Last reviewed 2026-05-14 · How we verify

"FOLFIRI" cures

Centre Hospitalier Universitaire Dijon · Phase 3 active Small molecule

"FOLFIRI" cures is a Chemotherapy regimen (combination of antimetabolite and topoisomerase I inhibitor) Small molecule drug developed by Centre Hospitalier Universitaire Dijon. It is currently in Phase 3 development for Metastatic colorectal cancer, Locally advanced colorectal cancer.

FOLFIRI is a chemotherapy regimen that combines three drugs to inhibit DNA synthesis and cell division, primarily used to treat colorectal cancer.

FOLFIRI is a chemotherapy regimen that combines three drugs to inhibit DNA synthesis and cell division, primarily used to treat colorectal cancer. Used for Metastatic colorectal cancer, Locally advanced colorectal cancer.

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	"FOLFIRI" cures
Sponsor	Centre Hospitalier Universitaire Dijon
Drug class	Chemotherapy regimen (combination of antimetabolite and topoisomerase I inhibitor)
Target	Thymidylate synthase (5-FU), Topoisomerase I (irinotecan)
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

FOLFIRI consists of fluorouracil (5-FU), leucovorin (folinic acid), and irinotecan (CPT-11). Fluorouracil is a pyrimidine antimetabolite that inhibits thymidylate synthase and disrupts DNA synthesis. Irinotecan is a topoisomerase I inhibitor that prevents DNA unwinding and causes double-strand breaks. Leucovorin enhances the cytotoxicity of 5-FU by stabilizing its binding to thymidylate synthase.

Approved indications

Metastatic colorectal cancer
Locally advanced colorectal cancer

Common side effects

Neutropenia
Diarrhea
Nausea/vomiting
Anemia
Mucositis
Fatigue
Alopecia

Key clinical trials

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:

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

Frequently asked questions about "FOLFIRI" cures

What is "FOLFIRI" cures?

"FOLFIRI" cures is a Chemotherapy regimen (combination of antimetabolite and topoisomerase I inhibitor) drug developed by Centre Hospitalier Universitaire Dijon, indicated for Metastatic colorectal cancer, Locally advanced colorectal cancer.

How does "FOLFIRI" cures work?

FOLFIRI is a chemotherapy regimen that combines three drugs to inhibit DNA synthesis and cell division, primarily used to treat colorectal cancer.

What is "FOLFIRI" cures used for?

"FOLFIRI" cures is indicated for Metastatic colorectal cancer, Locally advanced colorectal cancer.

Who makes "FOLFIRI" cures?

"FOLFIRI" 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 "FOLFIRI" cures in?

"FOLFIRI" cures belongs to the Chemotherapy regimen (combination of antimetabolite and topoisomerase I inhibitor) class. See all Chemotherapy regimen (combination of antimetabolite and topoisomerase I inhibitor) drugs at /class/chemotherapy-regimen-combination-of-antimetabolite-and-topoisomerase-i-inhibitor.

What development phase is "FOLFIRI" cures in?

"FOLFIRI" cures is in Phase 3.

What are the side effects of "FOLFIRI" cures?

Common side effects of "FOLFIRI" cures include Neutropenia, Diarrhea, Nausea/vomiting, Anemia, Mucositis, Fatigue.

What does "FOLFIRI" cures target?

"FOLFIRI" cures targets Thymidylate synthase (5-FU), Topoisomerase I (irinotecan) and is a Chemotherapy regimen (combination of antimetabolite and topoisomerase I inhibitor).

Drug class: All Chemotherapy regimen (combination of antimetabolite and topoisomerase I inhibitor) drugs
Target: All drugs targeting Thymidylate synthase (5-FU), Topoisomerase I (irinotecan)
Manufacturer: Centre Hospitalier Universitaire Dijon — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Metastatic colorectal cancer
Indication: Drugs for Locally advanced colorectal cancer

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