NDAINTRAVENOUSINJECTABLEPriority Review
Approved
Apr 2007
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 21h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RECLAST (zoledronic acid) is an intravenous bisphosphonate approved in 2007 for treatment of osteoporosis and bone metastases. It works by inhibiting osteoclast-mediated bone resorption, reducing bone turnover and fracture risk in at-risk populations. The drug is administered as a once-yearly IV infusion, offering convenient dosing compared to oral alternatives.
LOE Approaching1.9 years to LOE
With loss of exclusivity imminent (1.9 years remaining), brand teams will focus on lifecycle management and transition strategies rather than growth initiatives.
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 (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.