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FOLFIFINOX
FOLFIFINOX is a chemotherapy regimen Small molecule drug developed by AIO-Studien-gGmbH. It is currently in Phase 2 development for Metastatic pancreatic cancer.
FOLFIRINOX is a chemotherapy regimen that combines four different drugs to target rapidly dividing cancer cells.
FOLFIFINOX is a chemotherapy regimen used to treat Ductal Adenocarcinoma of the Pancreas. It is composed of the interventions Gem/nab-Pac and FOLFIRINOX, which are part of a clinical trial (NCT02125136) investigating intensified neoadjuvant chemotherapy in locally advanced pancreatic cancer.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | FOLFIFINOX |
|---|---|
| Sponsor | AIO-Studien-gGmbH |
| Drug class | chemotherapy regimen |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
FOLFIRINOX is a combination of the chemotherapy drugs folinic acid, fluorouracil, irinotecan, and oxaliplatin. This regimen works by interfering with the DNA replication process in cancer cells, ultimately leading to cell death.
Approved indications
- Metastatic pancreatic cancer
Common side effects
- Nausea
- Diarrhea
- Fatigue
- Neutropenia
- Anemia
Key clinical trials
- Trial to Investigate Intensified Neoadjuvant Chemotherapy in Locally Advanced Pancreatic 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:
- FOLFIFINOX CI brief — competitive landscape report
- FOLFIFINOX updates RSS · CI watch RSS
- AIO-Studien-gGmbH portfolio CI
Frequently asked questions about FOLFIFINOX
What is FOLFIFINOX?
How does FOLFIFINOX work?
What is FOLFIFINOX used for?
Who makes FOLFIFINOX?
What drug class is FOLFIFINOX in?
What development phase is FOLFIFINOX in?
What are the side effects of FOLFIFINOX?
Related
- Drug class: All chemotherapy regimen drugs
- Manufacturer: AIO-Studien-gGmbH — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic pancreatic cancer
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing