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 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
StatusClinical development
PlatformNonclinicalSafety trialEfficacy trialFuture 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.