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Mesalamine
Apriso, Canasa, Delzicol, Lialda, Pentasa, Rowasa, Sfrowasa (mesalamine) is a small molecule pharmaceutical. Mesalamine was first approved as Rowasa on 1987-12-24. It is used to treat proctitis, sigmoid diseases, and ulcerative colitis in the USA. It is known to target peroxisome proliferator-activated receptor gamma.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
Trade Name
FDA
EMA
Apriso, Canasa, Delzicol, Lialda, Pentasa, Rowasa, Sfrowasa (generic drugs available since 2004-09-17, discontinued: Asacol)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Mesalamine
Tradename
Company
Number
Date
Products
CANASAAbbVieN-021252 RX2004-11-05
1 products, RLD, RS
DELZICOLAbbVieN-204412 RX2013-02-01
1 products, RLD, RS
SFROWASAMylanN-019618 RX2008-06-20
1 products, RLD
ROWASAMylanN-019618 RX1987-12-24
1 products, RLD, RS
PENTASATakedaN-020049 RX1993-05-10
2 products, RLD
LIALDATakedaN-022000 RX2007-01-16
1 products, RLD, RS
APRISOBausch Health CompaniesN-022301 RX2008-10-31
1 products, RLD, RS
Show 4 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
aprisoNew Drug Application2020-10-13
asacol hdNew Drug Application2020-10-12
canasaNew Drug Application2020-10-09
delzicolNew Drug Application2023-02-06
lialdaNew Drug Application2021-02-23
mesalamineANDA2023-06-19
pentasaNew Drug Application2021-02-08
rowasaNew Drug Application2020-10-29
sfrowasaNew Drug Application2020-10-15
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
proctitisEFO_0005628D011349K62.89
sigmoid diseasesD012810
ulcerative colitisEFO_0000729D003093K51
Agency Specific
FDA
EMA
Expiration
Code
MESALAMINE, LIALDA, TAKEDA PHARMS USA
2023-06-26NPP
Patent Expiration
Patent
Expires
Flag
FDA Information
Mesalamine, Apriso, Valeant Pharms Intl
88656882030-05-01U-1310
Mesalamine, Canasa, Abbvie
82170832028-06-06DP
84360512028-06-06DP
Mesalamine, Rowasa, Mylan Speciality Lp
76458012027-07-24DS, DP
ATC Codes
A: Alimentary tract and metabolism drugs
A07: Antidiarrheals, intestinal antiinflammatory/antiinfective agents
A07E: Intestinal antiinflammatory agents
A07EC: Aminosalicylic acid and similar agents
A07EC02: Mesalazine
HCPCS
No data
Clinical
Clinical Trials
140 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Ulcerative colitisD003093EFO_0000729K516842111175
Crohn diseaseD003424EFO_0000384K50283113
Irritable bowel syndromeD043183EFO_0000555K584328
Inflammatory bowel diseasesD015212EFO_000376731126
Hiv infectionsD015658EFO_0000764B202113
Diverticular diseasesD000076385K57112
Immune system diseasesD007154D89.911
Acquired immunodeficiency syndromeD000163EFO_0000765B2011
Sexually transmitted diseasesD012749A50-A6411
Lentivirus infectionsD016180EFO_100135711
Show 1 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DiverticulitisD004238EFO_1001460K57134
DiarrheaD003967HP_0002014R19.71313
ProctitisD011349EFO_0005628K62.89112
Lymphocytic colitisD046730EFO_1001294K52.83211
Collagenous colitisD046729EFO_1001293K52.83111
Fecal microbiota transplantationD000069467111
Oral ulcerD019226HP_000015511
Gastrointestinal diseasesD005767111
Digestive system diseasesD004066EFO_0000405K92.9111
Intestinal diseasesD007410HP_0002242K63.9111
Show 3 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Colorectal neoplasmsD01517922
ColitisD003092EFO_0003872K52.9122
Colonic diverticulosisD043963K57.30112
Hermanski-pudlak syndromeD022861E70.33111
LymphocytosisD00821811
Drug evaluationD00434111
CytokinesisD04874911
Protozoan infectionsD011528B50-B64111
MalnutritionD044342EFO_0008572E40-E46111
BerylliosisD001607EFO_0007168J63.2111
Show 6 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients9110
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMESALAMINE
INNmesalazine
Description
Mesalamine is a monohydroxybenzoic acid that is salicylic acid substituted by an amino group at the 5-position. It has a role as a non-steroidal anti-inflammatory drug. It is an aromatic amine, an amino acid, a member of phenols, a monocarboxylic acid and a monohydroxybenzoic acid. It is functionally related to a salicylic acid. It is a conjugate acid of a mesalaminate(1-).
Classification
Small molecule
Drug classanti-inflammatory agents (salicylic acid derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Nc1ccc(O)c(C(=O)O)c1
Identifiers
PDB
CAS-ID89-57-6
RxCUI52582
ChEMBL IDCHEMBL704
ChEBI ID6775
PubChem CID4075
DrugBankDB00244
UNII ID4Q81I59GXC (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
PPARG
PPARG
Organism
Homo sapiens
Gene name
PPARG
Gene synonyms
NR1C3
NCBI Gene ID
Protein name
peroxisome proliferator-activated receptor gamma
Protein synonyms
Nuclear receptor subfamily 1 group C member 3, peroxisome proliferator-activated receptor-gamma 5, peroxisome proliferator-activated receptor-gamma splicing, PPAR-gamma
Uniprot ID
Mouse ortholog
Pparg (19016)
peroxisome proliferator-activated receptor gamma (P37238)
Variants
Clinical Variant
No data
Financial
Pentasa - Shire
$
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Canasa - Allergan
$
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Canasa - Warner Chilcott
$
£
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Asacol - Allergan
$
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Asacol - Warner Chilcott
$
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Lialda - Shire
$
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,781 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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8,407 adverse events reported
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