NDAINTRAVENOUSSOLUTION
Approved
Jun 2025
Lifecycle
Launch
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
AVGEMSI (gemcitabine) by Viatris (2) is g1/s-phase boundary. First approved in 2025.
Drug data last refreshed 11h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AVGEMSI (gemcitabine) is a nucleoside analog chemotherapy agent approved as an intravenous solution that blocks DNA synthesis by inhibiting ribonucleotide reductase and incorporating into DNA strands at the G1/S phase boundary. It is a cytotoxic small molecule indicated for various solid tumors, with efficacy driven by self-potentiating mechanisms that reduce deoxynucleotide pools and force incorporation of the drug into replicating DNA. The mechanism triggers apoptosis after single-nucleotide extension, making it effective against rapidly dividing cancer cells.
Launch
Early-stage launch with moderate competitive pressure (30) suggests growing team expansion in sales, market access, and brand management roles.
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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Neoadjuvant Intravesical Nadofaragene Firadenovec With Gemcitabine, Cisplatin and Durvalumab for the Treatment of Muscle Invasive Bladder Cancer, TRIFECTA Trial
Started Sep 2026
33 enrolled
Muscle Invasive Bladder Urothelial CarcinomaStage II Bladder Cancer AJCC v8Stage IIIA Bladder Cancer AJCC v8
Gemcitabine, Cisplatin, Nab-paclitaxel (GAP) and Cemiplimab for Locally Advanced Biliary Tract Cancer (BTC)
Started Aug 2026
20 enrolled
Colon and Rectal Cancer
Open-Label, Phase 1 Clinical Trial of Neoadjuvant Nogapendekin Alfa Inbakicept, Sotevtamab, and Zabadinostat in Combination With Gemcitabine and Nab-Paclitaxel for Participants With Borderline Resectable or Locally Advanced Pancreatic Cancer
Started Jun 2026
30 enrolled
Pancreatic Cancer ResectablePancreatic Cancer
A Study of NDV-01 (Sustained-release Gemcitabine-docetaxel) in Participants With Non-muscle Invasive Bladder Cancer
Started Jun 2026
393 enrolled
Bladder (Urothelial, Transitional Cell) CancerBladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)Urothelial Carcinoma Bladder+2 more
Cemiplimab Plus Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma
Started May 2026
43 enrolled
Pancreatic Ductal Adenocarcinoma (mPDAC)
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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.