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Right now the FDAs official explanation for thymosin alpha-1s place in the Category 2 list is that the safety-related information is inadequate for the agency to sufficiently understand the extent of any safety issues raised by the proposed compounded drug. Thymosin Alpha-1 Up for Review in 2027

Morrison, M., et al

FOXO4-DRI has been investigated extensively in preclinical academic literature for p53 transactivation domain binding, senescence-associated apoptosis pathway research, p16 and IL-6 marker dynamics in senescent cell research models, and SASP (senescence-associated secretory phenotype) signaling

P., Trimble, E