Drug intelligence / Profile preview

fespixon (Oneness Biotech Co., Ltd., b30555)

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

Fespixon (ON101) is a first-in-class topical botanical cream developed by Oneness Biotech for wound healing. It is a combination product containing two active herbal extracts: 0.25% Plectranthus amboinicus extract (PA-F4) and 1% Centella asiatica extract (S1). [1, 7] The drug's mechanism of action involves modulating the wound's immune microenvironment by promoting the transition of pro-inflammatory M1 macrophages to pro-regenerative M2 macrophages, which advances the wound from the inflammatory to the proliferative stage. [1, 3, 5] Primarily developed for diabetic foot ulcers (DFUs), Fespixon has demonstrated superior complete healing rates compared to standard care in Phase 3 trials and has received marketing approval in Taiwan, Singapore, Malaysia, and China. [2, 5, 6] It is also being investigated for other indications, including a Phase 4 study for Stage 2 pressure injuries. [9]

Brand names
FespixonXianglei Tangzu GaoBonvadis
Other names
PA-F4 + S1Plectranthus amboinicus and Centella asiatica extracts

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