NDAINTRAMUSCULAR, INTRAVENOUSSOLUTION
Approved
Feb 2026
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
7
Data completeness
4/8 — Partial
VYKOURA (leucovorin calcium) by Viatris is clinical pharmacology leucovorin is a mixture of the diastereoisomers of the 5-formyl derivative of tetrahydrofolic acid (thf). First approved in 2026.
Drug data last refreshed 36m ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VYKOURA (leucovorin calcium) is a reduced folate derivative that participates in one-carbon transfer reactions essential for DNA synthesis and repair. It counteracts the toxic effects of folic acid antagonists like methotrexate and enhances the therapeutic efficacy of fluoropyrimidines such as 5-fluorouracil in cancer therapy. The drug works by providing an active folate cofactor that bypasses the dihydrofolate reductase enzyme, making it clinically valuable in both rescue and potentiation strategies.
Launch18.1 years to LOE
As a newly launched Viatris generic product with no direct competitors documented, commercial teams face a build-phase opportunity but limited growth trajectory in a mature supportive care category.
Mechanism of Action
CLINICAL PHARMACOLOGY Leucovorin is a mixture of the diastereoisomers of the 5-formyl derivative of tetrahydrofolic acid (THF). The biologically active compound of the mixture is the (-)- l -isomer, known as Citrovorum factor or (-)-folinic acid. Leucovorin does not require reduction by the enzyme…
Worked on VYKOURA at Viatris? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.