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It is not approved by any regulatory agency for clinical or medical use

Moreover, this inflammatory state may lead to a potential loss of proteostasis, autophagy, and mitochondrial dysfunction, 310 diminishing the ability of cells to repair or regenerate, further exacerbating the pathologies linked to stroke progression

This makes LDN potentially a really important tool in immune system regulation because of its effects on the Treg cells

The approval was backed by the Phase II open-label AGAVE-201 trial, where treatment with a 0.3-mg/kg dose of Niktimvo elicited an overall response rate of 75%, with a median time to response of 1.5 months

Jiang S, Xu L, Xu Y, Guo Y, Wei L, Li X, et al