Is UBX0101 legal in the United States?

The first senolytic taken into a randomised phase 2 trial for a symptom endpoint. In 183 people with knee osteoarthritis, pain scores at 12 weeks were the same on every dose of UBX0101 as on placebo, according to the results Unity Biotechnology posted to ClinicalTrials.gov.

UBX0101 is a small molecule that blocks the interaction between MDM2 and p53, which stabilises p53 and pushes senescent cells into apoptosis. It was developed by Unity Biotechnology for injection directly into an osteoarthritic knee, and it is a different molecule from UBX1325 (foselutoclax), the BCL-xL inhibitor Unity took into eye disease.

Mechanism: Established in mice and in cells: inhibiting the MDM2 to p53 interaction prevents p53 degradation, and senescent cells, which depend on suppressing p53-driven apoptosis to survive, die selectively. Delivery is by direct injection into the joint, which was intended to confine the effect to the knee.

Regulatory history: Not approved. Investigational; the phase 2 osteoarthritis trial completed in 2020 with results posted to ClinicalTrials.gov in December 2021, and the long-term follow-up study was terminated for inability to achieve primary or secondary study objectives.

Approves prescription drugs by indication and polices unapproved products, including peptides sold online. Compounding pharmacies may prepare some compounds under a prescription when the FDA places them on a permitted bulk-substances category.

The classification above is the The Longevity Archive reading of U.S. Food and Drug Administration listings for UBX0101 at the reviewed date, not a legal opinion. Rules change, and importing, prescribing and possessing a compound can each be treated differently. Check the regulator directly before acting on anything here.