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ON101 (FESPIXON®) FB825 FB704A OB318 FB918 SNS812 Research Publication/ Abstract

FESPIXON®

FESPIXON® Cream About Diabetic Foot Ulcers Expanded Access Program Medical Subsidies for low-Income DFU Patients Patient Brochure Request Care for Diabetic Foot The Ph3 Data and the Mechanism of Action of FESPIXON®(ON101) FESPIXON® received International Innovation Awards from Enterprise Asia Media Coverage

FESPIXON® Cream

 
  • Brand Name
 FESPIXON® Cream
  • Taiwan FDA Approval Number

060827
  • Singapore HSA Approval Number
 SIN16683P
  • Malaysia NPRA Approval Number 
 MAL23076025B
  • Clinical Information
 NCT04962139 (More Information)
NCT01898923 (More Infromation)
  • Research Publication/ Abstract
 More Infromation

You are encouraged to report negative side effects of prescription drugs to:
Phone: 0800-215-988
Mail: medicalscience@onenessbio.com.tw

 

Package Insert Download

Package Insert (Singapore Version) Download

Package Insert (Malaysia Version) Download

 
  • Brand Name
FESPIXON® Cream
  • Taiwan FDA Approval Number

060827
  • Singapore HSA Approval Number

SIN16683P
  • Malaysia NPRA Approval Number

MAL23076025B
  • Clinical Information
NCT04962139 (More Informtaion)
NCT01898923 (More Informtaion)
  • Research Publication/ Abstract

Click Here

 

You are encouraged to report negative side effects of prescription drugs to:
Phone: 0800-215-988
Mail: medicalscience@onenessbio.com.tw

Package Insert Download

 

Package Insert (Singapore Version) Download

 

Package Insert (Malaysia Version) Download

 

Mechanism of Action

Novel Mechanism Promotes Healing by Regulating M1/M2 Macrophages
and Rebalancing the Wound Microenvironment

Inhibit pro-inflammatory M1 φ and stimulate adipose precursor cells to secrete GCSF and CXCL3 to increase repairing M2a/M2c φ

Reference: Restoring Pro-healing/remodeling-associated M2a/c Macrophages using ON101 Accelerates Diabetic Wound Healing, JID Innovations (2022);2:100138, doi: https://doi.org/10.1016/j.xjidi.2022.100138.

 

Superior Efficacy to Current Standard Care

 

Incidence of Complete Healing - Full Analysis Set

FESPIXON® group achieved significant efficacy vs standard care (AQUACEL® Hydrofiber®) group (p=0.0001)

The Cumulative Rate of Complete Healing

The healing trend of FESPIXON® remained steady and robust at each observation time point.  

Incidence of Complete Healing - Full Analysis Set

FESPIXON® group achieved significant efficacy vs standard care (AQUACEL® Hydrofbier®) group (p=0.0001)

The Cumulative Rate of Complete Healing

The healing trend of FESPIXON® remained steady and robust at each observation time point.  

Reference: Effect of a Novel Macrophage-Regulating Drug on Wound Healing in Patients With Diabetic Foot Ulcers, JAMA Netw Open. 2021;4(9):e2122607, doi:10.1001/jamanetworkopen.2021.22607.

 

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