FDA Approves AbbVie's JUVMO, the First New Type of Dopamine Drug for Parkinson's in Decades
The once-daily pill targets different dopamine receptors than existing options and is expected in U.S. pharmacies this month.
People living with Parkinson's disease have a new treatment option. The U.S. Food and Drug Administration has approved AbbVie's JUVMO (tavapadon), a once-daily tablet that AbbVie says is the first and only selective D1/D5 receptor agonist approved for adults with Parkinson's.
"The approval of JUVMO marks the first dopaminergic breakthrough for Parkinson's disease in decades." — Roopal Thakkar, M.D., AbbVie
A different approach
Current dopamine agonists mainly target D2 and D3 receptors, which can limit their use because of side effects. JUVMO targets D1 and D5 receptors instead, and can be taken with or without levodopa.
What the trials showed
AbbVie's Phase 3 TEMPO program tested the drug in more than a thousand people:
- Early Parkinson's (TEMPO-1 and TEMPO-2): patients not on levodopa improved on everyday-activity scores at 26 weeks, while placebo groups held steady or worsened.
- Alongside levodopa (TEMPO-3): daily "on" time without troublesome involuntary movement rose by 1.7 hours, versus 0.6 hours on placebo.
- Long term (TEMPO-4): 93% of people taking JUVMO with levodopa did not need to raise their levodopa dose, and 94% of those taking it alone did not need to start levodopa.
The most common side effects were nausea, headache, change in taste, fatigue, vomiting, dry mouth and anxiety.
"Each therapy approval is an important milestone in building a diverse treatment pipeline." — Brian Fiske, PhD, The Michael J. Fox Foundation
AbbVie expects JUVMO to be available in the U.S. in October 2026.