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FUDR +oxaliplatin
FUDR +oxaliplatin is a Chemotherapy combination (fluoropyrimidine + platinum agent) Small molecule drug developed by Xu jianmin. It is currently in Phase 3 development for Colorectal cancer (metastatic or locally advanced), Hepatic arterial infusion chemotherapy for hepatic metastases. Also known as: fluorodeoxyuridine (FUDR).
FUDR (floxuridine) and oxaliplatin work together as a chemotherapy combination to inhibit DNA synthesis and cross-link DNA, killing rapidly dividing cancer cells.
FUDR (floxuridine) and oxaliplatin work together as a chemotherapy combination to inhibit DNA synthesis and cross-link DNA, killing rapidly dividing cancer cells. Used for Colorectal cancer (metastatic or locally advanced), Hepatic arterial infusion chemotherapy for hepatic metastases.
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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 | FUDR +oxaliplatin |
|---|---|
| Also known as | fluorodeoxyuridine (FUDR) |
| Sponsor | Xu jianmin |
| Drug class | Chemotherapy combination (fluoropyrimidine + platinum agent) |
| Target | Thymidylate synthase (FUDR); DNA (oxaliplatin cross-linking) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
FUDR is a fluoropyrimidine antimetabolite that inhibits thymidylate synthase and gets incorporated into DNA/RNA, disrupting nucleotide synthesis. Oxaliplatin is a platinum-based alkylating agent that forms DNA cross-links, preventing replication and transcription. Together, they provide synergistic cytotoxic effects against colorectal and other solid tumors.
Approved indications
- Colorectal cancer (metastatic or locally advanced)
- Hepatic arterial infusion chemotherapy for hepatic metastases
Common side effects
- Neutropenia
- Thrombocytopenia
- Anemia
- Nausea and vomiting
- Diarrhea
- Peripheral neuropathy
- Hepatotoxicity
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)
- A Study of the Use of the Medtronic Pump and Codman Catheter to Give Chemotherapy to Patients With Colorectal Carcinoma or Cholangiocarcinoma (PHASE2)
- Study of Safety/Feasibility of a Hybrid Model of Tertiary and Community Delivery of Hepatic Artery Infusion Chemotherapy (PHASE2)
- Hepatic Artery Chemotherapy for Patients With Localized Pancreas Cancer (PHASE4)
- Hepatic Artery Infusion Pump Chemotherapy With Floxuridine and Dexamethasone in Combination With Systemic Chemotherapy for Patients With Colorectal Cancer Metastatic to the Liver (PHASE2)
- Gemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump in People With Cholangiocarcinoma That Cannot Be Removed With Surgery (PHASE2)
- Hepatic Arterial Infusion With Floxuridine and Dexamethasone Combined With Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver (PHASE2)
- mFOLFIRINOX Followed by Hepatic Arterial Infusion of Floxuridine and Dexamethasone With Systemic mFOLFIRI for Unresectable Liver-dominant Intrahepatic Cholangiocarcinoma (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:
- FUDR +oxaliplatin CI brief — competitive landscape report
- FUDR +oxaliplatin updates RSS · CI watch RSS
- Xu jianmin portfolio CI
Frequently asked questions about FUDR +oxaliplatin
What is FUDR +oxaliplatin?
How does FUDR +oxaliplatin work?
What is FUDR +oxaliplatin used for?
Who makes FUDR +oxaliplatin?
Is FUDR +oxaliplatin also known as anything else?
What drug class is FUDR +oxaliplatin in?
What development phase is FUDR +oxaliplatin in?
What are the side effects of FUDR +oxaliplatin?
What does FUDR +oxaliplatin target?
Related
- Drug class: All Chemotherapy combination (fluoropyrimidine + platinum agent) drugs
- Target: All drugs targeting Thymidylate synthase (FUDR); DNA (oxaliplatin cross-linking)
- Manufacturer: Xu jianmin — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Colorectal cancer (metastatic or locally advanced)
- Indication: Drugs for Hepatic arterial infusion chemotherapy for hepatic metastases
- Also known as: fluorodeoxyuridine (FUDR)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing