BioVie (BIVI) has upcoming FDA regulatory milestones for Bezisterim. The table below outlines estimated target dates and event types for these pending regulatory actions.
This section highlights FDA-related milestones and regulatory updates for drugs developed by BioVie (BIVI).
Over the past two years, BioVie has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Bezisterim and NE3107. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Bezisterim FDA Regulatory Timeline and Events
Bezisterim is a drug developed by BioVie for the following indication: For Parkinson's Disease Patients.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Bezisterim
- Announced Date:
- May 18, 2026
- Indication:
- For Parkinson's Disease Patients
Announcement
BioVie Inc. announced that the last patient evaluation visit has been completed for the Company's SUNRISE-PD Phase 2 trial evaluating its drug candidate bezisterim in early-stage Parkinson's disease.
AI Summary
BioVie Inc. said the last patient evaluation visit has been completed for its SUNRISE-PD Phase 2b trial of bezisterim in early-stage Parkinson’s disease. The study tested patients who had not yet been treated with carbidopa/levodopa. It used a randomized, double-blind, placebo-controlled design and followed participants for 20 weeks, including screening and safety follow-up.
During the 12-week blinded part of the trial, 57 patients were assigned evenly to receive either bezisterim, 20 mg twice daily, or placebo. The company said the trial used a hybrid decentralized design, which allowed some study activities to be done remotely. With the final patient visit now finished, BioVie is expected to review the data from the study and assess how well bezisterim may help people with early Parkinson’s disease.
Read Announcement- Drug:
- Bezisterim
- Announced Date:
- April 27, 2026
- Indication:
- For Parkinson's Disease Patients
Announcement
BioVie Inc. announced that it will host a virtual key opinion leader (KOL) event on Thursday, May 7, 2026 at 2:00 PM ET featuring Suzanne de la Monte, MD, MPH (Brown University Warren Alpert Medical School, Providence VA Medical Center), who will join company management to discuss how bezisterim's mechanism of action could potentially address the pathology and progression of neurodegenerative diseases, including Parkinson's disease.
AI Summary
BioVie Inc. will host a virtual key opinion leader (KOL) event on Thursday, May 7, 2026 at 2:00 PM ET. Suzanne de la Monte, MD, MPH (Brown University Warren Alpert Medical School; Providence VA Medical Center) will join company management to discuss how bezisterim’s mechanism of action could potentially address the pathology and progression of neurodegenerative diseases, including Parkinson’s disease. A live question-and-answer session will follow the formal presentations.
Bezisterim is being studied for multiple neurological conditions. The ADDRESS‑LC trial is enrolling about 200 patients to test whether bezisterim can reduce brain fog, fatigue, and other Long COVID neurological symptoms; topline data are expected mid‑2026. In Alzheimer’s disease, BioVie has completed Phase 2 and Phase 3 trials with preliminary signals of cognitive and biomarker improvement, supporting further study of bezisterim as a potential therapy for neurodegeneration.
Read Announcement- Drug:
- Bezisterim
- Announced Date:
- April 14, 2026
- Indication:
- For Parkinson's Disease Patients
Announcement
BioVie Inc. announced the acceptance of an abstract from its SUNRISE-PD study on lead candidate bezisterim (NE3107) in the treatment of patients with Parkinson's Disease at the upcoming American Academy of Neurology Annual Meeting (AAN), to be held in Chicago, IL from April 18–22, 2026.
AI Summary
BioVie Inc. announced that an abstract from its SUNRISE‑PD study of lead candidate bezisterim (NE3107) has been accepted for presentation at the American Academy of Neurology (AAN) Annual Meeting in Chicago, April 18–22, 2026. The SUNRISE‑PD trial studies bezisterim in patients with Parkinson’s disease, and topline results are expected in mid‑2026.
Bezisterim is an oral drug that crosses the blood‑brain barrier and aims to reduce brain inflammation and improve insulin sensitivity without suppressing the immune system. It targets signaling pathways tied to neuroinflammation and has a low risk of drug‑drug interactions. Beyond Parkinson’s, bezisterim is being explored for other brain disorders where inflammation and metabolic dysfunction play a role, such as Long COVID and Alzheimer’s disease.
