Is OSKM Cyclic Partial Reprogramming legal in the United States?

The full four-factor Yamanaka set delivered in short bursts. It extended lifespan in a progeroid mouse, not a normal one, and the same manoeuvre in living mice produces teratomas and kidney tumours.

The 2016 Cell paper from the Izpisua Belmonte laboratory is the foundation of the whole partial reprogramming field, and what it actually reported is narrower than how it is usually quoted. In a progeroid mouse model, a strain engineered to age prematurely, short-term cyclic expression of Oct4, Sox2, Klf4 and c-Myc improved cellular and physiological hallmarks of ageing and prolonged lifespan.

Mechanism: Established in mice only. Short pulses of Oct4, Sox2, Klf4 and c-Myc push cells part-way along the dedifferentiation trajectory, resetting epigenetic marks associated with age while, if the pulse is short enough, stopping before the cell loses its identity and becomes pluripotent.

Regulatory history: Not approved anywhere. There is no registered human trial of four-factor OSKM reprogramming on ClinicalTrials.gov. The only registered human reprogramming study uses the three-factor OSK set.

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 OSKM Cyclic Partial Reprogramming 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.