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Drug ReportsPentosan polysulfate sodium
Elmiron(pentosan polysulfate sodium)
Elmiron (pentosan polysulfate sodium) is a small molecule pharmaceutical. Pentosan polysulfate sodium was first approved as Elmiron on 1996-09-26. It has been approved in Europe to treat interstitial cystitis.
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Drug
Target
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5D
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3M
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YTD
1Y
2Y
5Y
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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
Elmiron
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Pentosan polysulfate sodium
Tradename
Company
Number
Date
Products
ELMIRONJohnson & JohnsonN-020193 RX1996-09-26
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
elmironNew Drug Application2024-09-18
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
C: Cardiovascular system drugs
— C05: Vasoprotectives
— C05B: Antivaricose therapy drugs
— C05BA: Heparins or heparinoids for topical use
— C05BA04: Pentosan polysulfate sodium
G: Genito urinary system and sex hormones
— G04: Urologicals
— G04B: Urologicals
— G04BX: Other urologicals in atc
— G04BX15: Pentosan polysulfate sodium
HCPCS
No data
Clinical
Clinical Trials
19 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Interstitial cystitisD018856EFO_1000869N30.1———112
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Retinal diseasesD012164—H35.9————11
Macular degenerationD008268EFO_0001365H35.30————11
Retinitis pigmentosaD012174—H35.52————11
CystitisD003556EFO_1000025N30————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePentosan polysulfate sodium
INNpentosan polysulfate sodium
Description
[(2R,3R,4S,5R)-2-Hydroxy-5-{[(2S,3R,4S,5R)-5-hydroxy-3,4-bis(sulfooxy)oxan-2-yl]oxy}-4-(sulfooxy)oxan-3-yl]oxidanesulfonic acid is a glycoside.
Classification
Small molecule
Drug class—
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Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID37300-21-3
RxCUI—
ChEMBL IDCHEMBL1201516
ChEBI ID—
PubChem CID37720
DrugBankDB00686
UNII IDF59P8B75R4 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Pentosan polysulfate sodium
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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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 991 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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5,105 adverse events reported
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