Fosamax, Fosavance(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
Binosto, Fosamax (generic drugs available since 2008-08-04)
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 | 2023-11-12 |
| alendronate sodium | ANDA | 2024-01-22 |
| binosto | New Drug Application | 2023-12-20 |
| fosamax | New Drug Application | 2023-11-24 |
| fosamax plus d | New Drug Application | 2023-11-24 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| extramammary paget disease | — | D010145 | — |
| postmenopausal osteoporosis | EFO_0003854 | D015663 | — |
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
202 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 | 22 | 34 | 23 | 18 | 100 |
| Postmenopausal osteoporosis | D015663 | EFO_0003854 | — | — | 4 | 10 | 13 | 9 | 36 |
| Metabolic bone diseases | D001851 | HP_0000938 | — | 3 | 6 | 5 | 4 | 3 | 20 |
| Healthy volunteers/patients | — | — | — | 4 | — | — | 1 | 1 | 6 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | — | 1 | 2 | 1 | 4 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | 1 | 1 | 1 | — | 3 |
| Bone resorption | D001862 | — | — | — | 2 | 1 | 1 | — | 3 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | — | 1 | 1 | 2 |
| Primary hyperparathyroidism | D049950 | EFO_0008519 | E21.0 | — | — | — | 1 | 1 | 2 |
| Osteogenesis imperfecta | D010013 | — | Q78.0 | — | — | — | 2 | — | 2 |
Show 14 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 |
| 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 |
| Hypogonadism | D007006 | HP_0000044 | E23.0 | — | 1 | 1 | — | — | 2 |
| Vitamin d deficiency | D014808 | EFO_0003762 | E55 | — | — | 2 | — | — | 2 |
Show 10 more
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 |
| Osteonecrosis | D010020 | EFO_0004259 | M87 | 1 | 1 | — | — | 1 | 3 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | 1 | — | — | — | 1 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | 1 | — | — | — | 1 |
| Hiv | D006678 | — | O98.7 | — | 1 | — | — | — | 1 |
| Coronary stenosis | D023921 | EFO_1000882 | — | — | 1 | — | — | — | 1 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | 1 | — | — | — | 1 |
| Gaucher disease | D005776 | Orphanet_355 | E75.22 | — | 1 | — | — | — | 1 |
| Polyostotic fibrous dysplasia | D005359 | Orphanet_562 | Q78.1 | — | 1 | — | — | — | 1 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatitis b | D006509 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female genital neoplasms | D005833 | — | — | — | — | — | — | 1 | 1 |
| Femoral fractures | D005264 | — | S72 | — | — | — | — | 1 | 1 |
| Thyroid neoplasms | D013964 | EFO_0003841 | — | — | — | — | — | 1 | 1 |
| Bisphosphonate-associated osteonecrosis of the jaw | D059266 | — | — | — | — | — | — | 1 | 1 |
| Ankylosing spondylitis | D013167 | EFO_0003898 | M45 | — | — | — | — | 1 | 1 |
| Esophageal neoplasms | D004938 | — | C15 | — | — | — | — | 1 | 1 |
| Adenocarcinoma | D000230 | — | — | — | — | — | — | 1 | 1 |
| Squamous cell carcinoma | D002294 | — | — | — | — | — | — | 1 | 1 |
| Squamous cell neoplasms | D018307 | — | — | — | — | — | — | 1 | 1 |
| Replacement arthroplasty hip | D019644 | — | — | — | — | — | — | 1 | 1 |
Show 3 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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Tabular view
Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 16,413 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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63,583 adverse events reported
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