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buntanetap/posiphen

Phase 3

Early Alzheimers Disease | Small molecule | Neurology |Annovis Bio, Inc.|Last Updated: Aug 19, 2026

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment760

FDA Designations

No designations recorded

Clinical trial landscape

buntanetap/posiphen · 5 trials · 6 indications

Phase 3 2Phase 2 3
NCT06709014A Double-blind Dual Study Assessing Safety and Efficacy of Buntanetap in Participants With Early ADEarly Alzheimers Disease
ACTIVE NOT_RECRUITING760 Analytics
NCT05357989A Double-blind Study to Investigate Efficacy and Safety of Buntanetap Compared With Placebo in Participants With Early PDParkinson's Disease, Idiopathic
COMPLETED523 Analytics
PHASE3ACTIVE NOT_RECRUITING
A Double-blind Dual Study Assessing Safety and Efficacy of Buntanetap in Participants With Early AD
Early Alzheimers DiseaseUnlock trial analytics
PHASE3COMPLETED
A Double-blind Study to Investigate Efficacy and Safety of Buntanetap Compared With Placebo in Participants With Early PD
Parkinson's Disease, IdiopathicUnlock trial analytics

Study Endpoints

Primary Endpoints

Alzheimer's Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog13)
From screening to 6-month readout, to end of treatment at 18 months.

ADAS-Cog13 includes the original ADAS-Cog11 items that assess cognitive function across the memory, language, praxis, and orientation domains and adds a number cancellation task and a delayed free recall task. Total scores range from 0-85, with higher scores indicating greater cognitive impairment.

Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Scale (ADCS-iADL)
From screening to 6-month readout, to end of treatment at 18 months.

The Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale (ADCS-ADL) is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's study partner to assess function to the degree to which the participant can perform a variety of tasks. The questionnaire asks 6 questions of basic ADLs and 17 instrumental ADLs. The iADL are more complex tasks, including activities such as shopping, maintaining appointments, or managing one's belongings or finances. The ADCS-iADL subset is assessed with items 6a and 7-23; scores range from 0 to 59, with lower scores indicating greater impairment in function.

Change From Baseline to Month 6 in MDS-UPDRS Part II (OFF-state)
Baseline and 6 months visits

Change in the Score from the MDS- Unified Parkinson's Disease Rating Scale (UPDRS) Parts II from Baseline to the End of Trial. MDS-UPDRS Part II (Motor experiences of daily living) has 13 items and the score ranges from 0-52, with higher scores reflecting greater severity.

Safety of buntanetap
24 months of treatment

Safety assessments of participants with AD receiving treatment with buntanetap

Adverse Events (AE)
24 months of study

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)
24 months of study

TEAE is an event that emerges during treatment, having been absent pretreatment, or worsens relative to the pretreatment state

Serious Adverse Events (SAE)
24 months of study

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

Change From Baseline to Week 12 in ADAS-Cog11
Baseline to the end of treatment period (12 weeks)

Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11) measures cognitive functions and non-cognitive functions such as mood and behavior. It was designed to measure the cognitive and behavioral domains known to be affected in Alzheimer disease, including memory, language, orientation, construction, and planning of simple designs, and completed simple goal-oriented behaviors. Specifically, the ADAS-Cog comprises ratings from 11 components: word recall, word recognition, constructional praxis, orientation, naming objects and fingers, commands, ideational praxis, remembering test instructions, spoken language, word finding, and comprehension. Total scores range from 0-70, with higher scores indicating greater cognitive impairment.

ADCS-CGIC at Week 12
Baseline to the end of treatment period (12 weeks)

Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) focuses on clinicians' observations of change in the patient's cognitive, functional, and behavioral performance since the beginning of a trial. It relies on both direct examination of the patient and interview of informants. The ADCS-CGIC measures whether the effects of active treatment are substantial enough to be detected by a skilled and experienced clinician on the basis of a clinical interview and examination. It relies on both direct examination of the patient and an interview of the study partner. A skilled and experienced clinician who is blinded to treatment assignment rates the patient on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening). Lower scores indicate better improvement.