Read Announcement- Drug:
- Bezisterim
- Announced Date:
- January 8, 2026
- Indication:
- For Parkinson's Disease Patients
Announcement
BioVie Inc. announced that it has completed enrollment of 60 patients in its Phase 2 SUNRISE-PD clinical trial evaluating the safety and efficacy of bezisterim (NE3107) on motor and non-motor symptoms in individuals with early-stage Parkinson's disease (PD) who have not been treated with carbidopa/levodopa.
AI Summary
BioVie Inc. completed enrollment of 60 patients in its Phase 2 SUNRISE-PD trial testing bezisterim (NE3107) in early-stage Parkinson's disease patients who have not yet been treated with carbidopa/levodopa. The study will evaluate safety and whether bezisterim can improve motor and non-motor symptoms and potentially slow symptomatic progression in people diagnosed within the past four years.
SUNRISE-PD uses a hybrid, decentralized design so participants aged 41–80 can do visits at home or in clinic, reducing barriers like limited mobility and travel. Bezisterim is an oral agent that crosses the blood–brain barrier and targets inflammation and insulin-resistance pathways thought to drive Parkinson's damage. The design maintains centralized oversight and rigorous data quality while improving access and flexibility. Completion of enrollment reflects strong community engagement and supports the feasibility of patient-centric trials. BioVie expects topline results in the first half of 2026.
Read Announcement- Drug:
- Bezisterim
- Announced Date:
- July 9, 2025
- Indication:
- For Parkinson's Disease Patients
Announcement
BioVie Inc. presented "Bezisterim Epigenetic Effects on Aging and Neurodegeneration" at the 7th World Aging and Rejuvenation Conference (ARC-2025) taking place in Vienna, Austria, July 9th –10th, 2025.
AI Summary
At the 7th World Aging and Rejuvenation Conference (ARC-2025) in Vienna, Austria, BioVie Inc. presented its study titled "Bezisterim Epigenetic Effects on Aging and Neurodegeneration." The presentation focused on how bezisterim, a stabilized version of Beta AET, may help improve conditions related to aging and neurodegenerative diseases like Alzheimer’s. Unlike traditional therapies that target one gene product at a time, bezisterim works by modulating inflammation and adjusting multiple genes simultaneously through anti-inflammatory epigenetic changes.
Preliminary data from a Phase 3 Alzheimer’s study showed that bezisterim treatment could slow biological aging as measured by several epigenetic “clocks.” The findings indicate that reducing inflammation might lower the risk of dementia. This research highlights a promising strategy that could improve healthspan by directly targeting the underlying mechanisms of neurodegeneration.
Read Announcement- Drug:
- Bezisterim
- Announced Date:
- June 26, 2025
- Indication:
- For Parkinson's Disease Patients
Announcement
BioVie Inc announced that a poster highlighting the patient-centric design and accessibility of its ongoing SUNRISE-PD Phase 2 clinical trial will be presented at the Advanced Therapeutics in Movement & Related Disorders® Congress, to be held at National Harbor, MD, from June 27-30, 2025.
AI Summary
BioVie Inc. announced that a poster detailing the patient-centric design and accessible nature of its ongoing SUNRISE-PD Phase 2 clinical trial will be presented at the Advanced Therapeutics in Movement & Related Disorders® Congress, held at National Harbor, MD, from June 27-30, 2025. The trial evaluates bezisterim (NE3107) for individuals with early Parkinson’s disease and features a hybrid decentralized model. This design allows patients to complete clinical trial visits at home or in a clinic, helping overcome obstacles like limited mobility and geographical barriers. The poster presentation, scheduled for Friday, June 27, highlights how this innovative approach can increase trial participation without compromising scientific rigor. BioVie’s initiative demonstrates a commitment to making clinical trials more inclusive and patient-friendly, addressing key challenges for Parkinson’s patients in accessing specialized care.
Read Announcement- Drug:
- Bezisterim
- Announced Date:
- May 15, 2025
- Target Action Date:
- H1 2026
- Estimated Target Date Range:
- January 1, 2026 - June 30, 2026
- Indication:
- For Parkinson's Disease Patients
Announcement
BioVie Inc. announced that The Company anticipates topline data to be available in the first half of 2026.
AI Summary
BioVie Inc. announced an important update regarding its Phase 2 ADDRESS-LC clinical trial. The trial is designed to test bezisterim for treating neurological symptoms associated with long COVID, including fatigue and brain fog. The drug targets neuroinflammation, an underlying factor believed to contribute to these ongoing symptoms in many patients. As long COVID continues to affect millions worldwide, finding an effective treatment remains a high priority.
A key highlight of the announcement is that BioVie anticipates topline data from the trial to be available in the first half of 2026. This upcoming data release is eagerly awaited, as it could provide valuable insights into the safety, tolerability, and potential benefits of bezisterim. The results may help pave the way for new therapeutic options to improve daily functioning and quality of life for those suffering from long COVID.
Read Announcement- Drug:
- Bezisterim
- Announced Date:
- May 15, 2025
- Indication:
- For Parkinson's Disease Patients
Announcement
BioVie Inc. announced first patient enrollment in the Phase 2 ADDRESS-LC clinical trial (NCT06847191) evaluating bezisterim (NE3107) for the treatment of neurological symptoms associated with long COVID.
AI Summary
BioVie Inc. announced that the first patient has been enrolled in the Phase 2 ADDRESS-LC clinical trial (NCT06847191) to evaluate bezisterim (NE3107) for treating neurological symptoms related to long COVID. The study aims to determine the safety, tolerability, and potential effectiveness of bezisterim in reducing issues like brain fog and fatigue that many long COVID patients face. The trial is randomized, placebo-controlled, and multicenter, and is fully funded by a grant from the U.S. Department of Defense. Researchers hope that by targeting neuroinflammation and correcting metabolic dysfunction, bezisterim could help restore normal brain function and improve quality of life. Topline data is expected in the first half of 2026, potentially paving the way for future treatments for the millions affected by long COVID in the United States and globally.
Read Announcement- Drug:
- Bezisterim
- Announced Date:
- May 14, 2025
- Target Action Date:
- May 28, 2025
- Indication:
- For Parkinson's Disease Patients
Announcement
BioVie Inc. announced that it will host a virtual key opinion leader (KOL) event featuring Suzanne de la Monte, MD, MPH (Brown University Warren Alpert Medical School, Providence VA Medical Center) and Mark Stacy, MD (Medical University of South Carolina College of Medicine), who will join company management to discuss the unmet need and current treatment landscape for Parkinson's disease on Wednesday, May 28, 2025 at 12:00 PM ET.
AI Summary
BioVie Inc. announced an online key opinion leader (KOL) event scheduled for Wednesday, May 28, 2025, at 12:00 PM ET. The session will feature renowned experts Suzanne de la Monte, MD, MPH, from Brown University and the Providence VA Medical Center, and Mark Stacy, MD, from the Medical University of South Carolina College of Medicine. These experts will join BioVie management to discuss the unmet need in Parkinson’s disease treatment and review the current treatment landscape.
The event will provide key insights into new therapeutic approaches, highlighting BioVie’s ongoing Phase 2 SUNRISE-PD trial evaluating bezisterim (NE3107). This novel, orally administered drug is designed to reverse insulin resistance and control inflammation—factors that play a role in Parkinson’s symptoms. A live question and answer session will follow the presentations, allowing for direct interaction with the specialists.
Read Announcement- Drug:
- Bezisterim
- Announced Date:
- April 16, 2025
- Target Action Date:
- LATE 2025
- Estimated Target Date Range:
- October 1, 2025 - December 31, 2025
- Indication:
- For Parkinson's Disease Patients
Announcement
BioVie Inc announced that Topline data anticipated in Late 2025 or Early 2026
AI Summary
BioVie Inc. announced that it is now enrolling patients in its Phase 2 SUNRISE-PD clinical trial. The trial evaluates bezisterim, a treatment aimed at targeting both the inflammation and insulin resistance believed to drive early Parkinson’s disease symptoms in patients who have not yet been treated with carbidopa/levodopa.
One distinct feature of the SUNRISE-PD trial is its decentralized design, which enables patients to participate remotely as well as at a clinical site. This approach broadens access to the study, ensuring that more individuals can contribute to understanding the disease’s early progression. BioVie expects to release topline data from the trial in late 2025 or early 2026. The upcoming results could provide valuable insights into how an anti-inflammatory, insulin-sensitizing treatment might improve both motor and non-motor symptoms in early Parkinson’s disease.
Read Announcement- Drug:
- Bezisterim
- Announced Date:
- April 16, 2025
- Indication:
- For Parkinson's Disease Patients
Announcement
BioVie Inc announced that patient enrollment is now open for the Phase 2 SUNRISE-PD clinical trial evaluating the safety and efficacy of bezisterim (NE3107) on motor and non-motor symptoms in patients with Parkinson's disease (PD) who haven't been treated with carbidopa/levodopa.
AI Summary
BioVie Inc. has announced that patient enrollment is now open for its Phase 2 SUNRISE-PD clinical trial. This study will evaluate the safety and efficacy of their anti-inflammatory, insulin-sensitizing drug candidate, bezisterim (NE3107), in patients with Parkinson’s disease who have not yet been treated with carbidopa/levodopa. The trial will assess both motor and non-motor symptoms in early-stage patients, aiming to explore whether bezisterim can slow disease progression, not just provide symptom relief.
The SUNRISE-PD trial features a hybrid decentralized design, allowing patients to participate remotely or visit a clinical site, which helps improve access to the study. By focusing on untreated patients, the study could offer new insights into managing Parkinson’s disease from its early stages. Support for the trial comes from leading advocacy groups dedicated to improving care for Parkinson’s patients.
Read Announcement- Drug:
- Bezisterim
- Announced Date:
- November 20, 2024
- Indication:
- For Parkinson's Disease Patients
Announcement
BioVie Inc. announced that an abstract on the design of its planned Phase 2 trial evaluating bezisterim in Long COVID has been accepted as a poster presentation at the Demystifying Long COVID International Conference, November 21st & 22nd 2024, in Barcelona Spain.
AI Summary
BioVie Inc. announced that its abstract on the design of a planned Phase 2 trial evaluating bezisterim in Long COVID has been accepted for a poster presentation at the Demystifying Long COVID International Conference. The event will take place on November 21–22, 2024, in Barcelona, Spain. The upcoming trial is a double-blind, randomized, placebo-controlled, multicenter study involving around 200 patients. It is fully funded by a U.S. Department of Defense grant and will assess the safety, tolerability, and potential efficacy of a three-month course of bezisterim to reduce neurocognitive symptoms associated with Long COVID. Dr. Penelope Markham, Senior Vice President and Program Lead at BioVie, will present the poster (Poster #28), outlining the study’s design and potential to offer new insights into managing the persistent effects of Long COVID.
Read Announcement- Drug:
- Bezisterim
- Announced Date:
- September 16, 2024
- Indication:
- For Parkinson's Disease Patients
Announcement
BioVie Inc announced that Company anticipates Phase 2 trial to commence by early 2025
AI Summary
BioVie Inc. announced that it expects its Phase 2 clinical trial to start by early 2025. The upcoming study will test bezisterim, a drug candidate designed to reduce neurological symptoms associated with long COVID. The trial, set to be randomized, placebo-controlled, and conducted at multiple centers, aims to enroll around 200 patients. It will examine the safety, tolerability, and potential effectiveness of treating these lingering symptoms with bezisterim over a three‐month period.
The company achieved a key milestone by receiving approval from the U.S. Army Medical Research and Development Command’s Office of Human Research Oversight. This clearance was the final review needed before BioVie can secure additional grant funding. With this financial support in place, the company is now moving forward to initiate the Phase 2 testing in its effort to address the unmet medical needs of individuals suffering from long COVID.
Read Announcement- Drug:
- Bezisterim
- Announced Date:
- September 16, 2024
- Indication:
- For Parkinson's Disease Patients
Announcement
BioVie Inc announced that the U.S. Army Medical Research and Development Command, Office of Human Research Oversight, (OHRO) has approved BioVie's plan to evaluate bezisterim for the treatment of neurological symptoms that are associated with long COVID.
AI Summary
BioVie Inc. announced that the U.S. Army Medical Research and Development Command’s Office of Human Research Oversight (OHRO) has approved its plan to evaluate bezisterim for treating neurological symptoms associated with long COVID. This approval is the final scientific milestone the company needs to receive the bulk of a $13.1 million grant, marking a significant step forward in its research efforts.
The planned Phase 2 trial will be a randomized, placebo-controlled, multicenter study involving around 200 patients. The study aims to assess the safety, tolerability, and potential efficacy of three months of bezisterim treatment in alleviating cognitive problems and fatigue experienced by long COVID patients. BioVie expects to initiate the trial by early 2025, potentially paving the way for a novel treatment option to improve the quality of life for those suffering from prolonged neurological symptoms after COVID-19.
