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Infusional 5-Fluorouracil
Infusional 5-Fluorouracil is a Pyrimidine analog Small molecule drug developed by Italian Trial in Medical Oncology. It is currently in Phase 2 development for Colorectal cancer. Also known as: Adrucil, Efudex, Fluoroplex.
Inhibits thymidylate synthase
Infusional 5-Fluorouracil is used to treat various types of cancer, including colorectal cancer, gastroesophageal junction adenocarcinoma, colon cancer, stomach neoplasm, and metastatic cancer. It works by inhibiting the enzyme thymidylate synthase, which is involved in DNA synthesis.
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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 | Infusional 5-Fluorouracil |
|---|---|
| Also known as | Adrucil, Efudex, Fluoroplex |
| Sponsor | Italian Trial in Medical Oncology |
| Drug class | Pyrimidine analog |
| Target | Thymidylate synthase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
5-Fluorouracil works by inhibiting thymidylate synthase, an enzyme involved in DNA synthesis, thereby preventing cancer cell growth.
Approved indications
- Colorectal cancer
Common side effects
- Hand-foot syndrome
- Diarrhea
- Mucositis
Key clinical trials
- Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer (PHASE3)
- Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors (PHASE2)
- Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer (PHASE3)
- Camrelizumab and Apatinib With or Without FOLFOX Chemotherapy for Advanced HCC (PHASE3)
- Infusional FOLFOX Plus Camrelizumab and Apatinib vs HAIC-FOLFOX Plus Camrelizumab and Apatinib for Advanced HCC (PHASE3)
- Hepatic Arterial Infusion Chemotherapy With Lipiodol Embolization in Advanced Hepatocellular Carcinoma (PHASE2)
- Individualized Dose Escalation of 5-FU for Gastrointestinal Cancer (NA)
- A Study to Evaluate PEEL-224 in Patients With Advanced Solid Tumors (PHASE1)
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:
- Infusional 5-Fluorouracil CI brief — competitive landscape report
- Infusional 5-Fluorouracil updates RSS · CI watch RSS
- Italian Trial in Medical Oncology portfolio CI
Frequently asked questions about Infusional 5-Fluorouracil
What is Infusional 5-Fluorouracil?
How does Infusional 5-Fluorouracil work?
What is Infusional 5-Fluorouracil used for?
Who makes Infusional 5-Fluorouracil?
Is Infusional 5-Fluorouracil also known as anything else?
What drug class is Infusional 5-Fluorouracil in?
What development phase is Infusional 5-Fluorouracil in?
What are the side effects of Infusional 5-Fluorouracil?
What does Infusional 5-Fluorouracil target?
Related
- Drug class: All Pyrimidine analog drugs
- Target: All drugs targeting Thymidylate synthase
- Manufacturer: Italian Trial in Medical Oncology — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Colorectal cancer
- Also known as: Adrucil, Efudex, Fluoroplex
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing