Fosamax, Fosavance(alendronic acid)
Adrovance, 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
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
Alendronate sodium
+
Cholecalciferol
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| FOSAMAX PLUS D | Organon | N-021762 RX | 2005-04-07 | 2 products, RLD |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| alendronate sodium | ANDA | 2023-05-24 |
| binosto | New Drug Application | 2021-03-03 |
| fosamax plus d | New Drug Application | 2021-08-31 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| extramammary paget disease | — | D010145 | — |
| postmenopausal osteoporosis | EFO_0003854 | D015663 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ALENDRONATE SODIUM, ALENDRONATE SODIUM, NOVITIUM PHARMA | |||
| 2023-11-20 | CGT | ||
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
161 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 | EFO_0003882 | M81.0 | 5 | 19 | 31 | 20 | 10 | 81 |
| Postmenopausal osteoporosis | D015663 | EFO_0003854 | — | 4 | 8 | 8 | 6 | 26 | |
| Metabolic bone diseases | D001851 | HP_0000938 | 2 | 5 | 5 | 3 | 3 | 17 | |
| Healthy volunteers/patients | — | 4 | — | — | 1 | — | 5 | ||
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | 1 | 1 | 1 | — | 3 |
| Bone resorption | D001862 | — | 2 | 1 | 1 | — | 3 | ||
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | — | 1 | 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 12 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 | — | 5 | 4 | — | — | 5 |
| 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 | E23.0 | — | 1 | 1 | — | — | 2 | |
| Vitamin d deficiency | D014808 | EFO_0003762 | E55 | — | — | 2 | — | — | 2 |
Show 9 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 | |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | 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 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Osteonecrosis | D010020 | EFO_0004259 | M87 | 1 | — | — | — | — | 1 |
| Hepatitis b | D006509 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Thyroid neoplasms | D013964 | EFO_0003841 | — | — | — | — | 1 | 1 | |
| Ankylosing spondylitis | D013167 | EFO_0003898 | M45 | — | — | — | — | 1 | 1 |
| Esophageal neoplasms | D004938 | C15 | — | — | — | — | 1 | 1 | |
| Adenocarcinoma | D000230 | — | — | — | — | 1 | 1 | ||
| Squamous cell neoplasms | D018307 | — | — | — | — | 1 | 1 | ||
| Replacement arthroplasty hip | D019644 | — | — | — | — | 1 | 1 | ||
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | — | — | — | 1 | 1 |
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 | 236083 |
| 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
Clinical Variant
No data
Financial
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Fosamax - Merck Sharp & Dohme
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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780 adverse events reported
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