Read Announcement- Drug:
- Bezisterim
- Announced Date:
- September 3, 2024
- Indication:
- For Parkinson's Disease Patients
Announcement
BioVie Inc. announced that the U.S. Food and Drug Administration (FDA) has authorized the Company's Investigational New Drug ("IND") application to evaluate bezisterim for the treatment of neurological symptoms that are associated with long COVID.
AI Summary
BioVie Inc. announced that the U.S. Food and Drug Administration (FDA) has authorized its Investigational New Drug (IND) application for bezisterim. This FDA approval allows the company to start a Phase 2, placebo-controlled, multicenter trial that will evaluate bezisterim as a treatment for the neurological symptoms associated with long COVID. BioVie plans to enroll roughly 200 patients to assess the safety, tolerability, and potential benefits of the drug over a three‐month treatment period. The company believes bezisterim, with its anti-inflammatory properties, could address symptoms such as brain fog and fatigue by reducing inflammation linked to long COVID. This key milestone not only paves the way for clinical testing but also positions BioVie to secure an additional $12.6 million from the Department of Defense. This development is a promising step in tackling the unmet needs of long COVID patients.
Read Announcement- Drug:
- Bezisterim
- Announced Date:
- August 27, 2024
- Indication:
- For Parkinson's Disease Patients
Announcement
BioVie Inc announced data from an oral presentation at the 11th Aging Research and Drug Discovery Meeting (ARDD 2024) being held August 26-30, 2024 in Copenhagen, Denmark.
AI Summary
BioVie Inc. announced new clinical data during an oral presentation at the 11th Aging Research and Drug Discovery Meeting (ARDD 2024) in Copenhagen, Denmark, held from August 26-30, 2024. The presentation, titled “Bezisterim Effects on Biological Age, Alzheimer’s Epigenetics, and Neurologic Assessments,” focused on clinical findings related to the drug candidate bezisterim. It highlighted that patients treated with bezisterim experienced a two- to four-year age deceleration advantage compared to placebo, as measured by various biological clocks.
The data also revealed that bezisterim modulates DNA methylation of proinflammatory genes, which may help shift immune cells from a proinflammatory to an anti-inflammatory state. These insights provide a deeper understanding of how bezisterim could reduce inflammation and potentially impact pathways linked to neurological disorders such as Alzheimer’s and Parkinson’s disease.
Read Announcement- Drug:
- Bezisterim
- Announced Date:
- August 13, 2024
- Indication:
- For Parkinson's Disease Patients
Announcement
BioVie Inc., announced that a poster presentation will be shared at the 11th Aging Research and Drug Discovery Meeting (ARDD 2024) being held August 26-30, 2024 in Copenhagen, Denmark.
AI Summary
BioVie Inc. announced that it will share a poster presentation at the 11th Aging Research and Drug Discovery Meeting (ARDD 2024) in Copenhagen, Denmark, from August 26 to 30, 2024. The poster, titled "Bezisterim Effects on Biological Age, Alzheimer’s Epigenetics, and Neurologic Assessments," will provide an overview of clinical data related to bezisterim. This innovative drug is being studied for its potential to impact biological aging and various aspects of neurological health. The presentation will include analyses and measurements that demonstrate bezisterim’s effects on longevity and will be delivered by Christopher L. Reading, the Senior Vice President of BioVie’s Alzheimer’s Disease Program, on Tuesday, August 27, from 14:40 to 15:00 CEST.
Further details and conclusions from the clinical data will be shared during the conference, highlighting BioVie’s commitment to developing therapies for neurological and aging-related conditions.
Read Announcement- Drug:
- Bezisterim
- Announced Date:
- August 8, 2024
- Target Action Date:
- Q4 2024
- Estimated Target Date Range:
- October 1, 2024 - December 31, 2024
- Indication:
- For Parkinson's Disease Patients
Announcement
BioVie Inc., he Company is conducting trial start-up activities with a view to initiate patient screening in Q4 2024.
AI Summary
BioVie Inc. announced that it has aligned with the FDA on the upcoming SUNRISE-PD trial. The trial will focus on Parkinson’s patients who have not yet begun carbidopa/levodopa treatment, evaluating how bezisterim affects motor and non-motor symptoms. The company is busy with trial start-up activities and plans to begin patient screening in the fourth quarter of 2024.
Designed as a Phase 2, double-blind, placebo-controlled study, the SUNRISE-PD trial will involve about 60 patients. It will include a decentralized design that allows participants to complete appointments at home under remote supervision. This approach aims to provide more flexibility for patients while exploring the potential benefits of bezisterim in early Parkinson’s disease. BioVie’s progress with this trial, guided by FDA recommendations, marks an important milestone in their efforts to develop new treatments for neurological disorders.
