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Drug ReportsAlendronic acid
Fosamax, Adrovance(alendronic acid)
Adrovance, Alendronate, Alendronic Acid / Colecalciferol, Binosto, Fosamax, Fosavance, Vantavo (alendronic acid) is a small molecule pharmaceutical. Alendronic acid was first approved as Fosamax on 1995-09-29. It is used to treat extramammary paget disease and postmenopausal osteoporosis in the USA. It has been approved in Europe to treat postmenopausal osteoporosis. The pharmaceutical is active against farnesyl pyrophosphate synthase.
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5D
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3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
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Study first post date
Last update post date
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Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
musculoskeletal diseasesD009140
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Alendronate, Binosto, Fosamax (discontinued: Alendronate, Fosamax)
Combinations
Fosamax d
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Alendronate sodium
Tradename
Company
Number
Date
Products
FOSAMAXOrganonN-020560 RX2000-10-20
1 products, RLD, RS
BINOSTORadius HealthN-202344 RX2012-03-12
1 products, RLD, RS
Show 2 discontinued
Alendronate sodium
+
Cholecalciferol
Tradename
Company
Number
Date
Products
FOSAMAX PLUS DOrganonN-021762 RX2005-04-07
2 products, RLD
Labels
FDA
EMA
Brand Name
Status
Last Update
alendronateANDA2025-09-10
alendronate sodiumANDA2025-11-11
binostoNew Drug Application2025-02-24
fosamaxNew Drug Application2024-04-16
fosamax plus dNew Drug Application2025-11-24
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
postmenopausal osteoporosisEFO_0003854D015663—
extramammary paget disease—D010145—
chronic kidney failureEFO_0003884D007676N18.6
cardiovascular diseasesEFO_0000319D002318I98
psoriasisEFO_0000676D011565L40
lung neoplasms—D008175C34.90
crohn diseaseEFO_0000384D003424K50
skin neoplasmsEFO_0004198D012878C44
familial hypophosphatemic rickets—D053098—
osteoporosisEFO_0003882D010024M81.0
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Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Alendronate Sodium, Binosto, Radius
95921952031-12-05DP
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
— M05BA04: Alendronic acid
— M05BB: Bisphosphonates, combinations affecting bone structure and mineralization
— M05BB03: Alendronic acid and colecalciferol
— M05BB05: Alendronic acid, calcium and colecalciferol, sequential
— M05BB06: Alendronic acid and alfacalcidol, sequential
HCPCS
No data
Clinical
Clinical Trials
211 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
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———1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAlendronic acid
INNalendronic acid
Description
Alendronic acid is a 1,1-bis(phosphonic acid) that is methanebis(phosphonic acid) in which the two methylene hydrogens are replaced by hydroxy and 3-aminopropyl groups. It has a role as an EC 2.5.1.1 (dimethylallyltranstransferase) inhibitor and a bone density conservation agent. It is a 1,1-bis(phosphonic acid) and a primary amino compound. It is a conjugate acid of an alendronate(1-).
Classification
Small molecule
Drug classcalcium metabolism regulators
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
NCCCC(O)(P(=O)(O)O)P(=O)(O)O
Identifiers
PDB—
CAS-ID66376-36-1
RxCUI—
ChEMBL IDCHEMBL870
ChEBI ID2567
PubChem CID2088
DrugBankDB00630
UNII IDX1J18R4W8P (ChemIDplus, GSRS)
Target
Agency Approved
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)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Fosamax – Organon
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Fosamax – Merck & Co
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Estimated US medical usage
Alendronic acid
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Price per prescription (USD)
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Alendronic acid
+
Cholecalciferol
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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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 18,998 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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78,486 adverse events reported
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