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# Clinical Hold Lifted on Vigil Neuro’s VGL101
- URL: https://www.fdaweb.com/clinical-hold-lifted-on-vigil-neuros-vgl101/
- Published: 2023-03-30T12:00:00.000Z
- Updated: 2026-09-14T18:22:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154105

FDA has lifted its partial clinical hold against Vigil Neuroscience and doses greater than 20 mg/kg for VGL101 in clinical trials in patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP). The investigational drug is currently being studied in IGNITE, a Phase 2 proof-of-concept trial in patients with ALSP as well as in an ongoing Phase 1 single and multiple ascending dose healthy volunteer trial.

Vigil describes VGL101 as a fully human monoclonal antibody targeting human triggering receptor expressed on myeloid cells 2 (TREM2), which is responsible for maintaining microglial cell function. “TREM2 deficiency is believed to be a driver of certain neurodegenerative diseases,” it says, adding that it is being developed in other neurodegenerative diseases for which this deficiency is thought to be a key driver of the disease pathway.