Italian pharmaceutical company Zambon announced on Friday that the European Commission has granted marketing authorisation for Hopledo, a first-in-class oral, modified-release formulation of levodopa/carbidopa for adults with Parkinson's disease and moderate to severe motor fluctuations who are not sufficiently stabilised on oral levodopa/dopa decarboxylase inhibitor-based treatments.

Zambon expects to begin a phased rollout across European markets in October 2026.

The approval is based on the Phase 3 RISE-PD trial, in which Hopledo demonstrated a significant increase in Good ON time per day and per dose versus immediate-release levodopa/carbidopa, with fewer daily doses and a comparable safety profile.

Hopledo combines immediate-release granules and extended-release beads in a single hard capsule, designed to provide both rapid onset and prolonged therapeutic benefit. In 2024, Zambon entered into an exclusive licensing agreement with Amneal Pharmaceuticals Inc (NASDAQ:AMRX) for commercialisation of Hopledo in the European Union, United Kingdom and Switzerland.

Formerly known as IPX203, Hopledo is already approved and marketed in the United States as CREXONT.