Mesalazine

Phase 3Small molecule

Ferring

Mesalazine is one of 184 small molecule programs targeting Colitis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

183

Competitors

Pipeline

Status by Indication[3][1]

Indication

ColitisActive, not recruiting

Diverticular DiseaseActive, not recruiting

Oral UlcerActive, not recruiting

DiverticulitisActive, not recruiting

Inflammatory Bowel DiseaseActive, not recruiting

ProctitisActive, not recruiting

Colorectal AdenomaActive, not recruiting

Colorectal CancerActive, not recruiting

Ulcerative ColitisActive, not recruiting

Irritable Bowel SyndromeActive, not recruiting

ColitisPhase 3

Active, not recruiting

Diverticular DiseasePreclinical

Active, not recruiting

Oral UlcerPhase 3

Active, not recruiting

DiverticulitisPhase 3

Active, not recruiting

Inflammatory Bowel DiseasePhase 2

Active, not recruiting

ProctitisPreclinical

Active, not recruiting

Colorectal AdenomaPhase 2

Active, not recruiting

Colorectal CancerPhase 2

Active, not recruiting

Ulcerative ColitisPhase 3

Active, not recruiting

Irritable Bowel SyndromePhase 3

Active, not recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

949 competitors in Colorectal Cancer

#DrugCompanyPhaseTrials

Mesalazine

Ferring

Phase 3

1 2

Eylea

Regeneron

Preclinical

5 3

Emend IV

PORTRAZZA

Andriol

1 6

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 7

Vascepa

AAmarin Pharma Inc.

Preclinical

1 8

Gas-X

PPortuguese Oncology Institute, Coimbra

Preclinical

1 9

Ketalar

AAultman Health Foundation

Preclinical

1 10

Xylocaine

MMEDRx USA, Inc.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

N/ANot yet recruiting

Ulcerative Colitis

NCT07389824

Clinical

Trials by Indication[1]

Ulcerative Colitis17 trials

Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative Colitis

Completed· Takeda logo

Takeda·Phase 3·NCT00548574·343 enrolled

Budesonide Capsules Versus Mesalazine Granules in Active Ulcerative Colitis (UC)

Completed·—·Phase 3·NCT00747110·343 enrolled

OD vs. TID Dosing With Mesalazine Granules in Active Ulcerative Colitis

Completed·—·Phase 3·NCT00449722·380 enrolled

Show 14 more trials

Efficacy of Mesalazine Combined With Biologics in the Treatment of Moderate to Severe Ulcerative Colitis

Unknown status·SSixth Affiliated Hospital, Sun Yat-sen University·Phase 4·NCT05205603·438 enrolled

Efficacy of Acupuncture-Mesalazine Combination Therapy in Ulcerative Colitis.

Not yet recruiting·QQin Yu·N/A·NCT07389824·80 enrolled

Minocyclin in Ulcerative Colitis as Added on Therapy

Completed·MMostafa Bahaa·Phase 2·NCT06201793·46 enrolled

Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission Phase

Completed·TTillotts Pharma AG·Phase 3·NCT01257399·251 enrolled

Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis

Completed·TTillotts Pharma AG·Phase 3·NCT01257386·251 enrolled

Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis

Unknown status·FFlemming Bendtsen·Phase 4·NCT04133194·200 enrolled

Effectiveness of Fecal Microbiota Transplantation as add-on Therapy in Mild-to-moderate Ulcerative Colitis

Completed·—·N/A·NCT05538026·53 enrolled

Induction and Maintenance of Remission With Pentasa as Ulcerative Colitis Treatment

Completed· Ferring logo

Ferring··NCT02261636·150 enrolled

Phase III Multicentre Trial of Oral Mesalazine in Patients With Mild to Moderate Ulcerative Colitis.

Unknown status·FFaes Farma, S.A.·Phase 3·NCT06176560·376 enrolled

Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative Colitis

Completed·—·N/A·NCT02537210·177 enrolled

Mesalazine With Hydrocortisone Sodium Succinate Enema for 4-Week Treatment in Patients With Ulcerative Colitis

Unknown status·XXijing Hospital of Digestive Diseases·Phase 4·NCT03110198·528 enrolled

A Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Ulcerative Colitis

Completed·PPalau Pharma S.L.U.·Phase 2·NCT00808977·80 enrolled

To Evaluate the Efficacy and Safety of FE 999315 in Japanese Subjects With Mild to Moderate Active Ulcerative Colitis

Completed· Ferring logo

Ferring·Phase 3·NCT03412682·274 enrolled

Role of Intestinal Protozoa and Helminths in the Course of Ulcerative Colitis

Unknown status·RResearch Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan·Phase 1/2·NCT03441893·300 enrolled

Irritable Bowel Syndrome4 trials

Mesalazine for the Treatment of Diarrhoea-predominant Irritable Bowel Syndrome (IBS-D)

Completed·UUniversity of Nottingham·Phase 4·NCT01316718·108 enrolled

A Randomized Controlled Pilot Trial of Mesalazine in Patients With Irritable Bowel Syndrome

Completed·SSOFAR S.p.A.·Phase 2/3·NCT00774007·20 enrolled

Mesalazine Therapy in Patients With Irritable Bowel Syndrome

Completed·SSOFAR S.p.A.·Phase 3·NCT00626288·187 enrolled

Show 1 more trial

Effects of Mesalamine and Amitriptyline on Irritable Bowel Syndrome

Withdrawn·TTehran University of Medical Sciences·Phase 4·NCT02190526

Crohn's Disease3 trials

Preventing Postoperative Relapse in Crohn's Disease Patients at Risk: Azathioprine Versus Mesalazine

Completed·—·Phase 3·NCT00946946·78 enrolled

The Effect on Mucosal Healing With Pentasa Sachet in Mild to Moderate Active "Drug: Crohn's Disease"

Terminated· Ferring logo

Ferring·Phase 3·NCT00245505·3 enrolled

Phase III Study of D9421-C 9 mg in Patients With Active Crohn's Disease in Japan

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT01514240·123 enrolled

Colitis2 trials

Predicting Response to Standardized Pediatric Colitis Therapy

Completed·—·Phase 4·NCT01536535·431 enrolled

The Colitis Once Daily Asacol Study

Completed·—·Phase 3·NCT00708656·213 enrolled

Proctitis2 trials

QUality of Life in pAtients With Mild to modeRate Active procTitis Treated by mesalaZine (Pentasa®)

Completed· Ferring logo

Ferring··NCT02368743·117 enrolled

Budesonide vs. Mesalazine vs. Budesonide/Mesalazine Suppository Combination Therapy in Acute Ulcerative Proctitis

Completed·—·Phase 2·NCT01966783·320 enrolled

11 more indications

Diverticulitis2 trials

Mesalazine Granules vs. Placebo for the Prevention of Recurrence of Diverticulitis

Terminated·—·Phase 3·NCT00695643·345 enrolled

Two Doses Mesalazine Granules Versus Placebo for the Prevention of Recurrence of Diverticulitis

Terminated·—·Phase 3·NCT01038739·330 enrolled

Diverticular Disease2 trials

Evaluation of the Metabolome in Diverticular Disease

Unknown status·—··NCT01831323·40 enrolled

Mesalazine and/or Lactobacillus Casei in the Diverticular Disease of the Colon

Completed·HHospital Cristo Re·Phase 4·NCT01534754·250 enrolled

Colorectal Cancer1 trial

Chemopreventive Action of Mesalazine on Colorectal Cancer: a Pilot Study for an "in Vivo" Evaluation of the Molecular Effects on β-catenin Signaling Pathway.

Completed·SSOFAR S.p.A.·Phase 2·NCT02077777·21 enrolled

Colorectal Adenoma1 trial

Mesalazine Effects in Sporadic Colorectal Adenoma Patients

Completed·UUMC Utrecht·Phase 2·NCT01894685·74 enrolled

Safety and Efficacy1 trial

The Safety and Efficacy of TET Enema in the Treatment of UC

Unknown status·TThe Second Hospital of Nanjing Medical University·N/A·NCT03917095·75 enrolled

Inflammatory Bowel Disease1 trial

Standardized Fecal Microbiota Transplantation for Inflammatory Bowel Disease

Unknown status·YYanling Wei·Phase 2·NCT02335281·40 enrolled

Treatment1 trial

Mesalazine Treatment in IBS (The MIBS Study)

Completed·HHans Törnblom·Phase 2·NCT01699438·211 enrolled

Collagenous Colitis1 trial

Budesonide Capsules vs. Mesalazine Granules vs. Placebo in Collagenous Colitis

Completed·—·Phase 3·NCT00450086·92 enrolled

Crohn's Disease (CD)1 trial

Oral Budesonide vs. Oral Mesalazine in Active Crohn's Disease (CD)

Completed·—·Phase 3·NCT00300118·311 enrolled

Oral ulcer1 trial

The Efficacy of Topical Mesalazine Sustained-Release Tablets in Crohn's Disease Patients With Oral Ulcer

Withdrawn·XXijing Hospital of Digestive Diseases·Phase 3·NCT02769494

Unspecified1 trial

Therapeutic Effect of Methalazine on 27 Cases of Suppurative Hidradenitis

Completed·TThe First Affiliated Hospital with Nanjing Medical University··NCT06568224·27 enrolled

Sources

References

[1]
ClinicalTrials.gov — 41 trial records for Mesalazine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Mesalazine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Mesalazine. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Ferring company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Ferring

Mesalazine

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Trials by Indication[1]

Ulcerative Colitis17 trials

Irritable Bowel Syndrome4 trials

Crohn's Disease3 trials

Colitis2 trials

Proctitis2 trials

Diverticulitis2 trials

Diverticular Disease2 trials

Colorectal Cancer1 trial

Colorectal Adenoma1 trial

Safety and Efficacy1 trial

Inflammatory Bowel Disease1 trial

Treatment1 trial

Collagenous Colitis1 trial

Crohn's Disease (CD)1 trial

Oral ulcer1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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