— FDA gives go-ahead to D1/D5 dopamine agonist tavapadon
by Judy George, Deputy Managing Editor, MedPage Today
September 28, 2026
The FDA approved the dopamine agonist tavapadon (Juvmo) to treat adults with Parkinson's disease, drugmaker AbbVie announced Monday.
Tavapadon is an oral selective D1/D5 dopamine agonist that was studied as monotherapy for early Parkinson's in the TEMPO-1 and TEMPO-2 trials, and as adjunctive therapy with oral levodopa in advanced Parkinson's patients who had motor fluctuations in the TEMPO-3 trial.
Dopamine agonists are used to help manage symptoms and reduce reliance on oral levodopa escalation. Tavapadon is the first D1/D5 receptor agonist approved for Parkinson's; other available dopamine agonists primarily target D2/D3 receptors.
"Parkinson's disease treatment has long required healthcare providers to balance the need for dependable motor symptom control with considerations around treatment tolerability," said principal TEMPO trial investigator Hubert Fernandez, MD, of the Cleveland Clinic Lerner College of Medicine, in a news release.
"Now we have a novel therapy that selectively targets D1/D5 receptors, which addresses a longstanding need for innovation and provides healthcare providers with greater flexibility to tailor treatment to individual patient needs," he added.
In the TEMPO-1 (fixed dose) and TEMPO-2 (flexible dose) studies, participants receiving tavapadon as monotherapy had a significant reduction in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part II and III combined scores at week 26 compared with placebo. MDS-UPDRS parts II and III scores reflect activities of daily living and motor performance.
In TEMPO-3, tavapadon adjunctive to levodopa significantly increased daily "on" time without troublesome dyskinesia at 27 weeks compared with placebo. Sustained efficacy to 85 weeks was seen for patients who continued in the open-label TEMPO-4 extension, AbbVie said.
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