CADEMPINO, Switzerland — Zambon Biotech said the first patient with advanced Parkinson’s disease has been dosed in its European Phase 3b ADIP clinical study evaluating IPX203, marking a key milestone in the development of the therapy.
The ADIP study is designed to assess the efficacy and safety of IPX203 compared with immediate-release levodopa/carbidopa in a dosing regimen that has not previously been the focus of a Phase 3 trial. The study will enroll patients with advanced Parkinson’s disease and moderate to severe motor fluctuations.
IPX203 is a novel oral modified-release formulation of levodopa/carbidopa that combines immediate-release granules with extended-release beads to provide both rapid onset of action and a longer duration of therapeutic benefit compared with immediate-release formulations. Parkinson’s disease is the fastest-growing neurological condition globally, according to the World Health Organization.
Last year, Zambon Biotech entered into an exclusive licensing agreement with Amneal Pharmaceuticals for IPX203 in the European Union, United Kingdom, and Switzerland. The company submitted IPX203 to the European Medicines Agency for regulatory review in June 2025.
“Dosing the first person in our Phase 3b ADIP study marks an important milestone for our company and for the people living with Parkinson’s disease who urgently need new therapies that truly improve their quality of life and the therapeutic outcomes,” said Mathias Knecht, M.D., Chief Medical Officer of Zambon Biotech. “We recognise the substantial need for new treatment options, and with ADIP we aim to demonstrate the potential of IPX203 to become a core therapy for people with Parkinson’s disease and moderate to severe motor fluctuations.”
ADIP is a Phase 3b, open-label, randomized, active-comparator trial designed to evaluate IPX203 in patients with advanced Parkinson’s disease experiencing motor fluctuations. The study will compare IPX203 with standard immediate-release levodopa/carbidopa, focusing on improvements in ON time and reductions in OFF time through individualized dosing schedules. Unlike previous trials, ADIP allows dosing intervals to be tailored to each patient’s needs, an approach intended to enhance symptom control and overall outcomes.
The trial will run for up to 25 weeks, including a one-week screening period, a 12-week treatment phase, and an optional 12-week extension. A total of 92 patients are expected to be enrolled across clinical sites in Italy, Spain, and Poland.
“At Zambon Biotech we are fully committed to build a long-term pipeline of innovative medicines that make patients’ lives better,” said Frank Weber, M.D., Chief Executive Officer of Zambon Biotech. “Given our group’s capabilities in commercialization and our existing footprint in neurology, particularly Parkinson’s, we believe IPX203 could represent a valuable therapeutic option in Europe to improve the lives of moderate to severe Parkinson patients.”
