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Any compound that potentiates this pathway carries a theoretical risk of promoting neoplastic processes (PMID: 34179015) No Chronic Toxicity Data: Long-term effects of sustained HGF/c-Met potentiation are unstudied even in animal models Uncharacterized Dose-Response: The relationship between Dihexa dose and adverse effects in any living system is poorly defined beyond acute preclinical studies No Regulatory Review: Dihexa has never undergone the systematic safety evaluation required for regulatory submission Safety Comparison Summary: Cerebrolysin has a known, well-characterized safety profile from decades of clinical use

Johnson 2012)

Its ability to penetrate the BBB, its metabolic stability, and its significant efficacy in restoring cognitive and motor functions in animal models of AD and PD, likely through modulating the HGF/c-Met system, position it as a highly promising therapeutic candidate for these debilitating neurodegenerative diseases [2]

The agencys 2023 decision to ban certain peptides was supported by numerous documented safety concerns, they said

The Bottom Line A Hone Health survey suggests many people are already using peptides the FDA is considering reclassifying