Milan, Italy – August 28, 2026

Zambon announced that the European Commission has granted marketing authorization for Hopledo® (modified-release levodopa/carbidopa) for adults with Parkinson’s disease and moderate to severe motor fluctuations who are not sufficiently stabilized on oral levodopa/dopa decarboxylase inhibitor-based treatment. The approval makes Hopledo a first-in-class oral modified-release formulation of levodopa/carbidopa designed to provide both rapid onset and prolonged symptom control through a combination of immediate-release granules and extended-release beads in a single capsule. The authorization is based on results from the Phase 3 RISE-PD trial, in which Hopledo demonstrated a significant increase in Good ON time per day and per dose compared with immediate-release levodopa/carbidopa, while requiring fewer daily doses and showing a comparable safety profile. Zambon expects to begin a phased European launch from October 2026.

Hopledo Gains EU Approval for Parkinson’s Motor Fluctuations

The European Commission approval covers adults with Parkinson’s disease and moderate to severe motor fluctuations who remain insufficiently controlled on conventional oral levodopa/DDC inhibitor treatment. Hopledo is formulated using a combination of immediate-release granules and extended-release beads, intended to provide an initial therapeutic effect while extending levodopa exposure over a longer period. This approach is designed to address one of the major challenges associated with conventional immediate-release levodopa therapy: fluctuations in symptom control as drug concentrations rise and fall. Zambon stated that the modified-release formulation is intended to provide more sustained motor control while reducing the frequency of daily dosing. The company plans to begin a phased introduction across European markets in October 2026, subject to individual market requirements and access processes.

Phase 3 RISE-PD Trial Demonstrated More Good ON Time

The approval was supported by the randomized, double-blind, double-dummy, active-controlled RISE-PD Phase 3 trial, which compared Hopledo with immediate-release levodopa/carbidopa in patients experiencing Parkinson’s-related motor fluctuations. The primary endpoint evaluated the change from baseline in Good ON time, representing periods when Parkinson’s symptoms are adequately controlled without troublesome dyskinesia. Hopledo demonstrated a statistically significant increase in Good ON time per day and Good ON time per dose compared with immediate-release LD/CD. The treatment also achieved these results with fewer daily doses, potentially reducing the medication-management burden for patients. The trial enrolled 506 patients diagnosed with Parkinson’s disease at age 40 or older and assessed additional measures including OFF time, patient-reported global improvement and motor-function scores.

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Hopledo Targets Longer Symptom Control With Fewer Daily Doses

Motor fluctuations are a major challenge as Parkinson’s disease progresses, with patients experiencing periods when levodopa provides inadequate symptom control despite continued treatment. Hopledo is designed to maintain more consistent levodopa exposure by combining immediate- and extended-release components within the same capsule. In the RISE-PD study, the resulting increase in Good ON time per dose is particularly relevant because it suggests patients may obtain longer periods of symptom control from each administration while taking the medication fewer times per day. Hopledo was reported to have a safety profile comparable to immediate-release levodopa/carbidopa in the Phase 3 trial. The product was previously known as IPX203 and is already approved and marketed in the United States as CREXONT®, providing prior regulatory and commercial experience for its European expansion.

Source: Zambon press relese