BRESSO, Milan, Italy, June 29, 2026
Zambon has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of Hopledo® (IPX203) for the treatment of adult patients with Parkinson’s disease experiencing moderate to severe motor fluctuations. The recommendation represents a significant regulatory milestone for the company and moves the innovative modified-release levodopa/carbidopa therapy one step closer to commercialization across Europe. The positive opinion is supported by compelling data from the Phase 3 RISE-PD clinical trial, which demonstrated that Hopledo® significantly increased “Good ON” time while requiring fewer daily doses compared with immediate-release levodopa/carbidopa, offering patients more sustained symptom control and improved treatment convenience. Subject to final European Commission approval, Zambon expects to begin the phased launch of Hopledo® across European markets starting in October 2026, expanding treatment options for more than one million people living with Parkinson’s disease in the European Union, where over 80% of patients develop motor fluctuations during disease progression.
Phase 3 RISE-PD Trial Demonstrates Superior Clinical Benefits
The CHMP positive opinion is based on results from the multicenter, randomized, double-blind, active-controlled Phase 3 RISE-PD trial, which enrolled 506 patients diagnosed with Parkinson’s disease and moderate to severe motor fluctuations. The study compared Hopledo® with conventional immediate-release levodopa/carbidopa and successfully met its primary endpoint by demonstrating a significant increase in daily “Good ON” time, allowing patients to experience longer periods of symptom control without troublesome dyskinesia. The therapy also achieved important secondary endpoints, including reduced “Off” time, improvements in patient-reported outcomes, and favorable scores on the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS). Importantly, Hopledo® maintained a comparable safety profile while reducing the need for frequent daily dosing. Its innovative formulation combines immediate-release granules with extended-release pellets, providing both a rapid onset of action and prolonged therapeutic benefit, helping stabilize levodopa exposure throughout the day and improving disease management for patients with advanced Parkinson’s disease.
Innovative Formulation Addresses Longstanding Treatment Challenges
Parkinson’s disease remains the fastest-growing neurological disorder worldwide, and despite the widespread use of oral levodopa therapies, many patients eventually develop unpredictable motor fluctuations that significantly impact daily activities and quality of life. Hopledo® has been specifically designed to address this unmet clinical need through its first-in-class modified-release formulation, which extends the duration of levodopa effectiveness while minimizing fluctuations between medication doses.
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By delivering longer-lasting “Good ON” periods with fewer daily administrations, the therapy has the potential to simplify treatment regimens and improve adherence. Hopledo® is already approved and marketed in the United States under the brand name CREXONT®, providing established regulatory and commercial experience that supports its anticipated European introduction. Through its exclusive licensing agreement with Amneal Pharmaceuticals, Zambon holds commercialization rights across the European Union, the United Kingdom, and Switzerland, positioning the company to expand patient access rapidly following regulatory approval.
European Approval Could Expand Access to Advanced Parkinson’s Care
The CHMP recommendation marks another important milestone in Zambon’s strategy to strengthen its leadership in neurodegenerative diseases and deliver innovative therapies addressing significant unmet medical needs. Following anticipated European Commission approval, the company plans a phased commercial rollout beginning in October 2026, working closely with healthcare authorities and reimbursement bodies to ensure timely patient access across Europe. As healthcare systems continue seeking treatments that improve long-term symptom management while reducing treatment burden, Hopledo® offers a promising new option capable of delivering more consistent motor control, fewer daily doses, and improved quality of life for patients living with Parkinson’s disease. The positive regulatory opinion highlights the growing importance of advanced modified-release formulations in neurological care and reinforces the value of continued innovation in improving outcomes for patients with chronic neurodegenerative disorders.
Source: Zambon press release
