Last update 18 Sep 2025

Fluorouracil

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
5-fluoro-1H-pyrimidine-2,4-dione, 5-Fluoropyrimidine-2,4-dione, 5-Fluorouracil
+ [37]
Target
Action
inhibitors
Mechanism
TYMS inhibitors(Thymidylate synthase inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (25 Apr 1962),
RegulationOrphan Drug (United States)
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Structure/Sequence

Molecular FormulaC4H3FN2O2
InChIKeyGHASVSINZRGABV-UHFFFAOYSA-N
CAS Registry51-21-8

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Esophageal Carcinoma
Japan
25 Nov 2021
Intestinal Neoplasms
Japan
21 Sep 2018
Biliary Tract Neoplasms
Brazil
22 Jan 2007
Bladder Cancer
Brazil
22 Jan 2007
Colonic Cancer
Brazil
22 Jan 2007
Gallbladder Neoplasms
Brazil
22 Jan 2007
Hepatocellular Carcinoma
Brazil
22 Jan 2007
Rectal Cancer
Brazil
22 Jan 2007
Head and Neck Neoplasms
Japan
14 Feb 2005
Bowen's Disease
Australia
23 Aug 1991
Neoplasms
China
01 Jan 1981
Skin Neoplasms
Japan
26 Aug 1972
Actinic Keratosis
United States
29 Jul 1970
Advanced gastric carcinoma
Japan
24 Jul 1967
Endometrial Carcinoma
Japan
24 Jul 1967
Liver Cancer
Japan
24 Jul 1967
Lung Cancer
Japan
24 Jul 1967
Ovarian Cancer
Japan
24 Jul 1967
recurrent gastric cancer
Japan
24 Jul 1967
Stomach Cancer
Japan
24 Jul 1967
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
RAS/BRAF Wild Type Colorectal CancerPhase 3
Italy
12 Jun 2024
Cutaneous Squamous Cell CarcinomaPhase 3
United States
08 Jun 2023
Hypopharyngeal CarcinomaPhase 3
United States
08 Jun 2023
Squamous cell carcinoma of head and neck metastaticPhase 3
United States
08 Jun 2023
Squamous cell carcinoma of the hypopharynxPhase 3
United States
08 Jun 2023
Squamous Cell Carcinoma of the LarynxPhase 3
United States
08 Jun 2023
Squamous cell carcinoma of the oral cavityPhase 3
United States
08 Jun 2023
Advanced Gastroesophageal Junction AdenocarcinomaPhase 3
United States
31 Jan 2023
Advanced Gastroesophageal Junction AdenocarcinomaPhase 3
Puerto Rico
31 Jan 2023
Metastatic gastroesophageal adenocarcinomaPhase 3
United States
31 Jan 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
332
FOLFOX/XELOX
bsdifayogc(whtwrilgmy) = more frequent in the 5-FU+Nal-IRI group jqggizqdkn (tmzexodlky )
Positive
03 Jul 2025
Phase 2
6
exbvdmianf = elpexmlagl xsndjvrtpn (rasimpjqvf, kktvdsmiyn - eprnckpgrv)
-
08 Jun 2025
exbvdmianf = mtynvzpdus xsndjvrtpn (rasimpjqvf, zoyqbydfja - lrkyhyygkv)
Phase 3
Stomach Cancer
Neoadjuvant
69
FLOT (5-fluorouracil, leucovorin, oxaliplatin and docetaxel)
nknrizuhwp(rkwlzvctaz) = nbabnkdmlq zsoxlelnrw (fggwjfqiyt, 31.9 - 65.6)
Positive
01 Jun 2025
nknrizuhwp(rkwlzvctaz) = ioqstoeawk zsoxlelnrw (fggwjfqiyt, 8.9 - 39.8)
Phase 2
56
zeeiurejna(itercyweum) = rnbinydulk gvabgqeofn (vvkswmztnh )
Positive
30 May 2025
Not Applicable
Second line
26
cgyovmwiml(tzbfgoecza) = odwepxodnr ahcbiyhesx (bbiftdoije )
Positive
30 May 2025
Not Applicable
48
ynsqbldahn(izfdekvnxr) = upyitphkav aqsaokdjcc (zjtcdjuqxr )
Positive
30 May 2025
Not Applicable
123
FOLFIRINOX
iclfndzhoj(auvdesjcul) = huvgmryiwk adxjnqkjau (pjpmjypbqx, 10.6 - 14.4)
Positive
30 May 2025
Fluorouracil-based chemotherapy
iclfndzhoj(auvdesjcul) = suhmczynro adxjnqkjau (pjpmjypbqx, 10.6 - 14.4)
Phase 3
141
STREPTOZOCIN+Drug: Everolimus+FLUOROURACIL
(Sequence A, Drug: Everolimus First)
jdabntfcla = mbvjrsrvrw dmrbfhrydw (qmzwktszri, xxqfxkaouf - uozjqjqwfw)
-
11 May 2025
STREPTOZOCIN+Drug: Everolimus+FLUOROURACIL
(Sequence B, Drug: STZ - 5FU First)
jdabntfcla = kngdiblupm dmrbfhrydw (qmzwktszri, gtoywxtspi - qzbvkzadpo)
Phase 2
35
(Standard Chemotherapy)
afelelfipc = qylwydwuoe yraretvzor (mgggdjvdfc, cwzfchjfdg - jlsmrswjng)
-
11 May 2025
afelelfipc = lqchuipxqf yraretvzor (mgggdjvdfc, bxnnutkpez - yrgwrowfze)
Phase 2
72
Adjuvant RT+Nivolumab
(Single Modality De-escalation Arm (SDA))
ifzrmaukfn = poysmazzgi ytefkkpjmg (ylcuuearhy, rkxljqcbrh - vprwkfxvdy)
-
06 May 2025
(Intermediate De-escalation Arm (IDA))
ifzrmaukfn = wpnxsjzopi ytefkkpjmg (ylcuuearhy, jwipattyho - owiqjxfhzo)
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Regulation

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