NDAINTRAVENOUSSOLUTION
Approved
Jun 2025
Lifecycle
Launch
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
AVGEMSI (gemcitabine) by Viatris is g1/s-phase boundary. First approved in 2025.
Drug data last refreshed 26m ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AVGEMSI (gemcitabine) is an IV chemotherapy agent approved by Viatris in June 2025 that works by inhibiting ribonucleotide reductase and incorporating into DNA to halt cell division at the G1/S phase boundary. It is indicated for cancer patients requiring cytotoxic chemotherapy, functioning as a nucleoside analog that triggers apoptosis in dividing cells. The mechanism involves self-potentiation whereby gemcitabine diphosphate reduces dCTP pools, enhancing triphosphate incorporation into DNA and terminating strand extension.
Launch
Recently launched IV product with low current visibility in job market; team build-out and market penetration phase likely underway.
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)
A Study of NDV-01 (Sustained-release Gemcitabine-docetaxel) in Participants With Non-muscle Invasive Bladder Cancer
Started Feb 2027
393 enrolled
Bladder (Urothelial, Transitional Cell) CancerBladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)Urothelial Carcinoma Bladder+2 more
Neoadjuvant Intravesical Nadofaragene Firadenovec With Gemcitabine, Cisplatin and Durvalumab for the Treatment of Muscle Invasive Bladder Cancer, TRIFECTA Trial
Started Dec 2026
33 enrolled
Muscle Invasive Bladder Urothelial CarcinomaStage II Bladder Cancer AJCC v8Stage IIIA Bladder Cancer AJCC v8
A Prospective, Multi-Center, Phase 4, Single Arm Study To Assess The Safety and Tolerability of Perioperative Durvalumab in Combination With Neoadjuvant Gemcitabine Plus Cisplatin in Indian Patients With Muscle-Invasive Bladder Cancer Cle-Invasive
Started Oct 2026
50 enrolled
Muscle-Invasive Bladder Cancer (MIBC)
PHASE 1 TRIAL OF Lm-LLO-TT AND GEMCITABINE IN UNRESECTABLE PANCREATIC DUCTAL ADENOCARCINOMA
Started Oct 2026
18 enrolled
Pancreas Cancer, Duct Cell AdenocarcinomaPancreatic CancerAdvanced Pancreatic Adenocarcinoma
A Phase II Study of Single Tremelimumab With Regular Interval Durvalumab Plus Gemcitabine and Cisplatin in Locally Advanced Unresectable/Metastatic Combined Hepatocellular-cholangiocarcinoma
Started Oct 2026
29 enrolled
Combined Hepatocellular and Cholangiocarcinoma
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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.