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Drug ReportsSilodosin
Rapaflo, Silodyx(silodosin)
Rapaflo, Silodosin, Silodyx, Urorec (silodosin) is a small molecule pharmaceutical. Silodosin was first approved as Rapaflo on 2008-10-08. It is used to treat prostatic hyperplasia in the USA. It has been approved in Europe to treat prostatic hyperplasia. The pharmaceutical is active against alpha-1A adrenergic receptor. In addition, it is known to target alpha-1B adrenergic receptor and alpha-1D adrenergic receptor.
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Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
urogenital diseasesD000091642
Trade Name
FDA
EMA
Rapaflo, Silodosin (discontinued: Silodosin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Silodosin
Tradename
Company
Number
Date
Products
RAPAFLOAbbVieN-022206 RX2008-10-08
2 products, RLD
Labels
FDA
EMA
Brand Name
Status
Last Update
rapafloNew Drug Application2020-12-15
silodosinANDA2024-10-08
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
prostatic hyperplasiaEFO_0000284D011470N40
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
G: Genito urinary system and sex hormones
— G04: Urologicals
— G04C: Drugs used in benign prostatic hypertrophy
— G04CA: Alpha-adrenoreceptor antagonists, benign prostatic hypertrophy
— G04CA04: Silodosin
HCPCS
No data
Clinical
Clinical Trials
40 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic hyperplasiaD011470EFO_0000284N401347419
HyperplasiaD006965EFO_0000536—1346418
Ureteral calculiD014514——22—328
UreterolithiasisD053039EFO_1001228N20.122—328
CalculiD002137——12—2—5
Lower urinary tract symptomsD059411EFO_0008008———1214
NocturiaD053158—R35.1—1—1—2
HypertrophyD006984EFO_0002460————1—1
Neurogenic urinary bladderD001750HP_0000011N31———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Kidney calculiD007669EFO_0004253N20122—15
UrolithiasisD052878—N20-N23—21——3
Urinary calculiD014545———21——3
Prostatic neoplasmsD011471—C61——1——1
Urination disordersD014555————1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NephrolithiasisD053040—N20.012——13
Urinary retentionD016055HP_0000016R33—1——12
Premature birthD047928EFO_0003917O60—1———1
Premature ejaculationD061686HP_0012876F52.4—1———1
ProstatitisD011472EFO_0003830N41—1———1
Chronic diseaseD002908———1———1
Pelvic painD017699———1———1
SyndromeD013577———1———1
Somatoform disordersD013001—F45—1———1
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Overactive urinary bladderD053201EFO_1000781N32.81————11
Pathologic dilatationD004108——————11
TrichinellosisD014235EFO_0007520B75————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSilodosin
INNsilodosin
Description
Silodosin is an indolecarboxamide.
Classification
Small molecule
Drug class—
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Structure (InChI/SMILES or Protein Sequence)
C[C@H](Cc1cc2c(c(C(N)=O)c1)N(CCCO)CC2)NCCOc1ccccc1OCC(F)(F)F
Identifiers
PDB—
CAS-ID160970-54-7
RxCUI—
ChEMBL IDCHEMBL24778
ChEBI ID—
PubChem CID5312125
DrugBankDB06207
UNII IDCUZ39LUY82 (ChemIDplus, GSRS)
Target
Agency Approved
ADRA1A
ADRA1A
Organism
Homo sapiens
Gene name
ADRA1A
Gene synonyms
ADRA1C
NCBI Gene ID
Protein name
alpha-1A adrenergic receptor
Protein synonyms
Alpha-1A adrenoceptor, Alpha-1A adrenoreceptor, Alpha-1C adrenergic receptor, Alpha-adrenergic receptor 1c, G protein coupled receptor
Uniprot ID
Mouse ortholog
Adra1a (11549)
alpha-1A adrenergic receptor (Q8BV77)
Alternate
ADRA1B
ADRA1B
ADRA1D
ADRA1D
Organism
Homo sapiens
Gene name
ADRA1B
Gene synonyms
NCBI Gene ID
Protein name
alpha-1B adrenergic receptor
Protein synonyms
adrenergic, alpha-1B-, receptor, Alpha-1B adrenoceptor, Alpha-1B adrenoreceptor
Uniprot ID
Mouse ortholog
Adra1b (11548)
alpha-1B adrenergic receptor (P97717)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Rapaflo – Allergan
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Rapaflo – Warner Chilcott
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Estimated US medical usage
Silodosin
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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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 977 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,555 adverse events reported
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