Comprehensive Report on Reproxalap (DB16688)

1. Executive Summary

Reproxalap (DrugBank ID: DB16688), also known by its developmental codes ADX-102 and NS-2, is an investigational, first-in-class, small-molecule modulator of Reactive Aldehyde Species (RASP) developed by Aldeyra Therapeutics.[1] Its novel mechanism involves sequestering RASP, which are pro-inflammatory aldehydes elevated in various ocular and systemic inflammatory conditions, thereby acting upstream in the inflammatory cascade.[5] Reproxalap has been investigated across multiple therapeutic indications, primarily focusing on ocular inflammation. Key indications include dry eye disease (DED) and allergic conjunctivitis (AC), where it is in late-stage development.[2] Development for noninfectious anterior uveitis (NAU) was discontinued following a Phase 3 trial failure.[12] Reproxalap has also been studied for the rare genetic disorder Sjögren-Larsson syndrome (SLS), specifically targeting the associated ichthyosis, and holds U.S. Food and Drug Administration (FDA) Orphan Drug Designation (ODD) for this condition (under the designation for congenital ichthyosis).[1]