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The DoD SBIR program includes Army, Navy, Air Force, DARPA, MDA, DTRA, DHA, SOCOM, DLA, DMEA, NGA, and SCO

a small molecule that remains preclinical and not approved

1A, E, F)

Studies show that GI side effects in tirzepatide trials were predominantly mild to moderate and concentrated during the dose escalation period

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

A dose used in a study is not automatically a dose for routine care