For people living with Parkinson’s, “on” time—hours when symptoms are under better control—is the difference between a day that works and a day that stalls. AbbVie says a new once-daily option just cleared the FDA with a different dopamine target than older agonists.
On September 28, AbbVie announced U.S. Food and Drug Administration approval of JUVMO (tavapadon) tablets as the first and only selective D1/D5 receptor agonist for adults with Parkinson’s disease. It can be taken once daily alone or with levodopa. Parkinson’s affects more than 11 million people worldwide. Existing dopamine agonists mostly lean on D2/D3 pathways and can bring tolerability tradeoffs; AbbVie positions JUVMO as a differentiated approach across the disease continuum.
Approval rests on the Phase 3 TEMPO program. In early disease without levodopa (TEMPO-1 and TEMPO-2), tavapadon improved scores tied to daily functioning—tasks like dressing, eating, and personal hygiene—versus placebo. In TEMPO-3, for people already on levodopa with motor fluctuations, JUVMO plus levodopa increased total daily “on” time without troublesome dyskinesia versus placebo plus levodopa (about 1.7 hours versus 0.6 hours at week 26). In longer follow-up (TEMPO-4), among people on JUVMO with levodopa for 85 weeks, 93% had not increased their oral levodopa dose; among those on JUVMO without levodopa, 94% had not started it. Common side effects included nausea, headache, and dizziness; the label also flags risks such as low blood pressure on standing, unusual urges, hallucinations, and dyskinesia. AbbVie expects U.S. availability in October 2026.
Why it matters
Parkinson’s is not rare, and treatment often becomes a balancing act: more levodopa can help movement but may feed complications like dyskinesia. A once-daily pill that hits a different receptor set—and showed more usable “on” time in Phase 3—gives clinicians another dial to turn. For families, that can mean more predictable hours for the ordinary things that make a day feel like a day.
What’s next
JUVMO is slated to reach U.S. patients in October 2026. Patients and clinicians will watch real-world tolerability, how it pairs with levodopa over time, and whether selective D1/D5 targeting becomes a lasting new lane beside older D2/D3 agonists.
Sources: PR Newswire — FDA approves AbbVie’s JUVMO (tavapadon)