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Drug ReportsOlsalazine
Olsalazine
Dipentum (olsalazine) is a small molecule pharmaceutical. Olsalazine was first approved as Dipentum on 1990-07-31. It is used to treat ulcerative colitis in the USA.
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Target
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Financial
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Safety
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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
digestive system diseasesD004066
Trade Name
FDA
EMA
Dipentum
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Olsalazine sodium
Tradename
Company
Number
Date
Products
DIPENTUMMylanN-019715 RX1990-07-31
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
dipentumNew Drug Application2024-07-18
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
ulcerative colitisEFO_0000729D003093K51
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
A07: Antidiarrheals, intestinal antiinflammatory/antiinfective agents
A07E: Intestinal antiinflammatory agents
A07EC: Aminosalicylic acid and similar agents
A07EC03: Olsalazine
HCPCS
No data
Clinical
Clinical Trials
2 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Ulcerative colitisD003093EFO_0000729K5111
ColitisD003092EFO_0003872K52.911
UlcerD014456MPATH_57911
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Ankylosing spondylitisD013167EFO_0003898M4511
SpondylarthritisD02524111
SpondylitisD013166M46.911
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameOlsalazine
INNolsalazine
Description
Olsalazine is an azobenzene that consists of two molecules of 4-aminosalicylic acid joined by an azo linkage. A prodrug for mesalazine, an anti-inflammatory drug, it is used (as the disodium salt) in the treatment of inflammatory bowel disease. It has a role as a prodrug and a non-steroidal anti-inflammatory drug. It is a dicarboxylic acid and a member of azobenzenes. It is functionally related to a salicylic acid. It is a conjugate acid of an olsalazine(2-).
Classification
Small molecule
Drug classantiarrhythmic/antianginal/antihypertensive agents, phthalazine like structure; anti-inflammatory agents (salicylic acid derivatives)
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Structure (InChI/SMILES or Protein Sequence)
O=C(O)c1cc(/N=N/c2ccc(O)c(C(=O)O)c2)ccc1O
Identifiers
PDB
CAS-ID15722-48-2
RxCUI
ChEMBL IDCHEMBL425
ChEBI ID
PubChem CID22419
DrugBankDB01250
UNII IDULS5I8J03O (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
No data
Estimated US medical usage
Olsalazine
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 1,057 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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57 adverse events reported
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