Zambon Biotech, the specialized arm of the Zambon group focused on developing patient-oriented therapies, has announced the enrollment of the first participant in its European Phase 3b ADIP study for IPX203, a novel treatment for advanced Parkinson’s disease. 

 

The trial will evaluate the efficacy and safety of IPX203 versus immediate-release levodopa/carbidopa (LD/CD) in a regimen not previously tested in a Phase 3 setting.

 

IPX203 is a modified-release oral formulation designed to provide both rapid onset and longer-lasting relief of Parkinson’s symptoms. It combines immediate-release granules with extended-release beads, sustaining levodopa’s therapeutic effect longer than standard IR LD/CD. 

 

Last year, Zambon Biotech secured an exclusive licensing deal with Amneal Pharmaceuticals for the drug in the EU, UK, and Switzerland, and submitted it to the EMA for regulatory approval 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, Chief Medical Officer at 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 PD and moderate to severe motor fluctuations.”

 

ADIP is a 25-week, open-label, active-comparator, randomized trial across Italy, Spain, and Poland, enrolling 92 patients. Unlike previous trials, it allows individualized dosing schedules to optimize symptom control and improve ON time while reducing OFF time.

 

“At Zambon Biotech we are fully committed to build a long-term pipeline of innovative medicines that make patients’ lives better. 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,” said Frank Weber, Chief Executive Officer at Zambon Biotech.