Last reviewed 2026-04-22 · How we verify

Granulated mesalamine

Bausch Health Americas, Inc. · Phase 3 active Small molecule

Granulated mesalamine is a 5-aminosalicylic acid (5-ASA) agent Small molecule drug developed by Bausch Health Americas, Inc.. It is currently in Phase 3 development for Ulcerative colitis (induction and maintenance of remission), Crohn's disease (colonic involvement). Also known as: mesalamine pellets.

Mesalamine is an anti-inflammatory agent that acts locally in the colon to reduce inflammation by inhibiting prostaglandin and leukotriene production.

Mesalamine is an anti-inflammatory agent that acts locally in the colon to reduce inflammation by inhibiting prostaglandin and leukotriene production. Used for Ulcerative colitis (induction and maintenance of remission), Crohn's disease (colonic involvement).

Likelihood of approval

59.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Immunology slight uplift +1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Granulated mesalamine
Also known as	mesalamine pellets
Sponsor	Bausch Health Americas, Inc.
Drug class	5-aminosalicylic acid (5-ASA) agent
Target	Prostaglandin and leukotriene synthesis inhibition
Modality	Small molecule
Therapeutic area	Gastroenterology / Immunology
Phase	Phase 3

Mechanism of action

Mesalamine (5-aminosalicylic acid) works primarily through local anti-inflammatory effects in the gastrointestinal tract. It inhibits the production of inflammatory mediators including prostaglandins and leukotrienes, and may also have immunomodulatory effects. The granulated formulation allows for targeted delivery to the colon where it exerts its therapeutic effect.

Approved indications

Ulcerative colitis (induction and maintenance of remission)
Crohn's disease (colonic involvement)

Common side effects

Headache
Abdominal pain
Diarrhea
Nausea
Rash

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Granulated mesalamine CI brief — competitive landscape report
Granulated mesalamine updates RSS · CI watch RSS
Bausch Health Americas, Inc. portfolio CI

Frequently asked questions about Granulated mesalamine

What is Granulated mesalamine?

Granulated mesalamine is a 5-aminosalicylic acid (5-ASA) agent drug developed by Bausch Health Americas, Inc., indicated for Ulcerative colitis (induction and maintenance of remission), Crohn's disease (colonic involvement).

How does Granulated mesalamine work?

Mesalamine is an anti-inflammatory agent that acts locally in the colon to reduce inflammation by inhibiting prostaglandin and leukotriene production.

What is Granulated mesalamine used for?

Granulated mesalamine is indicated for Ulcerative colitis (induction and maintenance of remission), Crohn's disease (colonic involvement).

Who makes Granulated mesalamine?

Granulated mesalamine is developed by Bausch Health Americas, Inc. (see full Bausch Health Americas, Inc. pipeline at /company/bausch-health-americas-inc).

Is Granulated mesalamine also known as anything else?

Granulated mesalamine is also known as mesalamine pellets.

What drug class is Granulated mesalamine in?

Granulated mesalamine belongs to the 5-aminosalicylic acid (5-ASA) agent class. See all 5-aminosalicylic acid (5-ASA) agent drugs at /class/5-aminosalicylic-acid-5-asa-agent.

What development phase is Granulated mesalamine in?

Granulated mesalamine is in Phase 3.

What are the side effects of Granulated mesalamine?

Common side effects of Granulated mesalamine include Headache, Abdominal pain, Diarrhea, Nausea, Rash.

What does Granulated mesalamine target?

Granulated mesalamine targets Prostaglandin and leukotriene synthesis inhibition and is a 5-aminosalicylic acid (5-ASA) agent.

Drug class: All 5-aminosalicylic acid (5-ASA) agent drugs
Target: All drugs targeting Prostaglandin and leukotriene synthesis inhibition
Manufacturer: Bausch Health Americas, Inc. — full pipeline
Therapeutic area: All drugs in Gastroenterology / Immunology
Indication: Drugs for Ulcerative colitis (induction and maintenance of remission)
Indication: Drugs for Crohn's disease (colonic involvement)
Also known as: mesalamine pellets

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing