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 diseases | D004066 |
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 |
|---|---|---|---|---|
| CANASA | AbbVie | N-021252 RX | 2004-11-05 | 1 products, RLD, RS |
| DELZICOL | AbbVie | N-204412 RX | 2013-02-01 | 1 products, RLD, RS |
| SFROWASA | Mylan | N-019618 RX | 2008-06-20 | 1 products, RLD |
| ROWASA | Mylan | N-019618 RX | 1987-12-24 | 1 products, RLD, RS |
| PENTASA | Takeda | N-020049 RX | 1993-05-10 | 2 products, RLD |
| LIALDA | Takeda | N-022000 RX | 2007-01-16 | 1 products, RLD, RS |
| APRISO | Bausch Health Companies | N-022301 RX | 2008-10-31 | 1 products, RLD, RS |
Show 4 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| apriso | New Drug Application | 2020-10-13 |
| asacol hd | New Drug Application | 2020-10-12 |
| canasa | New Drug Application | 2020-10-09 |
| delzicol | New Drug Application | 2023-02-06 |
| lialda | New Drug Application | 2021-02-23 |
| mesalamine | ANDA | 2023-06-19 |
| pentasa | New Drug Application | 2021-02-08 |
| rowasa | New Drug Application | 2020-10-29 |
| sfrowasa | New Drug Application | 2020-10-15 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| proctitis | EFO_0005628 | D011349 | K62.89 |
| sigmoid diseases | — | D012810 | — |
| ulcerative colitis | EFO_0000729 | D003093 | K51 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
MESALAMINE, LIALDA, TAKEDA PHARMS USA | |||
| 2023-06-26 | NPP | ||
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 colitis | D003093 | EFO_0000729 | K51 | 6 | 8 | 42 | 11 | 11 | 75 |
| Crohn disease | D003424 | EFO_0000384 | K50 | — | 2 | 8 | 3 | 1 | 13 |
| Irritable bowel syndrome | D043183 | EFO_0000555 | K58 | — | 4 | 3 | 2 | — | 8 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | 3 | 1 | 1 | 2 | 6 | |
| Hiv infections | D015658 | EFO_0000764 | B20 | 2 | 1 | — | 1 | — | 3 |
| Diverticular diseases | D000076385 | K57 | — | — | 1 | 1 | — | 2 | |
| Immune system diseases | D007154 | D89.9 | — | — | — | 1 | — | 1 | |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | — | — | 1 | — | 1 |
| Sexually transmitted diseases | D012749 | A50-A64 | — | — | — | 1 | — | 1 | |
| Lentivirus infections | D016180 | EFO_1001357 | — | — | — | 1 | — | 1 |
Show 1 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diverticulitis | D004238 | EFO_1001460 | K57 | — | 1 | 3 | — | — | 4 |
| Diarrhea | D003967 | HP_0002014 | R19.7 | 1 | 3 | 1 | — | — | 3 |
| Proctitis | D011349 | EFO_0005628 | K62.89 | — | 1 | 1 | — | — | 2 |
| Lymphocytic colitis | D046730 | EFO_1001294 | K52.832 | — | — | 1 | — | — | 1 |
| Collagenous colitis | D046729 | EFO_1001293 | K52.831 | — | — | 1 | — | — | 1 |
| Fecal microbiota transplantation | D000069467 | — | 1 | 1 | — | — | 1 | ||
| Oral ulcer | D019226 | HP_0000155 | — | — | 1 | — | — | 1 | |
| Gastrointestinal diseases | D005767 | — | 1 | 1 | — | — | 1 | ||
| Digestive system diseases | D004066 | EFO_0000405 | K92.9 | — | 1 | 1 | — | — | 1 |
| Intestinal diseases | D007410 | HP_0002242 | K63.9 | — | 1 | 1 | — | — | 1 |
Show 3 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | — | 2 | — | — | — | 2 | ||
| Colitis | D003092 | EFO_0003872 | K52.9 | 1 | 2 | — | — | — | 2 |
| Colonic diverticulosis | D043963 | K57.30 | — | 1 | — | — | 1 | 2 | |
| Hermanski-pudlak syndrome | D022861 | E70.331 | — | 1 | — | — | — | 1 | |
| Lymphocytosis | D008218 | — | 1 | — | — | — | 1 | ||
| Drug evaluation | D004341 | — | 1 | — | — | — | 1 | ||
| Cytokinesis | D048749 | — | 1 | — | — | — | 1 | ||
| Protozoan infections | D011528 | B50-B64 | 1 | 1 | — | — | — | 1 | |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 1 | 1 | — | — | — | 1 |
| Berylliosis | D001607 | EFO_0007168 | J63.2 | 1 | 1 | — | — | — | 1 |
Show 6 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 9 | — | — | — | 1 | 10 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | MESALAMINE |
| INN | mesalazine |
| 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 class | anti-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-ID | 89-57-6 |
| RxCUI | 52582 |
| ChEMBL ID | CHEMBL704 |
| ChEBI ID | 6775 |
| PubChem CID | 4075 |
| DrugBank | DB00244 |
| UNII ID | 4Q81I59GXC (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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PubMed Central
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Safety
Black-box Warning
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Adverse Events
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8,407 adverse events reported
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