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 | 2022-07-07 |
| zoledronic | ANDA | 2015-01-10 |
| zoledronic acid | ANDA | 2024-10-03 |
Indications
FDA
EMA
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
387 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 | 14 | 31 | 34 | 24 | 103 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 8 | 24 | 32 | 11 | 12 | 81 |
| Prostatic neoplasms | D011471 | — | C61 | 5 | 14 | 17 | 15 | 6 | 55 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 7 | 9 | 21 | 17 | 3 | 53 |
| Multiple myeloma | D009101 | — | C90.0 | 4 | 11 | 10 | 8 | 3 | 35 |
| Plasma cell neoplasms | D054219 | — | — | 4 | 10 | 8 | 7 | 3 | 31 |
| Bone neoplasms | D001859 | EFO_0003820 | D16 | 4 | 8 | 10 | 8 | 1 | 28 |
| Neoplasms | D009369 | — | C80 | 4 | 8 | 11 | 1 | 5 | 26 |
| Postmenopausal osteoporosis | D015663 | EFO_0003854 | — | — | 2 | 2 | 12 | 6 | 22 |
| Metabolic bone diseases | D001851 | HP_0000938 | — | — | 5 | 6 | 6 | 4 | 21 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Adenocarcinoma | D000230 | — | — | 3 | 2 | 1 | — | — | 6 |
| Plasmacytoma | D010954 | — | C90.3 | 2 | 1 | 3 | — | 1 | 6 |
| Hypercalcemia | D006934 | HP_0003072 | E83.52 | 1 | 1 | 3 | — | 2 | 6 |
| Syndrome | D013577 | — | — | 1 | 3 | 1 | — | — | 5 |
| Sarcoma | D012509 | — | — | 2 | 1 | 2 | — | — | 4 |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | 1 | 3 | 1 | — | — | 4 |
| Triple negative breast neoplasms | D064726 | — | — | — | 2 | 1 | — | 1 | 4 |
| Bone resorption | D001862 | — | — | 1 | 2 | 2 | — | 1 | 4 |
| Giant cell tumor of bone | D018212 | — | — | 1 | 3 | 1 | — | — | 4 |
| Giant cell tumors | D005870 | — | — | 1 | 3 | 1 | — | — | 4 |
Show 33 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 | — | — | 6 | 9 |
| Neuroblastoma | D009447 | EFO_0000621 | — | 6 | 1 | — | — | — | 6 |
| Leukemia | D007938 | — | C95 | 1 | 3 | — | — | — | 4 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | 2 | — | — | — | 3 |
| Progeria | D011371 | EFO_0000671 | E34.8 | — | 3 | — | — | — | 3 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | 1 | — | — | — | 2 |
| Drug therapy | D004358 | — | — | — | 1 | — | — | 1 | 2 |
| Myelodysplastic syndromes | D009190 | — | D46 | 1 | 1 | — | — | — | 2 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | — | 1 | 1 | — | — | — | 2 |
| Rhabdomyosarcoma | D012208 | — | — | 2 | 1 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hematopoietic stem cell transplantation | D018380 | — | — | 1 | — | — | — | 1 | 2 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 2 | — | — | — | — | 2 |
| Secondary hyperparathyroidism | D006962 | EFO_1001173 | — | 1 | — | — | — | — | 1 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 1 | — | — | — | — | 1 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 1 | — | — | — | — | 1 |
| Hodgkin disease | D006689 | — | C81 | 1 | — | — | — | — | 1 |
| Primitive neuroectodermal tumors | D018242 | — | — | 1 | — | — | — | — | 1 |
| Neuroectodermal tumors | D017599 | — | — | 1 | — | — | — | — | 1 |
| Chondrosarcoma | D002813 | — | — | 1 | — | — | — | — | 1 |
| Precancerous conditions | D011230 | — | — | 1 | — | — | — | — | 1 |
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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 | — | — | — | — | — | — | 3 | 3 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | — | 2 | 2 |
| Musculoskeletal pain | D059352 | — | — | — | — | — | — | 2 | 2 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 1 | 1 |
| Communicable diseases | D003141 | — | — | — | — | — | — | 1 | 1 |
| Osteomyelitis | D010019 | EFO_0003102 | M86 | — | — | — | — | 1 | 1 |
| Healthy volunteers/patients | — | — | — | — | — | — | — | 1 | 1 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | — | — | — | 1 | 1 |
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | — | — | — | — | 1 | 1 |
| Ductal carcinoma breast | D018270 | — | — | — | — | — | — | 1 | 1 |
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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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88,082 adverse events reported
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