| 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 |
Randomised non-inferiority trial: 1600 mg versus 400 mg tablets of mesalazine f…
PMID: 28568974
Year: 2017
Relationship Type:
Treatment
Score: 6.3
BACKGROUND: High concentration mesalazine formulations are more convenient than conventional low concentration formulations for the treatment of ulce…
Oxidized 5-aminosalicylic acid activates Nrf2-HO-1 pathway by covalently bindin…
PMID: 28473247
Year: 2017
Relationship Type:
Treatment
Score: 6.3
Mesalazine (5-aminosalicylic acid, 5-ASA), a currently used drug for anti-inflammatory bowel disease, is easily oxidized by HOCl, a strong oxidant ge…
Accumulation of mesalazine pills in the medium ileum in a patient with Crohn´s …
PMID: 28256148
Year: 2017
Relationship Type:
Treatment
Score: 6.3
Crohn s disease is an inflammatory disease that can involve any portion of the gastrointestinal tract, although terminal ileum is the most commonly a…
Difficulties in Performing Mesalazine Enemas and Factors Related to Discontinua…
PMID: 27490278
Year: 2017
Relationship Type:
Treatment
Score: 6.3
Current first-line treatment of ulcerative colitis consists of a combination of mesalazine enemas and oral mesalazine; however, many patients may dis…
Effects of Mesalazine on Morphological and Functional Changes in the Indomethac…
PMID: 27294352
Year: 2017
Relationship Type:
Association
Score: 6.3
Morphological and functional changes have been investigated in the rat model of Crohn's disease. The inflammatory bowel disease was induced by indome…
Development of a zero-order sustained-release tablet containing mesalazine and …
PMID: 27000751
Year: 2016
Relationship Type:
Treatment
Score: 6.3
Ulcerative colitis (UC) and Crohn's disease (CD) are diseases affecting the gastrointestinal tract. Treatment depends on the severity of the disease,…
Ulcerative Colitis Remission Status After Induction With Mesalazine Predicts Ma…
PMID: 26908939
Year: 2016
Relationship Type:
Treatment
Score: 6.3
BACKGROUND AND AIMS: This study assessed the efficacy of maintenance treatment with multimatrix mesalazine following achievement of complete or parti…
Efficacy of mesalazine or beclomethasone dipropionate enema or their combinatio…
PMID: 26241537
Year: 2015
Relationship Type:
Treatment
Score: 6.3
OBJECTIVE: Mesalazine or Beclomethasone dipropionate (BDP) enema have been shown effective in treatment of distal active ulcerative colitis (UC). Thi…
Consecutive monitoring of faecal calprotectin during mesalazine suppository the…
PMID: 26140337
Year: 2015
Relationship Type:
Treatment
Score: 6.3
BACKGROUND: No studies have monitored the levels of faecal calprotectin (FC) during mesalazine suppository therapy for proctitis in ulcerative coliti…
[Cost-effectiveness assessment through theoretical cost-minimization analysis o…
PMID: 26072136
Year: 2016
Relationship Type:
Treatment
Score: 6.3
INTRODUCTION: The prevalence of ulcerative colitis (UC) and its associated economic burden is increasing in Spain. Oral mesalazines, which are the re…
Proposed case of mesalazine-induced cardiomyopathy in severe ulcerative colitis
PMID: 25805947
Year: 2015
Relationship Type:
Treatment
Score: 6.3
Five-amino salicylic acids are recommended for use in the management of inflammatory bowel disease, cardiac complications are a rare although recogni…
A mechanistic multicentre, parallel group, randomised placebo-controlled trial …
PMID: 25765462
Year: 2016
Relationship Type:
Treatment
Score: 6.3
INTRODUCTION: Immune activation has been reported in the mucosa of IBS patients with diarrhoea (IBS-D), and some small studies have suggested that me…
Ulcerative colitis patients with an inflammatory response upon mesalazine canno…
PMID: 25633468
Year: 2015
Relationship Type:
Treatment
Score: 6.3
BACKGROUND AND AIMS: Mesalazine is a key drug in the treatment of ulcerative colitis (UC). Intolerance to mesalazine has been described, including fe…
Dissolution of mesalazine modified release tablets under standard and bio-relev…
PMID: 25557626
Year: 2015
Relationship Type:
Treatment
Score: 6.3
OBJECTIVES: For the treatment of inflammatory bowel disease, the development of pH responsive modified release dosage forms is one of the most common…
Azathioprine is more effective than mesalazine at preventing recurrent bowel ob…
PMID: 25370731
Year: 2014
Relationship Type:
Treatment
Score: 6.3
BACKGROUND: Patients with subocclusive Crohn's disease (CD) who received azathioprine (AZA) therapy had lower re-hospitalization rates due to all cau…
Mesalazine in the initial management of severely acutely malnourished children …
PMID: 25189855
Year: 2014
Relationship Type:
Treatment
Score: 6.3
BACKGROUND: Environmental enteric dysfunction (EED) is an acquired syndrome of impaired gastrointestinal mucosal barrier function that is thought to …
Distinct kinetics in the frequency of peripheral CD4+ T cells in patients with …
PMID: 25144293
Year: 2014
Relationship Type:
Treatment
Score: 6.3
BACKGROUND: We found the first evidence of the efficacy of a herbal treatment with myrrh, dry extract of chamomile flowers, and coffee charcoal for u…
Efficacy of long-term 4.0 g/day mesalazine (Pentasa) for maintenance therapy in…
PMID: 25064629
Year: 2014
Relationship Type:
Treatment
Score: 6.3
BACKGROUND: High-dose (4.0 g/day) mesalazine is typically used for induction therapy, but its efficacy as maintenance therapy remains to be determine…
Pulmonary pathology in patients with ulcerative colitis treated with mesalazine…
PMID: 24964241
Year: 2014
Relationship Type:
Treatment
Score: 6.3
Pulmonary involvement in the course of inflammatory bowel disease has been a subject of interest to clinicians for long time, but despite this, its e…
A randomized clinical trial of mesalazine suppository: the usefulness and probl…
PMID: 24923656
Year: 2014
Relationship Type:
Clinical Trial
Score: 6.3
BACKGROUND: The methods of evaluating endoscopic mucosal findings and the definition of mucosal healing in inflammatory bowel disease have not been s…