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Tirzepatide was approved in 2022 as Mounjaro for diabetes, and in 2024 as Zepbound for obesity, with exclusivity running until May 2027

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Importantly, large-scale randomized trials, meta-analyses, and observational studies suggest that GLP-1RAs do not significantly increase AKI risk and may even confer renal benefits in high-risk populations

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FDA approval is anticipated in 2026, through the FDA's national priority voucher program, positioning Lilly to compete aggressively in the oral segment
Why the first non-peptide oral GLP-1 is drawing serious attentionand where caution still applies