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Fluoropyrimidine
Fluoropyrimidine is a Small molecule drug developed by Centre Hospitalier Universitaire Dijon. It is currently in Phase 3 development. Also known as: fluorouracil or capecitabine, Capecitabine, LV5FU2, S-1 / Teysuno.
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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).
| 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 | Fluoropyrimidine |
|---|---|
| Also known as | fluorouracil or capecitabine, Capecitabine, LV5FU2, S-1 / Teysuno, capecitabine |
| Sponsor | Centre Hospitalier Universitaire Dijon |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Observational Study Regarding the Combination of Fluoropyrimidine and Bevacizumab in Patients With mCRC
- Perioperative Systemic Therapy for Isolated Resectable Colorectal Peritoneal Metastases (PHASE2, PHASE3)
- Atezolizumab and Bevacizumab in Combination With Y^90 Radioembolization in HCC for Liver Transplant (PHASE4)
- A Clinical Study to Evaluate Injection TQB2102 for the Treatment of Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Progressed After Treatment With Oxaliplatin, Irinotecan and Fluoropyrimidine-Based Drugs (PHASE3)
- Study of the Interest of Pursuing or Not the Chemotherapy for Patients With Metastatic Esophageal Cancer (PHASE2)
- Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer (PHASE3)
- A Study to Investigate the Efficacy and Safety of ONO-4578 in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer) (PHASE2)
- A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma (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:
- Fluoropyrimidine CI brief — competitive landscape report
- Fluoropyrimidine updates RSS · CI watch RSS
- Centre Hospitalier Universitaire Dijon portfolio CI
Frequently asked questions about Fluoropyrimidine
What is Fluoropyrimidine?
Who makes Fluoropyrimidine?
Is Fluoropyrimidine also known as anything else?
What development phase is Fluoropyrimidine in?
Related
- Manufacturer: Centre Hospitalier Universitaire Dijon — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: fluorouracil or capecitabine, Capecitabine, LV5FU2, S-1 / Teysuno, capecitabine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing