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
Company Location: LOS ANGELES CA 90404
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: United States
Active Clinical Trial Count: 3
Recent & Upcoming Milestones
- Clinical Outcomes Reported - BioVie presented P2 Parkinson's Disease results on 2025-05-28 for Bezisterim
- Clinical Outcomes Reported - BioVie presented P2 Movement Disorders|Parkinson's Disease results on 2024-06-22 for Bezisterim
- Clinical Outcomes Reported - BioVie presented P2 Parkinson's Disease results on 2024-05-21 for Bezisterim
Highest Development Phases
Phase 3: Alzheimer Disease
Phase 2: 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 |
|---|---|---|---|---|---|---|---|---|
NCT06757010 |
SUNRISE-PD | P2 |
Recruiting |
Parkinson's Disease |
2025-12-01 |
12% |
2025-02-19 |
Primary Endpoints|Treatments|Trial Status |
NCT06847191 |
ADDRESS-LC | P2 |
Recruiting |
Post Acute COVID-19 Syndrome |
2025-11-01 |
2% |
2025-04-23 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT04669028 |
NM101 | P3 |
Completed |
Alzheimer Disease |
2023-09-30 |
5% |
2023-11-14 |