A 6-month & 18-month Prospective, Randomized, Placebo-controlled, Double-blind Dual Clinical Trial Investigating Efficacy and Safety of Buntanetap in Treating Participants of Early Alzheimer's Disease

The goal of this clinical trial is to learn if buntanetap/Posiphen works to treat early Alzheimer's disease in adults aged 55-85. It will also learn about the safety of buntanetap/Posiphen. The main questions it aims to answer are:
* Does buntanetap/Posiphen improve cognition as measured by ADAS-Cog13?
* Does buntanetap/Posiphen improve function as measured by ADCS-iADL?
* What medical issues do participants have, if any, when taking buntanetap/Posiphen?
Researchers will compare buntanetap/Posiphen to a placebo (a look-alike substance that contains no drug) to see if buntanetap/Posiphen works to treat early Alzheimer's disease.
Participants will:
* Take buntanetap/Posiphen or a placebo every day for 18 months
* Visit the clinic periodically for checkups, tests, and questionnaires (screening visits, enrollment, month 1, month 3, month 6, month 9, month 12, month 15, month 18), including a volumetric MRI at month 6 and month 18
* Complete pre- and post-clinic visit phone calls

Start Date04 Feb 2025

Sponsor / Collaborator

Annovis Bio, Inc.

[+1]

NCT05686044

/ CompletedPhase 2/3

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multicenter Study of Buntanetap in Participants With Mild to Moderate Alzheimer's Disease

The purpose of this study is to measure efficacy and safety of three different doses of buntanetap/Posiphen compared with placebo in participants with mild to moderate Alzheimer's disease.
Study details include:
The double-blind treatment duration will include a screening period of up to 42 days followed by 12 weeks of treatment at home.
The study duration will be 4-5 months. There will be 4 in-clinic visits and 1 phone call.

Start Date01 Apr 2023

Sponsor / Collaborator

Annovis Bio, Inc.

NCT05357989

/ CompletedPhase 3

A 6-month Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial Investigating the Efficacy, Safety, and Tolerability of Two Different Doses of Buntanetap or Placebo in Patients With Early Parkinson's Disease

The purpose of this study is to measure safety and efficacy of buntanetap/posiphen capsules compared with placebo capsules in participants with early PD.
Study details include:
* The study duration will be up to 7-8 months.
* The double-blind treatment duration will be up to 6 months.
* There will be 5 in-clinic visits and 7 phone calls

Start Date03 Aug 2022

Sponsor / Collaborator

Annovis Bio, Inc.

[+1]

100 Clinical Results associated with Buntanetap

100 Translational Medicine associated with Buntanetap

100 Patents (Medical) associated with Buntanetap

Literatures (Medical) associated with Buntanetap

01 Apr 2024·SLAS discovery : advancing life sciences R & D

Real-time thiol detection in iPSC-derived neuron cultures using SemKur-IM, a novel fluorescent dithio probe

Article

Author: Alvarez, Roxanne ; Sem, Daniel S ; Kurfis, Jayson ; Hendrickson, Michael

Neurological disorders associated with inflammation and oxidative stress show reduced glutathione (GSH) levels in the human brain. Drug discovery efforts and pharmacological studies would benefit from tools (e.g. chemical probes) that detect changes to oxidative stress, from the perspective of physiologically-relevant reporters like cellular thiols, including GSH. To this end, we have developed a fluorescence visualization assay using iPSC-derived cortical glutamatergic neurons that were loaded with 25 μM of a novel thiol-detection fluorescent probe, SemKur-IM. This probe enables visualization of cellular thiol level changes in the neuronal somas and neurites, in response exposure to N-acetyl-cysteine (NAC). Cellular thiol redox state was observed to change, based on an increase in green fluorescence (485 nm excitation maximum; 525 nm emission maximum) due to changes in thiol levels, from 0 to 40 mM. Interestingly, prior to treatment with NAC, cells did not appear to have significant levels of reduced thiols. Our studies demonstrate the utility of SemKur-IM in the detection of thiol levels in live cells in response to chemical exposures, such as from drugs that return the cell to a healthier reduced state. An initial application to screening the effects of an Alzheimer's disease drug candidate, Posiphen, using fluorescence cell sorting is presented. Other potential applications include high throughput screening of central nervous system (CNS) drugs thought to work by affecting cellular redox state in neurons.

01 Jan 2023·The journal of prevention of Alzheimer's disease

Buntanetap, a Novel Translational Inhibitor of Multiple Neurotoxic Proteins, Proves to Be Safe and Promising in Both Alzheimer's and Parkinson's Patients

Article

Author: Cheng Fang ; M. Maccecchini ; K. Liow ; P. Hernandez ; E. Damiano ; H. Zetterberg ; K. Blennow ; D. Feng ; M. Chen

BACKGROUND:

Previously we reported the clinical safety and pharmacological activity of buntanetap (known as Posiphen or ANVS401) in healthy volunteers and mild cognitive impaired (MCI) patients (21). The data supported continued clinical evaluation of buntanetap for treating Alzheimer's Disease (AD). Neurodegenerative diseases such as AD and Parkinson's disease (PD) share several pathological manifestations, including increased levels of multiple neurotoxic protein aggregates. Therefore, a treatment strategy that targets toxic species common to both disorders can potentially provide better clinical outcomes than attacking one neurotoxic protein alone. To test this hypothesis, we recently completed a clinical study in early AD and early PD participants and report the data here.

OBJECTIVES:

We evaluated safety, pharmacokinetics, biomarkers, and efficacy of buntanetap in treating early AD and PD patients.

DESIGN:

Double-blind, placebo-controlled, multi-center study.

SETTING:

13 sites in the US participated in this clinical trial. The registration number is NCT04524351 at ClinicalTrials.gov.

PARTICIPANTS:

14 early AD patients and 54 early PD patients.

INTERVENTION:

AD patients were given either 80mg buntanetap or placebo QD. PD patients were given 5mg, 10mg, 20mg, 40mg, 80mg buntanetap or placebo QD.

MEASUREMENTS:

Primary endpoint is safety and tolerability; secondary endpoint is pharmacokinetics of buntanetap in plasma; exploratory endpoints are 1) biomarkers in cerebrospinal fluid (CSF) in both AD and PD patients 2) psychometric tests specific for AD (ADAS-Cogs and WAIS coding test) or PD (MDS-UPDRS and WAIS coding test).

RESULTS:

Buntanetap was safe and well tolerated. Biomarker data indicated a trend in lowering levels of neurotoxic proteins and inflammatory factors and improving axonal integrity and synaptic function in both AD and PD cohorts. Psychometric tests showed statistically significant improvements in ADAS-Cog11 and WAIS coding in AD patients and MDS-UPDRS and WAIS coding in PD patients.

CONCLUSIONS:

Buntanetap is well tolerated and safe at doses up to 80mg QD in both AD and PD patients. Cmax and AUC increase with dose without evidence for a plateau up to 80mg QD. The drug shows promising evidence in exploratory biomarker and efficacy measures. Further evaluation of buntanetap in larger, longer-term clinical trials for the treatment of AD and PD are warranted.

11 Feb 2022·ACS pharmacology & translational science

In Silico and Ex Vivo Analyses of the Inhibitory Action of the Alzheimer Drug Posiphen and Primary Metabolites with Human Acetyl- and Butyrylcholinesterase Enzymes

Article

Author: Furqan, Tiyyaba ; Tweedie, David ; Hasan Mahmood, Muhammad Sibte ; Greig, Nigel H. ; Kamal, Mohammad A. ; Batool, Sidra

Alzheimer's disease (AD) is the most common neurodegenerative disorder worldwide. Ongoing research to develop AD treatments has characterized multiple drug targets including the cholinergic system, amyloid-β peptide, phosphorylated tau, and neuroinflammation. These systems have the potential to interact to either drive or slow AD progression. Promising agents that simultaneously impact many of these drug targets are the AD experimental drug Posiphen and its enantiomer phenserine that, currently, are separately being evaluated in clinical trials. To define the cholinergic component of these agents, the anticholinesterase activities of a ligand dataset comprising Posiphen and primary metabolites ((+)-N1-norPosiphen, (+)-N8-norPosiphen, and (+)-N1,N8-bisnorPosiphen) were characterized and compared to those of the enantiomer phenserine. The "target" dataset involved the human cholinesterase enzymes acetylcholinesterase (AChE) and butyrylcholinesterase (BChE). Binding interactions between the ligands and targets were analyzed using Autodock 4.2. The computationally determined inhibitory action of these ligands was then compared to ex vivo laboratory-measured values versus human AChE and BChE. While Posiphen lacked AChE inhibitory action, its major and minor metabolites (+)-N1-norPosiphen and (+)-N1,N8-bisnorPosiphen, respectively, possessed modest AChE inhibitory activity, and Posiphen and all metabolites lacked BChE action. Phenserine, as a positive control, demonstrated AChE-selective inhibitory action. In light of AChE inhibitory action deriving from a major and minor Posiphen metabolite, current Posiphen clinical trials in AD and related disorders should additionally evaluate AChE inhibition; particularly if Posiphen should be combined with a known anticholinesterase, since this drug class is clinically approved and the standard of care for AD subjects, and excessive AChE inhibition may impact drug tolerability.

129

News (Medical) associated with Buntanetap

03 Dec 2025

·www.globenewswire.com

Annovis To Present at the 2025 Annual Meeting of the Parkinson Study Group

MALVERN, Pa., Dec. 03, 2025 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced it will present at the 2025 Annual Meeting of the Parkinson Study Group (PSG), taking place December 4-6, 2025 in San Diego, California. The presentation builds on momentum from the Company’s recent Phase 3 PD biomarker data, showing that patients with amyloid co-pathology experience more pronounced cognitive decline, which is counteracted and reversed by buntanetap. In the same patients, buntanetap also reduces tau biomarkers, which are known to increase with disease severity. The presentation will also debut a cross-study comparison of the completed trials, providing the most comprehensive look yet at cognitive outcomes across all tested indications by Annovis and highlighting the population that benefits most – patients with amyloid pathology. In both Parkinson’s and Alzheimer’s, individuals with biomarker-confirmed presence of amyloid experience the greatest cognitive gain following buntanetap. These findings further validate the drug’s mechanism as a translational inhibitor of neurotoxic aggregating proteins and support the Company’s next strategic steps. Presentation details: Title: Amyloid co-pathology, cognitive decline, and improvement in buntanetap-treated Parkinson’s disease dementia patientsPresenter: Maria Maccecchini, Ph.D., President and CEOFormat: Poster guided tourTime of presentation: December 5, 6:15 p.m. PST The data presented at the meeting will be posted on the Company's website following the conference. The PSG Annual Meeting brings together leading investigators, coordinators, trainees, advocates, and allied stakeholders to advance collaborative research and showcase the latest advances and best practices in PD. About AnnovisHeadquartered in Malvern, Pennsylvania, Annovis is dedicated to addressing neurodegeneration in diseases such as Alzheimer’s disease (AD) and Parkinson’s disease (PD). The Company is committed to developing innovative therapies that improve patient outcomes and quality of life. For more information, visit www.annovisbio.com and follow us on LinkedIn, YouTube, and X. Investor AlertsInterested investors and shareholders are encouraged to sign up for press releases and industry updates by registering for email alerts at https://www.annovisbio.com/email-alerts. Forward-Looking StatementsThis press release contains forward-looking statements under the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended. Actual results may differ due to various risks and uncertainties, including those outlined in the Company’s SEC filings under “Risk Factors” in its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. The Company undertakes no obligation to update forward-looking statements except as required by law. Contact Information:Annovis Bio Inc.101 Lindenwood DriveSuite 225Malvern, PA 19355www.annovisbio.com Investor Contact:Alexander Morin, Ph.D.Director, Strategic CommunicationsAnnovis Bioir@annovisbio.com‍

Phase 3

24 Nov 2025

·www.globenewswire.com

Annovis Announces Two Presentations at the CTAD 2025 Conference

MALVERN, Pa., Nov. 24, 2025 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced two presentations at the 18th Clinical Trials on Alzheimer's Disease (CTAD) conference, taking place December 1-4, 2025 in San Diego, California. The presentations will highlight progress across the Alzheimer’s and Parkinson’s programs, with a particular focus on recent biomarker data supporting the potential disease-modifying activity of buntanetap. Details: Presentation #1 (P073) Title: Amyloid co-pathology and cognitive decline in buntanetap-treated Parkinson’s disease dementia patientsPresenter: Cheng Fang, Ph.D., Senior VP, Research & DevelopmentTime: December 1, 3:00 pm – December 2, 5:30 pm Presentation #2 (P007) Title: Double 6/18-month Phase 3 study to reproduce symptomatic and potentially show disease-modifying efficacy of buntanetap in treating Alzheimer’s diseasePresenter: Maria Maccecchini, Ph.D., President and CEOTime: December 1, 3:00 pm – December 2, 5:30 pm “We look forward to attending CTAD, which comes at the perfect moment to share our latest findings on biomarkers and cognition with the scientific community—work we believe will resonate with clinicians, researchers, and industry leaders,” said Maria Maccecchini, Ph.D., President and CEO of Annovis. “Across both disease indications, our biomarker data tell a clear story—buntanetap has the potential to address the root drivers of cognitive decline. These results not only confirm the efficacy of buntanetap seen in our earlier studies but also give us a clearer path forward as we work to bring an effective treatment to patients who urgently need better options.” About AnnovisHeadquartered in Malvern, Pennsylvania, Annovis is dedicated to addressing neurodegeneration in diseases such as Alzheimer’s disease (AD) and Parkinson’s disease (PD). The Company is committed to developing innovative therapies that improve patient outcomes and quality of life. For more information, visit www.annovisbio.com and follow us on LinkedIn, YouTube, and X. Investor AlertsInterested investors and shareholders are encouraged to sign up for press releases and industry updates by registering for email alerts at https://www.annovisbio.com/email-alerts. Forward-Looking StatementsThis press release contains forward-looking statements under the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended. Actual results may differ due to various risks and uncertainties, including those outlined in the Company’s SEC filings under “Risk Factors” in its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. The Company undertakes no obligation to update forward-looking statements except as required by law. Contact Information:Annovis Bio Inc.101 Lindenwood DriveSuite 225Malvern, PA 19355www.annovisbio.com Investor Contact:Alexander Morin, Ph.D.Director, Strategic CommunicationsAnnovis Bioir@annovisbio.com‍

