Endostar
Also known as: Endostar injection, Recombinant Human Endostatin, rh-Endostatin, YH-16
Summary
Endostar (recombinant human endostatin, rh-Endostatin) is a modified form of human endostatin developed in China. It is approved in China for the treatment of non-small cell lung cancer (NSCLC) in combination with chemotherapy. It inhibits angiogenesis by targeting endothelial cells in tumor vasculature.
Mechanism of Action
Inhibits angiogenesis by binding to vascular endothelial growth factor (VEGF) receptors and other pro-angiogenic factors, suppressing endothelial cell proliferation, migration, and tube formation; blocks tumor neovascularization leading to tumor growth arrest.
Routes of Administration
Goals & Uses
- Nasopharyngeal carcinomaOncologyLow
- Non-small cell lung cancer (NSCLC) treatmentOncologyHigh
- Hepatocellular carcinomaOncologyModerate
- Colorectal cancerOncologyModerate
- Malignant pleural effusionOncologyModerate
Contraindications
- Serious hypersensitivity to recombinant proteinsAllergy/ImmunologyHigh
- PregnancyPopulationHighPotential fetal risk or insufficient safety data
- Severe cardiac dysfunctionCardiovascularHigh
Adverse Effects
- Nausea/vomitingGastrointestinalCommon
- FatigueGeneralCommonLow energy or tiredness
- Cardiovascular events (arrhythmia, chest discomfort)CardiovascularUncommon
- Elevated liver enzymesHepaticUncommonIncrease in AST/ALT or other hepatic markers
- Infusion-related reactionsHypersensitivityUncommon
Drug Interactions
- Vinorelbine/Cisplatin (NP regimen)Low
- Anticoagulants (warfarin, heparin)Moderate
Population Constraints
- Pediatric patientsAgeRelative
- Patients with hepatic impairmentOrgan FunctionRelative
- Elderly patients (>70 years)AgeRelative
- Lactating womenReproductiveAbsolute
Regulatory Status
- European UnionUnapprovedNot approved by EMA; no marketing authorization in the European Union.
- United StatesUnapprovedNot FDA-approved; considered investigational in the United States.
- United KingdomUnapprovedNot approved by MHRA in the United Kingdom.
Approved by the China National Medical Products Administration (NMPA, formerly CFDA) in 2005 for NSCLC. Not approved by the US FDA or EMA; considered investigational in Western markets.
Evidence & Sources
No sources recorded yet.