In February 2025 Annovis launched its pivotal Phase 3 study (NCT06709014) in early Alzheimer’s disease, evaluating buntanetap over 18 months for symptomatic and disease-modifying effects. As of March 2026 the trial has enrolled 65% of its target population across 83 US sites, and a Data and Safety Monitoring Board issued a positive safety recommendation at the six-month interim.

Following novel biomarker data showing cognitive improvements and reductions in amyloid and tau pathology, Annovis initiated an open-label extension (OLE) study in Parkinson’s disease in January 2026. The OLE will enroll patients from prior PD trials and new participants with stable DBS therapy to assess buntanetap’s long-term safety, tolerability and efficacy over 36 months.

In August 2025 Annovis transferred patents to a new crystal form of buntanetap, enhancing solid-state stability and extending intellectual property protection until 2047. By year-end the company held 40 granted patents and 48 pending applications worldwide, with the new crystal form now used in both the pivotal Phase 3 AD trial and PD OLE study.

For fiscal 2025 Annovis reported R&D expenses of $25.2 million, up from $20.0 million in 2024, alongside ongoing general and administrative investments. The leadership team presented at multiple scientific and investor conferences and appointed Mark Guerin as CFO and Hui Liu as Director of Biostatistics to bolster financial operations and clinical trial analysis.