Zambon Announces European Commission Approval of Hopledo® for Adults with Parkinson's Disease and Moderate to Severe Motor Fluctuations

Zambon today announced that the European Commission (EC) has granted marketing authorization for Hopledo® (modified-release levodopa/carbidopa) for the treatment of adult patients with Parkinson’s disease and moderate to severe motor fluctuations who have not been sufficiently stabilized with oral levodopa/dopa decarboxylase (DDC) inhibitor-based treatment regimens. Zambon expects to begin the phased introduction of Hopledo® across European markets starting October 2026. The company is working closely with healthcare authorities and other stakeholders to support timely access for people with Parkinson’s disease who continue to experience moderate to severe motor fluctuations despite current oral therapies.

Hopledo® is a first-in-class, oral, modified-release formulation of levodopa/carbidopa (LD/CD) approved for the treatment of motor fluctuations of Parkinson’s disease, the fastest growing neurological condition in the world according to the World Health Organization¹. Despite available oral treatments, there is a substantial need for new therapeutic options; during the course of the disease, more than 80% of patients with Parkinson’s disease experience motor fluctuations 10 years after condition onset². Hopledo® contains a unique formulation combining immediate-release granules and extended-release beads in a single hard capsule, designed to provide both a rapid onset of action and prolonged therapeutic benefit, helping maintain more stable levodopa plasma concentrations and extending duration of symptom control.

The EC approval follows the positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and is based on data from the Phase 3 RISE-PD trial, which compared Hopledo® with an immediate-release LD/CD formulation in patients with Parkinson’s disease and moderate to severe motor fluctuations. In the study, Hopledo® demonstrated a significant increase in Good ON time per day and in Good ON time per dose compared with immediate-release LD/CD, with fewer daily doses and a comparable safety profile³.

“For people living with Parkinson’s disease, as well as their caregivers and healthcare professionals, the need for additional therapeutic options to help manage motor fluctuations remains significant. The approval of Hopledo® marks an important step in Zambon’s long-standing commitment to the Parkinson’s disease community. It reflects our focus on advancing meaningful innovation in both cure and care, with the aim of supporting patients facing the daily challenges of the disease and opening new life possibilities”, said Giovanni Magnaghi, Chief Executive Officer of Zambon.

“Motor fluctuations shape the daily lives of people with Parkinson's, often forcing them to plan their days around the timing of their medication. They decide whether someone can share a meal with family, keep a commitment, or simply move through the day with confidence. So, any advance that gives people more good hours in their day and more control over when those hours come is meaningful for our community. We welcome new options that give people with Parkinson's and their clinicians more ways to tailor treatment to individual lives, and we will keep advocating for timely and equitable access across Europe, so that everyone who could benefit is able to," commented Josefa Domingos, President of Parkinson's Europe.

“A major therapeutic challenge in Parkinson’s disease is maintaining stable motor control throughout the day. Many patients experience fluctuations in symptom control and often have to plan their daily activities around the timing and duration of levodopa’s effect”, said Prof. Günter Höglinger, MD, FEAN, Director of the Department of Neurology with Friedrich Baur Institute, LMU University Hospital Munich. “Thanks to its unique modified‑release formulation, Hopledo provides substantially more Good ON time per dose while maintaining a safety profile comparable to immediate‑release levodopa/carbidopa. This combination of extended benefit and reduced dosing frequency represents an important advancement in levodopa therapy in People with PD and motor fluctuations”.

In 2024, Zambon entered into an exclusive licensing agreement with Amneal Pharmaceuticals for the commercialization of Hopledo® in the European Union, United Kingdom and Switzerland.
Hopledo®, formerly known as IPX203, is already approved and marketed in the United States under the brand name CREXONT®, providing established regulatory and commercial experience as the therapy advances toward European launch.

About Hopledo®
Hopledo® is a modified-release oral formulation of levodopa/carbidopa developed for the treatment of adults with Parkinson's disease and moderate to severe motor fluctuations. It contains a unique formulation combining immediate-release granules and extended-release beads in a single hard capsule, designed to provide both a rapid onset of action and prolonged therapeutic benefit, helping maintain more stable levodopa plasma concentrations and extending duration of symptom control.

About Parkinson's Disease
Parkinson's disease is a chronic, progressive neurodegenerative disorder characterized by the loss of dopamine-producing neurons in the brain. Symptoms include tremors, rigidity, slowness of movement, and postural instability. As the disease progresses, many patients experience motor fluctuations, with periods during which symptoms are not adequately controlled despite treatment. More than one million people live with Parkinson's disease in the European Union.

About the RISE-PD Phase 3 Trial
The multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group RISE-PD trial evaluated the efficacy and safety of Hopledo® compared with IR LD/CD in the treatment of patients with PD with motor fluctuations. The primary endpoint of the trial assessed the change from baseline in “Good On” time in hours per day at the end of the double-blind treatment period (Week 20 or early termination). Secondary endpoints assessed the change from baseline in “Off” time in hours per day, proportion of patients who were either “much improved” or “very much improved” in Patients' Global Impression of Change (PGI-C) scores, change from baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score, and the change from baseline in sum of MDS-UPDRS Parts II and III scores. The study included 506 patients who had received a PD diagnosis at age 40 or older.

About Zambon
For further information on Zambon please visit www.zambon.com

References
1. https://www.who.int/publications/i/item/9789240050983
2. Fabbri M, et al. Off-time Treatment Options for Parkinson’s Disease. Neurol Ther. 2023;12(2):391-424; Demailly A, et al. Effectiveness of Continuous Dopaminergic Therapies in Parkinson’s Disease: A Review of L-DOPA Pharmacokinetics/ Pharmacodynamics. J Parkinsons Dis. 2024;14(5):925-939.
3. Hauser RA, et al. JAMA Neurol. 2023;80(10):1062-1069 and Supplementary materials

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