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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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Alendronate, Binosto, Fosamax (discontinued: Alendronate, Fosamax)
CombinationsFosamax 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 |
|---|---|---|---|---|
| FOSAMAX | Organon | N-020560 RX | 2000-10-20 | 1 products, RLD, RS |
| BINOSTO | Radius Health | N-202344 RX | 2012-03-12 | 1 products, RLD, RS |
Show 2 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| alendronate | ANDA | 2024-09-13 |
| alendronate sodium | ANDA | 2024-08-01 |
| binosto | New Drug Application | 2023-12-20 |
| fosamax | New Drug Application | 2024-04-16 |
| fosamax plus d | New Drug Application | 2024-04-17 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Alendronate Sodium, Binosto, Radius | |||
| 9592195 | 2031-12-05 | DP | |
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
203 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 | 7 | 25 | 46 | 37 | 30 | 141 |
| Postmenopausal osteoporosis | D015663 | EFO_0003854 | — | — | 4 | 10 | 13 | 10 | 37 |
| Metabolic bone diseases | D001851 | HP_0000938 | — | 3 | 10 | 7 | 7 | 5 | 29 |
| Periodontitis | D010518 | EFO_0000649 | K05.3 | — | 6 | 5 | 1 | — | 7 |
| Healthy volunteers/patients | — | — | — | 4 | — | — | 1 | 1 | 6 |
| Calcinosis | D002114 | — | — | 1 | 1 | — | 3 | — | 5 |
| Osteonecrosis | D010020 | EFO_0004259 | M87 | 1 | 1 | — | 1 | 2 | 5 |
| Bone resorption | D001862 | — | — | — | 2 | 1 | 2 | — | 4 |
| Fibrosis | D005355 | — | — | — | — | 1 | 2 | 1 | 4 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | — | 1 | 2 | 1 | 4 |
Show 29 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic periodontitis | D055113 | EFO_0006343 | K05.3 | — | 6 | 5 | — | — | 6 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | — | 2 | — | — | 4 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 2 | 1 | — | — | 3 |
| Prostatic neoplasms | D011471 | — | C61 | — | 1 | 2 | — | — | 3 |
| Anorexia | D000855 | HP_0002039 | R63.0 | — | — | 2 | — | — | 2 |
| Feeding and eating disorders | D001068 | — | F50 | — | — | 2 | — | — | 2 |
| Anorexia nervosa | D000856 | EFO_0004215 | F50.0 | — | — | 2 | — | — | 2 |
| Bone density | D015519 | EFO_0003923 | M85 | — | — | 1 | — | 1 | 2 |
| Heart transplantation | D016027 | EFO_0010673 | — | — | 1 | 2 | — | — | 2 |
| Furcation defects | D017823 | — | — | — | 2 | 2 | — | — | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Spinal cord injuries | D013119 | EFO_1001919 | — | — | 2 | — | — | 1 | 3 |
| Wounds and injuries | D014947 | — | T14.8 | — | 1 | — | — | 1 | 2 |
| Adenocarcinoma | D000230 | — | — | — | 1 | — | — | 1 | 2 |
| Aortic valve stenosis | D001024 | HP_0001650 | — | — | 1 | — | — | — | 1 |
| Pathologic constriction | D003251 | — | — | — | 1 | — | — | — | 1 |
| Paralysis | D010243 | HP_0003470 | — | — | 1 | — | — | — | 1 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | 1 | — | — | — | 1 |
| Hiv | D006678 | — | — | — | 1 | — | — | — | 1 |
| Coronary stenosis | D023921 | EFO_1000882 | — | — | 1 | — | — | — | 1 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | 1 | — | — | — | 1 |
Show 7 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatitis b | D006509 | — | — | 1 | — | — | — | — | 1 |
| Hepatitis | D006505 | HP_0012115 | K75.9 | 1 | — | — | — | — | 1 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bone fractures | D050723 | EFO_0003931 | T14.8 | — | — | — | — | 4 | 4 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | — | — | — | 2 | 2 |
| Femoral fractures | D005264 | — | S72 | — | — | — | — | 2 | 2 |
| Chronic kidney disease-mineral and bone disorder | D012080 | EFO_1001152 | N25.0 | — | — | — | — | 1 | 1 |
| Female genital neoplasms | D005833 | — | — | — | — | — | — | 1 | 1 |
| Thyroid neoplasms | D013964 | EFO_0003841 | — | — | — | — | — | 1 | 1 |
| Thyroid diseases | D013959 | HP_0000820 | E00-E07 | — | — | — | — | 1 | 1 |
| Bisphosphonate-associated osteonecrosis of the jaw | D059266 | — | — | — | — | — | — | 1 | 1 |
| Ankylosing spondylitis | D013167 | EFO_0003898 | M45 | — | — | — | — | 1 | 1 |
| Spondylarthritis | D025241 | — | — | — | — | — | — | 1 | 1 |
Show 9 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Alendronic acid |
| INN | alendronic 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 class | calcium metabolism regulators |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | NCCCC(O)(P(=O)(O)O)P(=O)(O)O |
Identifiers
| PDB | — |
| CAS-ID | 66376-36-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL870 |
| ChEBI ID | 2567 |
| PubChem CID | 2088 |
| DrugBank | DB00630 |
| UNII ID | X1J18R4W8P (ChemIDplus, GSRS) |
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
No data
Financial
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Fosamax – Organon
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Fosamax – Merck & Co
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Estimated US medical usage
Alendronic acid
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Alendronate
Total medical expenditures per year (USD, in millions)
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Alendronic acid
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Alendronate
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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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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 17,029 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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71,800 adverse events reported
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