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Tegafur-uracil (UFT)
Tegafur-uracil (UFT) is a Antimetabolite Small molecule drug developed by Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group. It is currently in Phase 3 development for Colorectal cancer. Also known as: UFT.
Tegafur-uracil (UFT) is a prodrug that is metabolized into 5-fluorouracil (5-FU), which then inhibits thymidylate synthase.
Tegafur-uracil (UFT) is a small molecule used in the treatment of Colorectal Cancer and Hepatocellular Carcinoma. It is often combined with other interventions, such as Calcium folinate (LV) and Krestin (PSK), in clinical trials.
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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 | Tegafur-uracil (UFT) |
|---|---|
| Also known as | UFT |
| Sponsor | Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group |
| Drug class | Antimetabolite |
| Target | Thymidylate synthase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
This inhibition of thymidylate synthase leads to a decrease in DNA synthesis and cell proliferation, ultimately resulting in cell death. 5-FU is a pyrimidine analog that is incorporated into DNA, causing strand breaks and apoptosis. The uracil component of UFT helps to maintain a steady level of 5-FU in the body by inhibiting its degradation.
Approved indications
- Colorectal cancer
Common side effects
- Diarrhea
- Nausea
- Vomiting
- Fatigue
- Anemia
Key clinical trials
- Xeloda or UFT (Tegafur-uracil) With Folinic Acid in Advanced or Metastatic Colorectal Cancer (PHASE3)
- Modulated Electro-Hyperthermia in Combination With Multimodal Therapy for Locally Advanced Rectal Cancer (PHASE3)
- A Phase III Trial in NPC With Post-radiation Detectable Plasma EBV DNA (PHASE3)
- A Phase II Trial of PG2 in Patients With Advanced Pharyngeal or Laryngeal Squamous Cell Carcinoma Under Concurrent Chemoradiotherapy (PHASE2)
- Fluorouracil-Uracil and Leucovorin in Treating Elderly Patients With Metastatic Colorectal Cancer (PHASE2)
- Trial Testing Ftorafur (UFT) Associated With Neoadjuvant Radiotherapy Versus Radiotherapy Alone in Rectal Adenocarcinoma (PHASE3)
- A Multiple Ascending Dose Study of MEDI7247 in Advanced or Metastatic Solid Tumors (PHASE1)
- Maintenance Tegafur-uracil in Resected Oral Cavity Cancer With ECS+ (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:
- Tegafur-uracil (UFT) CI brief — competitive landscape report
- Tegafur-uracil (UFT) updates RSS · CI watch RSS
- Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group portfolio CI
Frequently asked questions about Tegafur-uracil (UFT)
What is Tegafur-uracil (UFT)?
How does Tegafur-uracil (UFT) work?
What is Tegafur-uracil (UFT) used for?
Who makes Tegafur-uracil (UFT)?
Is Tegafur-uracil (UFT) also known as anything else?
What drug class is Tegafur-uracil (UFT) in?
What development phase is Tegafur-uracil (UFT) in?
What are the side effects of Tegafur-uracil (UFT)?
What does Tegafur-uracil (UFT) target?
Related
- Drug class: All Antimetabolite drugs
- Target: All drugs targeting Thymidylate synthase
- Manufacturer: Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Colorectal cancer
- Also known as: UFT
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing