Drug intelligence / Profile preview

KSR-004

Development stage
Unknown
Lead developer
Kukje Pharm
Modality
Small Molecules
Administration
Ophthalmic
01

Overview

KSR-004 is an investigational ophthalmic formulation of rebamipide developed by Kukje Pharma for the treatment of dry eye syndrome. Rebamipide is a mucosal protective agent that acts as a mucin secretagogue, stimulating the production of membrane-associated mucins (such as MUC1, MUC4, and MUC16) and secreted mucins by the corneal and conjunctival epithelial cells. By increasing mucin levels and goblet cell density, the drug helps stabilize the tear film, improve ocular surface lubrication, and provide anti-inflammatory benefits. KSR-004 was evaluated in Phase 1 clinical trials (e.g., NCT04184323) as part of a dose-escalation study alongside other formulations in the KSR-001 development program to assess safety, tolerability, and pharmacokinetics in healthy volunteers. While the KSR-001 program eventually led to the approval of a 2% rebamipide solution (Tagreba) in South Korea, KSR-004 represents a specific formulation variant tested during early-stage development.

Other names
rebamipide

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