| 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 |
Physicochemical Compatibility Investigation of Mesalazine and Folic Acid Using …
PMID: 32784456
Year: 2020
Relationship Type:
Treatment
Score: 6.5
Inflammatory bowel disease is a common name for Crohn's disease and ulcerative colitis. These inflammatory states cause damage in the sidewalls of th…
Targeting IL-10, ZO-1 gene expression and IL-6/STAT-3 trans-signaling by a comb…
PMID: 32383169
Year: 2021
Relationship Type:
Treatment
Score: 6.5
Ulcerative colitis (UC) is a chronic inflammatory disease characterized by diffused inflammation of the colon and rectum mucosa. The pathogenesis of …
Mesalazine Induces Oxidative Stress and Cytochrome c Release in Isolated Rat He…
PMID: 32308077
Year: 2020
Relationship Type:
Adverse Effect
Score: 6.5
Mesalazine is widely used in the management of inflammatory bowel disease. Previous studies reported that mesalazine-induced cardiotoxicity is a rare…
Effects of mesalazine combined with bifid triple viable on intestinal flora, im…
PMID: 32017001
Year: 2020
Relationship Type:
Treatment
Score: 6.5
OBJECTIVE: Ulcerative colitis (UC) commonly occurs in young and middle-aged people and is characterized by frequent attacks and difficult cure. Mesal…
Mesalazine-induced airway obstruction: Utility of pulmonary function testing in…
PMID: 31601486
Year: 2019
Relationship Type:
Treatment
Score: 6.5
Mesalazine is a standard therapeutic agent for the treatment of inflammatory bowel diseases. A rare case of mesalazine-induced airway obstruction doc…
Regulatory mechanism of mesalazine on TLR4/MyD88-dependent pathway in mouse ulc…
PMID: 31378906
Year: 2019
Relationship Type:
Treatment
Score: 6.5
OBJECTIVE: The aim of this study was to investigate the regulatory mechanism of mesalazine (MSLZ) on microRNA-21, microRNA-31 and Toll-like receptor …
Utility of Mesalazine in Familial Adenomatous Polyposis: Clinical Report of Red…
PMID: 31067545
Year: 2019
Relationship Type:
Treatment
Score: 6.5
Mesalazine is the gold standard drug for treatment of ulcerative colitis (UC). Here, we describe 4 cases of familial adenomatous polyposis (FAP) pati…
Recurrent Eosinophilic Pneumonia Associated with Mesalazine Suppository in a Pa…
PMID: 31030460
Year: 2019
Relationship Type:
Adverse Effect
Score: 6.5
Mesalazine suppositories are widely used to treat ulcerative colitis and have a guaranteed safety profile, but although rare, they can cause pulmonar…
A case of nivolumab-associated colitis, which relapsed after mucosal healing an…
PMID: 30917094
Year: 2019
Relationship Type:
Treatment
Score: 6.5
Currently, the number of patients treated with immune-checkpoint inhibitor involving nivolumab is increasing. Nevertheless, it causes various immune-…
Recurrent mesalazine-induced myopericarditis in a patient with ulcerative colit…
PMID: 30709886
Year: 2019
Relationship Type:
Treatment
Score: 6.5
Mesalazine is a common treatment for inflammatory bowel disease and can be rarely associated with myopericarditis. We report a case of a 19-year-old …
Crohn's Disease with Mesalazine Allergy that Was Difficult to Differentiate fro…
PMID: 30333413
Year: 2019
Relationship Type:
Treatment
Score: 6.5
An 18-year-old man diagnosed with ileocolonic Crohn's disease with circumferential strictures of the ascending colon started treatment with mesalazin…
The study of marketed and experimental formulation approaches enabling site-spe…
PMID: 24111938
Year: 2014
Relationship Type:
Treatment
Score: 6.3
This patent review focuses exclusively on the oral delivery of mesalamine (5-ASA) and excludes oral mesalamine pro-drug and rectal delivery formulati…
Efficacy of mesalazine in combination with bifid triple viable capsules on ulce…
PMID: 30630805
Year: 2018
Relationship Type:
Treatment
Score: 6.3
Present investigation is conducted to investigate the clinical efficacy of mesalazine in combination with the Bifid Triple Viable Capsules on the ulc…
Mesalazine treatment causing resolution of intracranial hypertension secondary …
PMID: 30544405
Year: 2018
Relationship Type:
Treatment
Score: 6.3
RATIONALE: The association between intracranial hypertension (ICH) and ulcerative colitis (UC) is rare. We report the unusual case of a male patient …
Comparison of efficacy of once daily multimatrix mesalazine 2.4 g/day and 4.8 g…
PMID: 29743838
Year: 2018
Relationship Type:
Treatment
Score: 6.3
BACKGROUND: Patients with inflammatory bowel disease who achieve remission with anti-tumour necrosis factor (anti-TNF) drugs may have treatment with…
Optimized Management of Ulcerative Proctitis: When and How to Use Mesalazine Su…
PMID: 29393142
Year: 2018
Relationship Type:
Treatment
Score: 6.3
BACKGROUND: Ulcerative proctitis, one of the disease types of ulcerative colitis, is considered one of the initial manifestations of ulcerative colit…
Mesalazine as a cause of fetal anemia and hydrops fetalis: A case report
PMID: 29390381
Year: 2017
Relationship Type:
Association
Score: 6.3
RATIONALE: Mesalazine and its prodrug sulfasalazine are both used for inflammatory bowel disease. Sulfasalazine has been associated with hematologica…
Multi Matrix System Mesalazine Plus Rectal Mesalazine in the Treatment of Mild …
PMID: 29339645
Year: 2018
Relationship Type:
Treatment
Score: 6.3
BACKGROUND: Mesalazine 1 g suppository/die is used for mild to moderately active ulcerative proctitis (UP). Whether addiction of Multi Matrix System …
Mesalazine induced myopericarditis in a patient with ulcerative colitis
PMID: 29138234
Year: 2017
Relationship Type:
Association
Score: 6.3
A 25-year-old male with a background of ulcerative colitis presented with a two-week history of central chest pain. His ECG on presentation showed gl…
Urinalysis of MMX-mesalazine as a tool to monitor 5-ASA adherence in daily IBD …
PMID: 29073323
Year: 2018
Relationship Type:
Association
Score: 6.3
Rare inherited bleeding disorders (IBD) are a common cause of bleeding tendency. To ensure a correct diagnosis, specialized laboratory analyses are …