Mesalamine is named as an intervention in 7 current clinical trials in our Egypt, Sweden, Denmark and Canada registers. 7 are recruiting patients now. All registered phases are Phase 2. The sponsor with the most trials is Tanta University (2). The most-studied condition is Ulcerative Colitis.
Of the three regulators tracked here, the first to approve Mesalamine was the US, on 24 Dec 1987.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Protections still running for marketed products containing Mesalamine, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
Reproduced from the FDA Orange Book and Purple Book (checked 28 Sep 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome
NCT04920149 · ClinicalTrials.gov ↗ · Lynch Syndrome, Colon Cancer, Colon Neoplasm
|
Phase 2 | Recruiting | Ann-Sofie Backman | Sweden, Denmark |
|
Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab/Nivolumab (Ipi/Nivo)
NCT05663775 · ClinicalTrials.gov ↗ · Immune-related Adverse Event, Diarrhea, Advanced Melanoma
|
Phase 2 | Recruiting | AHS Cancer Control Alberta | Canada |
|
Beneficial Effect of Silymarin in Ulcerative Colitis
NCT06213857 · ClinicalTrials.gov ↗ · Ulcerative Colitis
|
Phase 2 | Recruiting | Tanta University | Egypt |
|
Nitazoxanide in Patients With Ulcerative Colitis
NCT06993974 · ClinicalTrials.gov ↗ · Ulcerative Colitis
|
Phase 2 | Recruiting | Alexandria University | Egypt |
|
Rupatadine in Patients With Ulcerative Colitis
NCT07064707 · ClinicalTrials.gov ↗ · Ulcerative Colitis
|
Phase 2 | Recruiting | Alexandria University | Egypt |
|
Desloratadine in Patients With Ulcerative Colitis
NCT07333716 · ClinicalTrials.gov ↗ · Ulcerative Colitis (UC), Ulcerative Colitis
|
Phase 2 | Recruiting | Tanta University | Egypt |
|
Pentoxifylline in Patients With Ulcerative Colitis
NCT07349472 · ClinicalTrials.gov ↗ · Inflammatory Bowel Diseases
|
Phase 2 | Recruiting | Ihab Elsayed Hassan | Egypt |
Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
| Lead sponsor | Trials |
|---|---|
| Tanta University | 2 |
| Alexandria University | 2 |
| Ann-Sofie Backman | 1 |
| AHS Cancer Control Alberta | 1 |
| Ihab Elsayed Hassan | 1 |
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in Egypt | 5 | 5 |
| Clinical trials in Sweden | 1 | 1 |
| Clinical trials in Denmark | 1 | 1 |
| Clinical trials in Canada | 1 | 1 |
A trial with sites in more than one country appears in each of those registers.
7 current trials in our Egypt, Sweden, Denmark and Canada registers name Mesalamine as a drug or biological intervention, as of the registry sync on 29 September 2026. Completed and withdrawn studies are not counted.
Yes. 7 of the 7 trials are recruiting: 5 with sites in Egypt, 1 with sites in Sweden, 1 with sites in Denmark and 1 with sites in Canada. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Tanta University (2), Alexandria University (2), Ann-Sofie Backman (1) and AHS Cancer Control Alberta (1), among 5 lead sponsors in total. The number in brackets is how many trials each organisation leads.
The registers we track list 1 entry for Mesalamine: US FDA: resolved. Shortages are product- and country-specific; check with a pharmacist.
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Mesalamine works or whether it is effective, and it is not medical advice.
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Mesalamine works or whether it is effective. Each trial links to its own record so you can check it yourself.
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Mesalamine (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 29 Sep 2026.