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Calcium folinate (LV)
Calcium folinate (LV) is a Reduced folate cofactor / Chemotherapy adjuvant 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 (adjuvant and metastatic, in combination with 5-fluorouracil). Also known as: LV.
Calcium folinate is a reduced form of folic acid that enhances the activity of fluorouracil (5-FU) by stabilizing the binding of fluorodeoxymonophosphate to thymidylate synthase.
Calcium folinate (LV) is a small molecule used in the treatment of various cancers, including colorectal, gastrointestinal, biliary tract, and pancreatic cancers, as well as recurrent childhood acute lymphoblastic leukemia. The exact mechanism of action of calcium folinate is currently unknown.
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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 | Calcium folinate (LV) |
|---|---|
| Also known as | LV |
| Sponsor | Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group |
| Drug class | Reduced folate cofactor / Chemotherapy adjuvant |
| Target | Thymidylate synthase (indirect, via 5-FU potentiation) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Calcium folinate (leucovorin) acts as a cofactor that increases the cytotoxic effect of 5-FU chemotherapy by providing the necessary reduced folate cofactor for thymidylate synthase inhibition. This combination enhances DNA synthesis inhibition and improves the anti-tumor efficacy of 5-FU in colorectal cancer. It is commonly used as an adjunct to 5-FU-based chemotherapy regimens.
Approved indications
- Colorectal cancer (adjuvant and metastatic, in combination with 5-fluorouracil)
Common side effects
- Gastrointestinal toxicity (nausea, vomiting, diarrhea)
- Myelosuppression (neutropenia, thrombocytopenia)
- Mucositis
- Fatigue
Key clinical trials
- A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment (PHASE3)
- Combination Chemotherapy Before and After Surgery in Treating Patients With Localized Pancreatic Cancer (PHASE2)
- A Study Evaluating AMG 193 in Combination With Other Therapies in Participants With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous Methylthioadenosine Phosphorylase (MTAP)-Deletion (MTAPESTRY 103) (PHASE1)
- Ivonescimab and ADG126, Alone, and in Combination With Leucovorin and Fluorouracil or FOLFIRI Regimen for the Treatment of Microsatellite Stable Advanced/Metastatic Colorectal Cancer (PHASE1)
- A Phase II Randomized Study of Gemcitabine and Nab-paclitaxel in Combination With S- 1/LV (GASL) or Oxaliplatin (GAP) as First-line Treatment for Metastatic Pancreatic Cancer (PHASE2)
- An Additional Analysis of Data From the PARADIGM Exploratory Study (NCT02394834) in Patients With Advanced/Recurrent Colorectal Cancer
- Irinotecan Hydrochloride Liposome Injection (II)in Combination With Oxaliplatin, 5-FU/LV Versus AG for First-line Treatment of Metastatic Pancreatic Cancer (PHASE3)
- Phase III Study to Compare GFH375 and Chemotherapy in Patients With KRAS G12D-Mutant Metastatic Pancreatic Cancer (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:
- Calcium folinate (LV) CI brief — competitive landscape report
- Calcium folinate (LV) updates RSS · CI watch RSS
- Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group portfolio CI
Frequently asked questions about Calcium folinate (LV)
What is Calcium folinate (LV)?
How does Calcium folinate (LV) work?
What is Calcium folinate (LV) used for?
Who makes Calcium folinate (LV)?
Is Calcium folinate (LV) also known as anything else?
What drug class is Calcium folinate (LV) in?
What development phase is Calcium folinate (LV) in?
What are the side effects of Calcium folinate (LV)?
What does Calcium folinate (LV) target?
Related
- Drug class: All Reduced folate cofactor / Chemotherapy adjuvant drugs
- Target: All drugs targeting Thymidylate synthase (indirect, via 5-FU potentiation)
- Manufacturer: Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Colorectal cancer (adjuvant and metastatic, in combination with 5-fluorouracil)
- Also known as: LV
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing