CHMP recommends approval of Hopledo for Parkinson’s disease based on Phase 3 RISE-PD results showing longer Good ON time with fewer daily doses than immediate-release levodopa/carbidopa.
Written By: Nalam Karthik, PharmD
Reviewed By: Pharmacally Editorial Team
Zambon and Amneal Pharmaceuticals have received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorization for Hopledo (modified-release levodopa/carbidopa) to treat adults with Parkinson’s disease and moderate to severe motor fluctuations that remain inadequately controlled with oral levodopa/dopa-decarboxylase (DDC) inhibitor therapy.
The recommendation moves Hopledo one step closer to European Commission approval. If authorized, the therapy is expected to become available progressively across European markets beginning in October 2026.
Hopledo, previously known as IPX203, is already approved in the United States as CREXONT, providing established regulatory and commercial experience as it advances toward the European market.
Modified-Release Formulation Extends Levodopa Benefit
Hopledo is a first-in-class oral modified-release formulation that combines immediate-release granules with extended-release pellets in a single capsule. The formulation delivers rapid symptom relief while maintaining therapeutic levodopa concentrations for a longer period, helping reduce fluctuations in motor control throughout the day.
Parkinson’s disease affects more than one million people across the European Union, and over 80% develop motor fluctuations as the disease progresses. Many patients require increasingly frequent levodopa dosing but continue to experience alternating periods of symptom control (“ON” time) and worsening symptoms (“OFF” time), highlighting the need for longer-acting treatment options.
Phase 3 RISE-PD Trial Demonstrated Longer Good ON Time
The CHMP opinion is supported by findings from the Phase 3 RISE-PD trial (NCT03670953), a multicenter, randomized, double-blind, double-dummy, active-controlled study that enrolled 506 patients diagnosed with Parkinson’s disease at age 40 years or older who experienced motor fluctuations.
The trial compared Hopledo with immediate-release levodopa/carbidopa over a 20-week double-blind treatment period.
The primary endpoint evaluated the change from baseline in daily “Good ON” time at Week 20. Hopledo significantly increased Good ON time compared with immediate-release levodopa/carbidopa while requiring fewer daily doses. The therapy also demonstrated a safety profile comparable to the standard immediate-release regimen.
Secondary endpoints included changes in daily OFF time, Patient Global Impression of Change (PGI-C), Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III scores, and combined MDS-UPDRS Parts II and III scores.
Clinical Perspective on Extended Good ON Time and Reduced Dosing
Professor Fabrizio Stocchi, Full Professor of Neurology at San Raffaele University in Rome and Head of Clinical Research in Movement Disorders and the Parkinson’s Disease Research Centre, said maintaining consistent symptom control remains a key treatment goal in Parkinson’s disease. He noted that extending Good ON time while reducing daily dosing may improve management of motor symptoms and provide more stable therapeutic benefit.
Mathias Knecht, MD, Chief Medical Officer of Innovative Therapies at Zambon, said the positive CHMP opinion marks an important step toward expanding access for European
Regulatory Path and Anticipated European Launch
The European Commission will make the final regulatory decision based on the CHMP recommendation. If approved, Zambon plans a phased European launch beginning in October 2026 under its exclusive commercialization agreement with Amneal Pharmaceuticals covering the European Union, the United Kingdom, and Switzerland.
The positive opinion further expands the global footprint of the modified-release levodopa/carbidopa formulation, which is already marketed in the United States as CREXONT, while strengthening Amneal’s international specialty medicines portfolio.
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About the Writer
Nalam Karthik (LinkedIn) is a healthcare writer and PharmD graduate with interests in pharmacovigilance, drug safety, clinical data analysis, and quality assurance. He is passionate about translating clinical and pharmaceutical knowledge into accessible healthcare content while staying engaged with advancements in drug development and patient safety initiatives.