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NCT07284784
An Open-label Clinical Trial Investigating the Long-term Safety of Buntanetap in Treating Participants With Parkinson's Disease
Phase 2/Phase 3 trial testing buntanetap/posiphen in Parkinson's Disease (PD) in 500 participants. Currently enrolling.
1 September 2029
Quick facts
| Lead sponsor | Annovis Bio Inc. |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 500 |
| Start date | 9 January 2026 |
| Primary completion | 1 September 2029 |
| Estimated completion | 1 November 2029 |
| Sites | 27 locations across United States |
Drugs / interventions tested
- buntanetap/posiphen — full drug profile →
Conditions studied
- Parkinson's Disease (PD) — all drugs for Parkinson's Disease (PD) →
- Deep Brain Stimulation — all drugs for Deep Brain Stimulation →
Sponsor
Annovis Bio Inc. — full company profile →
Who can join
Adults 40 to 85, any sex, with Parkinson's Disease (PD) or Deep Brain Stimulation. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Safety of buntanetap
Time frame: 36-months of treatment
Safety assessments of participants with PD receiving treatment with buntanetap -
Adverse Events (AE)
Time frame: 36-months of treatment
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention -
Treatment Emergent Adverse Events (TEAE)
Time frame: 36-months of treatment
TEAE is an event that emerges during treatment, having been absent pretreatment, or worsens relative to the pretreatment state -
Serious Adverse Events (SAE)
Time frame: 36-months of treatment
SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization, or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a birth defect or congenital anomaly
Sponsor's own description
This study will examine the long-term safety of buntanetap in participants with PD. This will be a 36-month open-label safety study. This study will be conducted with two cohorts. Cohort 1 will enroll via invitation only for PD participants who have previously participated in buntanetap clinical trials. Cohort 2 will be for PD participants who are receiving deep brain stimulation (DBS) treatment. Qualified participants will receive buntanetap 30mg QD after a screening period of up to 42 days.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Strategies for Optimizing Genetic Mouse Models to Enhance the Understanding of Parkinson's Disease.
Shen Z, Ma L, Mellick GD. · · 2026 · PMID 42193484 · DOI 10.3390/biomedicines14051162
Verify or expand the search:
- PubMed search for NCT07284784
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of buntanetap/posiphen
Trials testing the same drug.
- NCT05357989 — A Double-blind Study to Investigate Efficacy and Safety of Buntanetap Compared With Placebo in Participants With Early P · Phase 3 · completed
Other recruiting trials for Parkinson's Disease (PD)
Currently open trials in the same condition.
- NCT07322887 — A Phase 2 Study to Assess the Effects of SUL-238 on High Energy Phosphates With ³¹P-MRS in Patients With Early, Untreate · Phase 2 · recruiting
- NCT07348705 — Electrophysiology-based DBS Programming for PD · NA · recruiting
- NCT07316296 — Pharmacologically Modulating the Noradrenergic Arousal System to Reduce Freezing of Gait in Parkinson's Disease: a Multi · Phase 3 · recruiting
- NCT07417280 — LIFUS For Neurological Disorders · NA · recruiting
- NCT07310264 — Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease · Phase 1 · recruiting
Other Annovis Bio Inc. trials
Trials by the same sponsor.
- NCT05686044 — A Dose-ranging Study to Investigate Efficacy of Buntanetap in Mild to Moderate AD · Phase 2, PHASE3 · completed
- NCT05357989 — A Double-blind Study to Investigate Efficacy and Safety of Buntanetap Compared With Placebo in Participants With Early P · Phase 3 · completed
- NCT04524351 — Posiphen® Dose-Finding, Biomarker Study in Early Alzheimer's and Parkinson's Patients · Phase 1, PHASE2 · completed
- NCT02925650 — Safety, Tolerability, PK and PD of Posiphen® in Subjects With Early Alzheimer's Disease · Phase 1, PHASE2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07284784 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Annovis Bio Inc.
- Last refreshed: 2 June 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07284784.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing