The U.S. Food and Drug Administration approved Tavapadon, a once-daily oral medication developed by AbbVie for adults with Parkinson’s disease.
Commercialized under brand name Juvmo, Tavapadon can be prescribed alone or alongside Levodopa to manage motor symptoms at different stages of the disease. According to Abbvie, the treatment is the first and only selective D1/D5 receptor agonist approved for adults with Parkinson’s disease.
While the tablets received FDA approval, there is still a long road ahead of them. The advantages of the drug over existing therapies remain unclear. Researchers have not yet conducted head-to-head studies comparing Tavapadon to other treatments. However, clinicians believe the new trestment could give clinicians another option for patients with early Parkinson’s disease.
Clinicians Now Have A New Approach
Tavapadon is the first new non-levodopa drug approved for Parkinson’s in decades. The approval signals progress toward alternative treatment approaches for the disease, which damages dopamine-producing neurons in the brain and causes symptoms, such as tremors, muscle stiffness and slowed movement.
For nearly 60 years, approvals introduced new formulations or delivery methods for Levodopa. Though Levodopa remains the gold standard for managing Parkinson’s motor symptoms, some patients do not respond to treatment. Others continue to experience fluctuations in symptom control and involuntary movements while on treatment.
Tavapadon is a selective D1/D5 dopamine receptor agonist that offers a new option for clinicians to use in treating patients. Unlike Levodopa, dopamine agonists mimic the effects of it in the brain, according to the Michael J. Fox Foundation.
The American Parkinson Disease Association described Tavapadon’s approval as “a huge milestone.”
“Tavapadon and its FDA approval means there is now a new way of targeting dopamine signaling that can be used with or without levodopa to best manage PD symptoms moving forward,” the association wrote in a statement.
Tavapadon Phase 3 Data Support FDA Approval
The FDA based its approval of Tavapadon on AbbVie’s Phase 3 TEMPO clinical trial program. Early research at the University of Virginia helped establish the scientific foundation.
The trials evaluated tavapadon in patients with early Parkinson’s disease and those who experienced motor fluctuations while taking levodopa. Researchers tested the drug as a standalone treatment for early Parkinson’s and as an add-on therapy for patients taking levodopa.
Clinical Trial Outcomes
The TEMPO-3 trial evaluated tavapadon as an add-on treatment for patients already taking levodopa. Researchers measured daily “on” time, when medication controls symptoms, and “off” time, when symptoms return or worsen between doses.
At 26 weeks, patients who received tavapadon alongside levodopa gained an average of 1.7 hours of daily “on” time without troublesome dyskinesia, compared with 0.6 hours among those who received placebo. Daily “off” time decreased by 1.9 hours in the Tavapadon group, compared with 0.9 hours in the placebo group.
The TEMPO-1 and TEMPO-2 trials enrolled patients with early Parkinson’s who had not started levodopa. After 26 weeks, researchers found that Tavapadon significantly improved motor symptoms and activities of daily living compared with placebo.
Longer-term findings from the TEMPO-4 extension study supported continued efficacy through 85 weeks. At that point, 93% of participants taking Tavapadon alongside levodopa had not increased their levodopa dose. Among participants with early Parkinson’s who took Tavapadon alone, 94% had not started levodopa.
Safety
Investigators reported that Tavapadon was generally well tolerated in the clinical trials. Common adverse effects included nausea, headache and dizziness. Patients who took Tavapadon alongside levodopa also experienced dyskinesia, orthostatic hypotension and hallucinations. The FDA prescribing information also warns about daytime sleepiness, falling asleep during daily activities, hallucinations and impulse-control problems.
The drug label notes that Tavapadon can cause hypotension and orthostatic hypotension, particularly during dose escalation. The label also advises caution when prescribing tavapadon to patients with a major psychotic disorder because it may worsen psychosis.
Tavapadon Limitations In Focus
The Michael J. Fox Foundation for Parkinson’s Research supported recruitment for Tavapadon’s clinical trials. The foundation convened a patient advisory meeting to incorporate patient perspectives into drug development.
However, the trial populations had an underrepresentation of Black patients, highlighting a persistent limitation in Parkinson’s research. This small number could limit evidence on potential differences in treatment response across racial populations. In TEMPO-3, which enrolled 507 participants, fewer than 2% were Black while 97% were White. Four Black participants in the placebo group and two were in the Tavapadon group.
Researchers have found that Black patients are diagnosed with Parkinson’s disease at roughly half the rate of White patients. Black patients are also significantly less likely to receive anti-parkinsonian medications, including levodopa and dopamine agonists, after diagnosis.
Access will also influence prescribing and equity in impact. AbbVie announced plans to to launch Juvmo in October 2026. Insurance coverage and out-of-pocket costs will ultimately affect when and if patients can start treatment. The Michael J. Fox Foundation contributed to the Institute for Clinical and Economic Review’s assessment of Tavapadon’s clinical and economic value. Final determination could help support broader coverage decisions among health insurance companies.
Disparities In Parkinson’s Treatment
Medical literature and Parkinson’s advocacy organizations are increasingly urging clinicians to recognize racial disparities in diagnosis and treatment.
Researchers have raised concerns that clinical tools may be less effective at identifying symptoms in populations underrepresented in research. Studies have also found that Black and South Asian patients experienced worse motor outcomes over time than White patients, despite receiving equivalent medication.
Efforts to address this gap include the Global Parkinson’s Genetics Program, which aims to genotype more than 150,000 participants worldwide, with a focus on populations underrepresented in genetic research, including people of African, Asian and Hispanic ancestry.
