Drug ID:Drug26
Drug Name:Mesalazine
CID:4075
DrugBank ID:DB00244
Modality:Small Molecule
Groups:approved
US Approved:YES
Other Approved:YES
Identifier: NCT05992142, , NCT01532648, , NCT02665845, , NCT00603733, , NCT02683759, , NCT03804931, , NCT01320436, , NCT00984568, , NCT00167882, , NCT00713310, , NCT01004185, , NCT01903252, , NCT00151892, , NCT00349388, , NCT05753267, , NCT05781698, , NCT05988528, , NCT05567068, , NCT05986136, , NCT05119
Molecular Formula:C7H7NO3
Molecular Weight:153.14 g/mol
Isomeric SMILES:C1=CC(=C(C=C1N)C(=O)O)O
Synonyms:5-Aminosalicylic acid; mesalamine; Mesalazine; 89-57-6; 5-Amino-2-hydroxybenzoic acid; 5-ASA; m-Aminosalicylic acid; Lialda; Fisalamine; Apriso
Phase 0: 1
Phase 1: 39
Phase 2: 43
Phase 3: 94
Phase 4: 27
Description:An anti-inflammatory agent, structurally related to the salicylates, which is active in inflammatory bowel disease. It is considered to be the active moiety of sulphasalazine. (From Martindale, The Extra Pharmacopoeia, 30th ed)

Molecular Structure

2D Molecular Structure

Knowledge Graph

dtIDCIDCompound NameGene IDGene NameSpeciesPubMed IDsAction
dt238 4075 Mesalamine 3028 HSD17B10 Homo sapiens (human) None
dt239 4075 Mesalamine 2744 GLS Homo sapiens (human) None
dt240 4075 Mesalamine 3586 IL10 Homo sapiens (human) None
dt241 4075 Mesalamine 5743 PTGS2 Homo sapiens (human) Inhibitor
dt242 4075 Mesalamine 5742 PTGS1 Homo sapiens (human) Inhibitor
dt243 4075 Mesalamine 240 ALOX5 Homo sapiens (human) Inhibitor
dt244 4075 Mesalamine 5468 PPARG Homo sapiens (human) Agonist
dt245 4075 Mesalamine 1147 CHUK Homo sapiens (human) Inhibitor
dt246 4075 Mesalamine 3551 IKBKB Homo sapiens (human) Inhibitor
dt247 4075 Mesalamine 4843 NOS2 Homo sapiens (human) 17503181 Inhibitor

  • No data available

Phase Distribution
Phase Description
  • Phase 0: Exploratory trials to assess drug behavior in humans
  • Phase 1: Safety trials to determine safe dosage range
  • Phase 2: Efficacy trials to evaluate therapeutic effects
  • Phase 3: Large-scale trials to confirm efficacy and safety
  • Phase 4: Post-marketing surveillance for long-term safety and efficacy

Trial IDTitlePhaseStatusSponsorIndicationsInterventions
NCT05538026 Effectiveness of Fecal Microbiota Transplantation as add-on Therapy in Mild-to-moderate Ulcerative Colitis NA COMPLETED Bogomolets National Medical University Ulcerative Colitis Chronic Mild|Inflammatory Bowe… DRUG: Mesalazine|BIOLOGICAL: Fecal transplantation Details
NCT05386290 A Multicentered Prospective Cohort Study of Chinese IBD Patients NULL UNKNOWN Peking Union Medical College Hospital Ulcerative Colitis|Crohn Disease DRUG: Infliximab|DRUG: Vedolizumab|DRUG: Ustekinu… Details
NCT05205603 Efficacy of Mesalazine Combined With Biologics in the Treatment of Moderate to Severe Ulcerative Colitis PHASE4 UNKNOWN Sixth Affiliated Hospital, Sun Yat-sen University Ulcerative Colitis|Efficacy, Self|Biologics|Mesal… DRUG: Infliximab|DRUG: Vedolizumab|DRUG: Mesalazi… Details
NCT04276649 A Retrospective Analysis: the Influence of Caltrate Supplement on the Effect of Mesalazine in Ulcerative Colitis NULL COMPLETED Second Affiliated Hospital of Wenzhou Medical University Ulcerative Colitis|Vitamin D Deficiency|Vitamin D… DRUG: Caltrate Details
NCT04133194 Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis PHASE4 UNKNOWN Flemming Bendtsen Ulcerative Colitis DRUG: Mesalazine|DRUG: Mesalazine Details
NCT03917095 The Safety and Efficacy of TET Enema in the Treatment of UC NA UNKNOWN The Second Hospital of Nanjing Medical University Ulcerative Colitis Chronic Mild|Ulcerative Coliti… DEVICE: The Colonic Transendoscopic enteral Tubin… Details
NCT03441893 Role of Intestinal Protozoa and Helminths in the Course of Ulcerative Colitis PHASE1|PHASE2 UNKNOWN Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan Ulcerative Colitis|Ulcerative Colitis Exacerbatio… DIAGNOSTIC_TEST: parasitological diagnostics (cop… Details
NCT03412682 To Evaluate the Efficacy and Safety of FE 999315 in Japanese Subjects With Mild to Moderate Active Ulcerative Colitis PHASE3 COMPLETED Ferring Pharmaceuticals Colitis, Ulcerative DRUG: Budesonide (6 mg)|DRUG: Budesonide (9 mg)|D… Details
NCT03110198 Mesalazine With Hydrocortisone Sodium Succinate Enema for 4-Week Treatment in Patients With Ulcerative Colitis PHASE4 UNKNOWN Xijing Hospital of Digestive Diseases Ulcerative Colitis, Unspecified DRUG: Mesalazine|DRUG: hydrocortisone sodium succ… Details
NCT03104036 Faecal Bacteriotherapy for Ulcerative Colitis PHASE2 COMPLETED Institute for Clinical and Experimental Medicine Ulcerative Colitis OTHER: Faecal bacterial transplantation|DRUG: Mes… Details
NCT02769494 The Efficacy of Topical Mesalazine Sustained-Release Tablets in Crohn's Disease Patients With Oral Ulcer PHASE3 WITHDRAWN Xijing Hospital of Digestive Diseases Crohn's Disease|Oral Ulcer DRUG: Mesalazine Sustained-Release Tablets|DRUG: … Details
NCT02537210 Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative Colitis NA COMPLETED Chinese University of Hong Kong Colitis, Ulcerative|Aminosalicylic Acid DRUG: Mesalazine|DRUG: Placebo oral capsule Details
NCT02368717 An Efficacy and Safety Study of PENTASA in Chinese Patients With Left-sided Active Ulcerative Colitis Followed by a 24-Week Open-Label Extension Phase PHASE3 COMPLETED Ferring Pharmaceuticals Ulcerative Colitis DRUG: Mesalazine Enema|DRUG: Placebo Enema Details
NCT02335281 Standardized Fecal Microbiota Transplantation for Inflammatory Bowel Disease PHASE2 UNKNOWN Yanling Wei Inflammatory Bowel Disease|Ulcerative Colitis|Cro… PROCEDURE: FMT|DRUG: Mesalazine Details
NCT02261636 Induction and Maintenance of Remission With Pentasa as Ulcerative Colitis Treatment NULL COMPLETED Ferring Pharmaceuticals Ulcerative Colitis DRUG: mesalazine Details
NCT02190526 Effects of Mesalamine and Amitriptyline on Irritable Bowel Syndrome PHASE4 WITHDRAWN Tehran University of Medical Sciences Diarrhea- Predominant Irritable Bowel Syndrome|Qu… DRUG: Mesalazine(asacol 800 mg)|DRUG: Amitriptyli… Details
NCT02093663 Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis PHASE3 COMPLETED Shire Ulcerative Colitis DRUG: MMX Mesalamine/Mesalazine (Low Dose)|DRUG: … Details
NCT02044952 Efficacy and Safety Study of Tripterygium Glycoside in the Treatment of Crohn's Disease for Induction Remission PHASE2|PHASE3 UNKNOWN Zhu Weiming Inflammatory Bowel Diseases|Crohn's Disease|Gastr… DRUG: Mesalazine, Tripterygium glycosides Details
NCT01745770 TID 1000 mg Mesalazine Versus TID 2x500 mg Mesalazine in Active Ulcerative Colitis (UC) PHASE3 COMPLETED Dr. Falk Pharma GmbH Active Ulcerative Colitis DRUG: Mesalazine - TID 1000 mg|DRUG: Mesalazine -… Details
NCT01699438 Mesalazine Treatment in IBS (The MIBS Study) PHASE2 COMPLETED Hans Törnblom Irritable Bowel Syndrome DRUG: Mesalazine|DRUG: Placebo Details

Disease IDDisease NameDefinitionCategoryRelated DrugsMechanism
No data available

Strategy IDTherapeutic StrategySynonymsRelated DrugsMechanism
S01 Anti-inflammatory inflammatory 5-Aminosalicylates (5-ASAs); corticosteroids Crohn's disease and ulcerative colitis are the two main com… Details

Twelve-month persistency with oral 5-aminosalicylic acid therapy for ulcerative…

PMID: 21879279
Year: 2011
Relationship Type: Treatment Score: 5.1

BACKGROUND: Patients receiving 5-aminosalicylic acid (5-ASA) require long-term therapy to achieve good outcomes. Persistency (duration of time from i…

Expanding applications: the potential usage of 5-aminosalicylic acid in diverti…

PMID: 21567193
Year: 2011
Relationship Type: Treatment Score: 5.1

Diverticular disease is a common bowel condition, the pathogenesis of which is incompletely understood. Acute exacerbations of diverticular disease u…

Clinical trial: once-daily mesalamine granules for maintenance of remission of …

PMID: 20937044
Year: 2010
Relationship Type: Treatment Score: 5.1

BACKGROUND: Ulcerative colitis (UC) is a chronic relapsing and remitting idiopathic inflammatory bowel disorder. AIM: To evaluate once-daily mesalami…

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