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Both remain in phase 3 clinical development programs [16]: Cagrilintide Status: Phase 3 trials ongoing for CagriSema (cagrilintide + semaglutide combination) Expected approval timeline: 2027-2028 for the combination product Monotherapy development pathway unclear Retatrutide Status: Phase 3 trials initiated in 2024-2025 Monotherapy development for obesity and metabolic dysfunction Expected approval timeline: 2028-2029 if trials succeed This regulatory status means any use of these compounds, whether individually or in cagrilintide dosage with retatrutide combinations, occurs in research contexts or through off-label prescribing once (if) individual approvals are obtained
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They fall under the Food and Drugs Act as unapproved drugs, and their importation for personal use is technically prohibited, though enforcement at the individual level varies
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