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Risedronic acid
Actonel, Atelvia (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
No data
Trade Name
FDA
EMA
Actonel, Atelvia (generic drugs available since 2007-10-05)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Calcium carbonate
+
Risedronate sodium
Tradename
Company
Number
Date
Products
ACTONEL WITH CALCIUM (COPACKAGED)Warner ChilcottN-021823 DISCN2005-08-12
1 products, RLD
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Risedronate sodium
Tradename
Company
Number
Date
Products
ACTONELAllerganN-020835 RX2002-05-25
2 products, RLD, RS
ATELVIAAllerganN-022560 RX2010-10-08
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
actonelNew Drug Application2019-11-01
atelviaNew Drug Application2020-08-05
risedronate sodiumANDA2022-11-26
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Risedronate Sodium, Atelvia, Apil
76454592028-01-09DPU-662
76454602028-01-09DPU-662
82469892026-01-16DP
Risedronate Sodium, Actonel, Apil
71929382023-05-06U-353
77186342023-05-06U-662
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
2 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hepatitis cD006526B19.2————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameRISEDRONIC ACID
INNrisedronic acid
Description
Risedronic acid is a member of pyridines.
Classification
Small molecule
Drug classcalcium 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-ID105462-24-6
RxCUI73056
ChEMBL IDCHEMBL923
ChEBI ID8869
PubChem CID5245
DrugBankDB00884
UNII IDKM2Z91756Z (ChemIDplus, GSRS)
Target
Agency Approved
FDPS
FDPS
Organism
Homo sapiens
Gene name
FDPS
Gene synonyms
FPS, KIAA1293
NCBI Gene ID
2224
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
Q96G29
Mouse ortholog
Fdps (110196)
farnesyl pyrophosphate synthase (Q920E5)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,949 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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32 adverse events reported
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