Read Announcement- Drug:
- Bezisterim
- Announced Date:
- August 8, 2024
- Indication:
- For Parkinson's Disease Patients
Announcement
BioVie Inc., announced that it has achieved alignment with the Food and Drug Administration (FDA) on its upcoming SUNRISE-PD trial in Parkinson's disease ("PD").
AI Summary
BioVie Inc. announced that it has reached alignment with the FDA on its upcoming SUNRISE-PD trial for Parkinson’s disease. The trial is designed to evaluate the effect of bezisterim (NE3107) on both motor and non-motor symptoms in about 60 patients who have not yet started carbidopa/levodopa treatment. BioVie submitted the trial protocol to the FDA, which provided one recommendation: to include the Part II score from the Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale as a primary endpoint for future filings. Since this measure is already a secondary endpoint in the current design, the company will proceed as planned. Patient screening is expected to begin in the fourth quarter of 2024 as trial start-up activities are underway.
Read Announcement- Drug:
- Bezisterim
- Announced Date:
- June 25, 2024
- Indication:
- For Parkinson's Disease Patients
Announcement
BioVie Inc., announced data from two presentations at the Advanced Therapeutics in Movement and Related Disorders Congress® (ATMRD Congress) held June 21-25, 2024 in Washington, D.C.
AI Summary
BioVie Inc. presented new data at the Advanced Therapeutics in Movement and Related Disorders Congress® held in Washington, D.C. from June 21-25, 2024. One presentation introduced the protocol for the upcoming SUNRISE-PD Phase 2 trial, designed to evaluate the effects of bezisterim (NE3107) on motor and non-motor symptoms in early Parkinson’s patients who have had minimal exposure to carbidopa/levodopa. This randomized, placebo-controlled study will include around 60 patients over a 20-week period, using both in-clinic and at-home assessments.
The second presentation showcased earlier Phase 2a trial results supporting bezisterim’s potential as an add-on therapy to existing treatments. The data demonstrated promising improvements in both motor functions and non-motor symptoms, strengthening the case for further studies. BioVie leadership emphasized that these findings could help address unmet needs in Parkinson’s disease treatment.
Read Announcement- Drug:
- Bezisterim
- Announced Date:
- June 4, 2024
- Indication:
- For Parkinson's Disease Patients
Announcement
BioVie Inc. announced the formation of a long COVID Advisory Board that will provide the Company with strategic guidance on the design and execution of a Phase 2b trial in patients with long COVID, with funding from the U.S. Department of Defense.
AI Summary
BioVie Inc. has formed a long COVID Advisory Board to help guide the design and execution of a Phase 2b clinical trial aimed at treating patients with long COVID. The trial will evaluate the use of bezisterim, a novel oral treatment that is both an anti-inflammatory and an insulin-sensitizer capable of crossing the blood-brain barrier, potentially targeting key symptoms like cognitive dysfunction and fatigue. The advisory board is made up of leading long COVID experts, including infectious disease and neuropsychiatric specialists from renowned institutions. Their role is to provide strategic guidance during the planning phase of the study. This initiative is supported by funding from the U.S. Department of Defense, which underlines the importance and potential impact of BioVie’s research in addressing the persistent and debilitating effects of long COVID.
Read Announcement
NE3107 FDA Regulatory Timeline and Events
NE3107 is a drug developed by BioVie for the following indication: Mild to moderate Alzheimer's Disease (AD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NE3107
- Announced Date:
- February 12, 2026
- Indication:
- Mild to moderate Alzheimer's Disease (AD)
Announcement
BioVie Inc. announced the acceptance of two abstracts from studies on its lead candidate bezisterim (NE3107), in the treatment of Alzheimer's Disease and Long COVID at the 2026 American College of Psychiatrists (ACP) annual meeting, to be held February 18-22, in Bonita Springs, FL.
AI Summary
BioVie Inc. announced that two abstracts on its lead candidate bezisterim (NE3107) were accepted for poster presentation at the American College of Psychiatrists annual meeting, Feb. 18–22, 2026, in Bonita Springs, FL. Both posters will be presented on February 18. The first is titled “Bezisterim-Associated Anti-inflammatory Epigenetic Modulation of Age Acceleration and Cognition in Alzheimer's Disease.” The second summarizes baseline characteristics of participants in the Phase 2 ADDRESS-LC study of bezisterim for Long COVID.
