Juvmo becomes the first selective D1/D5 agonist for Parkinson disease

FDA has approved Juvmo (tavapadon) for the treatment of adults with Parkinson disease, making it the first selective dopamine D1/D5 receptor agonist approved for the condition. The once-daily oral therapy can be used as monotherapy in earlier disease or as an adjunct to levodopa in patients experiencing motor fluctuations.

"Parkinson's disease treatment has long required health care providers to balance the need for dependable motor symptom control with considerations around treatment tolerability," said Hubert Fernandez, MD, of the Cleveland Clinic Lerner College of Medicine and global principal TEMPO trial investigator. "Now we have a novel therapy that selectively targets D1/D5 receptors, which addresses a longstanding need for innovation and provides health care providers with greater flexibility to tailor treatment to individual patient needs."

Approval was supported by the phase 3 TEMPO clinical trial program, which evaluated Juvmo both in patients with early Parkinson disease and in those experiencing motor fluctuations despite levodopa treatment. In the TEMPO-1 and TEMPO-2 studies, Juvmo improved activities of daily living and motor function compared with placebo, supporting its use as a standalone treatment earlier in the disease course.

In the adjunctive TEMPO-3 study, adding Juvmo to levodopa increased daily "on" time without troublesome dyskinesia by approximately 1.7 hours, compared with 0.6 hours for placebo, while reducing daily "off" time by about 1.9 hours. Benefits were maintained through 85 weeks in an open-label extension study.

Long-term findings also suggest Juvmo may help delay levodopa escalation. After 85 weeks of treatment, 93% of patients receiving Juvmo with levodopa had not increased their levodopa dose, while 94% of those receiving Juvmo without levodopa had not initiated levodopa therapy.

Most treatment-emergent adverse events were mild to moderate. Common adverse reactions included nausea, headache, dizziness, fatigue, altered taste, vomiting, dry mouth, and anxiety. Labeling also includes warnings regarding orthostatic hypotension, impulse-control and compulsive behaviors, hallucinations, and dyskinesia.

"For people with Parkinson's and their families, progress means having treatment options that deliver meaningful benefit in everyday life," said Brian Fiske, PhD, chief scientist of The Michael J. Fox Foundation for Parkinson's Research. "Each therapy approval is an important milestone in building a diverse treatment pipeline needed to meet the full range of unmet needs across the Parkinson's community."

Source: AbbVie. (2026 Sep 28). U.S. FDA Approves AbbVie's JUVMO™ (tavapadon) for Parkinson's Disease