Drug · Small Molecule

Fluorouracil

CI-DRUG-00000250Explore in graph →NCIt C505 CHEMBL185 CIViC Approved

Regulatory

Approvals (22)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

health-canada-dpdRegulatory22 approval records from 2 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as FLUOROURACIL INJECTION (DIN 02473763) under ATC L01BC02 FLUOROURACIL. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Dec 2, 2021	health-canada-dpd
CA Health Canada	—	Marketed in Canada as TOLAK (DIN 02485346) under ATC L01BC02 FLUOROURACIL. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jun 25, 2019	health-canada-dpd
CA Health Canada	—	Marketed in Canada as FLUOROURACIL INJECTION (DIN 02473771) under ATC L01BC02 FLUOROURACIL. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jun 6, 2019

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 2 days agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	262	140	368	1,314	22	CA, US	Jul 29, 1970	1977-09
Malignant Gastric Neoplasm	Approved	Phase 4	42	25	34	134	1	US	Feb 20, 2026	1994-06
Malignant Pancreatic Neoplasm	Approved	Phase 4	41	20	25	150	1	US	Feb 20, 2026	1995-08
Malignant Colon Neoplasm	Approved	Phase 4	8	4	18	51

Curated evidence

Clinical evidence (43)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–43 of 43 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
ERBB2 L755S1
Fluorouracil + Leucovorin

Clinical trials

Trials with this intervention (1,324)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 1,324 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT05007106	MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)	completed	Phase 2	611	Merck Sharp & Dohme LLCINDUSTRY	15	Sep 28, 2026	clinicaltrials
NCT05564377	Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial	recruiting

Molecule

Record

Kind: Small Molecule
Mechanism: Thymidylate synthase inhibitor; DNA inhibitor; RNA inhibitor
Targets: 1 gene
UNII: U3P01618RT
Aliases: 2,4-Dioxo-5-fluoropyrimidine, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5 Fluorouracil, 5 Fluorouracilum, 5-fluoruracil, 5-Fluracil, 5.f.u., 5 FU, 5FU, Accusite, AccuSite, Actikerall, Adrucil, Carac, EFUDEX, Efudix, FAVLYXA, Fluoroplex, Fluorouracil, Fluoro Uracil, Fluorouracil component of folfox, Fluorouracilo, Fluoro-uracil roche, Fluorouracil Sodium, Fluorouracilum, Fluorouricil, Fluouracil, Flurablastin, Fluracedyl, Fluracil … (+10)

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (34)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01BC02	FLUOROURACIL
ATC (WHO)	L01BC52

MTHFR A222V2
Fluorouracil	Malignant Gastric Neoplasm	Predictive	B	Supports Sensitivity Response	3	accepted	EID669 The MTHFR C667T variant was associated with significantly lower relapse-free survival and overall survival in stomach cancer patients treated with 5-Fluorouracil-based therapies. 116 Chinese patients … (full text at CIViC) PMID 18704422 · Huang et al., 2009 · Open in CIViC	civic
〃	Rectal CarcinomaALIAS	Predictive	B	Supports Sensitivity Response	4	accepted	EID1757 Patients with the wild type (C/C) MTHFR gene are 2.91 times (95% CI: [1.23, 6.89]) more likely to have a positive response to neoadjuvant CRT and 3.25 times more likely not to experience relapse (95%… (full text at CIViC) PMID 26693073 · Nikas et al., 2015 · Open in CIViC	civic