AbbVie Wins FDA Approval for JUVMO in Parkinson’s Disease

North Chicago, Illinois, U.S., September 28, 2026

JUVMO Introduces Selective D1/D5 Dopamine Approach

Tavapadon is a selective D1/D5 receptor partial agonist designed to activate dopamine D1-like receptors in the brain. This mechanism differs from conventional dopamine agonists that primarily target D2/D3 receptor families. Parkinson’s disease is associated with progressive loss of dopamine-producing neurons, contributing to motor symptoms such as tremor, rigidity and difficulty with movement. By selectively stimulating D1/D5 receptors, JUVMO represents a differentiated approach to dopaminergic treatment. The FDA approval allows JUVMO to be administered once daily, with or without levodopa. The treatment can therefore be used in adults with early Parkinson’s disease who are not yet receiving oral levodopa, as well as in patients receiving levodopa who experience motor fluctuations. This broad development strategy was evaluated through AbbVie’s Phase 3 TEMPO clinical program, which included studies covering different stages and treatment settings in Parkinson’s disease.

Phase 3 TEMPO Program Supports FDA Approval

The FDA decision was supported by results from the TEMPO Phase 3 program, including TEMPO-1 and TEMPO-2 in people with early Parkinson’s disease who were not taking oral levodopa and TEMPO-3 in patients experiencing motor fluctuations while receiving oral levodopa. The trials evaluated measures of daily functioning, motor symptoms and time spent in controlled or uncontrolled symptom states. In TEMPO-1, JUVMO produced statistically significant improvements in activities of daily living measured by the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale Part II at Week 26 compared with placebo. AbbVie reported improvements in combined activities-of-daily-living and motor scores as well. In TEMPO-2, the treatment also significantly improved the Part II score and the combined Part II plus Part III measure compared with placebo. For patients experiencing motor fluctuations while taking levodopa, TEMPO-3 showed that JUVMO combined with oral levodopa increased daily “on” time without troublesome dyskinesia by 1.7 hours, compared with 0.6 hours for placebo plus levodopa at Week 26. AbbVie also reported a reduction in daily “off” time with JUVMO plus levodopa. These findings contributed to the evidence supporting the new treatment’s use across the Parkinson’s disease treatment continuum.

AbbVie Advances Parkinson’s Treatment Portfolio

Longer-term findings from the TEMPO program provided additional information on treatment exposure. In the open-label TEMPO-4 extension, AbbVie reported sustained efficacy through 85 weeks. Among participants receiving JUVMO with oral levodopa, 93% had not increased their oral levodopa dose during the extension period, while 94% of participants receiving JUVMO without levodopa had not initiated oral levodopa. These are clinical-trial observations and do not establish that JUVMO prevents the need for levodopa in individual patients. The safety profile observed in the clinical program was also part of the FDA-supported evidence. AbbVie reported that most treatment-emergent adverse events were non-serious and mild or moderate. Frequently reported adverse events among patients receiving JUVMO without levodopa included nausea, headache, dizziness, fatigue, dysgeusia, vomiting, dry mouth and anxiety. When used with levodopa, commonly reported events included nausea, dyskinesia, dizziness, headache, hallucinations and orthostatic hypotension.

The approval adds a new mechanism to the pharmaceutical treatment landscape for Parkinson’s disease and expands AbbVie’s neuroscience portfolio. JUVMO is expected to reach U.S. patients in October 2026, giving clinicians another once-daily oral option for adults with Parkinson’s disease.

Source: AbbVie press release