NDAINJECTIONINJECTABLE
Approved
Aug 2011
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
GEMCITABINE HYDROCHLORIDE (gemcitabine) by Pfizer is g1/s-phase boundary. First approved in 2011.
Drug data last refreshed 18h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Gemcitabine hydrochloride is a nucleoside analog chemotherapy agent that acts at the G1/S-phase boundary by inhibiting ribonucleotide reductase and competing with dCTP for DNA incorporation, triggering apoptosis in rapidly dividing cancer cells. Approved in 2011, it is administered via injection and currently operates at peak commercial lifecycle. It treats multiple solid tumors and hematologic malignancies, with off-label use extending its clinical application.
Peak
Gemcitabine operates at peak commercial maturity with established market presence; competitive pressure at 30% suggests stable but not high-growth conditions, indicating mid-sized commercial teams focused on retention and life-cycle extension.
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.