Late-2025 events affecting semaglutide (Ozempic/Wegovy) strategy, labeling, and market expectations.
Key Events
- Nov 24, 2025 – Alzheimer’s trials fail: Novo Nordisk’s EVOKE / EVOKE+ did not meet cognitive endpoints for Alzheimer’s disease. Source
- Dec 2–4, 2025 – CTAD 2025 details: At CTAD, Novo Nordisk disclosed biomarkers improved but primary efficacy endpoints still failed. Source
- Nov 30, 2025 – Australia TGA suicide warning: TGA requires all GLP-1 RAs (Ozempic, Wegovy, Mounjaro, etc.) to add suicidal ideation/behavior warnings; 20 reports in 12 months. Source
Impact
- Label evolution: Expect global regulators to review neuropsychiatric risk language; plaintiffs may cite TGA warning as notice.
- R&D pivot: Failure in Alzheimer’s slows new indications and may increase reliance on weight-loss/diabetes markets.
- Litigation posture: Safety signals beyond GI/vision (mental health) broaden theory of liability.