Last reviewed 2026-05-24 · How we verify

Trifluridine cures

Centre Hospitalier Universitaire Dijon · Phase 3 active Small molecule Under review Quality 0/100

Trifluridine cures is a Nucleoside analog; antimetabolite Small molecule drug developed by Centre Hospitalier Universitaire Dijon. It is currently in Phase 3 development for Metastatic colorectal cancer, Gastric cancer, Pancreatic cancer.

Trifluridine is a nucleoside analog that inhibits thymidylate synthase and gets incorporated into DNA, disrupting cancer cell replication.

Trifluridine is a small molecule DNA inhibitor used in cancer treatment. It has been studied in clinical trials for the treatment of colon or upper rectum adenocarcinoma, specifically in combination with other interventions such as FOLFIRI.

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Oncology Phase 3 boost +3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Trifluridine cures
Sponsor	Centre Hospitalier Universitaire Dijon
Drug class	Nucleoside analog; antimetabolite
Target	Thymidylate synthase; DNA
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

Trifluridine acts as a thymidine analog that inhibits thymidylate synthase, an enzyme critical for DNA synthesis. It is incorporated into DNA during replication, causing DNA damage and cell death in rapidly dividing cancer cells. This dual mechanism makes it effective against various malignancies.

Approved indications

Metastatic colorectal cancer
Gastric cancer
Pancreatic cancer

Common side effects

Neutropenia
Anemia
Thrombocytopenia
Gastrointestinal toxicity
Fatigue

Key clinical trials

Investigate the Efficacy of Chemotherapy in Patients With Positive ctDNA After Surgery and Adjuvant Chemotherapy for a Stage III Colorectal Cancer (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Trifluridine cures CI brief — competitive landscape report
Trifluridine cures updates RSS · CI watch RSS
Centre Hospitalier Universitaire Dijon portfolio CI

Frequently asked questions about Trifluridine cures

What is Trifluridine cures?

Trifluridine cures is a Nucleoside analog; antimetabolite drug developed by Centre Hospitalier Universitaire Dijon, indicated for Metastatic colorectal cancer, Gastric cancer, Pancreatic cancer.

How does Trifluridine cures work?

Trifluridine is a nucleoside analog that inhibits thymidylate synthase and gets incorporated into DNA, disrupting cancer cell replication.

What is Trifluridine cures used for?

Trifluridine cures is indicated for Metastatic colorectal cancer, Gastric cancer, Pancreatic cancer.

Who makes Trifluridine cures?

Trifluridine cures is developed by Centre Hospitalier Universitaire Dijon (see full Centre Hospitalier Universitaire Dijon pipeline at /company/centre-hospitalier-universitaire-dijon).

What drug class is Trifluridine cures in?

Trifluridine cures belongs to the Nucleoside analog; antimetabolite class. See all Nucleoside analog; antimetabolite drugs at /class/nucleoside-analog-antimetabolite.

What development phase is Trifluridine cures in?

Trifluridine cures is in Phase 3.

What are the side effects of Trifluridine cures?

Common side effects of Trifluridine cures include Neutropenia, Anemia, Thrombocytopenia, Gastrointestinal toxicity, Fatigue.

What does Trifluridine cures target?

Trifluridine cures targets Thymidylate synthase; DNA and is a Nucleoside analog; antimetabolite.

Drug class: All Nucleoside analog; antimetabolite drugs
Target: All drugs targeting Thymidylate synthase; DNA
Manufacturer: Centre Hospitalier Universitaire Dijon — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Metastatic colorectal cancer
Indication: Drugs for Gastric cancer
Indication: Drugs for Pancreatic cancer

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing