GEMZAR
LOE ApproachingNDAINJECTIONINJECTABLEPriority Review
Approved
May 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
12
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 17h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GEMZAR (gemcitabine) is a small-molecule nucleoside analog approved by the FDA in May 1996 as an injectable chemotherapy agent. The exact indications are not specified in available data, but gemcitabine is clinically used across multiple solid tumors including pancreatic, breast, ovarian, and non-small-cell lung cancers. It functions as an antimetabolite that interferes with DNA synthesis and repair in rapidly dividing cells.
LOE Approaching
As a mature injectable chemotherapy approaching loss of exclusivity, GEMZAR likely operates with a stable, lean commercial team focused on maintaining market share against generic erosion and newer oncology therapies.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (12)
Disulfiram-Copper Gluconate in Met Pancreas Cancer w Rising CA19-9 on Abraxane-Gemzar, FOLFIRINOX or Gemcitabine
Started Oct 2019
1 enrolled
Metastatic Pancreatic Cancer
A Clinical Study of AL2846 Capsule Combined With Gemzar Injection in the Treatment of Advanced Pancreatic Cancer
Started Aug 2018
34 enrolled
Pancreatic Cancer
Safety Study of ABT-263 in Combination With Gemzar (Gemcitabine) in Subjects With Solid Tumors
Started Sep 2009
46 enrolled
Solid Tumors
Gleevec and Gemzar in Patients With Epithelial Ovarian Cancer
Started Jun 2009
8 enrolled
Ovarian CancerPrimary Peritoneal Cancer
Gemzar, Cisp, Sunitinib Urothelial Ca
Started Aug 2008
36 enrolled
Urothelial 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.