Mesalamine
Apriso, Canasa, Lialda, Mesalamine, 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.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| digestive system diseases | D004066 |
Trade Name
FDA
EMA
Apriso, Canasa, Lialda, Mesalamine, Pentasa, Sfrowasa (discontinued: Asacol, Canasa, Delzicol, Mesalamine, Rowasa)
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 |
| ROWASA | Mylan | N-019618 RX | 1987-12-24 | 1 products, RLD, RS |
| SFROWASA | Mylan | N-019618 RX | 2008-06-20 | 1 products, RLD |
| APRISO | Salix Pharmaceuticals | N-022301 RX | 2008-10-31 | 1 products, RLD, RS |
| LIALDA | Takeda | N-022000 RX | 2007-01-16 | 1 products, RLD, RS |
| PENTASA | Takeda | N-020049 RX | 1993-05-10 | 2 products, RLD |
Show 5 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| apriso | New Drug Application | 2024-01-09 |
| asacol | New Drug Application | 2014-03-07 |
| canasa | New Drug Application | 2024-09-08 |
| delzicol | New Drug Application | 2016-08-06 |
| lialda | New Drug Application | 2023-10-24 |
| mesalamine | ANDA | 2025-09-15 |
| mesalamine rectal | ANDA | 2023-12-15 |
| pentasa | New Drug Application | 2025-01-15 |
| rowasa | New Drug Application | 2024-07-15 |
| sfrowasa | New Drug Application | 2024-07-24 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| ulcerative colitis | EFO_0000729 | D003093 | K51 |
| proctitis | EFO_0005628 | D011349 | K62.89 |
| sigmoid diseases | — | D012810 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
MESALAMINE, LIALDA, TAKEDA PHARMS USA | |||
| 2023-06-26 | NPP | ||
HCPCS
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Clinical
Clinical Trials
231 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 | 15 | 28 | 56 | 22 | 34 | 149 |
| Colitis | D003092 | EFO_0003872 | K52.9 | 15 | 27 | 54 | 19 | 27 | 136 |
| Ulcer | D014456 | MPATH_579 | — | 12 | 18 | 52 | 17 | 26 | 121 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | 1 | 14 | 5 | 2 | 11 | 29 |
| Crohn disease | D003424 | EFO_0000384 | K50 | — | 2 | 9 | 5 | 5 | 20 |
| Intestinal diseases | D007410 | — | K63.9 | — | 4 | 3 | 1 | 5 | 11 |
| Syndrome | D013577 | — | — | — | 5 | 3 | 2 | — | 9 |
| Irritable bowel syndrome | D043183 | EFO_0000555 | K58 | — | 4 | 3 | 2 | — | 8 |
| Diarrhea | D003967 | — | R19.7 | 1 | 6 | 1 | 2 | — | 8 |
| Recurrence | D012008 | — | — | — | — | 6 | 1 | — | 7 |
Show 15 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 | 4 | — | 1 | 6 |
| Proctitis | D011349 | EFO_0005628 | K62.89 | — | 1 | 2 | — | 1 | 4 |
| Lymphocytic colitis | D046730 | EFO_1001294 | K52.832 | — | — | 1 | — | — | 1 |
| Collagenous colitis | D046729 | EFO_1001293 | K52.831 | — | — | 1 | — | — | 1 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | — | 1 | — | — | 1 |
| Fecal microbiota transplantation | D000069467 | — | — | — | 1 | 1 | — | — | 1 |
| Oral ulcer | D019226 | — | — | — | — | 1 | — | — | 1 |
| Gastrointestinal diseases | D005767 | — | — | — | 1 | 1 | — | — | 1 |
| Digestive system diseases | D004066 | EFO_0000405 | K92.9 | — | 1 | 1 | — | — | 1 |
| Proctocolitis | D011350 | EFO_1001223 | — | — | — | 1 | — | — | 1 |
Show 2 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | — | — | — | 2 | — | — | — | 2 |
| Hereditary nonpolyposis colorectal neoplasms | D003123 | EFO_0007354 | — | — | 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 |
| Helminthiasis | D006373 | EFO_1001342 | B65-B83 | 1 | 1 | — | — | — | 1 |
| Protozoan infections | D011528 | — | B50-B64 | 1 | 1 | — | — | — | 1 |
| Inflammation | D007249 | MP_0001845 | — | 1 | 1 | — | — | — | 1 |
Show 10 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 10 | — | — | — | 1 | 11 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Psoriasis | D011565 | EFO_0000676 | L40 | — | — | — | — | 1 | 1 |
| Papillomavirus infections | D030361 | — | — | — | — | — | — | 1 | 1 |
| Necrosis | D009336 | — | — | — | — | — | — | 1 | 1 |
| Squamous intraepithelial lesions | D000081483 | — | — | — | — | — | — | 1 | 1 |
| Herpes zoster | D006562 | EFO_0006510 | B02 | — | — | — | — | 1 | 1 |
| Hepatitis b | D006509 | — | — | — | — | — | — | 1 | 1 |
| Dentin dysplasia | D003805 | — | K00.5 | — | — | — | — | 1 | 1 |
| Cytomegalovirus infections | D003586 | EFO_0001062 | B25 | — | — | — | — | 1 | 1 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | — | — | — | 1 | 1 |
| Vitamin d deficiency | D014808 | EFO_0003762 | E55 | — | — | — | — | 1 | 1 |
Show 4 more
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 | — |
| ChEMBL ID | CHEMBL704 |
| ChEBI ID | 6775 |
| PubChem CID | 4075 |
| DrugBank | DB00244 |
| UNII ID | 4Q81I59GXC (ChemIDplus, GSRS) |
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Pentasa – Shire
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Lialda – 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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Tabular view
Estimated US medical usage
Mesalamine
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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Trends
PubMed Central
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Additional graphs summarizing 12,863 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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23,378 adverse events reported
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