Risedronic acid
Actonel, Atelvia, Risedronate (risedronic acid) is a small molecule pharmaceutical. Risedronic acid was first approved as Actonel on 1998-03-27. The pharmaceutical is active against farnesyl pyrophosphate synthase.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Actonel, Atelvia, Risedronate (discontinued: Actonel, Risedronate)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Risedronate sodium
Calcium carbonate
+
Risedronate sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ACTONEL WITH CALCIUM (COPACKAGED) | Warner Chilcott | N-021823 DISCN | 2005-08-12 | 1 products, RLD |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| actonel | New Drug Application | 2023-10-01 |
| atelvia | New Drug Application | 2023-10-20 |
| risedronate sodium | ANDA | 2024-11-22 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| postmenopausal osteoporosis | EFO_0003854 | D015663 | — |
| extramammary paget disease | — | D010145 | — |
Agency Specific
FDA
EMA
No data
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
— M05BA07: Risedronic acid
— M05BB: Bisphosphonates, combinations affecting bone structure and mineralization
— M05BB02: Risedronic acid and calcium, sequential
— M05BB04: Risedronic acid, calcium and colecalciferol, sequential
— M05BB07: Risedronic acid and colecalciferol
HCPCS
No data
Clinical
Clinical Trials
110 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 | 4 | 4 | 27 | 22 | 16 | 72 |
| Postmenopausal osteoporosis | D015663 | EFO_0003854 | — | — | 3 | 9 | 11 | 4 | 27 |
| Metabolic bone diseases | D001851 | — | — | 2 | 1 | 5 | 2 | 2 | 12 |
| Bone fractures | D050723 | EFO_0003931 | T14.8 | — | — | 1 | 3 | 5 | 9 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | 4 | 2 | 1 | 7 |
| Prostatic neoplasms | D011471 | — | C61 | — | — | 3 | 1 | — | 4 |
| Spinal fractures | D016103 | EFO_0003902 | S12 | — | — | 1 | 2 | 1 | 4 |
| Hip fractures | D006620 | EFO_0003964 | S72.00 | — | — | 1 | 1 | 1 | 3 |
| Osteogenesis imperfecta | D010013 | — | Q78.0 | — | 1 | 1 | 1 | — | 3 |
| Osteoporotic fractures | D058866 | — | — | — | — | — | 1 | 2 | 3 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Osteitis deformans | D010001 | EFO_0004261 | M88 | — | — | 2 | — | 1 | 3 |
| Bone diseases | D001847 | — | M89.9 | — | — | 2 | — | — | 2 |
| Back pain | D001416 | — | M54 | — | — | 1 | — | 1 | 2 |
| Anorexia | D000855 | — | R63.0 | — | 1 | 1 | — | 1 | 2 |
| Anorexia nervosa | D000856 | EFO_0004215 | F50.0 | — | 1 | 1 | — | 1 | 2 |
| Spinal cord injuries | D013119 | EFO_1001919 | — | — | — | 2 | — | — | 2 |
| Myositis | D009220 | EFO_0000783 | G72.49 | — | — | 1 | — | — | 1 |
| Muscular diseases | D009135 | EFO_0002970 | G72.9 | — | — | 1 | — | — | 1 |
| Menopause | D008593 | EFO_0003922 | N95 | — | — | 1 | — | — | 1 |
| Carcinoma in situ | D002278 | — | D09.9 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postmenopause | D017698 | — | — | 1 | 2 | — | — | — | 3 |
| Lung neoplasms | D008175 | — | C34.90 | — | 1 | — | — | — | 1 |
| Ankylosing spondylitis | D013167 | EFO_0003898 | M45 | — | 1 | — | — | — | 1 |
| Spondylarthritis | D025241 | — | — | — | 1 | — | — | — | 1 |
| Spondylitis | D013166 | — | M46.9 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | 1 | 2 |
| Biological availability | D001682 | — | — | 1 | — | — | — | — | 1 |
| Infertility | D007246 | EFO_0000545 | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Femoral fractures | D005264 | — | S72 | — | — | — | — | 2 | 2 |
| Osteonecrosis | D010020 | EFO_0004259 | M87 | — | — | — | — | 1 | 1 |
| Bisphosphonate-associated osteonecrosis of the jaw | D059266 | — | — | — | — | — | — | 1 | 1 |
| Esophageal neoplasms | D004938 | — | C15 | — | — | — | — | 1 | 1 |
| Adenocarcinoma | D000230 | — | — | — | — | — | — | 1 | 1 |
| Squamous cell carcinoma | D002294 | — | — | — | — | — | — | 1 | 1 |
| Squamous cell neoplasms | D018307 | — | — | — | — | — | — | 1 | 1 |
| Bone density | D015519 | EFO_0003923 | M85 | — | — | — | — | 1 | 1 |
| Suicidal ideation | D059020 | EFO_0004320 | R45.851 | — | — | — | — | 1 | 1 |
| Interoception | D065812 | — | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Risedronic acid |
| INN | risedronic acid |
| Description | Risedronic acid is a member of pyridines. |
| Classification | Small molecule |
| Drug class | calcium metabolism regulators |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=P(O)(O)C(O)(Cc1cccnc1)P(=O)(O)O |
Identifiers
| PDB | — |
| CAS-ID | 105462-24-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL923 |
| ChEBI ID | 8869 |
| PubChem CID | 5245 |
| DrugBank | DB00884 |
| UNII ID | KM2Z91756Z (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
Revenue by drug
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Estimated US medical usage
Risedronic acid
+
Calcium carbonate
+
Risedronate
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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Price per prescription (USD)
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Risedronic acid
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Risedronate
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
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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13,188 adverse events reported
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