This section highlights FDA-related milestones and regulatory updates for drugs developed by Vigil Neuroscience (VIGL).
Over the past two years, Vigil Neuroscience has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Iluzanebart and VG-3927. 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.
Iluzanebart FDA Regulatory Events
Iluzanebart is a drug developed by Vigil Neuroscience for the following indication: In people with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP).
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:
- Iluzanebart
- Announced Date:
- June 4, 2025
- Indication:
- In people with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP).
Announcement
Vigil Neuroscience, announced an update on the Phase 2 IGNITE open-label clinical trial evaluating iluzanebart, a monoclonal antibody TREM2 agonist, for the potential treatment of adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP).
AI Summary
Vigil Neuroscience shared an update on its Phase 2 IGNITE clinical trial for iluzanebart, a monoclonal antibody that works as a TREM2 agonist to potentially treat ALSP, a rare neurodegenerative disease. The trial evaluated two dosing levels—20 mg/kg and 40 mg/kg—in patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia. The study found that iluzanebart had a favorable safety and tolerability profile and an acceptable pharmacokinetic profile.
However, the treatment did not show any beneficial effects on biomarker or clinical efficacy endpoints. As a result, the long-term extension study of the trial is being discontinued. Despite the disappointing efficacy results, the data gathered has increased understanding of ALSP and contributed to research efforts aimed at addressing this serious condition.
Read Announcement- Drug:
- Iluzanebart
- Announced Date:
- July 18, 2024
- Indication:
- In people with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP).
Announcement
Vigil Neuroscience, Inc announced an update following a Type C Meeting with the U.S. Food and Drug Administration (FDA) to its clinical development strategy for its IGNITE clinical trial evaluating iluzanebart in people with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP). .
AI Summary
Vigil Neuroscience, Inc. has updated its clinical development strategy for the IGNITE clinical trial based on outcomes from a recent Type C meeting with the FDA. The company will now preserve the full dataset for a final analysis at 12 months instead of performing an interim analysis. This change is designed to strengthen the company’s biomarker approach and support the pursuit of an accelerated approval pathway for iluzanebart in patients with ALSP, a rare neurodegenerative disease.
The revised strategy follows updated guidance from the FDA, which is open to considering an accelerated approval pathway if additional supporting data is provided. The IGNITE trial is evaluating the safety, biomarker outcomes, and clinical endpoints in patients receiving either 20 mg/kg or 40 mg/kg doses, with the final results expected in the first half of 2025.
Read Announcement
VG-3927 FDA Regulatory Timeline and Events
VG-3927 is a drug developed by Vigil Neuroscience for the following indication: VG-3927, is designed to act as a molecular glue that potentiates the TREM2 signaling response to natural damage ligands.
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:
- VG-3927
- Announced Date:
- April 2, 2025
- Indication:
- VG-3927, is designed to act as a molecular glue that potentiates the TREM2 signaling response to natural damage ligands.
Announcement
Vigil Neuroscience presented data highlighting its oral small molecule program, including its lead clinical candidate VG-3927, in two oral presentations at the AD/PD™ 2025 International Conference on Alzheimer's and Parkinson's Diseases being held April 1 – April 5 in Vienna, Austria.
AI Summary
At the AD/PD™ 2025 International Conference on Alzheimer’s and Parkinson’s Diseases in Vienna, Austria, Vigil Neuroscience presented key data highlighting its oral small molecule program, focusing on its lead candidate VG-3927. Two oral presentations shared important findings from both preclinical studies and a Phase 1 trial. The preclinical data showed that VG-3927 is a highly potent, CNS-penetrant TREM2 agonist that works well with natural brain signals, such as aggregated amyloid-beta, to enhance microglial activity. This suggests that the drug could address multiple aspects of Alzheimer’s disease pathology.
The clinical presentation detailed Phase 1 SAD/MAD trial results that confirmed VG-3927’s favorable safety, tolerability, and predictable dosing effects. With its once-daily oral dosing schedule and strong brain engagement, the data supports progressing VG-3927 into Phase 2 development as a promising next-generation therapeutic option for Alzheimer’s disease.
Read Announcement- Drug:
- VG-3927
- Announced Date:
- March 13, 2025
- Indication:
- VG-3927, is designed to act as a molecular glue that potentiates the TREM2 signaling response to natural damage ligands.
Announcement
Vigil Neuroscience, provided updates on recent progress.
