Is UBX0101 legal in the United States?

The first clean-up drug for worn-out cells tested in a proper study against a real symptom. In 183 people with knee arthritis, knee pain at 12 weeks was the same on every dose as on a dummy shot, according to results the maker posted to the US trial registry.

UBX0101 is a small drug from Unity Biotechnology, made to be injected straight into an arthritic knee. It is meant to push worn-out cells to die.

How it works: Shown in mice and in cells: UBX0101 blocks a protein that normally breaks down p53, a protein that tells damaged cells to die. With more p53 around, worn-out cells, which rely on keeping p53 down to survive, die off.

Approval history: Not approved. Still investigational. The mid-stage study in osteoarthritis, the wear-and-tear kind of arthritis, finished in 2020. Its results were posted to ClinicalTrials.gov in December 2021. The long-term follow-up study was stopped because it could not meet its main or other goals.

Approves prescription drugs, each for a named use. It also acts against unapproved products, including peptides sold online. Compounding pharmacies, which mix drugs to order, may make some compounds with a prescription. That only applies when the FDA puts the compound in a category of bulk ingredients it allows.

The legal category above is how The Longevity Archive reads U.S. Food and Drug Administration listings for UBX0101 on the reviewed date. It is not a legal opinion. Rules change. Bringing a compound into the country, prescribing it and owning it can each be treated differently. Check with the agency before you act on anything here.

Check FDA directly

Whether UBX0101 is banned in sport is set by the World Anti-Doping Code and by military rules, not by its legal status in the United States. Before you compete or get tested, look up UBX0101 by name on the Prohibited List, or look up a named product in Global DRO. Under the World Anti-Doping Code, category S0 bans, at all times, any drug-like substance that meets two tests. No other section of the List covers it. And no government health regulator anywhere has a current approval for it as a treatment in people. Many substances that are approved somewhere are banned by name in another section. So approval does not mean a substance is allowed in sport.

• WADA Prohibited List
• Global DRO (check a named product)
• USADA (US athletes)
• Operation Supplement Safety (US service members)

The rules you compete or serve under decide this, not this page.