29 SEP 2026 — The US Food and Drug Administration has approved tavapadon for adults with Parkinson's disease. AbbVie will sell the once-daily tablet as Juvmo. It is the first approved Parkinson's drug to act selectively on the D1 and D5 dopamine receptors, rather than the D2/D3 targets used by existing dopamine agonists.
AbbVie announced the approval on 28 September and expects the drug to reach US patients in October.
What is different about it
Parkinson's disease destroys the brain cells that make dopamine, the chemical that helps control movement. Levodopa remains the main treatment because the brain can convert it into dopamine. Existing dopamine agonists mimic dopamine and act mostly on D2 and D3 receptors.
Tavapadon targets D1 and D5 instead. "What makes tavapadon unique is its D1 selectivity," Hubert Fernandez of Cleveland Clinic, an investigator in the trials, told NeurologyLive. The aim is to preserve movement benefit while avoiding side effects linked to D2 stimulation.
How it is taken
It is a once-daily tablet that can be taken alone or with levodopa. The FDA's novel approvals list records the approval on 25 September.
What the trials showed
The approval rests on AbbVie's TEMPO programme, the company says. TEMPO-1 and TEMPO-2 tested the drug alone over 26 weeks in people with early Parkinson's not yet taking levodopa, measuring changes in daily living and movement scores. Both showed significant improvement over placebo.
TEMPO-3 added tavapadon to levodopa in people whose symptoms fluctuate through the day. Over 26 weeks they gained 1.7 hours a day of good symptom control without troublesome involuntary movements, compared with 0.6 hours for those on placebo, while their daily "off" time fell by 1.9 hours against 0.9.
The side effects
Nausea was the most common side effect whether tavapadon was taken alone or with levodopa. Used alone, it also brought headache, dizziness, tiredness and a changed sense of taste for some patients. Alongside levodopa, involuntary movements, hallucinations and a drop in blood pressure on standing were among the more frequent problems.
The label warns about that fall in blood pressure, hallucinations, worsening involuntary movements, and impulse-control problems such as compulsive gambling, eating or shopping, which are known with dopamine drugs. NeurologyLive reports that 24% of patients stopped the drug in TEMPO-2, mostly while the dose was being raised, against 4% on placebo.
What is still unknown
No trial compared tavapadon directly with levodopa or an existing dopamine agonist, NeurologyLive notes. So far the evidence is against placebo only, which leaves open how it compares with what patients already take.
Whether the D1 approach really avoids the problems of older agonists over years of use will only become clear with wider experience. AbbVie has not announced a price.
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