European Commission authorizes Hopledo for Parkinson's disease

The European Commission has granted marketing authorization for Hopledo, a modified-release oral formulation of levodopa/carbidopa, to treat adult patients with Parkinson's disease. The treatment is specifically indicated for those experiencing moderate to severe motor fluctuations that are not adequately controlled by existing oral levodopa and dopamine decarboxylase inhibitor regimens.

Zambon, the company behind the therapy, announced that a gradual rollout in European markets is expected to begin in October 2026. The drug utilizes a unique formulation within a single hard capsule that combines immediate-release granules with prolonged-release pellets. This design aims to provide a rapid onset of therapeutic effect while maintaining stable plasma concentrations of levodopa to ensure prolonged symptom control.

The authorization follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) and is supported by results from the Phase 3 Rise-Pd study. This new option addresses a significant clinical need, as more than 80% of Parkinson's patients develop motor fluctuations within ten years of diagnosis.