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Approval Timeline and Availability CagriSema: Ahead in the Race FDA Submission: December 18, 2025 (NDA filed) Expected FDA Decision: Q4 2026 or Q1 2027 Predicted Launch: Mid-2027 Advantage: 6-12 month head start on retatrutide REDEFINE Program Status: REDEFINE-1: Completed (obesity, 20.4% weight loss) REDEFINE-2: Completed (type 2 diabetes, 13.7% weight loss) REDEFINE-3: Ongoing (cardiovascular outcomes trial) REDEFINE-8: Ongoing (body composition study) High-dose CagriSema (2.4/7.2mg): Starting late 2026 Retatrutide: More Trials Needed FDA Submission: Expected Q4 2026 or Q1 2027 Expected FDA Decision: Late 2027 Predicted Launch: Q1-Q2 2028 TRIUMPH Program Status: TRIUMPH-4: Completed (osteoarthritis, 28.7% weight loss) TRIUMPH-1: Complete 28.3% weight loss (May 2026) TRIUMPH-2: Expected Q3Q4 2026 (obesity + type 2 diabetes) TRIUMPH-3: Expected later 2026 (obesity + cardiovascular disease) TRIUMPH-6: Weight maintenance trial (ongoing) Disadvantage: Needs more trials before submission, 6-12 month delay vs CagriSema

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Xiao Liu, [email protected] These authors have contributed equally to this work and share first authorship Disclaimer All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers

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