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Drug ReportsIbandronate
Ibandronic acid
Bondronat, Bonviva, Iasibon, Ibandronate, Ibandronic Acid (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 bone fractures, breast diseases, breast neoplasms, calcium metabolism disorders, and hypercalcemia amongst others.
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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
Ibandronate (discontinued: Boniva, Ibandronate)
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 Application2010-12-02
ibandronate sodiumANDA2024-09-25
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
postmenopausal osteoporosisEFO_0003854D015663—
Agency Specific
FDA
EMA
No data
Patent Expiration
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
— M05BA06: Ibandronic acid
— M05BB: Bisphosphonates, combinations affecting bone structure and mineralization
— M05BB09: Ibandronic acid and colecalciferol
HCPCS
No data
Clinical
Clinical Trials
85 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
OsteoporosisD010024HP_0000939M81.0—411241351
Postmenopausal osteoporosisD015663EFO_0003854——2616529
Neoplasm metastasisD009362EFO_0009708——353—11
Bone neoplasmsD001859EFO_0003820D16—242—8
Bone diseasesD001847—M89.9——4116
Metabolic bone diseasesD001851HP_0000938———14—5
Liver cirrhosisD008103EFO_0001422K74.0———112
FibrosisD005355—————112
Rheumatoid arthritisD001172EFO_0000685M06.9———1—1
ArthritisD001168HP_0001369M05-M14———1—1
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C50—35—311
NeoplasmsD009369—C80—16——7
PainD010146EFO_0003843R52—14——5
OsteonecrosisD010020EFO_0004259M87——2—13
Osteoporotic fracturesD058866————1—12
HypercalcemiaD006934HP_0003072E83.52——2——2
EdemaD004487HP_0000969R60.9——1——1
Multiple myelomaD009101—C90.0——1——1
Plasma cell neoplasmsD054219————1——1
NecrosisD009336————1——1
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Second primary neoplasmsD016609———1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———3———14
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Bone fracturesD050723EFO_0003931T14.8————22
Femoral fracturesD005264—S72————22
Bisphosphonate-associated osteonecrosis of the jawD059266——————11
Esophageal neoplasmsD004938—C15————11
AdenocarcinomaD000230——————11
Squamous cell carcinomaD002294——————11
Squamous cell neoplasmsD018307——————11
Type 2 diabetes mellitusD003924EFO_0001360E11————11
MortalityD009026EFO_0004352—————11
Drug therapyD004358——————11
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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)Loading
Structure (InChI/SMILES or Protein Sequence)
CCCCCN(C)CCC(O)(P(=O)(O)O)P(=O)(O)O
Identifiers
PDB—
CAS-ID114084-78-5
RxCUI115264
ChEMBL IDCHEMBL997
ChEBI ID—
PubChem CID60852
DrugBankDB00710
UNII IDUMD7G2653W (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Ibandronic acid
+
Ibandronate
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,185 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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27,295 adverse events reported
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