Secondary Endpoints

Change From Baseline to Month 6 in the MDS-UPDRS Part III (OFF-state)
Baseline and 6 months visits
Change From Baseline to Week 12 in ADCS-ADL
Baseline to end of treatment period (12 weeks)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
buntanetapEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
10 mg buntanetap/posiphenEXPERIMENTALBuntanetap/posiphen 10 mg oral capsule with daily administration for a period of 6 months
20 mg buntanetap/posiphenEXPERIMENTALBuntanetap/posiphen 20 mg oral capsule with daily administration for a period of 6 months
Single ArmEXPERIMENTALAll participants receive buntanetap 30 mg qd
Cohort 1 - buntanetapEXPERIMENTALCohort 1 will enroll via invitation only for PD participants who have previously participated in bun
Cohort 2 - buntanetapEXPERIMENTALCohort 2 will be for PD participants who are receiving deep brain stimulation (DBS) treatment.
7.5mg Buntanetap/PosiphenEXPERIMENTALBuntanetap/Posiphen 7.5mg oral capsule with daily administration for a period of 12 weeks
15mg Buntanetap/PosiphenEXPERIMENTALBuntanetap/Posiphen 15mg oral capsule with daily administration for a period of 12 weeks
30mg Buntanetap/PosiphenEXPERIMENTALBuntanetap/Posiphen 30mg oral capsule with daily administration for a period of 12 weeks

Interventions

NameTypeDescription
buntanetap/posiphenDRUG30mg capsule by mouth once daily for 18 months
PlaceboDRUGPlacebo capsule by mouth once daily for 18 months
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Eligibility Criteria

Age Range55 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites78

Inclusion Criteria: 1. Diagnosis of AD according to the 2024 National Institute on Aging and Alzheimer's Association criteria. 2. Male or female, aged 55 - 85 years. 3. MMSE 20-28 at screening and baseline. 4. CDR global score=0.5 or 1, with memory box score at least 0.5 at screening and baseline. ...

Countries:United StatesGermanyHungaryItalyPolandSpain
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Recent Changes (Last 90 Days)

LOWAug 20, 2026NCT07757204lastUpdatePostDate: changed
LOWAug 20, 2026NCT07757204lastUpdatePostDate: changed
LOWAug 20, 2026NCT07757204lastUpdatePostDate: changed
LOWAug 20, 2026NCT07757204lastUpdatePostDate: changed
LOWAug 11, 2026NCT07757204NEW_TRIAL: changed
LOWAug 11, 2026NCT07757204NEW_TRIAL: changed
LOWJul 21, 2026NCT07284784lastUpdatePostDate: changed
LOWJun 16, 2026NCT07284784lastUpdatePostDate: changed
LOWJun 16, 2026NCT07284784lastUpdatePostDate: changed
LOWJun 16, 2026NCT07284784lastUpdatePostDate: changed
LOWJun 16, 2026NCT07284784lastUpdatePostDate: changed

Frequently asked questions about buntanetap/posiphen

What is Buntanetap used for?

Buntanetap is an investigational small molecule being studied for the treatment of early Alzheimer's disease, mild to moderate Alzheimer's disease, and Parkinson's disease. It is being evaluated in clinical trials for its potential to address these neurological conditions.

Who makes Buntanetap?

Buntanetap is being developed by Annovis Bio, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ANVS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Alzheimer's and Parkinson's disease.

What phase is Buntanetap in?

Buntanetap is in Phase 2 and Phase 3 clinical development. It has completed Phase 2 and Phase 3 trials in Parkinson's disease and Alzheimer's disease, and additional Phase 2 and Phase 3 trials are currently active or recruiting participants.

What clinical trials is Buntanetap in?

Buntanetap is being studied in several clinical trials, including NCT05357989, a completed Phase 3 trial in early Parkinson's disease; NCT05686044, a completed Phase 2 trial in mild to moderate Alzheimer's disease; NCT06709014, an active Phase 3 trial in early Alzheimer's disease; and NCT07284784, a recruiting Phase 2 trial in Parkinson's disease.

Is Buntanetap the same as Posiphen?

Yes, Buntanetap is also known as Posiphen. The drug is referred to by both names in clinical research and development contexts, and it is being investigated for the same neurological indications under both names.

How does Buntanetap work?

Buntanetap is a small molecule designed to target the underlying pathology of neurodegenerative diseases. It is being studied for its ability to reduce the production of toxic proteins associated with Alzheimer's and Parkinson's disease, potentially slowing disease progression.