North Chicago, Ill. – – September 28, 2026 -- AbbVie (NYSE: ABBV) has secured U.S. FDA approval for JUVMO (tavapadon), the first and only selective D1/D5 receptor agonist for adults with Parkinson's disease, with commercial availability set for October 2026.
JUVMO targets dopamine pathways differently than existing D2/D3 agonists
Roopal Thakkar, AbbVie's chief scientific officer, called the approval the first dopaminergic breakthrough for Parkinson's disease in decades. The once-daily oral tablet can be taken with or without levodopa, positioning it across the full disease continuum rather than a single treatment stage.
Phase 3 TEMPO data show reduced need for levodopa escalation
About 70% of Parkinson's patients require an oral levodopa dose increase within their first year of therapy, a common driver of treatment-related dyskinesia. After 85 weeks on JUVMO, 93% of trial participants on combination therapy (96 of 103) had not increased their levodopa dose, and 94% of early-stage patients (257 of 273) had not initiated levodopa at all.
Trial results show significant functional and motor improvements
In TEMPO-1 at week 26, JUVMO improved MDS-UPDRS Part II daily-living scores by 22-23% from baseline versus a 12% worsening on placebo (5 mg: -1.6; 15 mg: -1.7; p0.0001 for both doses). Combined Part II+III scores improved by up to 10.2 points versus a 1.8-point worsening on placebo. TEMPO-2 replicated the daily-living benefit (5-15 mg: -1.5 vs. placebo 0.0; p=0.0007). In TEMPO-3, patients on JUVMO plus levodopa gained 1.7 hours of daily "on" time without troublesome dyskinesia versus 0.6 hours on placebo plus levodopa (p0.0001), while "off" time fell by 1.9 hours versus 0.9 hours (p=0.0006).
Safety profile centers on nausea, dizziness and hallucination risk
Most treatment-emergent adverse events were mild to moderate. Without levodopa, the most common effects (≥5% of patients) were nausea, headache, dizziness, fatigue, dysgeusia, vomiting, dry mouth and anxiety. In combination with levodopa, the most frequent effects included nausea, dyskinesia, dizziness, headache, hallucinations and orthostatic hypotension. JUVMO carries warnings for low blood pressure, impulse-control disorders, hallucinations and dyskinesia.
Approval expands treatment options for an 11-million-patient global population
Parkinson's disease affects more than 11 million people worldwide, with motor symptoms typically emerging only after 60-80% of dopamine-producing brain cells are lost. Hubert Fernandez, global principal investigator on the TEMPO trials at Cleveland Clinic Lerner College of Medicine, said the D1/D5-selective mechanism gives clinicians new flexibility to tailor treatment to individual patients. JUVMO is available in 5 mg, 10 mg and 15 mg tablets, plus a titration pack with 0.25 mg and 1 mg doses.