Drug · Small Molecule
Zoledronic Acid
CI-DRUG-00000654Explore in graph →NCIt C1699 CHEMBL4303669 CIViC Approved
Regulatory
Approvals (14)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
openfdaProvenance
- Source
- openFDA — Drugs@FDA applications and drug labels (SPL)
- Dataset
- Drugs@FDA via openFDA
- Version
- drugsfda-2026-09-11
- Retrieved
- Sep 14, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- CC0 1.0 Universal (public domain; https://open.fda.gov/license/)
- Run
- ING-OPENFDA-20260914-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| US FDA | — | Hypercalcemia of malignancy. • Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. • Limitations of Use : The safety and efficacy of Zoledronic Acid Injection has not been established for use in hyperparathyroidism or non-tumor-related hypercalcemia. | approved | Aug 2, 2013 | openfda |
| US FDA | — | Efficacy supplement 2009-05-29 (see label) | approved | May 29, 2009 | openfda |
| US FDA | — | Efficacy supplement 2009-03-13 (see label) | approved | Mar 13, 2009 | openfda |
| US FDA | — | Efficacy supplement 2008-12-19 (see label) | approved |
Data updated 16 hours agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 4 | 9 | 4 | 68 | 172 | 14 | EU, US | Mar 20, 2001 | 1998-08 |
| Malignant Prostate Neoplasm | Phase4 | Phase 4 | 1 | 0 | 12 | 35 | 0 | — | — | 1999-09 |
| Non-Hodgkin Lymphoma | Phase4 | Phase 4 | 1 | 1 | 5 | 21 | 0 | — | — | 1998-12 |
| Malignant Breast Neoplasm | Phase4 | Phase 4 | 0 | 0 | 24 | 46 | 0 | — |
Curated evidence
Clinical evidence (1)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
civicProvenance
- Source
- CIViC — Clinical Interpretation of Variants in Cancer
- Dataset
- CIViC evidence items
- Version
- civic-2026-09-08
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- expert curation
- License
- CC0 1.0
- PMID
- 20504363
- Run
- ING-CIVIC-20260908-000001
| Therapy | Cancer | Type | Level | Direction · significance | Rating (1–5) | Status | Evidence | Source |
|---|---|---|---|---|---|---|---|---|
| ERBB2 Overexpression1 | ||||||||
| Capecitabine + | ||||||||
Clinical trials
Trials with this intervention (178)
Most recently updated first, 50 per page.
clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT00375427 | Safety and Efficacy of Zoledronic Acid in Patients With Breast Cancer With Metastatic Bone Lesions | completed | Phase 3 | 430 | Novartis PharmaceuticalsINDUSTRY | 1 | Apr 11, 2012 | clinicaltrials |
| NCT00697619 | To Evaluate the Efficacy of ZOMETA® in Treatment of Bone Metastases in Patients With Stage IV Nasopharyngeal Cancer | completed |