Drug intelligence / Profile preview

fespixon (Oneness Biotech Co., Ltd., 0439aa)

Development stage
Unknown
Lead developer
Oneness Biotech
Modality
Metabolically Activated Prodrugs → Prodrugs/Conditional Activator Small Molecules → Small Molecules, Classical Binding Small Molecules → Small Molecules
Administration
Topical
01

Overview

ON101 (fespixon) is a first-in-class topical botanical drug developed by Oneness Biotech for the treatment of chronic wounds, primarily diabetic foot ulcers (DFU). It is composed of specific extracts from *Plectranthus amboinicus* (Lour.) Spreng. and *Centella asiatica* (L.) Urb. The cream works by modulating the wound microenvironment, specifically by promoting the polarization of macrophages from a pro-inflammatory M1 phenotype to a pro-healing M2 phenotype. This shift reduces the levels of inflammatory cytokines such as TNF-α and IL-6 while enhancing collagen deposition and angiogenesis, facilitating the closure of hard-to-heal ulcers. It has received regulatory approval in several Asian markets, including Taiwan, Singapore, and Malaysia, and is undergoing global Phase 3 clinical trials to support broader international registration.

Brand names
Fespixon
Other names
PA-F4 + S1Plectranthus amboinicus extract + Centella asiatica extract

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