FDA approves once-daily Parkinson’s pill (Juvmo) built on decades of work by husband-and-wife team

A once-daily Parkinson’s pill has reached FDA approval after decades of work on a dopamine pathway that early treatments largely overlooked.

Tavapadon, sold as Juvmo, offers adults another way to manage movement symptoms, either alone or alongside levodopa. It directly stimulates selected dopamine receptors instead of being converted into dopamine. The approval expands treatment options without establishing a cure or a way to halt the disease.

The FDA approved the drug September 25, and AbbVie announced plans to make it available in October. Research by University of Virginia scientists Richard Mailman and Xuemei Huang helped establish the case for targeting D1-like receptors.

The clinical evidence is published in TEMPO-1, TEMPO-2, TEMPO-3 and TEMPO-4 studies. Those trials tested symptom control in early Parkinson’s and in people experiencing fluctuations while taking levodopa.

Parkinson’s gradually damages dopamine-producing nerve cells involved in controlling movement. Dopamine is a chemical messenger, and its declining supply contributes to tremor, stiffness and slowness. More than 11 million people worldwide live with the condition. Problems with sleep, cognition and other functions can accompany its movement symptoms.

Levodopa remains a central treatment because the brain converts it into dopamine. As Parkinson’s progresses, reduced dopamine-handling capacity and levodopa’s short duration of action can make symptom control fluctuate. Patients may alternate between “on” periods of better movement and “off” periods when symptoms return. More frequent doses can help, but managing that schedule can become burdensome.

“Patients’ lives become bound by their medication,” Huang said, describing the demands of frequent dosing. She sees the once-daily approach as a way to ease that burden. Whether it simplifies an individual regimen will depend on the other treatments still needed.

Juvmo is a selective partial agonist at D1 and D5 receptors, meaning it activates those receptors without producing their maximum possible response. Most established dopamine agonists primarily target D2 and D3 receptors. This different receptor profile provides another route to motor symptom relief. However, it does not establish superiority over levodopa or other active treatments.

Mailman’s interest began with movement problems caused by antipsychotic drugs that block D2 receptors. He wondered whether blocking D1 receptors could avoid those effects. Instead, his animal experiments produced pronounced movement impairment, suggesting that D1 activation might matter for treating Parkinson’s. By 1984, he was pursuing that possibility and collaborating on compounds to test it.

Early experimental D1 drugs presented practical problems, including the need for injection and potentially severe drops in blood pressure. Huang joined the research effort in the late 1990s and proposed administering a compound under the skin. Slower entry into the bloodstream offered a way around the abrupt pressure drop associated with intravenous administration. The resulting clinical work helped demonstrate that the approach could improve movement in people.

Turning that proof of concept into an oral medicine required further chemistry and sustained industry interest. Pfizer scientists led by David Gray developed oral compounds after Mailman made the case for D1 targeting. Tavapadon subsequently moved through Cerevel Therapeutics and AbbVie. Mailman and Huang’s contribution was to the scientific foundation, while the eventual pill emerged from a broader development effort.

The TEMPO-1 trial, published in JAMA Neurology, enrolled 529 people with early Parkinson’s. Participants received daily tavapadon at five or 15 milligrams, or placebo. At week 26, combined scores measuring daily activities and motor examination improved by 9.7 and 10.2 points in the treatment groups. The placebo group worsened by 1.8 points, producing treatment differences of 11.5 and 12.1 points.

The separate TEMPO-3 trial enrolled 507 people experiencing motor fluctuations despite levodopa treatment. Adding tavapadon increased daily “on” time without troublesome involuntary movements by 1.7 hours, compared with 0.6 hours for placebo. The additional benefit was therefore about 1.1 hours per day. Daily “off” time fell by approximately 1.9 hours with tavapadon and 0.9 hours with placebo.

These placebo-controlled comparisons support symptomatic benefit, but they do not compare tavapadon directly against another active drug. Nor do improved movement scores show that underlying degeneration has slowed. Both studies evaluated treatment over roughly six months. Longer use and broader patient populations will help define how those benefits translate into routine care.

AbbVie also reported findings from TEMPO-4, an open-label extension in which participants knew they were receiving treatment. Among people treated for 85 weeks, 96 of 103 taking tavapadon with levodopa had not increased their levodopa dose. That was approximately 93%. Among those receiving tavapadon without levodopa, 257 of 273 had not started levodopa, approximately 94%.

Those figures describe the participants included in the reported long-term analysis, rather than every person originally enrolled. An extension without a blinded placebo comparison can provide useful follow-up information but cannot establish the same conclusions as a randomized comparison. People who continue treatment may also differ from those who stop. The figures do not prove that tavapadon prevented progression or outperformed levodopa over 85 weeks.

The separate claim that about 70% of levodopa users need a dose increase within a year comes from company data on file. It is not a matched control group for TEMPO-4. Different populations, follow-up periods and study methods prevent a straightforward comparison. Stable medication requirements are encouraging, but they do not measure nerve-cell survival.

Juvmo’s prescribing information warns about low blood pressure, compulsive behaviors, hallucinations and involuntary movements called dyskinesia. Common side effects include nausea, headache and other symptoms, with the pattern differing depending on levodopa use. In TEMPO-3, adverse events occurred in 71.7% of tavapadon recipients and 55.1% of placebo recipients. Most were nonserious and mild or moderate, but the treatment still requires monitoring.

The once-daily schedule could reduce one part of the medication burden, especially when used alone. Adding it to levodopa does not automatically remove the need for existing doses. Treatment selection must account for symptom response, tolerability and interactions. The studies did not establish that Juvmo causes fewer side effects than levodopa.

Huang hopes D1-targeted treatment may eventually help people with very advanced disease, and the researchers also want to investigate cognition. Those remain questions for further study. Approval establishes a new option for managing Parkinson’s symptoms today. Whether D1-targeted medicines can deliver broader benefits will depend on evidence gathered beyond the initial trials.

These resources explain receptor targeting, established treatment choices and the new medicine’s approved uses and risks.

JUVMO prescribing information: Details the approved indication, clinical studies, drug interactions and safety warnings. (AbbVie/FDA-approved labeling, 2026)

FDA Approves Tavapadon: A New Treatment Option for Parkinson’s: Explains the approval and how tavapadon fits among symptom-management options. (American Parkinson Disease Association, 2026)

Dopaminergic Therapy for Motor Symptoms in Early Parkinson Disease Practice Guideline Summary: A Report of the AAN Guideline Subcommittee: Reviews established treatment tradeoffs before tavapadon’s approval. (Neurology, 2021)

Rationale and Development of Tavapadon, a D1/D5-Selective Partial Dopamine Agonist for the Treatment of Parkinson’s Disease: Describes the receptor strategy and evidence supporting clinical development. (CNS & Neurological Disorders - Drug Targets, 2024)

Global, regional, national epidemiology and trends of Parkinson’s disease from 1990 to 2021: findings from the Global Burden of Disease Study 2021: Examines the worldwide burden and changing prevalence of Parkinson’s. (Frontiers in Aging Neuroscience, 2025)

Research findings are available online in the journals for TEMPO-1, TEMPO-2, TEMPO-3 and TEMPO-4.

The original story "FDA approves once-daily Parkinson’s pill (Juvmo) built on decades of work by husband-and-wife team" is published in The Brighter Side of News.

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