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OLSALAZINE

FDA-approved approved Small molecule Quality 41/100

Olsalazine is converted to 5-ASA by colonic bacteria, which has a topical anti-inflammatory effect on colonic epithelial cells.

Olsalazine is a marketed drug used for the maintenance of remission in ulcerative colitis, leveraging its conversion to 5-ASA by colonic bacteria to exert a topical anti-inflammatory effect. Its key strength lies in its established mechanism and efficacy, supported by a key composition patent expiring in 2028. The primary risk is the potential increase in competition as the patent approaches expiration.

At a glance

Generic nameOLSALAZINE
ModalitySmall molecule
PhaseFDA-approved
First approval1990

Mechanism of action

When olsalazine reaches the colon, it is converted by colonic bacteria into 5-aminosalicylic acid (5-ASA). 5-ASA exerts its effects by reducing inflammation in the colon, possibly by blocking the production of inflammatory substances like prostaglandins.

Approved indications

Common side effects

Drug interactions

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.

SourceUsed for
FDA labelMechanism, indications, dosing, boxed warnings, drug interactions
ClinicalTrials.govTrial 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: