The US Food and Drug Administration (FDA) has approved tavapadon (Juvmo) for the treatment of adults with Parkinson’s disease, introducing a new once-daily oral treatment that selectively targets dopamine D1/D5 receptors.
The FDA approved tavapadon on 25 September. The drug can be used in early Parkinson’s disease and alongside levodopa in patients experiencing motor fluctuations. It is the first selective D1/D5 dopamine receptor agonist approved in the US.
Approval was supported by the phase 3 TEMPO clinical trial programme. In the TEMPO-1 study, patients with early Parkinson’s disease receiving tavapadon showed significant improvements in activities of daily living and motor function compared with placebo after 26 weeks.
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The TEMPO-3 trial evaluated tavapadon as an adjunct to levodopa in 507 patients experiencing motor fluctuations. Tavapadon increased daily ‘on’ time without troublesome dyskinesia by 1.7 hours from baseline, compared with 0.6 hours with placebo. Daily ‘off’ time decreased by 1.88 hours with tavapadon compared with 0.93 hours with placebo.
Adverse events were more frequent with tavapadon than placebo in TEMPO-3, occurring in 71.7% and 55.1% of participants respectively, although most were non-serious and mild to moderate. Common adverse events included nausea, dyskinesia and dizziness.
Unlike established dopamine agonists that primarily target D2/D3 receptors, tavapadon is a selective D1/D5 receptor partial agonist. The phase 3 trials did not directly compare tavapadon with existing dopamine agonists or other adjunctive Parkinson’s therapies, and longer-term efficacy and safety continue to be evaluated.
AbbVie expects tavapadon to become available in the US in October 2026.
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This news item has been summarised using AI and checked by humans before publication.
Sources
U.S. FDA Approves AbbVie’s JUVMO™ (tavapadon) for Parkinson’s Disease
AbbVie, US FDA approves Juvmo (tavapadon) for Parkinson’s disease
JAMA Neurology, Fixed-Dose Tavapadon for Early Parkinson Disease: A Randomized Clinical Trial
