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FOLFOXIRI chemotherapy
FOLFOXIRI chemotherapy is a Combination chemotherapy regimen Small molecule drug developed by Sun Yat-sen University. It is currently in Phase 3 development for Metastatic colorectal cancer, Locally advanced colorectal cancer (neoadjuvant setting). Also known as: 5-fluorouracil, leucovorin, oxaliplatin, irinotecan.
FOLFOXIRI is a combination chemotherapy regimen that uses three cytotoxic agents to inhibit DNA synthesis and cell division in cancer cells.
FOLFOXIRI is a combination chemotherapy regimen that uses three cytotoxic agents to inhibit DNA synthesis and cell division in cancer cells. Used for Metastatic colorectal cancer, Locally advanced colorectal cancer (neoadjuvant setting).
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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.
| 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 | FOLFOXIRI chemotherapy |
|---|---|
| Also known as | 5-fluorouracil, leucovorin, oxaliplatin, irinotecan |
| Sponsor | Sun Yat-sen University |
| Drug class | Combination chemotherapy regimen |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
FOLFOXIRI combines 5-fluorouracil (5-FU), oxaliplatin, and irinotecan to attack cancer cells through multiple mechanisms: 5-FU inhibits thymidylate synthase and disrupts RNA synthesis; oxaliplatin forms DNA cross-links; and irinotecan inhibits topoisomerase I. The triple-agent approach targets rapidly dividing cells with complementary mechanisms to improve efficacy in colorectal cancer.
Approved indications
- Metastatic colorectal cancer
- Locally advanced colorectal cancer (neoadjuvant setting)
Common side effects
- Neutropenia
- Diarrhea
- Nausea/vomiting
- Anemia
- Peripheral neuropathy
- Mucositis
- Fatigue
Key clinical trials
- Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial (PHASE3)
- Neoadjuvant FOLFOXIRI and Chemoradiotherapy Versus Neoadjuvant CAPOX/FOLFOX and Chemoradiotherapy Followed by Surgery or a Watch-and-Wait Approach in High Risk Locally Advanced Rectal Cancer (PHASE3)
- AK112 and Chemotherapy in First-line Metastatic Colorectal Cancer (PHASE3)
- Frailty Scales for Predicting Chemotherapy Toxicity in Older Adults With Gastrointestinal Cancers
- Anti-EGFR Agents in Patients With Right-sided Advanced Colorectal Cancer With Wild-type RAS and AREG/EREG High Status (PHASE4)
- A Single-arm, Single-center, Phase II Clinical Study of Aipalolitovorelizumab (QL1706) Combined With Bevacizumab and Standard Chemotherapy as First-line Treatment for MSS/pMMR Metastatic Colorectal Cancer With BRAF V600E Mutation (PHASE2)
- PD-1 + FOLFOXIRI vs CAPOX as Total Neoadjuvant Therapy for pMMR Low Rectal Cancer (PHASE3)
- Preoperative ChemoRadiation And FOLFOXIRI for Rectal Cancer (CRAFTER) for Rectal Cancer (PHASE2)
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:
- FOLFOXIRI chemotherapy CI brief — competitive landscape report
- FOLFOXIRI chemotherapy updates RSS · CI watch RSS
- Sun Yat-sen University portfolio CI
Frequently asked questions about FOLFOXIRI chemotherapy
What is FOLFOXIRI chemotherapy?
How does FOLFOXIRI chemotherapy work?
What is FOLFOXIRI chemotherapy used for?
Who makes FOLFOXIRI chemotherapy?
Is FOLFOXIRI chemotherapy also known as anything else?
What drug class is FOLFOXIRI chemotherapy in?
What development phase is FOLFOXIRI chemotherapy in?
What are the side effects of FOLFOXIRI chemotherapy?
Related
- Drug class: All Combination chemotherapy regimen drugs
- Manufacturer: Sun Yat-sen University — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic colorectal cancer
- Indication: Drugs for Locally advanced colorectal cancer (neoadjuvant setting)
- Also known as: 5-fluorouracil, leucovorin, oxaliplatin, irinotecan
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing