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5-Fluorouracil (5-FU) (5-fluorouracil-5-fu)
5-Fluorouracil (5-FU) (generic name: 5-fluorouracil-5-fu) is a drug developed by Pfizer Inc.. It is currently in Phase 1 development.
5-Fluorouracil (5-FU) inhibits thymidylate synthase, disrupting DNA synthesis and repair in rapidly dividing cells.
5-Fluorouracil (5-FU) is used in the treatment of pancreatic cancer, often in combination with other therapies such as FOLFIRINOX. It is also studied in combination with stereotactic body radiotherapy (SBRT) as part of neoadjuvant therapy for pancreatic cancer.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Pfizer Inc. is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | 5-fluorouracil-5-fu |
|---|---|
| Sponsor | Pfizer Inc. |
| Phase | Phase 1 |
Mechanism of action
5-Fluorouracil works by blocking an enzyme called thymidylate synthase, which is crucial for making DNA. This disruption prevents cancer cells from reproducing and spreading.
Approved indications
Common side effects
- Diarrhoea
- Nausea
- DIARRHOEA
- Peripheral sensory neuropathy
- Fatigue
- Neutrophil count decreased
- NAUSEA
- Neutropenia
- Vomiting
- Stomatitis
- Constipation
- Anaemia
Key clinical trials
- A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers (PHASE3)
- A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid/Leucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal Cancer (PHASE2)
- A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012) (PHASE3)
- A Study to Investigate Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (PHASE3)
- A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (mCRC) (PHASE2)
- Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01) (PHASE1)
- MRI-Guided Adaptive Radiation Therapy for Organ Preservation in Rectal Cancer (PHASE1)
- Substudy 06C: A Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With First-Line Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (MK-3475-06C/KEYMAKER-U06) (PHASE1, 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:
- 5-Fluorouracil (5-FU) CI brief — competitive landscape report
- 5-Fluorouracil (5-FU) updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI
Frequently asked questions about 5-Fluorouracil (5-FU)
What is 5-Fluorouracil (5-FU)?
How does 5-Fluorouracil (5-FU) work?
Who makes 5-Fluorouracil (5-FU)?
What is the generic name of 5-Fluorouracil (5-FU)?
What development phase is 5-Fluorouracil (5-FU) in?
What are the side effects of 5-Fluorouracil (5-FU)?
Related
- Manufacturer: Pfizer Inc. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing