Zometa(zoledronic acid)
Aclasta, Reclast, Zometa (zoledronic acid) is a small molecule pharmaceutical. Zoledronic acid was first approved as Zometa on 2001-03-20. It is used to treat bone neoplasms, extramammary paget disease, hypercalcemia, and multiple myeloma in the USA. It has been approved in Europe to treat bone fractures, hypercalcemia, neoplasms, osteitis deformans, and osteoporosis amongst others. The pharmaceutical is active against farnesyl pyrophosphate synthase.
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Commercial
Trade Name
FDA
EMA
Reclast, Zoledronic, Zoledronic acid (discontinued: Zoledronic acid, Zometa)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| reclast | New Drug Application | 2023-11-30 |
| zoledronic | ANDA | 2015-01-10 |
| zoledronic acid | ANDA | 2025-10-03 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| multiple myeloma | — | D009101 | C90.0 |
| bone neoplasms | EFO_0003820 | D001859 | D16 |
| hypercalcemia | HP_0003072 | D006934 | E83.52 |
| extramammary paget disease | — | D010145 | — |
Agency Specific
FDA
EMA
No data
ATC Codes
M: Musculo-skeletal system drugs
— M05: Drugs for treatment of bone diseases
— M05B: Drugs affecting bone structure and mineralization
— M05BA: Bisphosphonate drugs affecting bone structure and mineralization
— M05BA08: Zoledronic acid
— M05BB: Bisphosphonates, combinations affecting bone structure and mineralization
— M05BB08: Zoledronic acid, calcium and colecalciferol, sequential
HCPCS
Code | Description |
|---|---|
| J3489 | Injection, zoledronic acid, 1 mg |
Clinical
Clinical Trials
395 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 7 | 16 | 6 | 1 | 31 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | 3 | 9 | 13 | 3 | 29 |
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | — | 1 | 19 | 5 | 3 | 28 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 1 | 3 | 8 | 15 | 1 | 27 |
| Multiple myeloma | D009101 | — | C90.0 | 2 | 2 | 3 | 6 | 1 | 14 |
| Plasma cell neoplasms | D054219 | — | — | 2 | 2 | 1 | 5 | 1 | 11 |
| Lung neoplasms | D008175 | — | C34.90 | 1 | 2 | 3 | 3 | 1 | 10 |
| Bone neoplasms | D001859 | EFO_0003820 | D16 | 1 | 1 | 2 | 6 | — | 9 |
| Bone marrow diseases | D001855 | — | — | 1 | 1 | 2 | 5 | — | 8 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 2 | 2 | 3 | — | 7 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postmenopausal osteoporosis | D015663 | EFO_0003854 | — | — | — | 2 | — | 1 | 3 |
| Osteogenesis imperfecta | D010013 | — | Q78.0 | — | 2 | 1 | — | — | 3 |
| Bone resorption | D001862 | — | — | — | 1 | 2 | — | — | 2 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | — | 1 | — | — | 1 |
| Sclerosis | D012598 | — | — | — | — | 1 | — | — | 1 |
| Sarcoma | D012509 | — | — | — | — | 1 | — | — | 1 |
| Osteosarcoma | D012516 | — | — | — | — | 1 | — | — | 1 |
| Beta-thalassemia | D017086 | Orphanet_848 | D56.1 | — | 1 | 1 | — | — | 1 |
| Bone marrow transplantation | D016026 | — | — | — | 1 | 1 | — | — | 1 |
| Shock | D012769 | — | R57.1 | — | — | 1 | — | — | 1 |
Show 9 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Osteonecrosis | D010020 | EFO_0004259 | M87 | — | 2 | — | — | 1 | 3 |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | — | 2 | — | — | — | 2 |
| Carcinoma | D002277 | — | C80.0 | — | 2 | — | — | — | 2 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | — | 1 | — | — | — | 1 |
| Adenocarcinoma | D000230 | — | — | — | 1 | — | — | — | 1 |
| Leukemia | D007938 | — | C95 | — | 1 | — | — | — | 1 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | — | 1 | — | — | — | 1 |
| Myeloid leukemia | D007951 | — | C92 | — | 1 | — | — | — | 1 |
| Complex regional pain syndromes | D020918 | EFO_1001998 | — | — | 1 | — | — | — | 1 |
| Reflex sympathetic dystrophy | D012019 | EFO_1001147 | G90.5 | — | 1 | — | — | — | 1 |
Show 18 more
Indications Phases 1
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Plasmacytoma | D010954 | — | C90.3 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Zoledronic acid |
| INN | zoledronic acid |
| Description | Zoledronic acid is an imidazole compound having a 2,2-bis(phosphono)-2-hydroxyethane-1-yl substituent at the 1-position. It has a role as a bone density conservation agent. It is a member of imidazoles and a 1,1-bis(phosphonic acid). |
| Classification | Small molecule |
| Drug class | calcium metabolism regulators |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O |
Identifiers
| PDB | — |
| CAS-ID | 118072-93-8 |
| RxCUI | 1546014 |
| ChEMBL ID | CHEMBL924 |
| ChEBI ID | 46557 |
| PubChem CID | 68740 |
| DrugBank | DB00399 |
| UNII ID | 70HZ18PH24 (ChemIDplus, GSRS) |
Target
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Estimated US medical usage
Zoledronic acid
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Trends
PubMed Central
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Additional graphs summarizing 21,988 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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91,893 adverse events reported
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