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Retatrutide FDA Approval Timeline Phase 3 trials conclude: May 2026 NDA submission: Late 2026 (projected) FDA decision window: Q1Q2 2027 Read the full Retatrutide FDA roadmap (20262028) Safety Update & New Side Effects (Dysesthesia) While Retatrutides results are unprecedented, Phase 3 data identified a new safety signal not commonly seen with other GLP-1 drugs