NDAINTRAVENOUSINJECTABLE
Approved
Aug 2013
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
ZOLEDRONIC ACID (zoledronic acid) by Gland Pharma is bone. First approved in 2013.
Drug data last refreshed 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Zoledronic acid is an intravenous bisphosphonate that inhibits osteoclast-mediated bone resorption by targeting farnesyl pyrophosphate synthase in osteoclasts. It rapidly partitions to bone and localizes at sites of high bone turnover, providing long-duration action through high binding affinity to bone mineral. The drug is indicated for conditions involving excessive bone loss and resorption.
Peak
Product is at peak commercial performance with moderate competitive pressure (30/100), suggesting a stable, mature brand with established market presence and defined team structures.
Mechanism of Action
bone. It is an inhibitor of osteoclast-mediated bone resorption. The selective action of bisphosphonates on bone is based on their high affinity for mineralized bone. Intravenously administered zoledronic acid rapidly partitions to bone and localizes preferentially at sites of high bone turnover.…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to Assess the Prevention of Bone-related Events in Patients With Bone Metastases From Malignant Solid Tumors Treated With JMT103 Compared to Zoledronic Acid
Started Apr 2024
1,360 enrolled
Imaging Examination Shows at Least One Site With Bone Metastases From Soild Tumors
Treatment With Dinutuximab Beta, Zoledronic Acid and Low-dose Interleukin (IL-2) in Patients With Leiomyosarcoma
Started Nov 2021
7 enrolled
Leiomyosarcoma
A Study of AL2846 Versus Zoledronic Acid in Subjects With Advanced Non-Small Cell Lung Cancer With Bone Metastasis
Started Sep 2020
60 enrolled
Bone Metastatic Non-small Cell Lung Cancer
Activity of Pre-Osteoclasts and Osteoclasts Over Time in Postmenopausal Women Treated With Denosumab or Zoledronic Acid
Started Jan 2019
0Osteoporosis, Postmenopausal
Treatment With Zoledronic Acid Subsequent to Denosumab in Osteoporosis
Started Mar 2017
61 enrolled
Osteoporosis
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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.