| 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 | |
|---|---|---|---|---|---|---|---|
| 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 |
| NCT01011322 | A Study to Investigate the Efficacy of LT-02 in Patients With Mesalazine Refractory Ulcerative Colitis | PHASE2 | UNKNOWN | Lipid Therapeutics GmbH | Ulcerative Colitis|Large Intestine|Diarrhea|Abdom… | DRUG: LT-02|DRUG: placebo | Details |
| NCT04133194 | Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis | PHASE4 | RECRUITING | Flemming Bendtsen | Ulcerative Colitis | DRUG: Mesalazine|DRUG: Mesalazine | Details |
| NCT01257386 | Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis | PHASE3 | COMPLETED | Tillotts Pharma AG | Active Ulcerative Colitis | DRUG: Asacol|DRUG: Mesalazine | Details |
| NCT06176560 | Phase III Multicentre Trial of Oral Mesalazine in Patients With Mild to Moderate Ulcerative Colitis. | PHASE3 | NOT_YET_RECRUITING | Faes Farma, S.A. | Colitis, Ulcerative | DRUG: Mesalazine | Details |
| NCT00708656 | The Colitis Once Daily Asacol Study | PHASE3 | COMPLETED | Cardiff and Vale University Health Board | Ulcerative Colitis | DRUG: mesalazine (Asacol) | Details |
| NCT00151944 | Safety and Tolerability of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis. | PHASE3 | COMPLETED | Shire | Colitis, Ulcerative | DRUG: SPD476 (mesalazine) | Details |
| NCT00747110 | Budesonide Capsules Versus Mesalazine Granules in Active Ulcerative Colitis (UC) | PHASE3 | COMPLETED | Dr. Falk Pharma GmbH | Colitis, Ulcerative | DRUG: budesonide|DRUG: mesalazine | Details |
| NCT01257399 | Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission Phase | PHASE3 | COMPLETED | Tillotts Pharma AG | Ulcerative Colitis in Remission | DRUG: Asacol|DRUG: Mesalazine | Details |
| NCT05386290 | A Multicentered Prospective Cohort Study of Chinese IBD Patients | None | UNKNOWN | Peking Union Medical College Hospital | Ulcerative Colitis|Crohn Disease | DRUG: Infliximab|DRUG: Vedolizumab|DRUG: Ustekinu… | Details |
| NCT01124149 | Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative Colitis | PHASE4 | COMPLETED | Shire | Ulcerative Colitis | DRUG: MMX mesalamine/ mesalazine | Details |
| NCT00503243 | Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis | PHASE3 | COMPLETED | Shire | Colitis, Ulcerative | DRUG: Delayed and extended release mesalazine | Details |
| NCT00449722 | OD vs. TID Dosing With Mesalazine Granules in Active Ulcerative Colitis | PHASE3 | COMPLETED | Dr. Falk Pharma GmbH | Ulcerative Colitis | DRUG: mesalazine | Details |
| NCT00737789 | Mesalazine 4g Once Daily Versus 4g in Two Divided Doses in Active Ulcerative Colitis. | PHASE3 | COMPLETED | Ferring Pharmaceuticals | Ulcerative Colitis | DRUG: Mesalazine slow-release granules|DRUG: Mesa… | 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 |
| NCT00808977 | A Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Ulcerative Colitis | PHASE2 | COMPLETED | Palau Pharma S.L.U. | Ulcerative Colitis | DRUG: Dersalazine sodium|DRUG: Mesalazine|DRUG: P… | Details |
| NCT02537210 | Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative Colitis | None | COMPLETED | Chinese University of Hong Kong | Colitis, Ulcerative|Aminosalicylic Acid | DRUG: Mesalazine|DRUG: Placebo oral capsule | Details |
| NCT00545389 | Phase II Dose-Ranging Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476 | PHASE2 | COMPLETED | Shire | Colitis, Ulcerative | DRUG: SPD476 is a polymeric matrix formulation th… | Details |
| NCT02261636 | Induction and Maintenance of Remission With Pentasa as Ulcerative Colitis Treatment | None | COMPLETED | Ferring Pharmaceuticals | Ulcerative Colitis | DRUG: mesalazine | Details |
| NCT03917095 | The Safety and Efficacy of TET Enema in the Treatment of UC | None | UNKNOWN | The Second Hospital of Nanjing Medical University | Ulcerative Colitis Chronic Mild|Ulcerative Coliti… | DEVICE: The Colonic Transendoscopic enteral Tubin… | 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 |
Three cases of mesalazine-induced pneumonitis with eosinophilia
PMID: 24853024
Year: 2014
Relationship Type:
Treatment
Score: 6.3
Oral mesalazine, or 5-aminosalicylate, is one of the first-choice medications for the treatment of ulcerative colitis and is commonly used for both i…
Electronic monitoring of medication adherence in a 1-year clinical study of 2 d…
PMID: 24284414
Year: 2014
Relationship Type:
Association
Score: 6.3
BACKGROUND: Adherence to medication is an issue of great importance for patients with ulcerative colitis. Once daily mesalazine seems to be no worse …
Cost and quality-adjusted life year differences in the treatment of active ulce…
PMID: 24094599
Year: 2014
Relationship Type:
Treatment
Score: 6.3
BACKGROUND: Improved compliance in active ulcerative colitis (UC) is likely to improve healthcare efficiency by reducing time spent in active mild to…
