NEW results from the Phase 3 TEMPO-2 trial, presented at the 2025 American Academy of Neurology (AAN) Annual Meeting in San Diego, indicate that flexible-dose tavapadon significantly improved motor symptoms and daily functioning in adults with early Parkinson’s disease (PD), compared with placebo.
Tavapadon is an investigational, once-daily, oral partial dopamine agonist that selectively targets D1/D5 receptors. The 27-week, randomized, double-blind, placebo-controlled trial enrolled 304 adults aged 40 to 80 years with early-stage PD (Hoehn and Yahr stage 1–2). Participants received either placebo or tavapadon (5–15 mg daily, titrated to the maximum tolerated dose).
The primary endpoint was change from baseline in the combined score of the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Parts II and III. Results showed a statistically significant difference favoring tavapadon, with a least squares mean (LSM) change of -9.1 compared to placebo (95% CI: -11.7, -6.5; P<0.0001). The MDS-UPDRS Part II score, assessing activities of daily living, also showed significant improvement (LSM difference: -1.5; 95% CI: -2.4, -0.6; P=0.0007). Safety findings were consistent with previous tavapadon trials. Most adverse events were non-serious and classified as mild to moderate in severity. TEMPO-2 is part of a broader clinical development program evaluating tavapadon as a potential monotherapy or adjunctive treatment in Parkinson’s disease. While TEMPO-1 and TEMPO-3 have concluded, a long-term open-label extension (TEMPO-4) is ongoing. These findings support the continued investigation of selective D1/D5 receptor agonism as a therapeutic strategy in early-stage PD. Reference: Fernandez HH et al. Efficacy and Safety of Flexible-Dose Tavapadon, an Orally Administered, Once-Daily, Selective D1/D5 Partial Dopamine Agonist for the Treatment of Early Parkinson’s Disease. Abstract 001. 2025 American Academy of Neurology (AAN) Annual Meeting, April 5-9, 2025, San Diego, California, USA.