AI Summary
Vigil Neuroscience provided an update on its TREM2 programs, highlighting progress that could lead to breakthroughs in the treatment of neurodegenerative diseases. The company announced positive Phase 1 data for VG-3927, a small molecule TREM2 agonist aimed at treating Alzheimer’s disease. The trial demonstrated that VG-3927 is safe, well tolerated, and effective in lowering key biomarkers, supporting its potential for robust target engagement. As a result, Vigil plans to launch a Phase 2 trial for VG-3927 in the third quarter of 2025. Additionally, the company expects to report final Phase 2 data on its second candidate, iluzanebart, in ALSP during the second quarter of 2025. These milestones underline Vigil’s commitment to advancing novel therapies and may pave the way for new treatment options for patients with significant unmet medical needs.
Read Announcement- Drug:
- VG-3927
- Announced Date:
- January 23, 2025
- Indication:
- VG-3927, is designed to act as a molecular glue that potentiates the TREM2 signaling response to natural damage ligands.
Announcement
Vigil Neuroscience, Inc. announced positive data from its completed Phase 1 clinical trial evaluating VG-3927 for the potential treatment of AD.
AI Summary
Vigil Neuroscience, Inc. announced positive Phase 1 clinical trial results for VG-3927, a potential once-daily oral treatment for Alzheimer’s disease (AD). The trial showed that VG-3927 has a favorable safety and tolerability profile across all tested groups, including elderly participants, with all related adverse events being mild or moderate and self-resolving. Researchers observed robust, dose-dependent reductions of sTREM2, up to about 50% in the cerebrospinal fluid, which indicates strong and sustained target engagement. The pharmacokinetic data also supported predictable dosing, and the 25mg dose was identified as the level that fully engages the desired pharmacology. These results support advancing VG-3927 into Phase 2 clinical trials, expected to begin in the third quarter of 2025, offering hope for a novel, convenient treatment option for those impacted by AD.
Read Announcement- Drug:
- VG-3927
- Announced Date:
- January 23, 2025
- Estimated Event Date Range:
- July 1, 2025 - September 30, 2025
- Target Action Date:
- Q3 2025
- Indication:
- VG-3927, is designed to act as a molecular glue that potentiates the TREM2 signaling response to natural damage ligands.
Announcement
Vigil Neuroscience, Inc. announced that Company plans to advance VG-3927 into a Phase 2 trial in the third quarter of 2025
AI Summary
Vigil Neuroscience, Inc. announced that it plans to advance its potential Alzheimer’s disease treatment VG-3927 into a Phase 2 clinical trial in the third quarter of 2025. The company has chosen a once-daily oral dose of 25 mg, which in Phase 1 studies fully engaged the desired pharmacology. These studies showed that VG-3927 was safe, well-tolerated, and achieved robust, dose-dependent reductions in sTREM2 levels in the cerebrospinal fluid. The results indicate that the drug is highly brain penetrant and supports sustained target engagement, which is promising for addressing neurodegenerative aspects beyond amyloid plaques. This new Phase 2 trial is intended to further evaluate VG-3927’s effectiveness as a next-generation, convenient therapeutic option for Alzheimer’s patients by harnessing the neuroprotective potential of microglia.
Read Announcement- Drug:
- VG-3927
- Announced Date:
- January 8, 2025
- Indication:
- VG-3927, is designed to act as a molecular glue that potentiates the TREM2 signaling response to natural damage ligands.
Announcement
Vigil Neuroscience, Inc. today highlighted 2024 corporate achievements and upcoming 2025 milestones.
AI Summary
Vigil Neuroscience, Inc. celebrated a year of strong progress in 2024 and outlined exciting milestones for 2025. The company, dedicated to developing treatments for neurodegenerative diseases, advanced two key TREM2 agonist programs: VG-3927 and iluzanebart. In 2024, Vigil achieved important operational successes, including a $40 million strategic investment from Sanofi, which helped further their research and development efforts.
Looking ahead, the company plans to report Phase 1 clinical trial data for VG-3927 in the first quarter of 2025. This data, gathered from healthy volunteers and Alzheimer’s patients, will help shape the future dosing strategies for larger trials. Additionally, Vigil is set to release the final analysis from the Phase 2 IGNITE trial for iluzanebart in the second quarter of 2025. These upcoming milestones underline Vigil Neuroscience’s commitment to advancing transformative therapies for neurodegenerative conditions.
Read Announcement- Drug:
- VG-3927
- Announced Date:
- September 17, 2024
- Indication:
- VG-3927, is designed to act as a molecular glue that potentiates the TREM2 signaling response to natural damage ligands.
Announcement
Vigil Neuroscience, Inc. announced that the U.S. Food and Drug Administration (FDA) has removed the partial clinical hold on its ongoing Phase 1 clinical trial of VG-3927. The FDA's decision was based on a complete response submitted by the Company.
