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 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Gemcitabine hydrochloride is a nucleoside analog chemotherapy drug administered intravenously that works by inhibiting DNA synthesis at the G1/S-phase boundary. It is indicated for multiple solid tumors including pancreatic cancer, non-small cell lung cancer, and bladder cancer. The drug's mechanism involves metabolic activation to nucleotides that inhibit ribonucleotide reductase and compete with natural deoxynucleotides for DNA incorporation, triggering apoptosis.
Peak
Peak lifecycle stage with moderate competitive pressure (30%) suggests stable team size and focus on market defense and indication expansion rather than growth hiring.
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
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
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
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.