trials
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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
69 more indications
Esophageal Cancer8 trials
Show 5 more trials
Molecular Phenotyping in Predicting Response in Patients With Stage IB-III Esophageal Cancer Receiving Combination Chemotherapy
Terminated·—·Phase 2·NCT02392377·1 enrolled
Cancer of the Esophagus4 trials
Head and Neck Cancer4 trials
Radiation Therapy Cisplatin With or Without Fluorouracil Patients With Stage III or Stage IV Head and Neck Cancer
Completed·—·Phase 3·NCT00608205·69 enrolled
Gastric Cancer4 trials
Rectal Cancer4 trials
Esophageal Adenocarcinoma3 trials
Advanced Cancer3 trials
Bladder Cancer2 trials
Gallbladder Cancer2 trials
Gastroesophageal Junction Adenocarcinoma2 trials
Gastroesophageal Junction2 trials
Locally-advanced Rectal Cancer2 trials
Nasopharyngeal Carcinoma2 trials
Recurrent Head and Neck Cancer2 trials
Cervical Cancer2 trials
Stage III Colon Cancer2 trials
Adenocarcinoma2 trials
Cancer of the Pancreas2 trials
Intestinal Cancer2 trials
Chemotherapy1 trial
A Pilot, Prospective, Non-randomized Evaluation of the Safety of Anakinra Plus Standard Chemotherapy
Completed·—·Phase 1·NCT02021422·13 enrolled
Digestive System Neoplasm1 trial
Multiple Actinic Keratoses1 trial
Cervical Intraepithelial Neoplasia1 trial
Esophageal Squamous Cell Carcinoma1 trial
Patients With Solid Tumors1 trial
Phase II Clinical Trial1 trial
Solid Tumors1 trial
Head and Neck Squamous Cell Carcinoma1 trial
Advanced Solid Tumors1 trial
Cholangiocarcinoma1 trial
Intraperitoneal Chemotherapy1 trial
Colorectal Carcinoma1 trial
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
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
Cancer of Unknown Primary1 trial
Bevacizumab1 trial
Colon Cancer1 trial
Advanced or Metastatic Solid Tumors1 trial
Locally Advanced1 trial
Fluorouracil1 trial
Cancer of the Head and Neck1 trial
Bile Duct Cancer1 trial
Nausea and vomiting1 trial
Induction Chemotherapy1 trial
Unresectable1 trial
Squamous Cell Carcinoma1 trial
Kidney Cancer1 trial
Stage III Rectal Cancer1 trial
Stomach Cancer1 trial
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
Unresectable Solid Tumor1 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
Advanced Head and Neck Cancer1 trial
Liver Cancer1 trial
Skin Lesions1 trial
Biliary Tract Cancer1 trial
Locally Advanced Cancer1 trial
Gastroesophageal Junction Cancer1 trial
Refractory Solid Tumors1 trial
Neuroendocrine Carcinoma1 trial
Unspecified1 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.