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Adjuvant FOLFOX
Adjuvant FOLFOX is a Platinum-based chemotherapeutic agent and thymidylate synthase inhibitor Small molecule drug developed by Asan Medical Center. It is currently in Phase 2 development for Colorectal cancer. Also known as: fluorouracil, oxaliplatin, leucovorin.
Oxaliplatin and 5-fluorouracil inhibit DNA replication and transcription by cross-linking DNA and interfering with thymidylate synthase.
Adjuvant FOLFOX is a treatment for various conditions, including colon cancer, intraperitoneal rectal cancer, peritoneal carcinomatosis, colorectal cancer metastatic, and curatively resected stage III colon cancer. The treatment involves standard adjuvant systemic chemotherapy.
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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 | Adjuvant FOLFOX |
|---|---|
| Also known as | fluorouracil, oxaliplatin, leucovorin |
| Sponsor | Asan Medical Center |
| Drug class | Platinum-based chemotherapeutic agent and thymidylate synthase inhibitor |
| Target | DNA |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
Oxaliplatin is a platinum-based chemotherapeutic agent that forms platinum-DNA adducts, thereby inhibiting DNA replication and transcription. 5-fluorouracil is a thymidylate synthase inhibitor that interferes with DNA synthesis.
Approved indications
- Colorectal cancer
Common side effects
- Diarrhea
- Neutropenia
- Nausea
- Vomiting
Key clinical trials
- Perioperative Systemic Therapy for Isolated Resectable Colorectal Peritoneal Metastases (PHASE2, PHASE3)
- Response Adapted Neoadjuvant Therapy in Gastroesophageal Cancers (RANT-GC Trial) (PHASE1)
- Impact of Oral Versus Intravenous 5-FU-Based Adjuvant Regimens on Sleep Quality and Depression in Patients With Gastrointestinal Cancers
- Frailty Scales for Predicting Chemotherapy Toxicity in Older Adults With Gastrointestinal Cancers
- Early Commencement of Adjuvant Chemotherapy for Colon Cancer (PHASE3)
- Preoperative Sequential Short-course Radiation Therapy and FOLFOX for Locally Advanced Rectal Cancer (PHASE2)
- Neoadjuvant FOLFOX Chemotherapy for Patients With Locally Advanced Colon Cancer (PHASE3)
- Neoadjuvant Chemotherapy for Obstructive Colon cancER First Treated by cOlostomy (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:
- Adjuvant FOLFOX CI brief — competitive landscape report
- Adjuvant FOLFOX updates RSS · CI watch RSS
- Asan Medical Center portfolio CI
Frequently asked questions about Adjuvant FOLFOX
What is Adjuvant FOLFOX?
How does Adjuvant FOLFOX work?
What is Adjuvant FOLFOX used for?
Who makes Adjuvant FOLFOX?
Is Adjuvant FOLFOX also known as anything else?
What drug class is Adjuvant FOLFOX in?
What development phase is Adjuvant FOLFOX in?
What are the side effects of Adjuvant FOLFOX?
What does Adjuvant FOLFOX target?
Related
- Drug class: All Platinum-based chemotherapeutic agent and thymidylate synthase inhibitor drugs
- Target: All drugs targeting DNA
- Manufacturer: Asan Medical Center — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Colorectal cancer
- Also known as: fluorouracil, oxaliplatin, leucovorin
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing