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Drug

Mesalamine

Approved · FDA
Emerging researchLate-stage development
Also known as 3-carboxy-4-hydroxyaniline, 5-ASA, 5-aminosalicylic acid, Apriso+13 more

3-carboxy-4-hydroxyaniline, 5-ASA, 5-aminosalicylic acid, Apriso, Asacol, Canasa, Delzicol, FIV-ASA, Fisalamine, Lialda, Mesalazinum, Pentasa, Rowasa, m-Aminosalicylic acid, Mesalazina, Mesalazine, mesalazin.

RxNorm52582ChEMBLCHEMBL704UNII4Q81I59GXC
2
Research papers
11
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Prophylactic Oral Mesalamine for the Prevention of Immune-Related Colitis in Patients Treated With Ipilimumab/Nivolumab

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

A Randomized, Double-blind Study to Assess the Safety and Efficacy of Mesalamine Delayed-release Capsules in Children Aged 5 to 17 Years for the Maintenance of Remission of Ulcerative Colitis

Clinical trial2026-07-19Withdrawn · ClinicalTrials.gov

Clinical Study to Evaluate Safety and Efficacy of Rupatadine in Patients With Ulcerative Colitis.

Clinical trial2026-07-15Primary completion · ClinicalTrials.gov

Clinical Study Evaluating Safety and Efficacy of Pentoxifylline in Patients With Ulcerative Colitis

Clinical trial2026-04-15Results expected Q1 2027 · ClinicalTrials.gov

Activation of Autophagy and Suppression of Apoptosis by Dapagliflozin Attenuates Inflammatory Bowel Disease

Clinical trial2026-03-13Results expected Q3 2027 · ClinicalTrials.gov

Efficacy of Acupuncture Combined With Mesalazine in Inducing and Maintaining Clinical Remission in Mild-to-Moderate Active Ulcerative Colitis: A Single-Center, Randomized Controlled Clinical Trial.

Clinical trial2026-02-05Results expected Q3 2027 · ClinicalTrials.gov

Efficacy and Safety of Desloratadine as Adjuvant Therapy in Patients With Ulcerative Colitis

Clinical trial2026-01-29Results expected Q1 2027 · ClinicalTrials.gov

Clinical Study to Evaluate the Possible Efficacy of Fenofibrate in Patient With Ulcerative Colitis

Clinical trial2025-09-20Completed · ClinicalTrials.gov

A Randomised, Double-blind, Double-dummy, Multicentre, Phase III, Non Inferiority Trial of an Oral Mesalazine Formulation in Patients With Active Mild to Moderate Ulcerative Colitis for the Induction of Remission.

Clinical trial2025-08-01Primary completion · ClinicalTrials.gov

Approval: MESALAMINE (ANDA219028)

Regulatory2025-04-14FDA

Factors associated with early outcomes following standardised therapy in children with ulcerative colitis (PROTECT): a multicentre inception cohort study.

Research2017-09-20The lancet. Gastroenterology & hepatology

Mesalamine dose escalation reduces fecal calprotectin in patients with quiescent ulcerative colitis.

Research2014-04-30Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Mesalamine
Aliases & brands
3-carboxy-4-hydroxyaniline5-ASA5-aminosalicylic acidAprisoAsacolCanasaDelzicolFIV-ASAFisalamineLialdaMesalazinumPentasaRowasam-Aminosalicylic acidMesalazinaMesalazinemesalazin
RxNorm CUI
52582
ChEMBL ID
CHEMBL704
UNII
4Q81I59GXC
Regulatory jurisdictions
fda

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2025-04-14
Latest approval
2025-04-14
Authorities
FDA
Total events
1
fdaU.S. Food and Drug Administration· 1 event
2025-04-14Approval
Approval: MESALAMINE (ANDA219028)
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

101 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
101
registered trials across all phases
LATEST COMPLETION 2025
11
Active studies
10
Recruiting
69
Late-stage (III+)
66
Completed
24
Discontinued
PHASE DISTRIBUTIONn = 101
Early Phase 11Phase 17Phase 1 / 24Phase 220Phase 2 / 35Phase 342Phase 414Phase N / A8

