Drugs / buntanetap
buntanetap
also known as
Posiphen · ANVS401 · BUNTANETAP TARTRATE · Posiphen tartrate · R-phenserine · R-phenserine tartrate
Small molecule targets APP via inhibition
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01072812 | Feb → Jul 2010 | Alzheimer disease, amnestic disorder | Annovis Bio Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02925650 | Mar 2017 → Dec 2021 | Alzheimer disease | Annovis Bio Inc. | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT07284784 | Jan 2026 → Sep 2029 expected | Parkinson disease | Annovis Bio Inc. | Recruiting | No outcome recorded |
| Phase 2/3 | NCT05686044 | Apr 2023 → Feb 2024 | Alzheimer disease | Annovis Bio Inc. | Completed | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT06709014 | Feb 2025 → Dec 2027 expected | Alzheimer disease | Annovis Bio Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05357989 | Aug 2022 → Dec 2023 | Parkinson disease | Annovis Bio Inc. | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 1/2 | NCT04524351 Comparator | Aug 2020 → Aug 2021 | Alzheimer disease, Parkinson disease | Annovis Bio Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 49
| Date | Issuer | Release |
|---|---|---|
| 2026-04-28 | Annovis Bio Inc. | Results Annovis Publishes Phase 2/3 Alzheimer's Trial Results in Nature Portfolio annovisbio.com ↗
The study demonstrated that buntanetap was safe and well-tolerated across all disease stages and dose levels. |
| 2026-02-12 | Annovis Bio Inc. | Results Annovis Secures DSMB Approval to Advance Pivotal Phase 3 Trial of Buntanetap in Alzheimer’s Disease annovisbio.com ↗
Following a comprehensive evaluation, the DSMB concluded that no safety concerns were identified and recommended that the clinical trial continue as planned, without changes. |
| 2025-12-03 | Annovis Bio Inc. | Results Annovis To Present at the 2025 Annual Meeting of the Parkinson Study Group annovisbio.com ↗
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. |
| 2025-11-17 | Annovis Bio Inc. | Results Annovis Reports New Biomarker Data Linking Amyloid Co-Pathology to Accelerated Cognitive Decline in Parkinson's Patients annovisbio.com ↗
In the Company’s Phase 3 study in early PD (NCT05357989), buntanetap halted cognitive decline across the overall patient population, with the greatest improvement observed in those with mild dementia. |
| 2025-11-12 | Annovis Bio Inc. | Results Annovis Provides Corporate Updates and Reports Third Quarter 2025 Financial Results annovisbio.com ↗
Adding to all this, we are particularly encouraged by the new biomarker findings from our Phase 2/3 study showing meaningful reductions in inflammation and neurodegeneration—powerful evidence of buntanetap's disease-modifying potential. |
| 2025-10-09 | Annovis Bio Inc. | Results Annovis Announces Novel Biomarker Data in Alzheimer’s Patients Supporting Buntanetap’s Potential as a Disease-Modifying Treatment annovisbio.com ↗ |
| 2025-09-16 | Annovis Bio Inc. | Results Annovis Reports Peer-Reviewed Publication Highlighting Pharmacokinetics of Novel Crystal Buntanetap annovisbio.com ↗
The findings confirm that crystal buntanetap preserves the PK profile and metabolism of the original form, which are essential for the drug’s therapeutic efficacy. |
| 2025-01-07 | Annovis Bio Inc. | Regulatory FDA Accepts Final Protocol for Pivotal Phase 3 Alzheimer’s Disease Study, Streamlining Development Pathway annovisbio.com ↗
today announced that the FDA has accepted an updated protocol for the pivotal Phase 3 AD study, which is slated to begin in January 2025. |
| 2024-10-15 | Annovis Bio Inc. | Regulatory FDA Clears Annovis to Launch Pivotal Phase 3 Alzheimer’s Studies, Paving the Way to NDAs annovisbio.com ↗
During the meeting, the FDA granted clearance to proceed with pivotal Phase 3 studies, based on the Company's Phase 2/3 clinical data showing symptomatic improvement in early AD patients. |
| 2024-08-06 | Annovis Bio Inc. | Results Annovis’ Lead Compound Enhances Cognition Synergistically with GLP-1 Agonist annovisbio.com ↗
Annovis Bio Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative disorders such as Alzheimer’s disease (AD) and Parkinson’s disease (PD), today announced new preclinical data demonstrating the synergistic effect of its lead compound, buntanetap, when combined with the glucagon-like peptide 1 (GLP-1) agonist dulaglutide (Trulicity®) in a mouse model of Alzheimer’s disease. |
| 2024-07-16 | Annovis Bio Inc. | Regulatory Annovis Bio Receives FDA Approval to Transition to New Crystal Form of Buntanetap annovisbio.com ↗ |
| 2024-07-02 | Annovis Bio Inc. | Results Annovis Bio Announces New Data from Phase III Parkinson’s Study Highlighting Improvements in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and Cognition after Treatment with Buntanetap annovisbio.com ↗ |
| 2024-06-11 | Annovis Bio Inc. | Results Annovis Bio’s Buntanetap Found Safe and Effective in High-Risk Alzheimer's Patients annovisbio.com ↗
In patients with early AD (MMSE 21-24), Buntanetap showed a statistically significant dose-response in ADAS-Cog11 scores, with a -3.3 points improvement over baseline and -2.3 points improvement from placebo. |
| 2024-05-21 | Annovis Bio Inc. | Results Annovis Announces New Publication in a Peer-Reviewed Journal annovisbio.com ↗
This article synthesizes findings from various preclinical and clinical studies on Posiphen's absorption and metabolism from mice, rats, dogs, and humans. |
| 2024-05-06 | Annovis Bio Inc. | Results Annovis Bio CEO Maria Maccecchini Issues Letter to Stockholders annovisbio.com ↗
The table clearly shows a strong response in patients with early AD (MMSE 18-28 and MMSE 21-24), while in moderate AD patients (MMSE 14-20), the response is obscured by high placebo effect. |
| 2024-04-29 | Annovis Bio Inc. | Results Annovis Bio Announces Statistically Significant Phase II/III Data in Patients With Early Alzheimer’s Disease annovisbio.com ↗
Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a clinical-stage drug platform company developing novel therapies for neurodegenerative diseases, such as Alzheimer’s (AD) and Parkinson’s disease (PD), today announced the data from its Phase II/III Alzheimer study of buntanetap in mild to moderate AD patients. |
| 2024-04-01 | Annovis Bio Inc. | Results Annovis Announces Publication That Supports Understanding of Buntanetap’s Mechanism of Action in Humans annovisbio.com ↗
In general, buntanetap lowered the rate of translation, the maximum concentration (Cmax), lengthened the Tmax, and decreased the area under the curve (AUC). |
| 2024-01-30 | Annovis Bio Inc. | Regulatory Annovis Bio Announces the Filing of New Patent Application for Treatment of Mental Illnesses Expanding the Company’s Portfolio annovisbio.com ↗
Annovis Bio, Inc. (NYSE: ANVS), a clinical-stage drug platform company developing novel therapies for neurodegenerative diseases, announced the filing of a patent application covering the use of buntanetap and its analogues for the treatment of neuropsychiatric indications. |
| 2023-11-02 | Annovis Bio Inc. | Results Annovis Bio Measures Novel Biomarkers in Plasma of Parkinson’s Patients annovisbio.com ↗
Buntanetap lowers the levels of TDP43, NfL, and GFAP |
| 2023-10-30 | Annovis Bio Inc. | Results Annovis Bio Receives Positive Recommendation to Continue Phase 2/3 Trial of Buntanetap for Alzheimer’s Disease Patients From the Independent Data and Safety Monitoring Board (DSMB) annovisbio.com ↗
Annovis Bio, Inc. (NYSE: ANVS), announces the positive safety review by the Data and Safety Monitoring Board (DSMB) for its phase 2/3 trial of buntanetap, a drug candidate for moderate to mild Alzheimer’s Disease (AD) patients. |
| 2023-10-24 | Annovis Bio Inc. | Results Annovis Bio Showcases Promising Progress in Novel Drug Development at the 2023 Clinical Trials on Alzheimer's Disease Conference annovisbio.com ↗
Second, these findings have been replicated in all human AD and PD phase I and II trials to date, demonstrating decreased levels of toxic proteins in the brain, improved axonal transport, reduced inflammation, and neuroprotection. |
| 2023-10-12 | Annovis Bio Inc. | Results Annovis Bio Announces Positive Interim Independent Analysis for Statistical Power in Its Alzheimer’s Study annovisbio.com ↗
The interim analysis was based on 107 patients at 6 weeks from all cohorts collectively and showed that the AD trial should continue as planned with the same trial size to maintain the statistical power for both co-primary endpoints. |
| 2023-07-18 | Annovis Bio Inc. | Results Continued Positive Performance of Novel Drug Development by Annovis Bio Presented at 2023 Alzheimer's Association International Conference annovisbio.com ↗
These results showed evidence that buntanetap lowers the rate of production of APP, suggesting a dose-response relationship. |
| 2023-06-27 | Annovis Bio Inc. | Regulatory Annovis Bio Announces the Filing of a Groundbreaking Patent annovisbio.com ↗
Annovis Bio, Inc. (NYSE: ANVS), a clinical stage drug platform company developing novel and transformative therapies for neurodegenerative diseases, announces the creation of a novel crystalline form of buntanetap (ANVS402), and the filing of a new composition of matter provisional patent with the U.S. Patent and Trademark Office. |
| 2023-06-20 | Annovis Bio Inc. | Results Annovis Bio Receives Excellent Safety Rating and Positive Recommendation to Continue Phase III Trial of Buntanetap for Parkinson’s Disease Patients from the Independent Data and Safety Monitoring Board (DSMB) annovisbio.com ↗
The DSMB recommended that Annovis Bio continue the trial as originally designed. |
| 2023-02-08 | Annovis Bio Inc. | Regulatory Annovis Bio Announces Approval for European Union Clinical Trial Sites for the Phase 3 Study of Buntanetap for the Treatment of Parkinson's Disease annovisbio.com ↗ |
| 2022-10-11 | Annovis Bio Inc. | Results Annovis Bio Announces Publication of Phase 2a Clinical Data in The Journal of Prevention of Alzheimer's Disease annovisbio.com ↗
The study demonstrated that buntanetap was well tolerated, safe and significantly improved cognition in AD patients and motor function in PD patients. |
| 2022-10-06 | Annovis Bio Inc. | Regulatory Annovis Bio Announces FDA Authorization to Proceed with Phase 2/3 Trial for Buntanetap in Alzheimer's Disease annovisbio.com ↗
The FDA approved the Company's development plan, study protocol and authorized the initiation of the Phase 2/3 clinical study of buntanetap in AD. |
| 2022-07-07 | Annovis Bio Inc. | Regulatory Annovis Bio Announces Positive FDA Notice For Buntanetap Phase 3 Clinical Trial In Parkinson's Disease annovisbio.com ↗ |
| 2021-12-14 | Annovis Bio Inc. | Results Annovis Bio Announces Publication of ANVS401 Mechanism of Action in Peer-Reviewed Pharmaceutics annovisbio.com ↗
The results demonstrated that, in addition to the proteins already known to be reduced by ANVS401, other neurotoxic aggregating proteins - huntingtin protein (HTT) and TDP43 - were shown to be downregulated as well. |
| 2021-11-12 | Annovis Bio Inc. | Results Annovis Bio Presented at the 14th Clinical Trials on Alzheimer’s Disease Conference annovisbio.com ↗
Data from the Phase 2a clinical trial presented today at CTAD showed that treatment with ANVS401 reduced neurotoxic proteins in both AD and PD patients (Figure 1). |
| 2021-10-05 | Annovis Bio Inc. | Results Annovis Bio Announces Positive Phase 2 Efficacy Data for the Treatment of Parkinson’s Disease annovisbio.com ↗
Annovis Bio, Inc. (NYSE American: ANVS) ("Annovis" or the "Company"), a clinical-stage drug platform company addressing Alzheimer's disease (AD), Parkinson's disease (PD) and other neurodegenerative diseases, today announced results from the completed dose response Phase 2 clinical trial of ANVS401 in 54 PD patients, which found that once-daily ANVS401 was superior to placebo in improving motor function. |
| 2021-07-30 | Annovis Bio Inc. | Results Annovis Bio Pleased by Positive Interim Results from Ongoing Phase II Clinical Trials of ANVS401 (Posiphen) for the Treatment of Alzheimer's Disease and Parkinson's Disease annovisbio.com ↗
Over the course of the first 25 days of treatment, the initial patient cohorts demonstrated statistically significant positive results in both their cognitive and motor skills. |
| 2021-07-28 | Annovis Bio Inc. | Results Annovis Bio Presents New Clinical and Biomarker Data at 2021 Alzheimer's Association International Conference annovisbio.com ↗
The second part of the panel discussion will feature the clinical study and clinical data of the first 28 patients treated with ANVS401 in the Company’s ongoing Phase 2a trials. |
| 2021-07-20 | Annovis Bio Inc. | Results Annovis Bio Reports Positive Safety Data from its Phase 2 Alzheimer’s Study annovisbio.com ↗
The safety evaluation of Cohort 2, conducted by the DSMB, reviewed data from an additional eight patients treated with ANVS401 at a dosage of 120 mg per day (2x60 mg) or placebo. |
| 2021-06-08 | Annovis Bio Inc. | Results Annovis Bio Expands Potential Application of ANVS401 to Infectious Diseases with New Preclinical Study annovisbio.com ↗ |
| 2021-06-01 | Annovis Bio Inc. | Results Annovis Bio’s ANVS401 Improves Speed and Accuracy in Alzheimer’s and in Parkinson’s Patients annovisbio.com ↗
Annovis Bio found that speed and accuracy was increased in both patient populations of its Phase 2a study, whether the comparison was made between the same patients before and after treatment or between the placebo and ANVS401 treated groups at 25 days. |
| 2021-05-21 | Annovis Bio Inc. | Results Annovis Bio Announces Positive Phase 2 Data – ANVS401 Improves Cognition in Alzheimer’s Disease - Patients’ Cognition Improved 3.3 Points on ADAS-Cog11 annovisbio.com ↗
Patients treated with ANVS401 for 25 days showed statistically significant cognitive improvement as measured by the Alzheimer’s Disease Assessment Scale–Cognitive Subscale 11 (ADAS-Cog11). |
| 2021-05-20 | Annovis Bio Inc. | Results Annovis Bio Announces Positive Phase 2 Data: ANVS401 Significantly Lowers Inflammatory Markers in Parkinson's Patients annovisbio.com ↗
The levels of inflammatory markers in PD patients treated with ANVS401 were significantly lower than before treatment. |
| 2021-05-13 | Annovis Bio Inc. | Regulatory Annovis Bio Files for FDA Orphan Drug Designation for ANVS401 for the Treatment of Alzheimer’s Disease in Persons with Down Syndrome annovisbio.com ↗ |
| 2021-03-16 | Annovis Bio Inc. | Results Annovis Bio Announces Positive Phase 2 Data - Interim Data Shows ANVS401 Improves Speed and Coordination in Parkinson's Patients annovisbio.com ↗
Patients' speed and coordination scores both improved following 25 days of ANVS401 treatment, with no serious adverse events. |
| 2021-02-02 | Annovis Bio Inc. | Results Annovis Bio's Lead Candidate ANVS401 Improves Cognitive and Functional Outcomes in Stroke Mice Study annovisbio.com ↗
today announced study data showing that a combination treatment using the Company's lead candidate ANVS401 and pifithrin-α (PFT-α) after stroke improved mice locomotor activity and cognitive function more so than treatment with just one or the other agent. |
| 2020-12-15 | Annovis Bio Inc. | Results Annovis Bio Showcases its Unique Approach to Alzheimer’s at the New York Academy of Sciences annovisbio.com ↗
ANVS401 lowered APP and phospho-tau, reversed Rab5 hyperactivation and restored retrograde transport. |
| 2020-11-12 | Annovis Bio Inc. | Results Annovis Bio Reports Positive Results from Final Phase of $1.9M NIH Funded Chronic Toxicology Study for its Lead Compound for the Treatment of Alzheimer’s and Parkinson’s Diseases annovisbio.com ↗
The strong safety data corroborates the positive results from the Company’s prior one-month safety studies in mice, rats, dogs, and humans and six-month study in rats. |
| 2020-09-29 | Annovis Bio Inc. | Results Annovis Bio Demonstrates Improved Axonal Transport in Nerve Cells and Brain of Down Syndrome Mice, an Animal Model of Alzheimer’s Disease annovisbio.com ↗
today announced the publication of peer-reviewed data demonstrating the ability of its lead candidate, ANVS401, also known as Posiphen, to improve axonal transport, the information highway of nerve cells. |
| 2020-06-16 | Annovis Bio Inc. | Results Annovis Bio Announces Positive Results from NIH Funded Chronic Toxicology Study annovisbio.com ↗
Annovis Bio Inc. (NYSE American: ANVS), a clinical-stage drug platform company addressing Alzheimer’s disease (AD), Parkinson’s disease (PD) and other neurodegenerative diseases, today announced it successfully completed the rat cohort of a chronic toxicology study of its lead therapeutic compound ANVS401, reporting no negative side effects. |
| 2020-06-02 | Annovis Bio Inc. | Regulatory Annovis Bio Issued European Patent for Method of Treating Alzheimer’s Disease with ANVS401 annovisbio.com ↗ |
| 2020-04-23 | Annovis Bio Inc. | Results Annovis Bio Publishes Results of Alzheimer’s and Parkinson’s Animal Studies annovisbio.com ↗
In the study, ANVS401 treatment normalized impairments in spatial working memory, contextual fear learning, and synaptic function in APP/presenilin-1 mice, without affecting their visual activity, motor skills, or motivation and without affecting wild-type mice. |
| 2020-02-13 | Annovis Bio Inc. | Results Annovis Bio Announces Update on Phase II Clinical Trial for Alzheimer’s Disease annovisbio.com ↗
No adverse effects have been reported in any of the enrolled patients. |
All press releases naming this drug 69 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Buntanetap | “Previously we reported the clinical safety and pharmacological activity of buntanetap (known as Posiphen or ANVS401) in healthy volunteers and mild cognitive impaired (MCI)...” PMID 36641607 ↗ 2023 |
| Known as | ANVS401 | “Previously we reported the clinical safety and pharmacological activity of buntanetap (known as Posiphen or ANVS401) in healthy volunteers and mild cognitive impaired (MCI)...” PMID 36641607 ↗ 2023 |
| Known as | BUNTANETAP TARTRATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297417 ↗ |
| Known as | Posiphen | “The purpose of this study is to measure safety and efficacy of buntanetap/posiphen capsules compared with placebo capsules in participants with early PD.” NCT05357989 ↗6“The goal of this clinical trial is to learn if buntanetap/Posiphen works to treat early Alzheimer's disease in adults aged 55-85.” NCT06709014 ↗ “Buntanetap/Posiphen 7.5mg oral capsule with daily administration for a period of 12 weeks” NCT05686044 ↗ “buntanetap/posiphen” NCT07284784 ↗ |
| Known as | Posiphen tartrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297417 ↗ |
| Known as | R-phenserine | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297417 ↗ |
| Known as | R-phenserine tartrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297417 ↗ |
| Action | Inhibit | “specifically inhibits the synthesis of amyloid precursor protein (APP)” NCT02925650 ↗ |
| Modality | Small molecule | “Posiphen, an orally administered small molecule” PMID 38970127 ↗ Jul 2024 |
| Route | Oral | “The study drug Posiphen dosage of 60mg is to be taken orally in divided doses, three times per day for a total 23-25 days.” NCT02925650 ↗ |
| Target | APP | “Posiphen, an orally administered small molecule, binds to an iron-responsive element in APP mRNA and decreases translation of APP and Aβ.” PMID 38970127 ↗ Jul 2024 |