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Levo-Leucovorin
Levo-Leucovorin is a Reduced folate cofactor / Chemotherapy adjuvant Small molecule drug developed by Fujian Cancer Hospital. It is currently in Phase 3 development for Colorectal cancer (in combination with 5-fluorouracil), Metastatic colorectal cancer.
Levo-leucovorin is the active L-isomer of leucovorin that enhances the cytotoxic effects of fluorouracil by stabilizing the ternary complex between fluorodeoxymonophosphate, thymidylate synthase, and the cofactor.
Levo-leucovorin is the active L-isomer of leucovorin that enhances the cytotoxic effects of fluorouracil by stabilizing the ternary complex between fluorodeoxymonophosphate, thymidylate synthase, and the cofactor. Used for Colorectal cancer (in combination with 5-fluorouracil), Metastatic colorectal cancer.
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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 | Levo-Leucovorin |
|---|---|
| Sponsor | Fujian Cancer Hospital |
| Drug class | Reduced folate cofactor / Chemotherapy adjuvant |
| Target | Thymidylate synthase (indirect) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Levo-leucovorin (the pharmacologically active form of folinic acid) acts as a reduced folate cofactor that potentiates 5-fluorouracil (5-FU) activity in cancer cells. By providing the necessary one-carbon unit, it increases the binding affinity of 5-FU metabolites to thymidylate synthase, thereby enhancing inhibition of DNA synthesis and increasing cytotoxicity. This mechanism is particularly important in colorectal cancer and other solid tumors where 5-FU is a standard chemotherapy agent.
Approved indications
- Colorectal cancer (in combination with 5-fluorouracil)
- Metastatic colorectal cancer
Common side effects
- Myelosuppression
- Gastrointestinal toxicity
- Mucositis
- Diarrhea
- Nausea and vomiting
Key clinical trials
- Perioperative Systemic Therapy for Isolated Resectable Colorectal Peritoneal Metastases (PHASE2, PHASE3)
- A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer (PHASE3)
- A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer (PHASE1, PHASE2)
- Neoadjuvant FOLFOXIRI and Chemoradiotherapy Versus Neoadjuvant CAPOX/FOLFOX and Chemoradiotherapy Followed by Surgery or a Watch-and-Wait Approach in High Risk Locally Advanced Rectal Cancer (PHASE3)
- Clinical Efficacy of Transarterial Infusion Chemotherapy for Unresectable Colorectal Cancer (NA)
- Clinical Study on the First-line Treatment of Advanced Colorectal Cancer With Simultaneous Infusion of Levozolinate for Injection and 5-FU (PHASE2)
- Cetuximab and Envafolimab Plus mFOLFOXIRI as First-line Treatment for RAS/BRAF Wild-type, MSS, Unresectable Left-side Metastatic Colorectal Cancer (PHASE2)
- Phase Ib/II Single-arm Study of mFOLFOX6, Bevacizumab and Atezolizumab in Advanced Biliary Tract Cancer (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:
- Levo-Leucovorin CI brief — competitive landscape report
- Levo-Leucovorin updates RSS · CI watch RSS
- Fujian Cancer Hospital portfolio CI
Frequently asked questions about Levo-Leucovorin
What is Levo-Leucovorin?
How does Levo-Leucovorin work?
What is Levo-Leucovorin used for?
Who makes Levo-Leucovorin?
What drug class is Levo-Leucovorin in?
What development phase is Levo-Leucovorin in?
What are the side effects of Levo-Leucovorin?
What does Levo-Leucovorin target?
Related
- Drug class: All Reduced folate cofactor / Chemotherapy adjuvant drugs
- Target: All drugs targeting Thymidylate synthase (indirect)
- Manufacturer: Fujian Cancer Hospital — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Colorectal cancer (in combination with 5-fluorouracil)
- Indication: Drugs for Metastatic colorectal cancer
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing