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Synthesis of ROS-sensitive polymers conjugated with Ru(II)-OH (P4) At room temperature, 4-Dimethylaminopyridine (DMAP, 126 mg) was introduced to a solution of Ru(II)-OH (50 mg) and 1-(3-Dimethylaminopropyl)-3-ethylcarbodiimide hydrochloride (EDCl, 200 mg)

Patient Safety Data Driving the Posture The FDAs enforcement posture is anchored in accumulated adverse event data: 455+ adverse event reports linked to compounded semaglutide as of early 2025 (current counts higher) 320+ adverse event reports linked to compounded tirzepatide as of early 2025 (current counts higher) Many reports involve dosing errors from patients self-administering incorrect amounts from multidose vials Several reports document hospitalization following severe nausea, dehydration, or pancreatitis Concerns about counterfeit products entering supply chains through online channels Cold-chain integrity issues with compounded shipments arriving warm or with inadequate temperature controls Salt-form substitution risks products containing semaglutide acetate or sodium rather than semaglutide base used in FDA-approved products These data points feature prominently in FDA communications and the Federal Register notice rationale

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~7% for tirzepatide in SURMOUNT-1) and a new dysesthesia signal at ~21% incidence that didn't appear in Phase 2