Cerevance reported Phase 3 results for solengepras showing a reduction in Parkinson’s patients’ daily “off” time alongside other symptoms, setting up a potential regulatory discussion on approval. The privately held company said the pill approach is intended to avoid direct dopamine-targeting—an attempt to spare patients certain dopamine-related side effects. The trial enrolled 341 participants and tested once-daily solengepras add-on dosing compared with placebo. Cerevance highlighted that the higher dose met the trial’s primary goal by reducing average daily off time compared with placebo, alongside improvements in “on” time and patient-reported measures. The next step is regulator engagement on whether the observed functional and motor outcomes support a label strategy in a competitive add-on landscape, particularly for patients already on levodopa who experience motor fluctuations.