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Degradation products from improper storage may have their own biological activity

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Abstract The glucagon-like peptide-1 receptor agonist (GLP-1RA) semaglutide is the most recently approved agent of this drug class, and the only GLP-1RA currently available as both subcutaneous and oral formulation

Key FDA considerations will include the dysesthesia signal (up to 20.9% at the highest dose) and what comorbidity criteria will define the indication