Drug intelligence / Profile preview

mesalamine + sodium hyaluronate

Development stage
Phase 2
Lead developer
Holy Stone Healthcare
Modality
Implantable Hydrogels → Hydrogel Systems → Drug Delivery Systems, Small Molecules, Non-biodegradable Polymers → Polymer-based Nanoparticles → Nanoparticles → Drug Delivery Systems, Biodegradable Polymers → Polymer-based Nanoparticles → Nanoparticles → Drug Delivery Systems, Injectable Hydrogels → Hydrogel Systems → Drug Delivery Systems
Administration
Oral
01

Overview

**Mesalamine + sodium hyaluronate** is an investigational fixed-dose oral combination developed as **IBD98-M**, a delayed-release capsule for induction of remission in active mild to moderate ulcerative colitis. The product uses enteric-coated multilayer pellets intended to release mesalamine and sodium hyaluronate at approximately pH 6.8 or higher in the terminal ileum and ascending colon. Mesalamine is a locally acting 5-aminosalicylic acid anti-inflammatory agent with multiple anti-inflammatory actions, while sodium hyaluronate is intended to support restoration of the colonic mucosal protective barrier and epithelial wound repair. In a 51-patient placebo-controlled Phase 2a study, IBD98-M did not meet its primary clinical-remission endpoint at week 6, although numerical signals were observed for clinical response, endoscopic improvement, inflammatory-biomarker reduction, and physical-health quality-of-life measures. Holy Stone Healthcare continues development, including a registered Phase 1 sustained-release-capsule study in healthy Chinese volunteers.

Other names
mesalazine + sodium hyaluronatemesalamine-sodium hyaluronate
02

Targets

15-LOX (Lysyl Oxidase)COX

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