| 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 |
Mesalazine dose modification based on faecal calprotectin levels in patients wi…
PMID: 37806344
Year: 2024
Relationship Type:
Treatment
Score: 6.5
BACKGROUND: Faecal calprotectin (FC) shows an excellent correlation with endoscopic and histological activity of ulcerative colitis (UC) and it is th…
Myocarditis Related to the Use of Mesalazine
PMID: 37560552
Year: 2023
Relationship Type:
Treatment
Score: 6.5
Myocarditis is a rare complication of therapy with mesalazine, a drug traditionally used in the treatment of inflammatory bowel disease. We report a …
Efficacy of oral prolonged-release mesalazine in moderately active ulcerative c…
PMID: 37496812
Year: 2023
Relationship Type:
Treatment
Score: 6.5
New meta-analyses are presented that provide further evidence supporting the effectiveness of oral prolonged-release mesalazine compared to other ora…
Mesalazine granules promote disease clearance in patients with mild-to-moderate…
PMID: 37490352
Year: 2023
Relationship Type:
Treatment
Score: 6.5
BACKGROUND: Over the past decade, treatment targets for ulcerative colitis (UC) have become more stringent, incorporating multiple parameters. Recent…
Molecular Mechanisms of the Antitumor Effects of Mesalazine and Its Preventive …
PMID: 37446747
Year: 2023
Relationship Type:
Treatment
Score: 6.5
Chemoprevention is one of the ways to fight colorectal cancer, which is a huge challenge in oncology. Numerous pieces of evidence indicate that chron…
Mesalazine hollow suppositories based on 3D printing for treatment of ulcerativ…
PMID: 37399930
Year: 2023
Relationship Type:
Treatment
Score: 6.5
Mesalazine (MSZ) suppositories are a first-line medication for the localized treatment of ulcerative colitis (UC). However, the frequent defecation o…
Mesalazine-PAMAM Nanoparticles for Transporter-Independent Intracellular Drug D…
PMID: 37122501
Year: 2023
Relationship Type:
Treatment
Score: 6.5
BACKGROUND: Mesalazine is one of the main drugs used to treat inflammatory bowel diseases. However, its applicability is limited by its rapid inactiv…
Serum Bile Acid Metabolites Predict the Therapeutic Effect of Mesalazine in Pat…
PMID: 36921116
Year: 2023
Relationship Type:
Treatment
Score: 6.5
Ulcerative colitis (UC) is a systematic chronic disease characterized by insufficient intestinal absorption, and mesalazine is a common medical treat…
Insights into Mesalazine Use in Clinical Practice of Young Gastroenterologists
PMID: 36902792
Year: 2023
Relationship Type:
Association
Score: 6.5
BACKGROUND: Mesalazine is among the medications most prescribed by gastroenterologists, with variable and controversial use in different settings. We…
Mesalazine-Induced Interstitial Nephritis in a Patient With Ulcerative Colitis
PMID: 36644061
Year: 2022
Relationship Type:
Association
Score: 6.5
Acute interstitial nephritis (AIN) corresponds to a decline in kidney function due to an injury induced by drugs (in the majority of cases), infectio…
Effect of mesalazine combined with probiotics on inflammation and immune functi…
PMID: 36505287
Year: 2022
Relationship Type:
Treatment
Score: 6.5
OBJECTIVE: To determine the effects of mesalazine combined with probiotics on inflammation and immune function of patients with inflammatory bowel di…
Significance of 5-Aminosalicylic Acid Intolerance in the Clinical Management of…
PMID: 36366816
Year: 2023
Relationship Type:
Treatment
Score: 6.5
BACKGROUND: Two major types of 5-aminosalicylic acid (5-ASA)-containing preparations, namely, mesalazine/5-ASA and sulfasalazine (SASP), are currentl…
[Lung disease/pneumonitis in a patient with ulcerative colitis due to mesalazin…
PMID: 36286637
Year: 2021
Relationship Type:
Treatment
Score: 6.5
Mesalazine is a main medicine for treatment of ulcerative colitis. Most patience of left-sides and total colitis receive oral mesalazine for many yea…
Real-world evidence of quality of life improvement in patients with distal ulce…
PMID: 36165055
Year: 2022
Relationship Type:
Treatment
Score: 6.5
BACKGROUND: Distal ulcerative colitis (UC) is responsible for distressing symptoms and reduces quality of life (QoL). Oral and topical formulations o…
The safety of paternal and maternal use of 5-aminosalicylic acid during concept…
PMID: 36031741
Year: 2022
Relationship Type:
Association
Score: 6.5
BACKGROUND: Data on the safety of paternal use of 5-aminosalicylic acid (5-ASA) prior to conception are lacking, and the safety of maternal use of 5-…
The insoluble excretion of multi-matrix system mesalazine preparations in patie…
PMID: 35982420
Year: 2022
Relationship Type:
Treatment
Score: 6.5
BACKGROUND: Multi-matrix mesalazine (MMX) is an important treatment for ulcerative colitis (UC); however, it is often excreted intact, which increase…
Targeted colonic release formulations of mesalazine - A clinical pharmaco-scint…
PMID: 35926752
Year: 2022
Relationship Type:
Treatment
Score: 6.5
Colonic targeting of orally applied therapeutic drugs remains a challenge. Tablet coatings relying on gastrointestinal pH and colonic bacterial enzym…
[A preliminary study on the improved efficacy of mesalazine combined with vitam…
PMID: 35764562
Year: 2022
Relationship Type:
Treatment
Score: 6.5
Objective: To analyze the influence of vitamin D(3) supplementation on the clinical efficacy of mesalazine in patients with ulcerative colitis (UC). …
Integrated Analysis Reveals the Targets and Mechanisms in Immunosuppressive Eff…
PMID: 35662946
Year: 2022
Relationship Type:
Treatment
Score: 6.5
BACKGROUND: Ulcerative colitis (UC) is an inflammatory bowel disease that causes inflammation and ulcers in the digestive tract. Approximately 3 mill…
C-reactive protein levels and prevalence of leukopenia in patients with inflamm…
PMID: 35584442
Year: 2022
Relationship Type:
Treatment
Score: 6.5
OBJECTIVE: To examine serum C-reactive protein levels and the prevalence of leukopenia in patients with Crohn's disease or ulcerative colitis undergo…