Clinical Trials

Mesalazine (5-ASA) is supported by numerous clinical trials primarily focused on inflammatory gastrointestinal disorders, including ulcerative colitis, Crohn's disease, irritable bowel syndrome with diarrhoea, oral ulcers, and colonic diverticulosis. Ranging from Phase 1 pharmacokinetic evaluations to Phase 3 and Phase 4 assessments, these studies encompass completed, recruiting, terminated, and withdrawn protocols. Research is sponsored by both pharmaceutical entities, such as Ferring Pharmaceuticals and Tillotts Pharma AG, and academic medical centers, including Rush University Medical Center and the University of Nottingham.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07773948 NOT_YET_RECRUITING
Ulcerative Colitis (UC); Pouchitis
University Hospital, Linkoeping
 2027-04-01 PHASE4
NCT03804931 RECRUITING
Ulcerative Colitis; Fecal Microbiota Transplantation
Guangzhou First People's Hospital
 2019-01-20 PHASE2; PHASE3
NCT07767370 RECRUITING
Diarrhea Chronic; UC - Ulcerative Colitis
The Second Hospital of Nanjing Medical University
 2026-07-20 EARLY_PHASE1
NCT07389824 RECRUITING
Ulcerative Colitis
Qin Yu
 2026-02-01
NCT07782242 NOT_YET_RECRUITING
Etrasimod; Mesalazine; Ulcerative Colitis (UC); Head-to-head
Sir Run Run Shaw Hospital
 2026-07-31 PHASE4
NCT07248644 NOT_YET_RECRUITING
Ulcerative Colitis (UC)
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
 2026-05-01 PHASE4
NCT03261206 ACTIVE_NOT_RECRUITING
Crohn Disease; Remission
Alimentiv Inc.
 2017-11-20 PHASE4
NCT06878495 NOT_YET_RECRUITING
Ulcerative Colitis (UC); Crohn's Disease; Inflammatory Bowel Disease (IBD)
Pusan National University Hospital
 2025-06-15
NCT06176560 UNKNOWN
Colitis, Ulcerative
Faes Farma, S.A.
 2024-03 PHASE3
NCT03441893 UNKNOWN
Ulcerative Colitis; Ulcerative Colitis Exacerbation; Protozoan Infections; Helminth Infection
Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
 2015-01-01 PHASE1; PHASE2
NCT05912712 UNKNOWN
Ulcerative Colitis Chronic Moderate; Ulcerative Colitis Chronic Severe; Rectal Ulcer
Xijing Hospital of Digestive Diseases
 2023-07-01 PHASE1
NCT06201793 COMPLETED
Inflammatory Bowel Diseases
Mostafa Bahaa
 2024-01-22 PHASE2
NCT04133194 UNKNOWN
Ulcerative Colitis
Flemming Bendtsen
 2019-11-28 PHASE4
NCT05561062 COMPLETED
Inflammatory Bowel Diseases
Tanta University
 2022-12-01 PHASE2
NCT05780723 COMPLETED
Ulcerative Colitis
Beijing Hospital of Traditional Chinese Medicine
 2023-04-04
NCT05992142 COMPLETED
Ulcerative Colitis
Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
 2023-01-17 PHASE4
NCT05205603 COMPLETED
Ulcerative Colitis; Efficacy, Self; Biologics; Mesalazine
Sixth Affiliated Hospital, Sun Yat-sen University
 2022-01-15 PHASE4
NCT05488405 COMPLETED
Eosinophilic Esophagitis
Dr. Falk Pharma GmbH
 2023-02-09 PHASE2
NCT05992142 Completed
Ulcerative Colitis
Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW|Ferring Pharmaceuticals
 2023-01-17 Phase 4
NCT05538026 COMPLETED
Ulcerative Colitis Chronic Mild; Inflammatory Bowel Diseases
Bogomolets National Medical University
 2020-09-01
NCT04499495 Completed
Ulcerative Colitis
Ferring Pharmaceuticals
 2021-10-25 --
NCT02537210 COMPLETED
Colitis, Ulcerative; Aminosalicylic Acid
Chinese University of Hong Kong
 2015-09
NCT05213234 Recruiting
Ulcerative Colitis
Rush University Medical Center|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2021-07-09 Not Applicable
NCT02665845 COMPLETED
Ulcerative Colitis
Centre Hospitalier Universitaire de Saint Etienne
 2016-06-13 PHASE3
NCT01941589 COMPLETED
Ulcerative Colitis
Sheba Medical Center
 2013-09 PHASE4
NCT03104036 COMPLETED
Ulcerative Colitis
Institute for Clinical and Experimental Medicine
 2017-06-19 PHASE2
NCT05091775 COMPLETED
Fissure in Ano; Diarrhea
Shiraz University of Medical Sciences
 2020-06-01 PHASE1; PHASE2
NCT04969679 COMPLETED
Ulcerative Colitis
Kangbuk Samsung Hospital
 2018-03-16 PHASE4
NCT03412682 COMPLETED
Colitis, Ulcerative
Ferring Pharmaceuticals
 2018-03-02 PHASE3
NCT02277223 Withdrawn
Ulcerative Colitis
Schneider Children''s Medical Center Israel
 2020-03-01 Phase 3
NCT03917095 UNKNOWN
Ulcerative Colitis Chronic Mild; Ulcerative Colitis Chronic Moderate
The Second Hospital of Nanjing Medical University
 2019-05-15
NCT03070574 TERMINATED
Colorectal Cancer
Christoph Gasche
 2017-11-24 PHASE2
NCT02093663 COMPLETED
Ulcerative Colitis
Shire
 2014-12-12 PHASE3
NCT01536535 COMPLETED
Ulcerative Colitis
Connecticut Children's Medical Center
 2012-07-10 PHASE4
NCT03110198 UNKNOWN
Ulcerative Colitis, Unspecified
Xijing Hospital of Digestive Diseases
 2017-05 PHASE4
NCT02335281 UNKNOWN
Inflammatory Bowel Disease; Ulcerative Colitis; Crohn's Disease
Yanling Wei
 2015-01 PHASE2
NCT01209208 COMPLETED
Lymphocytic Colitis
Dr. Falk Pharma GmbH
 2010-05 PHASE3
NCT03415711 Terminated
Ulcerative Colitis
VSL Pharmaceuticals|Actial Farmaceutica S.r.l.
 2017-04-28 Not Applicable
NCT02368717 COMPLETED
Ulcerative Colitis
Ferring Pharmaceuticals
 2015-03 PHASE3
NCT02769494 WITHDRAWN
Crohn's Disease; Oral Ulcer
Xijing Hospital of Digestive Diseases
 2016-03 PHASE3
NCT01699438 COMPLETED
Irritable Bowel Syndrome
Hans Törnblom
 2012-04 PHASE2
NCT02077777 COMPLETED
Colorectal Cancer
SOFAR S.p.A.
 2012-10 PHASE2
NCT02044952 UNKNOWN
Inflammatory Bowel Diseases; Crohn's Disease; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases
Zhu Weiming
 2014-01 PHASE2; PHASE3
NCT02190526 WITHDRAWN
Diarrhea- Predominant Irritable Bowel Syndrome; Quality of Life
Tehran University of Medical Sciences
 2014-09 PHASE4
NCT01966783 COMPLETED
Proctitis
Dr. Falk Pharma GmbH
 2013-09 PHASE2
NCT01894685 COMPLETED
Sporadic Colorectal Adenoma
UMC Utrecht
 2012-07 PHASE2
NCT01745770 COMPLETED
Active Ulcerative Colitis
Dr. Falk Pharma GmbH
 2013-01 PHASE3
NCT04032652 TERMINATED
Ulcerative Colitis
Endeavor Health
 2012-12 PHASE2
NCT01514240 COMPLETED
Crohn's Disease
AstraZeneca
 2012-02 PHASE3
NCT01320436 COMPLETED
Ulcerative Colitis
Sheba Medical Center
 2011-07 PHASE3
NCT01534312 COMPLETED
Colitis, Ulcerative; Inflammatory Bowel Diseases
University of Aarhus
 2012-01
NCT02306798 COMPLETED
Ulcerative Colitis
Tillotts Pharma AG
 2013-09 PHASE1
NCT01532648 COMPLETED
Ulcerative Colitis
Bausch Health Americas, Inc.
 2012-01-27 PHASE3
NCT01316718 COMPLETED
Irritable Bowel Syndrome With Diarrhoea
University of Nottingham
 2011-03 PHASE4
NCT01038739 TERMINATED
Diverticulitis
Dr. Falk Pharma GmbH
 2010-01 PHASE3
NCT01257399 COMPLETED
Ulcerative Colitis in Remission
Tillotts Pharma AG
 2010-11 PHASE3
NCT01124149 COMPLETED
Ulcerative Colitis
Shire
 2010-06-29 PHASE4
NCT01257386 COMPLETED
Active Ulcerative Colitis
Tillotts Pharma AG
 2010-11 PHASE3
NCT00626288 COMPLETED
Irritable Bowel Syndrome
SOFAR S.p.A.
 2007-12 PHASE3
NCT02306772 COMPLETED
Ulcerative Colitis
Tillotts Pharma AG
 2011-12 PHASE1
NCT01469637 COMPLETED
Healthy
Shire
 2011-11-07 PHASE1
NCT00545103 COMPLETED
Diverticulitis
Shire
 2007-12-06 PHASE3
NCT01442688 COMPLETED
Healthy
Shire
 2011-10-07 PHASE1
NCT00695643 TERMINATED
Diverticulitis
Dr. Falk Pharma GmbH
 2008-01 PHASE3
NCT01418365 COMPLETED
Healthy
Shire
 2011-08-22 PHASE1
NCT01534754 COMPLETED
Diverticular Disease of the Colon
Hospital Cristo Re
 2009-01 PHASE4
NCT01402947 COMPLETED
Healthy
Shire
 2011-07-25 PHASE1
NCT01011322 UNKNOWN
Ulcerative Colitis; Large Intestine; Diarrhea; Abdominal Pain
Lipid Therapeutics GmbH
 2009-12 PHASE2
NCT00450086 COMPLETED
Collagenous Colitis
Dr. Falk Pharma GmbH
 2007-03 PHASE3
NCT00603733 COMPLETED
Active Ulcerative Colitis; Remission of Ulcerative Colitis
Ferring Pharmaceuticals
 2007-10 PHASE3
NCT00663247 COMPLETED
Diverticulosis, Colonic
University of Nottingham
 2008-04
NCT00862121 TERMINATED
Crohn´s Disease
Ferring Pharmaceuticals
 2009-04 PHASE3
NCT00976690 COMPLETED
Crohn Disease
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
 2002-10 PHASE3
NCT00708656 COMPLETED
Ulcerative Colitis
Cardiff and Vale University Health Board
 2006-10 PHASE3
NCT00737789 COMPLETED
Ulcerative Colitis
Ferring Pharmaceuticals
 2008-11 PHASE3
NCT00808977 COMPLETED
Ulcerative Colitis
Palau Pharma S.L.U.
 2008-12 PHASE2
NCT00151892 COMPLETED
Ulcerative Colitis
Shire
 2005-04-08 PHASE3
NCT00245505 TERMINATED
Crohn's Disease
Ferring Pharmaceuticals
 2009-02 PHASE3
NCT00747110 COMPLETED
Colitis, Ulcerative
Dr. Falk Pharma GmbH
 2007-10 PHASE3
NCT00300118 COMPLETED
Crohn's Disease
Dr. Falk Pharma GmbH
 2004-09 PHASE3
NCT00867438 COMPLETED
Ulcerative Colitis
Cosmo Technologies Ltd
 2007-01 PHASE2
NCT00408174 COMPLETED
Inflammatory Bowel Disease; Ulcerative Colitis
Bausch Health Americas, Inc.
 2006-05 PHASE3
NCT00946946 COMPLETED
Crohn's Disease
Dr. Falk Pharma GmbH
 2002-02 PHASE3
NCT00746447 COMPLETED
Colitis, Ulcerative; Recurrence
Dr. Falk Pharma GmbH
 2005-05 PHASE3
NCT00751699 COMPLETED
Healthy
Warner Chilcott
 2007-03 PHASE1
NCT00269438 COMPLETED
Ulcerative Colitis
Bausch Health Americas, Inc.
 2005-12 PHASE3
NCT00209287 TERMINATED
Ulcerative Colitis
Ferring Pharmaceuticals
 2005-06 PHASE4
NCT00151944 COMPLETED
Colitis, Ulcerative
Shire
 2003-11-26 PHASE3
NCT00774007 COMPLETED
Irritable Bowel Syndrome
SOFAR S.p.A.
 2004-09 PHASE2; PHASE3
NCT00503243 COMPLETED
Colitis, Ulcerative
Shire
 2003-09-30 PHASE3
NCT00545389 COMPLETED
Colitis, Ulcerative
Shire
 2003-02-10 PHASE2
NCT00548574 COMPLETED
Ulcerative Colitis
Shire
 2003-12-04 PHASE3
NCT01627262 COMPLETED
Colonic Diverticulosis
Dr. Falk Pharma GmbH
 2002-05 PHASE2
NCT00449722 COMPLETED
Ulcerative Colitis
Dr. Falk Pharma GmbH
 2005-07 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-08-19)

Check the Mesalazine (5-ASA) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Mesalazine acts as a targeted inhibitor of TNFα-induced IKK activity and a scavenger of reactive oxygen species, thereby preventing downstream NF-κB activation and suppressing mucosal oxidative pathways. This block in intracellular signaling reduces pro-inflammatory cytokine production and epithelial cell injury, mitigating the chronic intestinal mucosal inflammation characteristic of ulcerative colitis and Crohn's disease.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.