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UFT, Calcium Folinate
UFT, Calcium Folinate is a Antimetabolite Small molecule drug developed by Iwate Medical University. It is currently in Phase 3 development for Colorectal cancer, Gastric cancer.
UFT is a prodrug that is converted into 5-fluorouracil, which inhibits thymidylate synthase, leading to DNA damage and cell death.
Calcium Folinate is a small molecule with an unknown mechanism of action. It is used in combination with other chemotherapy agents, such as 5-fluorouracil and leucovorin calcium, to treat conditions including colorectal cancer, breast cancer, and unspecified adult solid tumors.
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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 | UFT, Calcium Folinate |
|---|---|
| Sponsor | Iwate Medical University |
| Drug class | Antimetabolite |
| Target | Thymidylate synthase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Calcium folinate is used to counteract the toxic effects of 5-fluorouracil on the bone marrow and mucosa. It works by replenishing folate stores and helping to maintain normal DNA synthesis.
Approved indications
- Colorectal cancer
- Gastric cancer
Common side effects
- Diarrhea
- Nausea
- Vomiting
- Mucositis
- Leukopenia
Key clinical trials
- Fluorouracil-Uracil and Leucovorin in Treating Elderly Patients With Metastatic Colorectal Cancer (PHASE2)
- Tegafur-Uracil and Leucovorin or S-1 in Treating Patients With Stage III Colon Cancer That Has Been Completely Removed by Surgery (PHASE3)
- Combination Chemotherapy and Radiation Therapy in Treating Patients With Colorectal Cancer (PHASE1)
- Combination Chemotherapy in Treating Patients With Advanced Solid Tumors (PHASE1)
- Paclitaxel Combined With Fluorouracil-Uracil and Leucovorin in Treating Patients With Solid Tumors (PHASE1)
- Combination Chemotherapy In Treating Patients With Advanced Cancer (PHASE1)
- A Phase III Trial Comparing UFT+PSK to UFT+LV in Stage IIB, III Colorectal Cancer (PHASE3)
- Fluorouracil-Uracil and Leucovorin in Treating Women With Metastatic Breast Cancer (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:
- UFT, Calcium Folinate CI brief — competitive landscape report
- UFT, Calcium Folinate updates RSS · CI watch RSS
- Iwate Medical University portfolio CI
Frequently asked questions about UFT, Calcium Folinate
What is UFT, Calcium Folinate?
How does UFT, Calcium Folinate work?
What is UFT, Calcium Folinate used for?
Who makes UFT, Calcium Folinate?
What drug class is UFT, Calcium Folinate in?
What development phase is UFT, Calcium Folinate in?
What are the side effects of UFT, Calcium Folinate?
What does UFT, Calcium Folinate target?
Related
- Drug class: All Antimetabolite drugs
- Target: All drugs targeting Thymidylate synthase
- Manufacturer: Iwate Medical University — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Colorectal cancer
- Indication: Drugs for Gastric cancer
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing