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 | 2025-04-02 |
Indications
FDA
EMA
No data
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 |
Show 13 more
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 |
Show 6 more
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
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Variants
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Financial
Revenue by drug
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Estimated US medical usage
Risedronic acid
+
Calcium carbonate
Total medical expenditures per year (USD, in millions)
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Risedronic acid
Total medical expenditures per year (USD, in millions)
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Trends
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Safety
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Adverse Events
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13,664 adverse events reported
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