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Diabetic foot ulcers are a common and costly complication for people with diabetes. ON101 is a promising new topical treatment anticipated for FDA approval in the coming years.

A novel treatment for healing diabetic foot ulcers (DFUs) could be on the horizon for people with diabetes in the U.S.

Approved by the Taiwan Food and Drug Administration in 2021, ON101 cream (brand name Fespixon) is used for topical treatment of DFUs. Clinical trials have found the wound-healing cream to have significant benefits for DFUs, with study participants experiencing a 60% complete healing rate over 16 weeks compared to 35% healing with an absorbent wound dressing.

The data offers a lot of promise for people living with DFUs, which are open sores commonly found on the bottom of the foot. DFUs are often a result of peripheral neuropathy, a complication that affects roughly 40% of people with diabetes.

DFUs do not heal on their own without medical care. Left untreated, DFUs put many patients at risk for amputations. Research finds that around 85% of lower extremity amputations in people with diabetes are preceded by foot ulcers.

“ON101 cream is an effective treatment to chronic, non-healing DFUs that have failed to heal via conventional therapy,” said Dr. Yur-Ren Kuo, professor and chief of plastic and reconstructive surgery at Kaohsiung Medical University Hospital in Taiwan.

Developed by Oneness Biotech, ON101 could be a game-changer for DFUs, which have been lacking effective treatments for decades and are a huge medical burden worldwide. Healthcare costs for DFU care are estimated to be upwards of $660,000 per year in the U.S.

“ON101 cream will be a new strategy to topically treat chronic DFUs,” said Kuo, who presented on the topic at the 2023 European Association for the Study of Diabetes Annual Meeting.

ON101 has been granted fast track designation by the U.S. FDA. Another late-stage clinical trial testing the therapeutic effects of the topical treatment is anticipated to wrap up this year. If approved, a global launch of ON101 is planned for 2025. ON101 has also been approved in Malaysia and Singapore.

This article is reposted from diaTribe Learn. Read the full article here: Click to view.