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis (EASI-trial)

Unknown statusPH IVFlemming Bendtsenn=2002025

Efficacy of Mesalazine Combined With Biologics in the Treatment of Moderate to Severe Ulcerative Colitis: a Multicenter, Prospective, Randomized, Controlled Clinical Study

CompletedPH IVSixth Affiliated Hospital, Sun Yat-sen Universityn=4382025

ChAracterizing the Remission Status in Patients With Ulcerative Colitis Treated by 5-ASA

CompletedPH IVBelgian Inflammatory Bowel Disease Research and Development (BIRD) VZWn=2002024

Multicenter Open-label Study Evaluating the Safety and Efficacy of Standardized Initial Therapy Using Either Mesalamine or Corticosteroids Then Mesalamine to Treat Children and Adolescents With Newly Diagnosed Ulcerative Colitis.

CompletedPH IVConnecticut Children's Medical Centern=4312018

A Randomized, Double-blind Study Investigating the Efficacy and Safety of Mesalazine With Hydrocortisone Sodium Succinate (100mg QD) Enema for 4-Week Treatment in Patients With Ulcerative Colitis (UC)

Unknown statusPH IVXijing Hospital of Digestive Diseasesn=5282018

Recent completions

Trials that read out recently, adding to the completed evidence base.

Clinical Study to Evaluate the Possible Efficacy of Fenofibrate in Patient With Ulcerative Colitis

CompletedPH II/IIITanta Universityn=602025

Repurposing Atorvastatin in Patients With Ulcerative Colitis Treated With Mesalamine by Modulation of mTOR/NLRP3 Pathway.

CompletedPH IITanta Universityn=542025

Clinical Study to Evaluate the Possible Efficacy of Nifuroxazide in Patient With Ulcerative Colitis

CompletedPH II/IIIMostafa Bahaan=502025

Clinical Study to Evaluate the Possible Efficacy and Safety of Minocycline in Patients With Ulcerative Colitis Treated With Mesalamine

CompletedPH IIMostafa Bahaan=462025

Efficacy of Mesalazine Combined With Biologics in the Treatment of Moderate to Severe Ulcerative Colitis: a Multicenter, Prospective, Randomized, Controlled Clinical Study

CompletedPH IVSixth Affiliated Hospital, Sun Yat-sen Universityn=4382025

Repurposing Fenofibrate in Modulating mTOR/NLRP3 Inflammasome in Patients With Ulcerative Colitis

CompletedPH IITanta Universityn=602024

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20142017
Most influential

Factors associated with early outcomes following standardised therapy in children with ulcerative colitis (PROTECT): a multicentre inception cohort study.

The lancet. Gastroenterology & hepatology · 2017 · 71 cites

Mesalamine dose escalation reduces fecal calprotectin in patients with quiescent ulcerative colitis.

Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2014 · 68 cites
Recent papers

Factors associated with early outcomes following standardised therapy in children with ulcerative colitis (PROTECT): a multicentre inception cohort study.

The lancet. Gastroenterology & hepatology · 2017 · 71 cites

Mesalamine dose escalation reduces fecal calprotectin in patients with quiescent ulcerative colitis.

Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2014 · 68 cites
Journals, researchers & institutions
Top journals
  • Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association1
  • The lancet. Gastroenterology & hepatology1
Leading researchers
  • Aberra FN1
  • Baker SS1
  • Baldassano RN1
  • Benkov K1
  • Boyle B1
  • Brensinger C1
  • Britt A1
  • Collins MH1
Leading institutions
free-text, unnormalised
  • Ann & Robert H Lurie Children's Hospital of Chicago1
  • Center for Clinical Epidemiology and Biostatistics1
  • Chevy Chase Clinic Research and George Washington University Medical School1
  • Children's Hospital of East Ontario1
  • Children's Hospital of Pittsburgh1
  • Cincinnati Children's Hospital Medical Center1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.