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 116 indications[4].[1]
Adrucil is one of 1113 small molecule programs targeting Biliary Tract Cancer. It is currently in Approved.
116
Indications
739
Total Trials
28
Active Trials
1,112
Competitors
8
FDA Applications
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 116 indications
Competition
Competitive Landscape
350 competitors in Treatment
#DrugCompanyPhaseTrials
1Adrucil
EElorac, Inc.
Approved
Dexilant
TakedaPreclinical
Alfenta
Jazz PharmaceuticalsPreclinical
Levulan
Sun Pharmaceutical Industries, Inc.Preclinical
Theo-Dur
PfizerPreclinical
Hivid
CConrado Roberto Hoffmann Filho
Preclinical
Foscavir
CClinigen, Inc.
Preclinical
Valium
Akero TherapeuticsPreclinical
Brevibloc
MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Preclinical
Reminyl
WWim Janssens
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Colorectal Cancer33 trials
Show 30 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
Combination Chemotherapy and Oblimersen in Treating Patients With Advanced Colorectal Cancer
Completed·TThe University of Texas Health Science Center at San Antonio·Phase 1/2·NCT00055822·16 enrolled
DC-CIK Immunotherapy Plus Chemotherapy vs Chemotherapy Alone in the Adjuvant Treatment of Stage III Colorectal Cancer
Unknown status·SSixth Affiliated Hospital, Sun Yat-sen University·Phase 2/3·NCT02415699·100 enrolled
Metastatic Colorectal Cancer26 trials
Show 23 more trials
Combination Chemotherapy in Treating Patients With Recurrent Metastatic Colorectal Cancer
Unknown status·GGERCOR - Multidisciplinary Oncology Cooperative Group·Phase 3·NCT00003260·109 enrolled
Irinotecan Hydrochloride, Fluorouracil, and Leucovorin Calcium With or Without Zibotentan in Treating Patients With Metastatic Colorectal Cancer
Completed·—·Phase 2·NCT01205711·111 enrolled
Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
Unknown status·GGERCOR - Multidisciplinary Oncology Cooperative Group·Phase 2/3·NCT00274872·600 enrolled
Pancreatic Cancer21 trials
Metformin Plus Modified FOLFOX 6 in Metastatic Pancreatic Cancer
Completed·—·Phase 2·NCT01666730·50 enrolled
Show 18 more trials
Gemcitabine Hydrochloride, and Radiation Therapy in Patients With Borderline Resectable Pancreatic Cancer
Terminated·—·Phase 2·NCT01897454·23 enrolled
Breast Cancer20 trials
Show 17 more trials
Combination Chemotherapy With or Without Fluorouracil and/or Pegfilgrastim in Treating Women With Node-Positive Breast Cancer
Active, not recruiting·IIRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy·Phase 3·NCT00433420·2,000 enrolled
Cyclophosphamide, Methotrexate, and Fluorouracil, With or Without Epirubicin Hydrochloride, in Treating Women Who Have Undergone Surgery for Breast Cancer (Group III Closed to New Patients as of 12/7/2009)
Unknown status·IIstituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS·Phase 3·NCT01031030·800 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
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Mouth Cancer
Completed·—·Phase 1/2·NCT00004901
Show 9 more trials
Radiation Therapy, Surgery, and Chemotherapy in Treating Patients With Rectal Cancer That Can Be Surgically Removed
Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00002523·1,011 enrolled
55 more indications
Esophageal Cancer5 trials
Bladder Cancer3 trials
Pancreatic Ductal Adenocarcinoma3 trials
Patients With Solid Tumors3 trials
Stage III Colon Cancer3 trials
Gastroesophageal Junction3 trials
Epirubicin, Oxaliplatin and Fluorouracil (EOF) in Cancer of the Esophagus, Gastroesophageal Junction, or Stomach
Completed·—·Phase 2·NCT00601705·61 enrolled
Intestinal Cancer3 trials
Fluorouracil2 trials
Patients With Advanced Solid Tumors2 trials
Squamous Cell Carcinoma2 trials
Nasopharyngeal Carcinoma2 trials
Colon Cancer2 trials
Recurrent Head and Neck Cancer2 trials
Cancer of the Esophagus2 trials
Trial2 trials
Chemotherapy2 trials
Patients With Locally Advanced Rectal Cancer2 trials
Head and Neck Cancer2 trials
Nasopharyngeal Cancer2 trials
Adenocarcinoma2 trials
Stomach Cancer2 trials
Treatment2 trials
Unresectable Solid Tumor1 trial
Adjuvant Chemotherapy1 trial
Immunoscore As Decision Guidance for Adjuvant Chemotherapy in Colon Cancer
Withdrawn·—·Phase 3·NCT04488159
Peritoneal Cancer1 trial
Stage III1 trial
Pancreatic Adenocarcinoma1 trial
Stage II Colon Cancer1 trial
Recurrent or Refractory1 trial
Locally Advanced Head and Neck Cancer1 trial
Neoadjuvant Treatment1 trial
Evaluating the Efficacy and Safety of Pembrolizumab Plus Standard Chemotherapy in the Neoadjuvant Treatment of Local Advanced (LA) HNSCC
Recruiting·—·Phase 3·NCT06102395·272 enrolled
Peritoneal Carcinomatosis1 trial
Gastric Cancer1 trial
Gastrointestinal Tumors1 trial
Liver Cancer1 trial
Transplant Recipient1 trial
Head and Neck Squamous Cell Carcinoma1 trial
Solid Tumors1 trial
Gallbladder Cancer1 trial
Cholangiocarcinoma1 trial
Advanced Solid Tumors1 trial
Premenopausal1 trial
Cervical Intraepithelial Neoplasia1 trial
Adjuvant Treatment1 trial
Esophageal Squamous Cell Carcinoma1 trial
Esophageal Squamous Cell Cancer1 trial
Oropharynx Cancer1 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
Locally Advanced1 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.