Phase 3

18 Nov 2025

·www.globenewswire.com

Annovis Announces FDA Meeting to Discuss Parkinson's Disease Dementia Program; Reaffirms FDA Alignment on Pivotal Phase 3 Alzheimer's Disease Study

MALVERN, Pa., Nov. 18, 2025 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced that the U.S. Food and Drug Administration (FDA) has scheduled a Type C meeting in January 2026 to discuss the Company's pathway for Parkinson's disease dementia (PDD). Annovis also reaffirmed that its ongoing Phase 3 AD clinical trial continues to progress with full regulatory alignment on study design, endpoints, and patient population. "We are pleased with such proactive engagement with the FDA on our PDD program, which represents a significant opportunity to address an underserved patient population," said Maria Maccecchini, Ph.D., President and CEO. "The scheduled January meeting marks a key milestone for our pipeline, underscoring buntanetap's potential across multiple neurodegenerative indications and the strength of our scientific approach." Parkinson's Disease Dementia Program The upcoming meeting will focus on the clinical development pathway for buntanetap in PDD, a debilitating condition affecting approximately 30% of PD patients, with some reports suggesting that up to 80% develop dementia over the long term. Dementia in Parkinson’s profoundly affects quality of life for both patients and caregivers, with limited approved treatment options currently available. The meeting agenda will include discussions on clinical trial design, patient population, and a potential approval route. "Parkinson's disease dementia represents a natural extension of both our Alzheimer's and Parkinson's programs," added Cheng Fang, Senior VP, Research & Development. "Across both indications, we have generated strong data demonstrating meaningful cognitive improvement with buntanetap. Despite being a serious problem, cognitive decline in Parkinson's patients has received limited attention in the field. Our integrated data across multiple studies has opened a unique opportunity to address this unmet need and alleviate the cognitive burden in the Parkinson's population." Phase 3 Alzheimer's Disease Study Progress Annovis also confirmed that its Phase 3 clinical trial in early AD continues to enroll patients according to plan, with full FDA agreement on all critical study parameters. The agency provided comprehensive feedback during the End-of-Phase 2 meeting in 2024, confirming its alignment on the study design, which is set to support two potential NDAs: one for symptomatic treatment and one for disease-modifying treatment with buntanetap. "The FDA's continued engagement across our clinical programs underscores the regulatory clarity we have established," said Maria Maccecchini, Ph.D. "We remain focused on executing our pivotal Phase 3 AD study while advancing opportunities in complementary indications like PDD, where our drug candidate may provide a truly meaningful benefit to patients." About AnnovisHeadquartered in Malvern, Pennsylvania, Annovis is dedicated to addressing neurodegeneration in diseases such as Alzheimer’s disease (AD) and Parkinson’s disease (PD). The Company is committed to developing innovative therapies that improve patient outcomes and quality of life. For more information, visit www.annovisbio.com and follow us on LinkedIn, YouTube, and X. Investor AlertsInterested investors and shareholders are encouraged to sign up for press releases and industry updates by registering for email alerts at https://www.annovisbio.com/email-alerts. Forward-Looking StatementsThis press release contains forward-looking statements under the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended. Actual results may differ due to various risks and uncertainties, including those outlined in the Company’s SEC filings under “Risk Factors” in its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. The Company undertakes no obligation to update forward-looking statements except as required by law. Contact Information:Annovis Bio Inc.101 Lindenwood DriveSuite 225Malvern, PA 19355www.annovisbio.com Investor Contact:Alexander Morin, Ph.D.Director, Strategic CommunicationsAnnovis Bioir@annovisbio.com‍

Phase 3

100 Deals associated with Buntanetap

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15317

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Alzheimer Disease	Phase 3	United States	Annovis Bio, Inc.	04 Feb 2025
Parkinson Disease	Phase 3	United States	Annovis Bio, Inc.	03 Aug 2022
Parkinson Disease	Phase 3	Germany	Annovis Bio, Inc.	03 Aug 2022
Parkinson Disease	Phase 3	Hungary	Annovis Bio, Inc.	03 Aug 2022
Parkinson Disease	Phase 3	Italy	Annovis Bio, Inc.	03 Aug 2022
Parkinson Disease	Phase 3	Poland	Annovis Bio, Inc.	03 Aug 2022
Parkinson Disease	Phase 3	Spain	Annovis Bio, Inc.	03 Aug 2022
Young onset Parkinson disease	Phase 2	United States	Annovis Bio, Inc.	14 Aug 2020
Cognitive Dysfunction	Phase 2	United States	Annovis Bio, Inc.	26 May 2009
Lewy Body Disease	Phase 2	-	Annovis Bio, Inc.	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05686044 (CTgov)	Phase 2/3	Alzheimer Disease	351	Placebo (Placebo)	yibuhnuyuv(gxqnemmoyt) = aoykbttidn zswogacxsg (xuznevuqzl, 0.533) View more	-	29 Apr 2025
				Buntanetap/Posiphen (7.5mg Buntanetap/Posiphen)	yibuhnuyuv(gxqnemmoyt) = avduvbgwej zswogacxsg (xuznevuqzl, 0.526) View more
NCT05357989 (CTgov)	Phase 3	Parkinson Disease	523	Placebo (Placebo)	beturekbwn(qqkusngycb) = szjhjinrkr pqvwlfuxoa (xmsobzdvmd, 0.311) View more	-	03 Mar 2025
				buntanetap/posiphen (10 mg Buntanetap/Posiphen)	beturekbwn(qqkusngycb) = qaxbmxmddo pqvwlfuxoa (xmsobzdvmd, 0.312) View more
NCT05357989 (Biospace) Manual	Phase 3	Parkinson Disease	-	Buntanetap	octiuvfljn(ffvzvmzoav) = In patients diagnosed with PD for longer than 3 years (MH>3), with measurable declines in MDS-UPDRS Part II, 20mg buntanetap significantly improved MDS-UPDRS Part II, Part III, Part II+III, and Total scores compared to placebo and baseline shgtpvnwzn (bybrwpejvm ) View more	Positive	02 Jul 2024
				Placebo
GlobeNewswire Manual	Not Applicable	Alzheimer Disease	-	Buntanetap 15mg	oslstfooeh(cfditsoglc) = oisujxiula oomskpqvjl (ikqkhrnlgu )	Positive	11 Jun 2024
				Placebo	oslstfooeh(cfditsoglc) = nxzizdvcwy oomskpqvjl (ikqkhrnlgu )
NCT05686044 (Biospace) Manual	Phase 2/3	Alzheimer Disease	325	Buntanetap 7.5 mg	lfjvyvssen(nswtvtuhgm) = treedxsbyq fvrevmydyg (cdbjckyftd, 0.87)	Positive	29 May 2024
				Buntanetap 15 mg	lfjvyvssen(nswtvtuhgm) = tfjwpuvhuu fvrevmydyg (cdbjckyftd, 0.81)
NCT05686044 (Biospace) Manual	Phase 2/3	Alzheimer Disease	107	Buntanetap	egjihxokhp(xykxgorswq) = hemexmhggh huyzjldhxt (dusbettuel )	Positive	30 Oct 2023
NCT04524351 (CTgov)	Phase 1/2	Young onset Parkinson disease \| Alzheimer Disease	75	Posiphen (Posiphen, 80mg (Parkinson's Participants))	hdrggetrbq = tnalyconjy douckhnbfg (rdlznjmkva, lepdbbxdoq - jpcenlleid) View more	-	28 Feb 2023
				Posiphen (Posiphen, 40mg (Parkinson's Participants))	hdrggetrbq = tvbnbfyxyb douckhnbfg (rdlznjmkva, dyslfdsqds - qstopdynah) View more
NCT02925650 (CTAD2022)	Phase 1	Mild cognitive disorder CSF Aβ42/40	19	Posiphen	fgcavigtku(laqnmwueor) = 8/19 participants reported headache either during CSF sampling (4),after the procedure (3), or both (1). 5 had blood patches with rapid resolution of headache. oaojllksqz (raebafrlcr )	-	03 Dec 2022

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis