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Zometa (ZOLEDRONIC ACID)
Zometa works by inhibiting the enzyme farnesyl pyrophosphate synthase, which is involved in the mevalonate pathway and ultimately leads to the inhibition of osteoclast activity.
Zoledronic Acid (Zometa), marketed by Novartis, is a leading bisphosphonate indicated for hypercalcemia of malignancy, with a key composition patent expiring in 2028. Its mechanism of action, inhibiting farnesyl pyrophosphate synthase, provides a strong competitive edge by effectively reducing osteoclast activity. The primary risk is the presence of multiple same-class competitors, including etidronic acid, pamidronic acid, alendronic acid, tiludronic acid, and ibandronic acid, all of which have been on the market for varying lengths of time.
At a glance
| Generic name | ZOLEDRONIC ACID |
|---|---|
| Sponsor | Novartis |
| Drug class | zoledronic acid |
| Target | Farnesyl pyrophosphate synthase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2001 |
Mechanism of action
The principal pharmacologic action of zoledronic acid is inhibition of bone resorption. Although the antiresorptive mechanism is not completely understood, several factors are thought to contribute to this action. In vitro, zoledronic acid inhibits osteoclastic activity and induces osteoclast apoptosis. Zoledronic acid also blocks the osteoclastic resorption of mineralized bone and cartilage through its binding to bone. Zoledronic acid inhibits the increased osteoclastic activity and skeletal calcium release induced by various stimulatory factors released by tumors.
Approved indications
- Hypercalcemia of Malignancy
- Multiple Myeloma
- Bone Metastases from Solid Tumors
Common side effects
- Pyrexia
- Influenza-like Illness
- Headache
- Myalgia
- Arthralgia
- Bone Pain
- Nausea
- Diarrhea
- Vomiting
- Dyspnea
- Abdominal Distension
- Abdominal Pain
Drug interactions
- Aminoglycosides
- Calcitonin
- Loop Diuretics
- Nephrotoxic Drugs
- Thalidomide
Key clinical trials
- Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Functional Hypothalamic Amenorrhea (PHASE3)
- Zoledronic Acid Treatment in Patients With Congenital Dyserythropoietic Anemia (PHASE1,PHASE2)
- Alpha/Beta T and B Cell Depletion With Zoledronic Acid for Solid Tumors (PHASE1,PHASE2)
- Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults (PHASE2)
- Contribution of Bone to Urine Citrate
- Zoledronate In the Prevention of Paget's Disease: Long Term Extension
- Romosozumab Use to Build Skeletal Integrity (PHASE4)
- The Comparison of Ibandronate and Zoledronic Acid After Denosumab Discontinuation (PHASE4)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Zometa CI brief — competitive landscape report
- Zometa updates RSS · CI watch RSS
- Novartis portfolio CI