AI Summary
Vigil Neuroscience, Inc. announced that the U.S. Food and Drug Administration (FDA) has removed the partial clinical hold on its ongoing Phase 1 clinical trial of VG-3927. The decision came after the company submitted a complete response that provided both non-clinical and clinical data from its current study. This removal of the hold allows Vigil Neuroscience to increase the exposure limit in the trial, enabling a more complete exploration of VG-3927’s effects. The company believes that this approach offers the best opportunity to examine the full pharmacology of VG-3927 as a potentially innovative treatment for Alzheimer’s disease. The FDA’s positive decision highlights the progress made in the trial and supports ongoing research efforts to develop effective therapies for neurodegenerative diseases using targeted mechanisms linked to microglial function.
Read Announcement- Drug:
- VG-3927
- Announced Date:
- July 24, 2024
- Estimated Event Date Range:
- January 1, 2025 - March 31, 2025
- Target Action Date:
- Q1 2025
- Indication:
- VG-3927, is designed to act as a molecular glue that potentiates the TREM2 signaling response to natural damage ligands.
Announcement
Vigil Neuroscience announced that Company plans to report complete Phase 1 data, including data from AD cohort, in Q1'2025 - ,
AI Summary
Vigil Neuroscience recently shared positive interim results from its Phase 1 clinical trial evaluating VG-3927, a potential once-daily oral therapy for Alzheimer’s disease. The data highlighted a well-tolerated safety profile and a robust decrease of sTREM2 in cerebrospinal fluid, indicating successful target engagement and a promising pharmacological profile. These early findings support VG-3927’s ongoing development as a TREM2 agonist aimed at activating protective microglia in the brain.
The company announced that it plans to report the complete Phase 1 data, including findings from the Alzheimer’s disease cohort, in the first quarter of 2025. Additionally, new preclinical and clinical data from single ascending dose cohorts will be presented at the 2024 Alzheimer’s Association International Conference. This upcoming publication of comprehensive data is anticipated to further clarify VG-3927’s potential in addressing critical treatment needs in Alzheimer’s disease.
Read Announcement- Drug:
- VG-3927
- Announced Date:
- July 24, 2024
- Indication:
- VG-3927, is designed to act as a molecular glue that potentiates the TREM2 signaling response to natural damage ligands.
Announcement
Vigil Neuroscience, announced interim data from its ongoing Phase 1 clinical trial of VG-3927 in healthy volunteers. Collectively, the interim safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profile supports continued clinical development of VG-3927 as a potential once-daily oral therapy for AD.
AI Summary
Vigil Neuroscience announced interim results from its Phase 1 clinical trial of VG-3927, a potential once-daily oral therapy for Alzheimer’s disease (AD). In healthy volunteers, VG-3927 was found to be safe and well-tolerated, with all adverse events being mild or moderate and resolving without intervention. The drug demonstrated a predictable pharmacokinetic profile and effective pharmacodynamic response, including a strong and sustained decrease in sTREM2 levels in cerebrospinal fluid—showing that the molecule is engaging its target. These findings support the continued clinical development of VG-3927 and suggest it could become a differentiated treatment for AD. The study, which involved both single and multiple ascending dose cohorts, has enrolled 80 healthy volunteers so far. Vigil Neuroscience plans to report the complete Phase 1 data, including results from the AD patient cohort, in the first quarter of 2025.
Read Announcement- Drug:
- VG-3927
- Announced Date:
- July 18, 2024
- Indication:
- VG-3927, is designed to act as a molecular glue that potentiates the TREM2 signaling response to natural damage ligands.
Announcement
Vigil Neuroscience, Inc. announced one oral and two poster presentations highlighting its oral small molecule VG-3927 at the 2024 Alzheimer's Association International Conference (AAIC)taking place on July 28-August 1, 2024 in Philadelphia, Pennsylvania and virtually.
AI Summary
Vigil Neuroscience, Inc. announced that it will showcase its oral small molecule, VG-3927, at the 2024 Alzheimer’s Association International Conference (AAIC) from July 28 to August 1, 2024. The company has planned one oral presentation and two poster presentations to highlight this promising TREM2 agonist. The oral presentation, scheduled for Tuesday, July 30, from 9:00 AM to 10:30 AM EDT, is titled “Characterization of the first TREM2 small molecule agonist, VG-3927, for clinical development in Alzheimer’s disease” and will be presented by Christian Mirescu, Ph.D. Two poster sessions will also be featured; one detailing the design of a Phase 1 clinical study and another on the pharmacological and functional characterization of VG-3927. These sessions will provide insights into the development and potential of VG-3927 for treating Alzheimer’s disease.
Read Announcement
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