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Calcium Folinate Injection
Calcium Folinate Injection is a Folate analog / Chemotherapy adjunct Small molecule drug developed by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. It is currently in Phase 3 development for Methotrexate toxicity rescue in high-dose methotrexate chemotherapy, Adjunctive therapy in colorectal cancer and other malignancies, Megaloblastic anemia due to folate deficiency. Also known as: Folinic Acid, Leucovorin, leucovorin, Leucovorin, LV.
Calcium folinate is a reduced form of folic acid that acts as a cofactor in one-carbon transfer reactions, supporting DNA synthesis and cell division.
Calcium folinate is a reduced form of folic acid that acts as a cofactor in one-carbon transfer reactions, supporting DNA synthesis and cell division. Used for Methotrexate toxicity rescue in high-dose methotrexate chemotherapy, Adjunctive therapy in colorectal cancer and other malignancies, Megaloblastic anemia due to folate deficiency.
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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 Injection |
|---|---|
| Also known as | Folinic Acid, Leucovorin, leucovorin, Leucovorin, LV, Calcium levofolinate |
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| Drug class | Folate analog / Chemotherapy adjunct |
| Target | Folate metabolism pathway; dihydrofolate reductase substrate |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Calcium folinate (leucovorin) is the active, reduced form of folic acid that bypasses the enzymatic reduction step required to convert dietary folate into its active form. It serves as a methyl donor and cofactor in nucleotide synthesis, supporting DNA replication and repair. It is commonly used as a rescue agent in high-dose methotrexate therapy and as an adjunct in cancer chemotherapy regimens.
Approved indications
- Methotrexate toxicity rescue in high-dose methotrexate chemotherapy
- Adjunctive therapy in colorectal cancer and other malignancies
- Megaloblastic anemia due to folate deficiency
Common side effects
- Allergic reactions
- Nausea and vomiting
- Diarrhea
- Stomatitis
Key clinical trials
- 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)
- Venetoclax Basket Trial for High Risk Hematologic Malignancies (PHASE1)
- 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)
- A Phase Ib/II Clinical Study on AK112 Combined or Not Combined With AK119 in pMMR/MSS Colorectal Cancer (PHASE1, PHASE2)
- Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer (PHASE3)
- A Single-arm, Single-center, Phase II Clinical Study of Aipalolitovorelizumab (QL1706) Combined With Bevacizumab and Standard Chemotherapy as First-line Treatment for MSS/pMMR Metastatic Colorectal Cancer With BRAF V600E Mutation (PHASE2)
- A Study of SHR-4375 Injection in Combination With Other Antitumor Therapies in Patients With Solid Tumors (PHASE1, PHASE2)
- A Trial to Evaluate Safety and Tolerability of TST001 in Advanced or Metastatic Solid Tumors (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:
- Calcium Folinate Injection CI brief — competitive landscape report
- Calcium Folinate Injection updates RSS · CI watch RSS
- Suzhou Suncadia Biopharmaceuticals Co., Ltd. portfolio CI
Frequently asked questions about Calcium Folinate Injection
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Related
- Drug class: All Folate analog / Chemotherapy adjunct drugs
- Target: All drugs targeting Folate metabolism pathway; dihydrofolate reductase substrate
- Manufacturer: Suzhou Suncadia Biopharmaceuticals Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Methotrexate toxicity rescue in high-dose methotrexate chemotherapy
- Indication: Drugs for Adjunctive therapy in colorectal cancer and other malignancies
- Indication: Drugs for Megaloblastic anemia due to folate deficiency
- Also known as: Folinic Acid, Leucovorin, leucovorin, Leucovorin, LV, Calcium levofolinate
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing