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# FDA Lifts Clinical Hold on Huntington’s Therapy
- URL: https://www.fdaweb.com/fda-lifts-clinical-hold-on-huntingtons-therapy/
- Published: 2021-04-26T12:00:00.000Z
- Updated: 2026-09-14T16:56:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149185

FDA has lifted a clinical hold against Voyager Therapeutics and its planned clinical trial for VY-HTT01 for treating Huntington’s disease. The hold removal followed a comprehensive review of the company’s chemistry, manufacturing and controls information previously submitted to the agency, according to the Voyager. The company plans to initiate VYTAL, a Phase 1/2 clinical trial of VY-HTT01, later this year.

  
Huntington’s disease is a neurodegenerative disorder caused by mutations in the huntingtin (HTT) gene, which causes the production of an abnormally large amount of HTT protein that accumulates inside nerve cells and causes their death. VY-HTT01 is described as a type of gene silencing therapy aimed at addressing the underlying cause of the disease by significantly reducing the amount of damaging HTT protein produced.