| 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
Knowledge Graph
| dtID | CID | Compound Name | Gene ID | Gene Name | Species | PubMed IDs | Action |
|---|---|---|---|---|---|---|---|
| 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 ID | Title | Phase | Status | Sponsor | Indications | Interventions | |
|---|---|---|---|---|---|---|---|
| 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 ID | Disease Name | Definition | Category | Related Drugs | Mechanism | |
|---|---|---|---|---|---|---|
| No data available | ||||||
| Strategy ID | Therapeutic Strategy | Synonyms | Related Drugs | Mechanism | |
|---|---|---|---|---|---|
| S01 | Anti-inflammatory | inflammatory | 5-Aminosalicylates (5-ASAs); corticosteroids | Crohn's disease and ulcerative colitis are the two main com… | Details |
A review of the biological and pharmacological activities of mesalazine or 5-am…
PMID: 34410540
Year: 2021
Relationship Type:
Treatment
Score: 10.0
Mesalazine, also known as 5-aminosalicylic acid (5-ASA), is a synthetic drug from the family of nonsteroidal anti-inflammatory drugs (NSAIDs) used fo…
Mesalazine granules 1.5 g once-daily maintain remission in patients with ulcera…
PMID: 22617015
Year: 2012
Relationship Type:
Treatment
Score: 10.0
BACKGROUND: Mesalazine (mesalamine) granules (MG) were shown to be effective for the maintenance of remission of ulcerative colitis (UC) in two doubl…
Review article: delivery and efficacy of topical 5-aminosalicylic acid (mesalaz…
PMID: 21385194
Year: 2011
Relationship Type:
Treatment
Score: 10.0
BACKGROUND: The use of topical therapy in the treatment of ulcerative colitis has declined in recent years despite evidence of good efficacy. AIMS: T…
Role of organic anion-transporting polypeptides for cellular mesalazine (5-amin…
PMID: 21430235
Year: 2011
Relationship Type:
Treatment
Score: 9.1
The therapeutic effects and metabolism of mesalazine (5-aminosalicylic acid) in patients with inflammatory bowel disease require intracellular accumu…
Mesalazine in inflammatory bowel disease: a trendy topic once again?
PMID: 20151072
Year: 2010
Relationship Type:
Treatment
Score: 9.1
5-aminosalicylic acid (5-ASA) preparations (eg, mesalazine, mesalamine) are well-established preparations used in the management of inflammatory bowe…
The colon targeting efficacies of mesalazine medications and their impacts on t…
PMID: 38599548
Year: 2024
Relationship Type:
Treatment
Score: 8.5
Successful treatment of ulcerative colitis (UC) is highly dependent on several parameters, including dosing regimen and the ability to deliver drugs …
Polymeric Systems for Colon-specific Mesalazine Delivery in the Intestinal Bowe…
PMID: 35796458
Year: 2023
Relationship Type:
Treatment
Score: 8.5
The anti-inflammatory 5-aminosalicylic acid (5-ASA) is the main therapeutic option used to prevent and treat inflammatory bowel diseases. The upper i…
[Mesalazine renal lithiasis.]
PMID: 32633252
Year: 2020
Relationship Type:
Treatment
Score: 8.5
Mesalazine (5-aminosalicylic acid, 5-ASA),is an anti-inflammatory drug well-established as first-line treatment in the management of inflammatory bow…
Prevention of postoperative recurrence of Crohn's disease: Tripterygium wilford…
PMID: 23569144
Year: 2013
Relationship Type:
Adverse Effect
Score: 8.1
OBJECTIVES: To explore effectiveness and safety of polyglycosides of Tripterygium wilfordii (GTW) and mesalazine (5-aminosalicylic acid [5-ASA]) in p…
Systematic review: molecular chemoprevention of colorectal malignancy by mesala…
PMID: 19891667
Year: 2010
Relationship Type:
Treatment
Score: 8.1
BACKGROUND: Mesalazine (mesalamine) (5-ASA) is considered an anti-inflammatory drug for the treatment of inflammatory bowel disease. It is well toler…
Influence of Pharmaceutical Formulation on the Mucosal Concentration of 5-Amino…
PMID: 30369547
Year: 2019
Relationship Type:
Treatment
Score: 7.5
The efficacy of 5-aminosalicylic acid (5-ASA) as the first-line therapy for ulcerative colitis (UC) is determined by the extent of drug delivery to t…
Possible Drug-Drug Interactions Between Mesalamine and Tricyclic Antidepressant…
PMID: 40169140
Year: 2025
Relationship Type:
Treatment
Score: 7.5
Mesalamine (mesalazine, 5-aminosalicylic acid, 5-ASA) is an essential anti-inflammatory agent both used for therapy and as a remission control in pat…
Mesalazine-Induced Myocarditis in Inflammatory Bowel Disease: A Systematic Revi…
PMID: 40027008
Year: 2025
Relationship Type:
Treatment
Score: 7.5
Crohn's disease (CD) and ulcerative colitis (UC) are two forms of inflammatory bowel disease (IBD). This chronic, immune-mediated disorder leads to i…
Mesalazine-Induced Acute Pancreatitis in Inflammatory Bowel Disease Patients: A…
PMID: 39897345
Year: 2025
Relationship Type:
Treatment
Score: 7.5
OBJECTIVE: Mesalazine is a widely used medication for treating mild to moderate inflammatory bowel disease (IBD). First identified as a potential cau…
Amelioration of inflammatory bowel disease by Bifidobacterium animalis subsp. l…
PMID: 39697653
Year: 2024
Relationship Type:
Treatment
Score: 7.5
The treatment of inflammatory bowel disease (IBD) remains challenging and significantly impacts both patients and their families. This study evaluate…
Solubility of mesalazine in pseudo-binary mixtures of choline chloride/ethylene…
PMID: 38017539
Year: 2023
Relationship Type:
Adverse Effect
Score: 7.5
Mesalazine (5-ASA) is a medication utilized to treat inflammatory bowel diseases involving ulcerative colitis and Crohn's disease. Mesalazine has few…
Mesalazine-induced myopericarditis: a case series
PMID: 37719002
Year: 2023
Relationship Type:
Treatment
Score: 7.5
BACKGROUND: Inflammatory bowel diseases (IBD) are characterized by chronic inflammation of the gastrointestinal tract but can have multiorgan involve…
[A case of ulcerative colitis with mesalazine intolerance complicated with agra…
PMID: 37690832
Year: 2023
Relationship Type:
Association
Score: 7.5
A 73-year-old woman developed ulcerative colitis with mesalazine intolerance a year ago. She relapsed 10 months later. Although she was in clinical r…
Potential of Mesalazine Therapeutic Drug Monitoring by Measuring Fecal Excretio…
PMID: 36823707
Year: 2023
Relationship Type:
Treatment
Score: 7.5
BACKGROUND: Therapeutic drug monitoring of mesalazine (5-ASA) in patients with ulcerative colitis is unavailable. Mucosal 5-ASA concentrations are as…
Analysis of clinical characteristics of mesalazine-induced cardiotoxicity
PMID: 36188558
Year: 2022
Relationship Type:
Treatment
Score: 7.5
Background: Mesalazine is the first-line inflammatory bowel disease (IBD) treatment. However, it can cause fatal cardiotoxicity. We aimed to analyze …