NDAINTRAVENOUSSOLUTION
Approved
Jun 2025
Lifecycle
Launch
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
AVGEMSI (gemcitabine) by Viatris (2) is g1/s-phase boundary. Approved for pancreatic cancer, non-small cell lung cancer, urothelial cancer and 2 more indications. First approved in 2025.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AVGEMSI (gemcitabine) is a nucleoside analog cytotoxic chemotherapy agent approved for treatment of pancreatic, non-small cell lung, urothelial, ovarian, and bladder cancers. It works by inhibiting ribonucleotide reductase and incorporating into DNA to trigger apoptosis at the G1/S-phase boundary. The drug is administered intravenously as a solution.
Growth
Recent NDA approval (June 2025) in launch phase signals opportunity for commercial team build-out, though competitive pressure (30/100) and generic/biosimilar landscape indicate moderate market headwinds.
Mechanism of Action
G1/S-phase boundary. Gemcitabine is metabolized by nucleoside kinases to diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleosides. Gemcitabine diphosphate inhibits ribonucleotide reductase, an enzyme responsible for catalyzing the reactions that generate deoxynucleoside triphosphates for DNA…
Indications (5)
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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.