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The FDA placed it in 503A Category 2 ("may present significant safety risks") in 2023, effectively barring compounding pharmacies from using it, then removed it from that category in April 2026 after nominators withdrew their submission, without adding it to the approved Category 1 compounding list
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While Semaglutide (Ozempic, Wegovy) targets one receptor and Tirzepatide (Mounjaro, Zepbound) targets two, Retatrutide activates three distinct metabolic receptors simultaneously
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