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Boniva, Bondronat(ibandronic acid)
Bondronat, Boniva, Bonviva (ibandronic acid) is a small molecule pharmaceutical. Ibandronic acid was first approved as Bondronat on 1996-06-25. It is used to treat postmenopausal osteoporosis in the USA. It has been approved in Europe to treat acer, bone fractures, breast diseases, breast neoplasms, and calcium metabolism disorders amongst others. It is known to target farnesyl pyrophosphate synthase.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
musculoskeletal diseasesD009140
skin and connective tissue diseasesD017437
nutritional and metabolic diseasesD009750
signs and symptoms pathological conditionsD013568
wounds and injuriesD014947
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ibandronate sodium
Tradename
Company
Number
Date
Products
BONIVARocheN-021455 DISCN2003-05-16
2 products, RLD
BONIVARocheN-021858 DISCN2006-01-06
1 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
bonivaNew Drug Application2021-11-16
ibandronate sodiumANDA2023-05-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
postmenopausal osteoporosisEFO_0003854D015663—
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Ibandronate Sodium, Boniva, Hoffmann La Roche
71929382023-05-06U-798
74109572023-05-06U-887
77186342023-05-06U-642
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
— M05BA06: Ibandronic acid
— M05BB: Bisphosphonates, combinations affecting bone structure and mineralization
— M05BB09: Ibandronic acid and colecalciferol
HCPCS
No data
Clinical
Clinical Trials
72 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Postmenopausal osteoporosisD015663EFO_0003854—2616327
OsteoporosisD010024EFO_0003882M81.0—236313
Bone neoplasmsD001859EFO_0003820D16—242—8
Metabolic bone diseasesD001851HP_0000938——12—3
Liver cirrhosisD008103EFO_0001422K74.0———1—1
Rheumatoid arthritisD001172EFO_0000685M06.9———1—1
Systemic lupus erythematosusD008180EFO_0002690M32———1—1
Hiv infectionsD015658EFO_0000764B20———1—1
Lung neoplasmsD008175C34.90———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C50—24—17
PainD010146EFO_0003843R52—14——5
Neoplasm metastasisD009362EFO_0009708—12——3
NeoplasmsD009369C80——3——3
HypercalcemiaD006934E83.52——2——2
OsteonecrosisD010020EFO_0004259M87——1——1
Multiple myelomaD009101C90.0——1——1
Hematologic neoplasmsD019337——1——1
Prostatic neoplasmsD011471C61——1——1
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—2————2
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Esophageal neoplasmsD004938C15————11
AdenocarcinomaD000230————11
Squamous cell neoplasmsD018307————11
Type 2 diabetes mellitusD003924EFO_0001360E11————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameIBANDRONIC ACID
INNibandronic acid
Description
Ibandronic acid is a bisphosphonate medication used in the prevention and treatment of osteoporosis and metastasis-associated skeletal fractures in people with cancer. It may also be used to treat hypercalcemia (elevated blood calcium levels). It is typically formulated as its sodium salt ibandronate sodium.
Classification
Small molecule
Drug classandrogens
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CCCCCN(C)CCC(O)(P(=O)(O)O)P(=O)(O)O
Identifiers
PDB2F94
CAS-ID114084-78-5
RxCUI115264
ChEMBL IDCHEMBL997
ChEBI ID—
PubChem CID60852
DrugBankDB00710
UNII IDUMD7G2653W (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
FDPS
FDPS
Organism
Homo sapiens
Gene name
FDPS
Gene synonyms
FPS, KIAA1293
NCBI Gene ID
2224
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
Q96G29
Mouse ortholog
Fdps (110196)
farnesyl pyrophosphate synthase (Q920E5)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,707 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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387 adverse events reported
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