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The agency considers the sale of unapproved peptide drugs to be illegal

And their regulatory footprints could hardly be more different: as of mid-2026 tirzepatide is an approved medicine on two continents, while CagriSema has completed its pivotal Phase 3a program but is not approved by any regulator

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Gajawat S, Sancheti G, Goyal PK

Additionally, disruptions in the blood-brain barrier in those with neurocognitive symptoms have been observed, as well as hypoperfusion in various organs, contributing to end-organ dysfunction [364, 365]