ZOMETA
LOE ApproachingNDAINTRAVENOUSINJECTABLEPriority Review
Approved
Aug 2001
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
11
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 2h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZOMETA (zoledronic acid) is an intravenous bisphosphonate approved in 2001 for managing bone metastases and hypercalcemia of malignancy. The mechanism involves inhibition of osteoclast-mediated bone resorption, reducing skeletal complications in cancer patients. It is administered as an IV infusion and represents a mature small-molecule oncology supportive care agent.
LOE Approaching1.6 years to LOE
Product is in late-stage lifecycle with formulation patent expiring in 2028, indicating shrinking commercial team investment and transition planning underway.
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 (11)
Zometa Adjuvant Treatment of Malignant Pleural Effusion Due To Non-Small Cell Lung Cancer
Started Nov 2009
3 enrolled
Malignant Pleural EffusionNon Small Cell Lung Cancer
Comparison of Zometa Retention and Effect in Multiple Myeloma and Breast Cancer
Started Dec 2008
60 enrolled
Multiple MyelomaBreast Cancer
Efficacy and Safety Study of ZOMETA® in Treatment of High-level NTX Non Small Cell Lung Cancer With Bone Metastasis
Started Sep 2008
156 enrolled
Non Small Cell Lung CancerBone MetastasesHigh NTX Level
Zometa and Circulating Vascular Endothelial Growth Factor (VEGF) in Breast Cancer Patients With Bone Metastasis
Started Nov 2006
60 enrolled
Metastatic Breast CancerBone Metastases
To Evaluate the Efficacy of ZOMETA® in Treatment of Bone Metastases in Patients With Stage IV Nasopharyngeal Cancer
Started Sep 2005
60 enrolled
Nasopharyngeal 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.