Is Mitoglitazone legal in the United States?

Extended male mouse median lifespan by 8.7 percent when started at 7 months, then failed a retest started at 18 months where it shortened female lifespan. In people it has completed a 356-patient phase 2b in type 2 diabetes and a 29-patient phase 2 in Alzheimer disease, both sponsor-run, neither followed by a phase 3.

Mitoglitazone is a thiazolidinedione designed to keep the insulin-sensitising effect of pioglitazone while largely avoiding the PPAR-gamma activation blamed for that class's fluid retention and weight gain. Its developer, Metabolic Solutions Development Company, traced the PPAR-gamma-independent action to a mitochondrial target it called mTOT, later identified as the mitochondrial pyruvate carrier (MPC1 and MPC2).

Mechanism: Mitoglitazone binds the mitochondrial pyruvate carrier complex (MPC1 and MPC2), identified by photo-crosslinking proteomics as the mitochondrial target of thiazolidinediones, and has minimal affinity for PPAR-gamma. Restricting pyruvate entry into mitochondria shifts fuel use and, in the developer's model, produces insulin sensitisation without the PPAR-gamma-driven fluid retention and adipose expansion.

Regulatory history: Investigational, not approved. Completed phase 2 in type 2 diabetes (2011) and Alzheimer disease (2013) with results posted; no phase 3 registered. The lifespan extension is in male mice started at 7 months; the retest started at 18 months found no male benefit and shorter female lifespan.

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The classification above is the The Longevity Archive reading of U.S. Food and Drug Administration listings for Mitoglitazone 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.