| 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 |
A Case Report and Literature Review of Mesalazine-Induced Kidney Injury in a Pe…
PMID: 35615637
Year: 2022
Relationship Type:
Treatment
Score: 7.5
BACKGROUND: Mesalazine, a preparation of 5-aminosalicylic acid, is a medication widely used in clinical practice as a first-line therapy in the treat…
Dapsone Azo-Linked with Two Mesalazine Moieties Is a "Me-Better" Alternative to…
PMID: 35336057
Year: 2022
Relationship Type:
Treatment
Score: 7.5
Dapsone (DpS) is an antimicrobial and antiprotozoal agent, especially used to treat leprosy. The drug shares a similar mode of action with sulfonamid…
The role of mesalazine co-treatment in the prevention of recurrence in subjects…
PMID: 35311735
Year: 2022
Relationship Type:
Treatment
Score: 7.5
AIM: To investigate the impact of mesalazine co-treatment in addition to the surgical intervention on recurrence rate in subjects with subclinical in…
Maternal mesalazine-induced neonatal gastrointestinal bleeding
PMID: 33858883
Year: 2021
Relationship Type:
Association
Score: 7.5
Ulcerative colitis often develops in the reproductive age women and can cause exacerbation by pregnancy. Mesalazine (5-aminosalicylic acid) is recomm…
Mesalazine-induced Hypersensitivity Pneumonitis
PMID: 33585338
Year: 2021
Relationship Type:
Treatment
Score: 7.5
A 57-year-old woman with Crohn's disease (ulcerative proctitis) treated with mesalazine (5-ASA) developed worsening respiratory distress and cough. T…
Nonasthmatic eosinophilic bronchitis in an ulcerative colitis patient - a putat…
PMID: 33024774
Year: 2020
Relationship Type:
Treatment
Score: 7.5
BACKGROUND: Lung and airway involvement in inflammatory bowel disease are increasingly frequently reported either as an extraintestinal manifestation…
Oral 5-aminosalicylic acid for maintenance of remission in ulcerative colitis
PMID: 32856298
Year: 2020
Relationship Type:
Treatment
Score: 7.5
BACKGROUND: Oral 5-aminosalicylic acid (5-ASA; also known as mesalazine or mesalamine) preparations were intended to avoid the adverse effects of sul…
Mesalazine induced focal segmental glomerulosclerosis in a patient with ulcerat…
PMID: 32394929
Year: 2020
Relationship Type:
Treatment
Score: 7.5
Focal segmental glomerulosclerosis (FSGS) and other glomerulonephritis due to the use of 5-aminosalicylic acid derivatives have been reported in the …
Plasma N-terminal pro-B-type natriuretic peptide (BNP) in mesalazine-induced my…
PMID: 30975785
Year: 2019
Relationship Type:
Treatment
Score: 7.5
Mesalazine (5-aminosalicylic acid)-based products are a widely used treatment for inflammatory bowel disease in children and adults. Associated myope…
Adherence, risk factors of non-adherence and patient's preferred treatment stra…
PMID: 29560753
Year: 2018
Relationship Type:
Treatment
Score: 7.3
OBJECTIVES: Compliance to therapy is a key factor in the efficacy of treatment in clinical practice. The aim of our study was to evaluate the rate of…
Once- Versus Twice-daily Mesalazine to Induce Remission in Paediatric Ulcerativ…
PMID: 28453754
Year: 2017
Relationship Type:
Adverse Effect
Score: 7.3
BACKGROUND: Trials in adults suggested that, in ulcerative colitis [UC], once-daily [OD] dosing of 5-ASA [5-amino salicylic acid] may be as or more e…
Mesalazine allergy in a boy with ulcerative colitis: clinical usefulness of muc…
PMID: 27503129
Year: 2016
Relationship Type:
Treatment
Score: 7.3
5-Aminosalicylic acid preparations have been used as first-line drugs for treatment of ulcerative colitis (UC). However, some patients with UC presen…
Gastroenterology case report of mesalazine-induced cardiopulmonary hypersensiti…
PMID: 25852295
Year: 2015
Relationship Type:
Treatment
Score: 7.3
Mesalazine is a 5-aminosalicylic acid derivative that has been widely used to treat patients with inflammatory bowel disease. Accumulating evidence i…
Combined oral and rectal mesalazine for the treatment of mild-to-moderately act…
PMID: 24012063
Year: 2014
Relationship Type:
Treatment
Score: 7.3
BACKGROUND AND AIMS: Mesalazine (5-aminosalicylic acid) is the standard first-line therapy for mild-to-moderate ulcerative colitis. In the PINCE stud…
In-vitro characterization of 5-aminosalicylic acid release from MMX mesalamine …
PMID: 21088944
Year: 2011
Relationship Type:
Association
Score: 7.1
INTRODUCTION: Substantial variability in gastrointestinal pH is observed in patients with ulcerative colitis (UC). We characterized the effect of pH …
Mesalazine for the treatment of inflammatory bowel disease
PMID: 23767798
Year: 2013
Relationship Type:
Treatment
Score: 7.1
INTRODUCTION: Ulcerative colitis (UC) and Crohn's disease (CD) represent a chronic inflammatory condition of the bowel that often require lifelong me…
Long-term oral mesalazine adherence and the risk of disease flare in ulcerative…
PMID: 22882428
Year: 2012
Relationship Type:
Association
Score: 7.1
BACKGROUND: Adherence is a major factor in determining disease activity in ulcerative colitis (UC). There are limited data on long-term nationwide ad…
Mesalazine granules are superior to Eudragit-L-coated mesalazine tablets for in…
PMID: 21923715
Year: 2011
Relationship Type:
Treatment
Score: 7.1
BACKGROUND: Different oral formulations of 'mesalazine (mesalamine)' may have different efficacy in distal ulcerative colitis. AIM: To evaluate the e…
Efficacy and safety of Fufangkushen colon-coated capsule in the treatment of ul…
PMID: 21911045
Year: 2012
Relationship Type:
Treatment
Score: 7.1
ETHNOPHARMACOLOGICAL RELEVANCE: Fufangkushen colon-coated capsule (FCC) was a newly developed herbal drug for treating ulcerative colitis (UC) patien…
Randomised clinical trial: early assessment after 2 weeks of high-dose mesalazi…
PMID: 21385195
Year: 2011
Relationship Type:
Treatment
Score: 7.1
BACKGROUND: Rapid resolution of rectal bleeding and stool frequency are important goals for ulcerative colitis therapy and may help guide therapeutic…