Product Description
BioVie's leading clinical candidate, NE3107, is an orally administered small molecule, anti-inflammatory, insulin-sensitizing agent with a novel mechanism of action has initiated a pivotal phase 3 clinical trial for the treatment of mild to moderate Alzheimers disease.
Mechanisms of Action: ERK Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: BioVie Inc.
Company Location:
Company Founding Year: None
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: United States
Active Clinical Trial Count: 3
Recent & Upcoming Milestones
- Clinical Outcomes Expected - BioVie announced they will present P2 Parkinson's Disease results in 3Q26 for Bezisterim
- Clinical Outcomes Reported - BioVie presented P2 Parkinson's Disease results on 2026-01-08 for Bezisterim
- Clinical Outcomes Reported - BioVie presented P2 Parkinson's Disease results on 2025-05-28 for Bezisterim
Highest Development Phases
Phase 3: Alzheimer Disease
Phase 2: Mental Fatigue|Parkinson's Disease|Post Acute COVID-19 Syndrome
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06847191 |
ADDRESS-LC | P2 |
Recruiting |
Mental Fatigue|Post Acute COVID-19 Syndrome |
2026-06-01 |
12% |
2026-01-30 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments |
NCT06757010 |
SUNRISE-PD | P2 |
Recruiting |
Parkinson's Disease |
2025-12-01 |
12% |
2025-02-19 |
Primary Endpoints|Treatments|Trial Status |
NCT04669028 |
NM101 | P3 |
Completed |
Alzheimer Disease |
2023-09-30 |
5% |
2023-11-14 |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
03/12/2026 |
News Article |
BioVie Announces Abstract Accepted for Presentation at AD/PD 2026 |
|
02/12/2026 |
News Article |
BioVie Announces Abstracts Accepted for Presentation at the 2026 American College of Psychiatrists Annual Meeting |
|
01/08/2026 |
News Article |
BioVie Completes Enrollment in Phase 2 SUNRISE-PD Trial in Early Parkinson's Disease |
|
11/19/2025 |
News Article |
Join Biovie's Exclusive Live Investor Webinar and Q&A Session on December 9 |
|
02/01/2024 |
PubMed |
Navigating the dementia landscape: Biomarkers and emerging therapies. |
|
01/01/2023 |
PubMed |
Neuroinflammation, immune response and Ī±-synuclein pathology: how animal models are helping us to connect dots. |
|
11/15/2022 |
PubMed |
Promising candidates from drug clinical trials: Implications for clinical treatment of Alzheimer's disease in China. |