Bezisterim is an oral drug that crosses the blood–brain barrier, aims to reduce inflammation and improve insulin sensitivity without suppressing the immune system, and has a low risk of drug–drug interactions. It modulates pathways such as ERK, NFκB and TNF-α and is being explored for Alzheimer’s, Long COVID and Parkinson’s. BioVie reports early Alzheimer’s data showing signals of cognitive and biomarker improvement and supports further trials.
Read Announcement- Drug:
- NE3107
- Announced Date:
- June 24, 2025
- Indication:
- Mild to moderate Alzheimer's Disease (AD)
Announcement
BioVie Inc. announced that a poster highlighting the decentralized design and patient experience of its Phase 2 SUNRISE-PD clinical trial evaluating bezisterim (NE3107) in early Parkinson's disease will be presented in poster session at the upcoming Advanced Therapeutics in Movement & Related Disorders® Congress, to be held at National Harbor, MD, from June 27 to June 30, 2025.
AI Summary
BioVie Inc. announced that a new poster from its Phase 2 SUNRISE-PD clinical trial on bezisterim (NE3107) in early Parkinson’s disease will be presented at the Advanced Therapeutics in Movement & Related Disorders® Congress in National Harbor, MD from June 27 to June 30, 2025. The poster highlights the trial’s decentralized design and emphasizes the patient experience, showing a hybrid approach that allows patients to participate fully from home or visit a clinical site. Study nurses conduct at-home visits while a neurologist supervises remotely via video, ensuring that patients receive expert care without the need for frequent travel. This innovative design aims to improve convenience, accessibility, and data collection reliability, enhancing the overall trial integrity and patient comfort during the study period.
Read Announcement- Drug:
- NE3107
- Announced Date:
- May 7, 2025
- Indication:
- Mild to moderate Alzheimer's Disease (AD)
Announcement
BioVie Inc announced that a poster on the rationale and design of its Phase 2 SUNRISE-PD clinical trial evaluating bezisterim (NE3107) in early Parkinson's disease will be presented in a Guided Poster Tour session at the 30th World Congress on Parkinson's Disease and Related Disorders (IAPRD 2025), being held May 7-10, 2025, in New York City.
AI Summary
BioVie Inc. recently announced that a poster detailing its Phase 2 SUNRISE-PD clinical trial will be highlighted at the 30th World Congress on Parkinson’s Disease and Related Disorders (IAPRD 2025) in New York City from May 7-10, 2025. The poster, titled “Assessment of Bezisterim (NE3107) in Patients with Early Parkinson’s Disease: A Phase 2, Placebo-Controlled, Hybrid Decentralized Study,” explains the study’s rationale and design. It will be presented during a Guided Poster Tour session on Saturday, May 10, from 8:00 to 9:00am EDT. Dr. Joseph M. Palumbo, Executive Vice President, Head of Research & Development and Chief Medical Officer at BioVie, will lead the presentation. The innovative trial uses a hybrid decentralized design, allowing patients to participate from home or at a clinical site, potentially setting a new standard in clinical research for early Parkinson’s disease.
Read Announcement- Drug:
- NE3107
- Announced Date:
- March 27, 2025
- Target Action Date:
- April 10, 2025
- Indication:
- Mild to moderate Alzheimer's Disease (AD)
Announcement
- BioVie Inc. announced that it will host a virtual investor event featuring key opinion leader (KOL) Lindsay McAlpine, MD, BSc (Yale University), who will join company management to discuss the unmet need and current treatment landscape for long COVID on Thursday, April 10, 2025 at 10:00 AM ET.
AI Summary
BioVie Inc. has announced a virtual investor event scheduled for Thursday, April 10, 2025 at 10:00 AM ET. The event will feature renowned key opinion leader Lindsay McAlpine, MD, BSc from Yale University, who will join company management to discuss the unmet need and current treatment landscape for long COVID. During the session, participants will learn more about the challenges faced by long COVID patients and how emerging treatment options are being explored. The discussion is set to shed light on innovative strategies and ongoing research efforts aimed at addressing persistent symptoms and improving patient outcomes. Additionally, a live question and answer session will follow the formal presentations, offering attendees the chance to engage directly with experts about the latest developments in long COVID treatment.
Read Announcement