Treatment of diarrhea-predominant irritable bowel syndrome with mesalazine and/…
PMID: 24474234
Year: 2013
Relationship Type:
Treatment
Score: 6.1
CONTEXT: Irritable bowel syndrome (IBS) is a functional bowel disease characterized by abdominal pain and altered intestinal habits. The pathophysiol…
Effect of azathioprine or mesalazine therapy on incidence of re-hospitalization…
PMID: 23989915
Year: 2013
Relationship Type:
Treatment
Score: 6.1
BACKGROUND: Although the cost of Crohn's disease (CD) treatment differs considerably, hospitalization and surgery costs account for most of the total…
Comparison of QD and TID oral mesalazine for maintenance of remission in quiesc…
PMID: 23624890
Year: 2013
Relationship Type:
Treatment
Score: 6.1
BACKGROUND: Mesalazine preparations are widely used to treat mild to moderately severe ulcerative colitis (UC). We compared once-daily administration…
Pure white cell aplasia induced by mesalazine in a patient with ulcerative coli…
PMID: 23321335
Year: 2013
Relationship Type:
Treatment
Score: 6.1
Objectives and importance: Mesalazine is a widely used and generally safe drug for the treatment of chronic inflammatory bowel diseases. Neutropenia …
[Rescue therapy with sulfasalazine prior to immunosuppressive or biological age…
PMID: 23195755
Year: 2013
Relationship Type:
Treatment
Score: 6.1
INTRODUCTION: In ulcerative colitis, aminosalicylates are the mainstay of maintenance therapy. Sulfasalazine was the first aminosalicylic used in the…
The effect of third-party reporting on adoption of evidence-based mesalazine re…
PMID: 22951030
Year: 2013
Relationship Type:
Association
Score: 6.1
BACKGROUND AND AIMS: The optimal mesalazine dosing strategy for ulcerative colitis (UC) continues to evolve. The current study aimed to explore wheth…
The economics of mesalazine in active ulcerative colitis and maintenance in the…
PMID: 22859419
Year: 2012
Relationship Type:
Treatment
Score: 6.1
BACKGROUND: In this study we investigate the costs and benefits of topical mesalazine combined with oral mesalazine therapy for active ulcerative col…
The impact of MMX mesalazine on disease-specific health-related quality of life…
PMID: 22536781
Year: 2012
Relationship Type:
Treatment
Score: 6.1
BACKGROUND: Past studies with ulcerative colitis (UC) patients indicate that disease activity strongly predicts health-related quality of life (HRQL)…
Mesalamine in the treatment and maintenance of remission of ulcerative colitis
PMID: 22390554
Year: 2012
Relationship Type:
Treatment
Score: 6.1
Ulcerative colitis (UC) is a chronic disease of the GI tract that is characterized by mucosal inflammation in the colon. Mesalamine (mesalazine) is a…
The pharmacological profile and clinical use of mesalazine (5-aminosalicylic ac…
PMID: 22344548
Year: 2012
Relationship Type:
Association
Score: 6.1
Not found
[A case of lung injury induced by long-term administration of mesalazine]
PMID: 22171492
Year: 2011
Relationship Type:
Adverse Effect
Score: 6.1
A 52-year-old man was given a diagnosis of ulcerative colitis and treated with mesalazine for 7.5 years. However, the unusually long administration o…
[Mesalazine and sulphasalazine for Crohn's disease: few indications, severe adv…
PMID: 22152414
Year: 2011
Relationship Type:
Treatment
Score: 6.1
We report 3 cases of the occurrence of adverse events in patients with Crohn's disease who were given aminosalicylic acids. The first case involved a…
Early symptomatic response and mucosal healing with mesalazine rectal suspensio…
PMID: 21848857
Year: 2011
Relationship Type:
Treatment
Score: 6.1
BACKGROUND: Rapid resolution of symptoms and endoscopic inflammation in ulcerative colitis (UC) represent important treatment goals. AIMS: To establi…
[Two cases of drug-induced intrathoracic lesions caused by mesalazine in patien…
PMID: 21842693
Year: 2011
Relationship Type:
Treatment
Score: 6.1
We encountered 2 cases of drug-induced intrathoracic lesions caused by allergic reactions to mesalazine in patients with ulcerative colitis. Case 1: …
Optimizing clinical use of mesalazine (5-aminosalicylic acid) in inflammatory b…
PMID: 21765868
Year: 2011
Relationship Type:
Treatment
Score: 6.1
Inflammatory bowel diseases (IBD) are classically divided in Crohn's disease (CD) and ulcerative colitis (UC). However, these two entities are still…
Evolution and predictive factors of relapse in ulcerative colitis patients trea…
PMID: 21575881
Year: 2011
Relationship Type:
Treatment
Score: 6.1
INTRODUCTION: Mesalazine remains the first line treatment for the induction and the maintenance of remission in mild to moderate ulcerative colitis (…
3g mesalazine granules are superior to 9mg budesonide for achieving remission i…
PMID: 21453882
Year: 2011
Relationship Type:
Treatment
Score: 6.1
BACKGROUND AND AIMS: Budesonide may be an effective therapy for mild-to-moderately active ulcerative colitis (UC). This study aimed to demonstrate no…