CHMP Recommends Hopledo (IPX203) for Parkinson's Disease with Motor Fluctuations, Paving Way for EU Approval
核心洞察
The CHMP adopted a positive opinion recommending EU marketing authorization for Hopledo (搜索) (modified-release levodopa/carbidopa) in adults with Parkinson's disease (搜索) and moderate to severe motor fluctuations.
The recommendation is based on the Phase 3 RISE-PD trial, which showed significantly more "Good ON" time with fewer daily doses versus immediate-release levodopa/carbidopa.
Hopledo (搜索) combines immediate-release granules and extended-release pellets for rapid onset and longer duration of effect, and is already marketed in the U.S. as CREXONT (搜索).
The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a marketing authorization by the European Medicines Agency (EMA) for Hopledo (搜索) (modified-release levodopa/carbidopa) for the treatment of adult patients with Parkinson's disease (搜索) and moderate to severe motor fluctuations who have not been sufficiently stabilized with oral levodopa/DDC inhibitor-based treatment regimens. The announcement was made on June 29, 2026 by Zambon (搜索) and Amneal Pharmaceuticals.
Hopledo (搜索), formerly known as IPX203, is a novel oral formulation of levodopa/carbidopa that is already approved and marketed in the United States under the brand name CREXONT (搜索). If approved by the European Commission, Hopledo would provide a new treatment option for patients across Europe who continue to experience motor fluctuations despite current oral therapies.
Clinical Evidence from the RISE-PD Trial
The CHMP recommendation is based on data from the Phase 3 RISE-PD trial, which compared Hopledo (搜索) with an immediate-release levodopa/carbidopa (LD/CD) formulation in patients with Parkinson's disease (搜索) and moderate to severe motor fluctuations. In the study, Hopledo demonstrated a significant increase in "Good ON" time over immediate-release LD/CD with fewer daily doses and a comparable safety profile.
The multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group RISE-PD trial evaluated the efficacy and safety of IPX203 compared with IR LD/CD in patients with Parkinson's disease (搜索) with motor fluctuations. The primary endpoint 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, the proportion of patients who were either "much improved" or "very much improved" in Patients' Global Impression of Change (PGI-C) scores, the 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 the sum of MDS-UPDRS Parts II and III scores. The study included 506 patients who had received a Parkinson's disease diagnosis at age 40 or older.
Participants taking Hopledo (搜索) received an average of three doses each day, compared with five among those receiving the immediate-release formulation. Findings from a nine-month extension study also indicated sustained symptom control and stable dosing frequency over the longer term.
A Novel Formulation Addressing an Unmet Need
Hopledo (搜索) is described as a first-in-class, oral, modified-release formulation of LD/CD designed for the treatment of fluctuations of Parkinson's disease (搜索), which the World Health Organization identifies as the fastest growing neurological condition in the world. 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.
Hopledo (搜索) contains a unique formulation combining immediate-release granules and extended-release pellets, providing both a rapid onset of action and a longer duration of benefit, sustaining the levodopa therapeutic effect for a longer period of time. The extended-release pellets contain a mucoadhesive polymer technology with a levodopa core for long-lasting efficacy.
"In Parkinson's disease (搜索) treatment is focused on maintaining consistent symptom control by prolonging levodopa benefit, reducing 'Off' time, and simplifying dosing. Hopledo (搜索) ability to extend 'Good On' time with fewer daily doses offers a significant advancement in the management of motor symptoms and in achieving more stable and sustained therapeutic effects," said Prof. Fabrizio Stocchi, Full Professor of Neurology at San Raffaele University in Rome and Head of Clinical Research in Movement Disorders and of the Parkinson's Disease Research Centre.
Günter Höglinger, director of the department of neurology at LMU University Hospital Munich, added: "A major therapeutic challenge in Parkinson's disease (搜索) 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. This combination of extended benefit and reduced dosing frequency represents an important advancement in levodopa therapy in [people with Parkinson's] and motor fluctuations."
Path Toward European Availability
"The CHMP positive opinion represents an important step towards expanding access to this important therapy to patients in Europe. As the disease progresses, many patients require frequent dosing yet continue to face motor fluctuations. Hopledo (搜索) addresses this unmet need by providing longer-lasting 'Good On' time with fewer daily doses. This achievement underscores Zambon (搜索)'s leadership in Parkinson's disease (搜索) and our unwavering commitment to more than one million people currently living with Parkinson's disease in the EU," said Mathias Knecht, M.D., Chief Medical Officer Innovative Therapies, Zambon.
More than one million people are living with Parkinson's disease (搜索) in the European Union. Subject to European Commission approval, Zambon (搜索) expects to begin the phased introduction of Hopledo (搜索) across European markets beginning in October 2026. Zambon and Amneal are working closely with healthcare authorities and other stakeholders to support timely patient access.
In 2024, Zambon (搜索) entered into an exclusive licensing agreement with Amneal Pharmaceuticals for the commercialization of Hopledo (搜索) in the European Union, United Kingdom and Switzerland. Giovanni Magnaghi, chief executive of Zambon, said: "For people living with Parkinson's disease (搜索), 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."
Josefa Domingos, president of Parkinson's Europe, noted that new treatment options can give "people with Parkinson's and their clinicians more ways to tailor treatment to individual lives," adding that the organization "will keep advocating for timely and equitable access across Europe, so that everyone who could benefit is able to."