people affected annually
FDA estimate presented at its 2022 Wound Healing Scientific Workshop.
Clinical development
Focused development in hard-to-heal wounds.
NOxy is advancing NOX1416 in Phase 2 clinical development as an investigational topical nitric oxide program, beginning with wound populations where better healing options are urgently needed.
Lead program
NOX1416
Investigational topical nitric oxide program
Development focusHard-to-heal wounds
Initial area of focusPressure injuries
StatusPhase 2 clinical development
PlatformNonclinicalPhase 1 safetyPhase 2Future development
NOX1416 is investigational. Its safety and effectiveness have not been established, and it has not been approved by the U.S. Food and Drug Administration.
Why chronic wounds
A large medical need with very few approved treatments.
Chronic wounds can cause pain, infection, reduced mobility, loss of independence, hospitalization, and amputation. FDA has described non-healing chronic wounds as a high-unmet-need priority and a significant public-health burden, with more than 6 million people affected annually in the United States.
estimated Medicare wound-care spending
Published 2019 estimate summarized in NOxy’s chronic-wound industry white paper.
approved small-molecule drugs
FDA’s 2022 review identified none for the treatment of a non-healing chronic-wound subtype.
Millions of patients, tens of billions of dollars in care, and decades of limited drug innovation define the need. That mismatch is why NOxy is concentrating its clinical-development program on chronic wounds.