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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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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 Application2020-10-01
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
82 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.95825111564
AsthmaD001249EFO_0000270J45—6—1—7
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—14————14
Liver diseasesD008107EFO_0001421K70-K771————1
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 anti-inflammatory medication used in the treatment of ulcerative colitis. It is sold under the brand name Dipentum.
Classification
Small molecule
Drug classantiarrhythmic/antianginal/antihypertensive agents, phthalazine like structure; anti-inflammatory agents (salicylic acid derivatives)
Image (chem structure or protein)
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
RxCUI32385
ChEMBL IDCHEMBL425
ChEBI ID—
PubChem CID6003770
DrugBankDB01250
UNII IDULS5I8J03O (ChemIDplus, GSRS)
Target
Agency Approved
No data
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 889 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,313 adverse events reported
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