Annovis Bio Advances Long-Term Buntanetap Safety Study in Parkinson’s Disease

Annovis Bio Inc (ANVS) announced an update on their ongoing clinical study.

Study Overview

Annovis Bio Inc. is launching a long-term safety study of its drug buntanetap for people with Parkinson’s disease (PD). The official title is “An Open-label Clinical Trial Investigating the Long-term Safety of Buntanetap in Treating Participants With Parkinson’s Disease.” The main goal is to track how safe the drug is over three years in real-world use, especially in patients already familiar with buntanetap and those who also receive deep brain stimulation. For investors, this is a key step in moving the drug closer to possible late-stage development and, ultimately, commercial use in PD.

Intervention/Treatment

The study tests buntanetap (also known as posiphen), an oral drug taken once daily as a 30 mg capsule. The treatment aims to improve outcomes in Parkinson’s by targeting disease processes rather than just symptoms. All qualified participants will receive the same dose, giving Annovis Bio a clearer picture of how patients tolerate long-term daily use.

Study Design

This is an interventional, open-label Phase 2/3 study. There is no randomization, and all participants receive buntanetap (single-group design). There is no placebo or blinding, so doctors and patients know they are on the drug. The primary purpose is treatment-focused: to understand safety and tolerability over 36 months, not to compare buntanetap to another drug or placebo. One cohort includes patients from prior buntanetap trials, and the other includes patients with PD who also use deep brain stimulation.

Study Timeline

The trial status is listed as “Not Yet Recruiting,” meaning enrollment has not started. Key timeline markers include the study’s first submission on November 26, 2025, which signals formal regulatory registration. The primary and final completion dates are not yet posted but the protocol describes a 36‑month follow-up period once participants begin treatment. The most recent update to the record was submitted on December 17, 2025, showing the study plan is active and being refined as it moves toward start-up.

Market Implications

For Annovis Bio, this study update supports the narrative that buntanetap is advancing into longer-term development in PD, a large and competitive neurology market. The focus on long-term safety is important because many PD drugs are used for years; reassuring data here could strengthen the company’s case with regulators and partners. In the near term, the “Not Yet Recruiting” status suggests there are no new efficacy readouts coming soon, so any stock reaction is more likely tied to sentiment around execution and regulatory progress rather than near-term sales. Investors may compare this program to other PD pipelines at larger players and mid-cap biotechs working on disease-modifying therapies. If enrollment launches smoothly and the company reports steady safety updates, confidence and valuation could benefit; delays or protocol changes could dampen sentiment in a crowded field.

The study is currently planned and updated on the ClinicalTrials portal, and investors can find further ongoing details there.

To learn more about ANVS’s potential, visit the Annovis Bio Inc drug pipeline page.