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5-flourouracil
5-flourouracil is a pyrimidine analog Small molecule drug developed by AstraZeneca. It is currently in Phase 2 development for Adjuvant treatment of colon cancer, Treatment of breast cancer, Treatment of stomach cancer. Also known as: 5-FU.
5-fluorouracil is a thymidylate synthase inhibitor that disrupts DNA synthesis in rapidly dividing cancer cells.
5-fluorouracil is a thymidylate synthase inhibitor that disrupts DNA synthesis in rapidly dividing cancer cells. Used for Adjuvant treatment of colon cancer, Treatment of breast cancer, Treatment of stomach cancer.
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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. -
Big-pharma sponsor
+3.0pp
AstraZeneca 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 | 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 | 5-flourouracil |
|---|---|
| Also known as | 5-FU |
| Sponsor | AstraZeneca |
| Drug class | pyrimidine analog |
| Target | thymidylate synthase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
It works by inhibiting the enzyme thymidylate synthase, which is necessary for DNA replication. This leads to the disruption of DNA synthesis and ultimately cell death in rapidly dividing cancer cells.
Approved indications
- Adjuvant treatment of colon cancer
- Treatment of breast cancer
- Treatment of stomach cancer
Common side effects
- Mucositis
- Diarrhea
- Leukopenia
- Neutropenia
- Thrombocytopenia
- Anemia
Key clinical trials
- Phase I/II Study of Perioperative Chemotherapy Plus Immunotherapy Followed by Surgery in Localized Esophageal and Gastroesophageal Adenocarcinoma (PHASE2)
- The Efficacy of Intralesional Bleomycin as Compared to 5-Flourouracil (5-FU) and Triamcinolone Acetonide (TAC) for the Treatment of Keloids: A Randomized Control Trial. (NA)
- Immunotherapy Before Transplantation for Skin Cancer Prevention in Organ Transplant Recipients (PHASE2)
- Evaluation of Efficacy of Microneedling and Topical Methotrexate Versus Microneedling and Topical 5-flourouracil in Treatment of Vitillgo Patients (NA)
- Study to Assess the Effects of GS-3583 in Participants With Advanced Solid Tumors (PHASE1)
- AZD9150 Plus Durvalumab Alone or in Combination With Chemotherapy in Patients With Advanced, Solid Tumours and in Patients With Non-Small-Cell Lung Cancer (PHASE1)
- Effect of Silymarin in Metastatic Colorectal Cancer Patients (PHASE3)
- NEOadjuvant Trial in Adenocarcinoma of the oEsophagus and oesophagoGastric Junction International Study (Neo-AEGIS) (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:
- 5-flourouracil CI brief — competitive landscape report
- 5-flourouracil updates RSS · CI watch RSS
- AstraZeneca portfolio CI
Frequently asked questions about 5-flourouracil
What is 5-flourouracil?
How does 5-flourouracil work?
What is 5-flourouracil used for?
Who makes 5-flourouracil?
Is 5-flourouracil also known as anything else?
What drug class is 5-flourouracil in?
What development phase is 5-flourouracil in?
What are the side effects of 5-flourouracil?
What does 5-flourouracil target?
Related
- Drug class: All pyrimidine analog drugs
- Target: All drugs targeting thymidylate synthase
- Manufacturer: AstraZeneca — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Adjuvant treatment of colon cancer
- Indication: Drugs for Treatment of breast cancer
- Indication: Drugs for Treatment of stomach cancer
- Also known as: 5-FU
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing