Drug · Small Molecule

Raltitrexed

CI-DRUG-00000506Explore in graph →NCIt C1804 CHEMBL225071 CIViC Approved

Regulatory

Approvals (1)

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-dpdRegulatory1 approval record · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as TOMUDEX (DIN 02229566) under ATC L01BA03 RALTITREXED. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Nov 18, 1996	health-canada-dpd

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 16 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	2	1	3	33	1	CA	Nov 18, 1996	1993-09
Malignant Mesothelioma	Phase3	Phase 3	0	0	1	2	0	—	—	1999-11
Malignant Rectal Neoplasm	Phase2	Phase 2	2	1	0	3	0	—	—	2006-12
Malignant Colon Neoplasm	Phase2	Phase 2	1	0	0	1	0	—

Curated evidence

Clinical evidence (1)

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

civicCuratedShowing 1–1 of 1 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
TYMS Overexpression1
Raltitrexed	Gastric Adenocarcinoma

Clinical trials

Trials with this intervention (33)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–33 of 33 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
NCT04761185	Raltitrexed in HIPEC	completed	Phase 1	30	Fudan UniversityOTHER	1	Feb 25, 2026	clinicaltrials
NCT06427005	Fruquintinib Plus S-1 and Raltitrexed (RSF) for MCRC	unknown	Phase 2	66	Meng QiuOTHER

Molecule

Record

Kind: Small Molecule
Mechanism: Thymidylate synthase inhibitor
Targets: 1 gene
Aliases: D1694, ICI D1694, N-[[5-[[(1,4-Dihydro-2-methyl-4-oxo-6-quinazolinyl)methyl]methylamino]-2-thienyl]carbonyl]-L-glutamic Acid, N-(5-[N-(3,4-Dihydro-2-methyl-4-oxoquinazolin-6-ylmethyl)-N-methylamino]-2-thenoyl)-L-glutamic Acid, Raltitrexed, Tomudex, ZD-16, ZD 1694, ZD-1694, ZD1694

Data updated 17 hours agoSource updated unknown

Identifiers

Codes (3)

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

System	Code	Label
ATC (WHO)	L01BA03	RALTITREXED
DIN (Health Canada)	02229566	TOMUDEX
DPD drug code	47482