Tesamorelin is an FDA-approved prescription therapeutic (brand name Egrifta) for a specific clinical indication, and its use for general bodybuilding, fat loss, or anti-aging purposes in people without that diagnosis is an off-label application, not an over-the-counter supplement use
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
Notably, a reduction was observed in T3 (4.33 0.45) compared to T1 (4.95 0.47
[DOI] [PubMed] [Google Scholar] 19.Yuan M, Breitkopf SB, Yang X, Asara JM
Frequency varies based on individual needs and clinical context
