Skip to main content

AbbVie’s JUVMO Gets FDA Approval for Parkinson’s Disease: New D1/D5 Targeted Treatment Approved in the U.S.

AbbVie’s JUVMO Gets FDA Approval for Parkinson’s Disease: New D1/D5 Targeted Treatment Approved in the U.S.

AbbVie’s JUVMO (tavapadon) has received approval from the U.S. Food and Drug Administration (FDA) for the treatment of Parkinson’s disease in adults. The once-daily oral medicine introduces a different approach to dopamine-based treatment by selectively targeting D1/D5 receptors.

AbbVie announced on September 28, 2026, that the FDA approved JUVMO tablets for adults with Parkinson’s disease. The company describes JUVMO as the first and only selective D1/D5 receptor agonist approved for adults with Parkinson’s disease.

The medicine is designed to be taken once daily, with or without levodopa therapy, giving clinicians another oral treatment option for managing motor symptoms associated with Parkinson’s disease.

AbbVie expects JUVMO to become available to patients in the United States in October 2026.

Tavapadon is a selective dopamine D1/D5 receptor agonist. This mechanism differs from currently available dopamine agonists, which primarily target D2/D3 receptors. The drug is intended to activate dopamine pathways involved in motor function while providing a mechanistically different option for Parkinson’s disease management.

FDA Approval Supported by Phase 3 TEMPO Program
The FDA approval was supported by data from AbbVie’s Phase 3 TEMPO clinical development program, which evaluated tavapadon in people with early Parkinson’s disease who were not receiving oral levodopa and in patients experiencing motor fluctuations while receiving levodopa.

In TEMPO-1, JUVMO significantly improved activities-of-daily-living scores compared with placebo at week 26. The combined measure of activities of daily living and motor function also showed statistically significant improvements.

In TEMPO-2, the drug again demonstrated a significant improvement in the MDS-UPDRS Part II score compared with placebo.

Meanwhile, TEMPO-3 evaluated JUVMO in combination with oral levodopa in patients experiencing motor fluctuations. At week 26, patients receiving JUVMO plus levodopa experienced an increase of 1.7 hours in daily “on” time without troublesome dyskinesia, compared with 0.6 hours for placebo plus levodopa. Daily “off” time decreased by 1.9 hours with JUVMO plus levodopa versus 0.9 hours with placebo plus levodopa.

JUVMO tablets are available in 5 mg, 10 mg and 15 mg strengths. A titration pack containing 0.25 mg and 1 mg tablets is also available.

Safety and Common Side Effects
According to information released by AbbVie, commonly reported adverse events varied depending on whether JUVMO was used without or with oral levodopa.

When used without oral levodopa, commonly reported side effects included: Nausea, Headache, Dizziness, Fatigue, Change in taste, Vomiting, Dry mouth, Anxiety

When used with oral levodopa, commonly reported adverse events included nausea, dyskinesia, dizziness, headache, hallucinations and orthostatic hypotension.


What This Approval Means for Parkinson’s Treatment
Parkinson’s disease is a progressive neurological disorder associated with symptoms including tremor, muscle rigidity, slowed movement and balance difficulties. More than 11 million people worldwide are living with Parkinson’s disease, according to AbbVie.

JUVMO provides a new pharmacological approach by selectively targeting the D1/D5 receptor family rather than the D2/D3 receptors primarily targeted by existing dopamine agonists.

The approval therefore adds another treatment option for clinicians managing adults with Parkinson’s disease, including patients with early disease and those experiencing motor fluctuations while taking levodopa.