Health · Pharma & Biotech · 2 hrs ago
EU Authorizes Phase 3 Huntington’s Disease Study of Pridopidine
Ferrer and Prilenia can begin their EU study of pridopidine, an investigational treatment for Huntington’s disease.
The confirmatory Phase 3 PRECISE-HD trial has received authorization in participating European Union member states.
The study will involve about 400 participants in a randomized, double-blind comparison with a placebo.
Researchers will assess the treatment’s safety and its effects on disease progression, daily function, movement, thinking, speech and quality of life.
Sites are already recruiting in the US and UK, and recruitment in the EU is expected to start this month.
Canada is expected to join later, according to the companies.
The study is designed to generate evidence for regulatory evaluation of pridopidine.
The European Union has authorized the start of the confirmatory Phase 3 PRECISE-HD study of investigational pridopidine for Huntington’s disease.
Ferrer and Prilenia Therapeutics announced the authorization.
The global study will enroll about 400 participants and compare pridopidine with a placebo.
The study will assess disease progression, functional capacity, motor function, cognition, speech and quality of life.
EU recruitment is expected to begin in October 2026, joining recruiting sites in the United States and United Kingdom.
- Who
- Ferrer and Prilenia Therapeutics announced the study authorization.
- What
- The EU authorized the start of the Phase 3 PRECISE-HD study of investigational pridopidine for Huntington’s disease.
- When
- The announcement was published on October 22, 2026. EU recruitment is expected to begin this month.
- Where
- Participating EU Member States; recruiting sites are also in the United States and United Kingdom.
- Why
- The study is designed to evaluate pridopidine’s efficacy and safety and generate data for regulatory evaluation.
This story does not have two clearly opposing sides.
Ferrer and Prilenia announced that the study had received authorization to begin in participating EU Member States.
Recruitment in the EU is expected to commence, alongside currently recruiting sites in the United States and United Kingdom.
Recruitment in Canada is expected to follow.
- Study name
- PRECISE-HD
- Study phase
- Phase 3 confirmatory study
- Planned enrollment
- Approximately 400 participants
- Treatment schedule
- Oral pridopidine capsule twice a day
- EU clinical trial number
- 2026-526093-16-00
- NCT number
- NCT07609108