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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Novartis Pharmaceuticals
Commercial
Trade Name
FDA
EMA
Reclast, Zometa (generic drugs available since 2013-03-04)
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 | 2020-04-29 |
| zoledronic acid | ANDA | 2023-06-12 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| bone neoplasms | EFO_0003820 | D001859 | D16 |
| extramammary paget disease | — | D010145 | — |
| hypercalcemia | HP_0003072 | D006934 | E83.52 |
| multiple myeloma | — | D009101 | C90.0 |
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
329 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 | EFO_0003882 | M81.0 | 1 | 12 | 25 | 14 | 10 | 61 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 5 | 16 | 29 | 7 | 8 | 60 |
| Prostatic neoplasms | D011471 | C61 | 3 | 12 | 14 | 13 | 4 | 44 | |
| Multiple myeloma | D009101 | C90.0 | 1 | 7 | 5 | 7 | 2 | 22 | |
| Postmenopausal osteoporosis | D015663 | EFO_0003854 | — | 1 | 2 | 10 | 4 | 17 | |
| Neoplasms | D009369 | C80 | 2 | 4 | 9 | 1 | 3 | 17 | |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 2 | 3 | 7 | 1 | 13 | |
| Pain | D010146 | EFO_0003843 | R52 | 2 | 2 | 7 | 1 | 3 | 13 |
| Non-small-cell lung carcinoma | D002289 | — | 5 | 2 | 3 | 1 | 11 | ||
| Metabolic bone diseases | D001851 | HP_0000938 | — | 3 | 4 | 1 | 2 | 10 |
Show 26 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypercalcemia | D006934 | E83.52 | 1 | 1 | 3 | — | 2 | 6 | |
| Lung neoplasms | D008175 | C34.90 | 1 | 1 | 3 | — | — | 5 | |
| Plasma cell neoplasms | D054219 | 2 | 1 | 2 | — | — | 4 | ||
| Giant cell tumor of bone | D018212 | 1 | 2 | 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 | |
| Osteosarcoma | D012516 | 1 | 1 | 1 | — | — | 2 | ||
| Ewing sarcoma | D012512 | EFO_0000173 | 1 | — | 1 | — | — | 2 |
Show 14 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 | — | — | 1 | 4 |
| Progeria | D011371 | E34.8 | — | 3 | — | — | — | 3 | |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | 1 | 3 | — | — | — | 3 |
| Castration-resistant prostatic neoplasms | D064129 | — | 2 | — | — | — | 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 | 1 | 1 | — | — | — | 2 | ||
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | — | 1 | — | — | — | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | 1 | — | — | — | 1 |
Show 20 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neuroblastoma | D009447 | EFO_0000621 | 4 | — | — | — | — | 4 | |
| Adenocarcinoma | D000230 | 2 | — | — | — | — | 2 | ||
| Hematopoietic stem cell transplantation | D018380 | 1 | — | — | — | 1 | 2 | ||
| 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 | ||
| Anterior cruciate ligament injuries | D000070598 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Musculoskeletal pain | D059352 | — | — | — | — | 2 | 2 | ||
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | — | — | — | 1 | 1 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | — | 1 | 1 |
| Ductal carcinoma breast | D018270 | — | — | — | — | 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 |
Target
Agency Approved
FDPS
FDPS
Organism
Homo sapiens
Gene name
FDPS
Gene synonyms
FPS, KIAA1293
NCBI Gene ID
Protein name
farnesyl pyrophosphate synthase
Protein synonyms
(2E,6E)-farnesyl diphosphate synthase, Dimethylallyltranstransferase, Farnesyl diphosphate synthase, farnesyl pyrophosphate synthetase, dimethylallyltranstransferase, geranyltranstransferase, FPP synthase, FPP synthetase, Geranyltranstransferase
Uniprot ID
Mouse ortholog
Fdps (110196)
farnesyl pyrophosphate synthase (Q920E5)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 14,470 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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20,286 adverse events reported
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