NDAINTRAMUSCULAR, INTRAVENOUSSOLUTION
Approved
Feb 2026
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
7
Data completeness
4/8 — Partial
VYKOURA (leucovorin calcium) by Viatris (2) 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 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VYKOURA (leucovorin calcium) is a reduced folate cofactor administered via IV or IM injection that does not require enzymatic reduction to participate in one-carbon transfer reactions. It counteracts the toxic effects of folic acid antagonists like methotrexate while enhancing the efficacy and toxicity of fluoropyrimidine chemotherapies such as 5-fluorouracil. The drug is used as a rescue agent and adjunctive therapy in cancer treatment regimens.
Launch18.5 years to LOE
Early-stage launch product with limited current commercial data; team building and market establishment phase likely underway.
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 (2)? 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.