> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Lifts Partial Clinical Hold on Alzheimer’s Drug
- URL: https://www.fdaweb.com/fda-lifts-partial-clinical-hold-on-alzheimers-drug/
- Published: 2024-09-17T12:00:00.000Z
- Updated: 2026-09-14T14:41:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157797

FDA has removed a partial clinical hold against Vigil Neuroscience and its ongoing Phase 1 clinical trial of VG-3927, a small molecule targeting human triggering receptor expressed on myeloid cells 2 (TREM2) agonist for treating common neurodegenerative diseases associated with microglial dysfunction, particularly Alzheimer’s disease. The decision to lift the hold follows a company-submitted complete response to [agency concerns](https://investors.vigilneuro.com/news-releases/news-release-details/vigil-neuroscience-announces-update-its-small-molecule-trem2?ref=fdaweb.com) raised 9/2023 that limited the maximum exposure of VG-3927 in healthy volunteers in the Phase 1 clinical trial

In July, the company said recent interim data from the ongoing clinical trial that showed a safety and tolerability profile supporting VG-3927’s continued clinical development. “In addition,” it said, “VG-3927 demonstrated a predictable PK profile supportive of once-daily dosing. Importantly, VG-3927 achieved a robust and sustained decrease of soluble TREM2 in the CSF \[cerebrospinal fluid\] demonstrating clinical proof-of-target engagement.”