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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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| alendronate | ANDA | 2024-11-22 |
| alendronate sodium | ANDA | 2025-02-19 |
| binosto | New Drug Application | 2025-02-24 |
| fosamax | New Drug Application | 2024-04-16 |
| fosamax plus d | New Drug Application | 2024-04-17 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
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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
206 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 | 7 | 25 | 46 | 38 | 30 | 142 |
| Postmenopausal osteoporosis | D015663 | EFO_0003854 | — | — | 4 | 10 | 13 | 10 | 37 |
| Metabolic bone diseases | D001851 | — | — | 3 | 10 | 7 | 7 | 5 | 29 |
| Periodontitis | D010518 | EFO_0000649 | K05.3 | — | 6 | 5 | 2 | — | 8 |
| Chronic periodontitis | D055113 | EFO_0006343 | K05.3 | — | 6 | 5 | 1 | — | 7 |
| Healthy volunteers/patients | — | — | — | 5 | — | — | 1 | 1 | 7 |
| 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 |
Show 31 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| 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 | — | 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 |
| Hypogonadism | D007006 | — | E23.0 | — | 1 | 1 | — | — | 2 |
Show 13 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 |
| Wounds and injuries | D014947 | — | T14.8 | — | 1 | — | — | 1 | 2 |
| Adenocarcinoma | D000230 | — | — | — | 1 | — | — | 1 | 2 |
| Aortic valve stenosis | D001024 | EFO_0000266 | — | — | 1 | — | — | — | 1 |
| Pathologic constriction | D003251 | — | — | — | 1 | — | — | — | 1 |
| Paralysis | D010243 | — | — | — | 1 | — | — | — | 1 |
| Diabetes mellitus | D003920 | EFO_0000400 | 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 |
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 | — | 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 | — | 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 | — | 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
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Variants
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Fosamax – Organon
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Fosamax – Merck & Co
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Trends
PubMed Central
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Safety
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Adverse Events
Top Adverse Reactions
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76,033 adverse events reported
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