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Gemcitabine (GEM)
Gemcitabine is a nucleoside analog that inhibits ribonucleotide reductase and gets incorporated into DNA, causing chain termination and cell death.
Gemcitabine is a nucleoside analog that inhibits ribonucleotide reductase and gets incorporated into DNA, causing chain termination and cell death. Used for Metastatic pancreatic cancer, Non-small cell lung cancer, Breast cancer.
At a glance
| Generic name | Gemcitabine (GEM) |
|---|---|
| Also known as | GEM, Gemcitabine Hydrochloride, Gemcitabine |
| Sponsor | Sun Yat-sen University |
| Drug class | Nucleoside analog; antimetabolite |
| Target | Ribonucleotide reductase; DNA polymerase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
Gemcitabine is a deoxycytidine analog that is phosphorylated intracellularly to its active triphosphate form. It inhibits ribonucleotide reductase, reducing deoxyribonucleotide pools, and is incorporated into DNA during replication, leading to chain termination and apoptosis. It is particularly effective against rapidly dividing cells.
Approved indications
- Metastatic pancreatic cancer
- Non-small cell lung cancer
- Breast cancer
- Ovarian cancer
- Bladder cancer
Common side effects
- Myelosuppression (neutropenia, thrombocytopenia, anemia)
- Nausea and vomiting
- Fatigue
- Fever
- Rash
- Elevated liver enzymes
- Hemolytic uremic syndrome (rare)
Key clinical trials
- Multicenter Phase 2 Study of Envafolimab in Biliary Tract Cancers (PHASE2)
- SSRI Antidepressant Fluoxetine Improving Immunotherapy Efficacy in Advanced Hepatobiliary Malignancy Patients With Depression and Anxiety (PHASE2)
- Efficacy and Safety of Glofitamab Combined With GemOxin the Treatment of Refractory Diffuse Large B-Cell Lymphoma (PHASE2)
- Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC (PHASE2)
- Treatment of Patients With Diffuse Large B Cell Lymphoma Who Are Not Suitable for Anthracycline Containing Chemotherapy (PHASE2)
- Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread (PHASE2)
- Becotatug Vedotin Plus Sintilimab in Locoregionally Advanced NPC (PHASE3)
- A Study of Suizenji in Patients With Unresectable Pancreatic Cancer (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Gemcitabine (GEM) CI brief — competitive landscape report
- Gemcitabine (GEM) updates RSS · CI watch RSS
- Sun Yat-sen University portfolio CI