A Danish pharmaceutical company called Lundbeck has shared early findings from a small clinical trial of a new oral medication called Lu AF28996 for people with advanced Parkinson’s disease whose symptoms are not well-controlled by standard treatments. These results will be presented at a global movement disorders conference in Seoul in 2026. Parkinson’s disease is a condition where the brain gradually loses cells that produce dopamine, a chemical that helps control movement. Over time, many patients experience motor problems, including unpredictable swings between periods of feeling mobile (ON-time) and periods of stiffness or difficulty moving (OFF-time), as well as involuntary movements called dyskinesia caused by long-term use of Parkinson’s medications. Current treatments for advanced disease often involve complex procedures or continuous drug delivery, which can be challenging for patients. This new drug is being developed as a pill, which could offer a simpler, non-invasive option.
Tarek Samad, Lundbeck’s Head of Research & Development, explained, “Many people with advanced Parkinson’s still struggle with motor fluctuations and dyskinesia that make everyday life difficult. We’re encouraged by the early results from this trial, which showed improvements in symptoms and allowed many patients to reduce their dose of the standard Parkinson’s medication, levodopa. A larger, more rigorous trial called DARE2 is now underway to further test this drug’s safety and effectiveness.”
In the second part of the trial, 34 adults with advanced Parkinson’s took Lu AF28996 twice daily for six weeks. Of these, 25 chose to continue for an additional 12 weeks. Most side effects were mild and expected, such as nausea, dizziness, and falls. No serious or unexpected safety concerns were reported.
At the start of the study, participants averaged 9.5 hours of good mobility (Good ON-time), 4.7 hours of poor mobility (OFF-time), and 1.8 hours of mobility with troublesome involuntary movements (ON-time with troublesome dyskinesia) per day. After 6 weeks and 18 weeks of treatment, Good ON-time increased by 3.6 and 3.4 hours respectively, OFF-time decreased by 2.3 and 2 hours, and ON-time with troublesome dyskinesia decreased by 1.2 and 1.4 hours. The severity of dyskinesia also improved significantly, with scores dropping by 8.5 points at 6 weeks and 14.5 points at 18 weeks. Importantly, the average daily dose of levodopa was reduced by 53.4% after 6 weeks and by 29.2% after 18 weeks.
For participants who experienced at least one hour of troublesome dyskinesia per day at the start, ON-time with troublesome dyskinesia decreased by 2.3 hours at 6 weeks and 2.8 hours at 18 weeks. It’s important to note that this trial was small and did not include a placebo group or a comparison to another active treatment, so the results should be interpreted with caution.
A larger, phase 2 clinical trial called DARE2 has now started. This study will include about 150 adults with advanced Parkinson’s and will compare Lu AF28996 to a placebo. The main goal is to measure changes in daily Good ON-time from the start of the study to week 19. Recruitment has begun in the United States, with plans to expand to Europe and Japan. Lu AF28996 has not yet been approved by any regulatory agency, including the U.S. Food and Drug Administration (FDA), and its safety and effectiveness have not been confirmed.