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Pienaar IS, Lee CH, Elson JL, McGuinness L, Gentleman SM, Kalaria RN, et al
The Phase 2 trial is the only controlled human efficacy study
Taken together, these findings indicate that MALAT1 knockdown induces both apoptosis and ferroptosis while reducing cell viability in KGN cells
Both were removed from the FDA's Category 2 interim compounding bulks list in September 2024 following nominators' withdrawal, and the FDA's Pharmacy Compounding Advisory Committee subsequently recommended against including them on the 503A Bulks list, leaving compounding in regulatory limbo as of early 2026
Key points Vascular damage in chronic kidney disease (CKD) increases the risk of stroke and cognitive impairment, with faster CKD progression linked to cerebral damage, subcortical infarcts and bloodbrain barrier disruption