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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| urogenital diseases | D000091642 |
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 |
|---|---|---|---|---|
| ELMIRON | Johnson & Johnson | N-020193 RX | 1996-09-26 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| elmiron | New Drug Application | 2024-09-18 |
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
16 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 cystitis | D018856 | EFO_1000869 | N30.1 | — | — | — | 1 | 4 | 5 |
| Cystitis | D003556 | EFO_1000025 | N30 | — | 1 | 1 | 1 | 3 | 5 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | 1 | 2 | — | 1 | 3 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | 1 | 2 | — | 1 | 3 |
| Diarrhea | D003967 | — | R19.7 | — | — | 1 | — | — | 1 |
| Enteritis | D004751 | — | K52.9 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Urinary bladder neoplasms | D001749 | — | C67 | — | 1 | — | — | — | 1 |
| Lower urinary tract symptoms | D059411 | EFO_0008008 | — | — | 1 | — | — | — | 1 |
| Mycobacterium bovis | D009163 | NCBITaxon_1765 | — | — | 1 | — | — | — | 1 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | 1 | — | — | — | 1 |
| Psychotic disorders | D011618 | — | F20.81 | — | 1 | — | — | — | 1 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | 1 | — | — | — | 1 |
| Mental disorders | D001523 | EFO_0000677 | F91.9 | — | 1 | — | — | — | 1 |
| Prostatitis | D011472 | EFO_0003830 | N41 | — | 1 | — | — | — | 1 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | 1 | — | — | — | 1 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | 1 | — | — | — | 1 |
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Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Syndrome | D013577 | — | — | — | — | — | — | 2 | 2 |
| Somatoform disorders | D013001 | — | F45 | — | — | — | — | 2 | 2 |
| Magnetic resonance imaging | D008279 | — | — | — | — | — | — | 1 | 1 |
| Sciatica | D012585 | — | M54.3 | — | — | — | — | 1 | 1 |
| Acupuncture therapy | D015670 | — | — | — | — | — | — | 1 | 1 |
| Retinal diseases | D012164 | — | H35.9 | — | — | — | — | 1 | 1 |
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | — | — | — | — | 1 | 1 |
| Retinitis pigmentosa | D012174 | — | H35.52 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Pentosan polysulfate sodium |
| INN | pentosan 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 | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 37300-21-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201516 |
| ChEBI ID | — |
| PubChem CID | 37720 |
| DrugBank | DB00686 |
| UNII ID | F59P8B75R4 (ChemIDplus, GSRS) |
Target
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Variants
No data
Financial
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Estimated US medical usage
Pentosan polysulfate sodium
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 942 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4,837 adverse events reported
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