NDAINTRAVENOUSSOLUTION
Approved
Aug 2017
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
GEMCITABINE HYDROCHLORIDE (gemcitabine) by Accord Biopharma is g1/s-phase boundary. First approved in 2017.
Drug data last refreshed 19h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Gemcitabine hydrochloride is a nucleoside analog chemotherapy agent administered intravenously that inhibits DNA synthesis by targeting the G1/S-phase boundary. It works by being metabolized into active nucleotides that inhibit ribonucleotide reductase and compete with natural nucleotides for DNA incorporation, triggering apoptosis. This is a generic small-molecule cytotoxic agent used across multiple solid tumor indications.
Peak
Product is in peak commercial phase with moderate competitive pressure (30), suggesting stable demand and established market presence with mature team structures.
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
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 Study to Compare the Efficacy and Safety of YL201 With Standard Chemotherapy in Patients With Metastatic Pancreatic Cancer After Failure of Gemcitabine-Based Systemic Chemotherapy
Started Oct 2026
320 enrolled
Metastatic Pancreatic CancerPancreatic Ductal Adenocarcinoma (PDAC)
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
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 Sep 2026
0Pancreatic Cancer ResectablePancreatic Cancer
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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.