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
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Reclast, Zometa (generic drugs available since 2013-03-04)
Drug Products
FDA
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
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Indications
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Agency Specific
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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
382 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Osteoporosis | D010024 | HP_0000939 | M81.0 | 1 | 12 | 26 | 20 | 18 | 76 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 7 | 20 | 30 | 9 | 10 | 71 |
| Prostatic neoplasms | D011471 | — | C61 | 4 | 12 | 14 | 13 | 5 | 46 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | 9 | 6 | 7 | 3 | 26 |
| Neoplasms | D009369 | — | C80 | 3 | 6 | 9 | 1 | 5 | 22 |
| Postmenopausal osteoporosis | D015663 | EFO_0003854 | — | — | 1 | 2 | 12 | 5 | 20 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 1 | 3 | 3 | 7 | 1 | 15 |
| Pain | D010146 | EFO_0003843 | R52 | 2 | 2 | 7 | 1 | 3 | 13 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 5 | 2 | 4 | 1 | 12 |
| Metabolic bone diseases | D001851 | HP_0000938 | — | — | 3 | 4 | 1 | 2 | 10 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 1 | 2 | 3 | — | 1 | 7 |
| Hypercalcemia | D006934 | HP_0003072 | E83.52 | 1 | 1 | 3 | — | 2 | 6 |
| Plasma cell neoplasms | D054219 | — | — | 2 | 1 | 2 | — | 1 | 5 |
| Giant cell tumor of bone | D018212 | — | — | 1 | 3 | 1 | — | — | 4 |
| Osteosarcoma | D012516 | — | — | 2 | 1 | 1 | — | — | 3 |
| Sarcoma | D012509 | — | — | 1 | — | 1 | — | — | 2 |
| Beta-thalassemia | D017086 | Orphanet_848 | D56.1 | — | 1 | 2 | — | — | 2 |
| Lymphoma | D008223 | — | C85.9 | — | 1 | 1 | — | — | 2 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 1 | — | 1 | — | — | 2 |
| Ewing sarcoma | D012512 | EFO_0000173 | — | 1 | — | 1 | — | — | 2 |
Show 17 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Osteonecrosis | D010020 | EFO_0004259 | M87 | — | 3 | — | — | 2 | 5 |
| Progeria | D011371 | EFO_0000671 | E34.8 | — | 3 | — | — | — | 3 |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | 1 | 3 | — | — | — | 3 |
| Drug therapy | D004358 | — | — | — | 1 | — | — | 1 | 2 |
| Myelodysplastic syndromes | D009190 | — | D46 | 1 | 1 | — | — | — | 2 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | 2 | — | — | — | 2 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 1 | 1 | — | — | — | 2 |
| Uterine cervical neoplasms | D002583 | HP_0030159 | — | 1 | 1 | — | — | — | 2 |
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | — | 1 | — | — | — | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | 1 | — | — | — | 1 |
Show 22 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neuroblastoma | D009447 | EFO_0000621 | — | 5 | — | — | — | — | 5 |
| Adenocarcinoma | D000230 | — | — | 2 | — | — | — | — | 2 |
| Hematopoietic stem cell transplantation | D018380 | — | — | 1 | — | — | — | 1 | 2 |
| Secondary hyperparathyroidism | D006962 | EFO_1001173 | — | 1 | — | — | — | — | 1 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 1 | — | — | — | — | 1 |
| Hodgkin disease | D006689 | — | C81 | 1 | — | — | — | — | 1 |
| Rhabdomyosarcoma | D012208 | — | — | 1 | — | — | — | — | 1 |
| Primitive neuroectodermal tumors | D018242 | — | — | 1 | — | — | — | — | 1 |
| Chondrosarcoma | D002813 | — | — | 1 | — | — | — | — | 1 |
| Precancerous conditions | D011230 | — | — | 1 | — | — | — | — | 1 |
Show 2 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bisphosphonate-associated osteonecrosis of the jaw | D059266 | — | — | — | — | — | — | 2 | 2 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | — | 2 | 2 |
| Musculoskeletal pain | D059352 | — | — | — | — | — | — | 2 | 2 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 1 | 1 |
| Femoral fractures | D005264 | — | S72 | — | — | — | — | 1 | 1 |
| Healthy volunteers/patients | — | — | — | — | — | — | — | 1 | 1 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | — | — | — | 1 | 1 |
| Ductal carcinoma breast | D018270 | — | — | — | — | — | — | 1 | 1 |
| Mortality | D009026 | EFO_0004352 | — | — | — | — | — | 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) |
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Zoledronic acid
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Safety
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80,595 adverse events reported
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