Tavapadon for Parkinson Disease Approved by FDA

The FDA has approved tavapadon, to be sold as Juvmo by AbbVie, as the first selective D1/D5 dopamine receptor agonist for Parkinson disease in adults.^1,2 The once-daily oral pill works by mimicking dopamine, the brain chemical that progressively declines in the more than 11 million people living worldwide with Parkinson disease, and was designed to work differently from every other dopamine agonist on the market, a distinction AbbVie and outside investigators say could matter for patients who have struggled to tolerate existing options.^1,3

In the US alone, 1.1 million individuals are living with the progressive neurodegenerative movement disorder, and 90,000 are diagnosed each year.⁴ Adults 65 years and older and men across all age groups are disproportionately affected.⁵

What Did the TEMPO Trial Program Show?

AbbVie gained tavapadon through its $8.7 billion acquisition of Cereval Therapeutics in 2023.⁶ The approval covers use as a monotherapy in early Parkinson disease and as an add-on to levodopa for patients with motor fluctuations, and rests on data from AbbVie’s phase 3 TEMPO trial program.¹ In the trial program (TEMPO-1, NCT04201093; TEMPO-2, NCT04223193; TEMPO-3, NCT04542499; TEMPO-4, NCT04760769), the drug improved daily living and motor scores vs placebo in early Parkinson disease.

Patients aged 40 to 80 years were enrolled in the TEMPO trials; they were either recently diagnosed and medication-naïve or on stable levodopa experiencing motor fluctuations.³ In the TEMPO-1 and TEMPO-2 trials, tavapadon monotherapy improved motor and activities of daily living scores relative to placebo at 26 weeks in early Parkinson disease.¹ In TEMPO-3, adding tavapadon to levodopa increased total daily “on” time without troublesome dyskinesia by roughly 1 hour more than placebo and cut “off” time by about an hour as well.

Durability data from the 85-week TEMPO-4 open-label extension were notable in that 93% of patients on tavapadon plus levodopa did not require a levodopa dose increase and 94% of patients on tavapadon monotherapy never initiated levodopa. This is clinically important because approximately 70% of patients on standard therapy require a levodopa dose increase in their first year of treatment, AbbVie explained.

The most common adverse effects (AEs), occurring in 5% or more of patients, differed by regimen.^1,2 As monotherapy, they included nausea, headache, dizziness, fatigue, altered taste, vomiting, dry mouth, and anxiety. With levodopa, they included nausea, dyskinesia, dizziness, headache, hallucinations, and orthostatic hypotension. AbbVie said most treatment-related emergent AEs were mild to moderate and nonserious.

How Tavapadon’s Mechanism Differs From Other Treatments

Current dopamine agonists work by activating the D2 and D3 receptors; these D2/D3 agonists have been linked to impulse control disorders, excessive daytime sleepiness, and lower-extremity swelling, tolerability issues that limit their use in some patients.³ Tavapadon instead selectively targets the D1 and D5 receptors, a mechanism AbbVie describes as the field’s most notable dopaminergic advance in decades¹ because it offers a potential option for patients limited by the tolerability of current therapies, a gap previously examined through research of adjuvant treatment for Parkinson disease.⁷

“Parkinson’s disease treatment has long required health care providers to balance the need for dependable motor symptom control with considerations around treatment tolerability,” said Hubert Fernandez, MD, professor of neurology at the Cleveland Clinic Lerner College of Medicine and global principal TEMPO trial investigator, in a statement.¹ “Now we have a novel therapy that selectively targets D1/D5 receptors, which addresses a longstanding need for innovation and provides health care providers with greater flexibility to tailor treatment to individual patient needs.”

AbbVie is targeting more than $5 billion in combined sales, although Citi analysts have said uptake will likely be gradual as Medicare coverage negotiations proceed.

The potential launch date is October 2026.

References

1. U.S. FDA approves AbbVie’s Juvmo (tavapadon) for Parkinson’s disease. News release. AbbVie. September 28, 2026. Accessed September 28, 2026. https://news.abbvie.com/2026-09-28-U-S-FDA-Approves-AbbVies-JUVMO-TM-tavapadon-for-Parkinsons-Disease
2. US FDA approves AbbVie’s drug for Parkinson disease. Reuters. September 25, 2026. Accessed September 28, 2026. https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-abbvies-drug-parkinsons-disease-2026-09-25/
3. Once-daily treatment for Parkinson’s motor symptoms submitted for FDA approval. The Michael J. Fox Foundation for Parkinson’s Research. November 6, 2025. Accessed September 28, 2026. https://www.michaeljfox.org/news/new-parkinsons-drug-tavapadon-submitted-fda-review
4. Statistics. Parkinson’s Foundation. Accessed September 28, 2026. https://www.parkinson.org/understanding-parkinsons/statistics
5. Prevalence & incidence. Parkinson’s Foundation. Accessed September 28, 2026. https://www.parkinson.org/understanding-parkinsons/statistics/prevalence-incidence
6. AbbVie pads neuroscience portfolio with $8.7B deal to acquire Cerevel. News release. Fierce Biotech. December 6, 2023. Accessed September 28, 2026. https://www.fiercebiotech.com/biotech/abbvie-pads-neuroscience-portfolio-87b-deal-acquire-cerevel
7. Inserro A. Examining adjuvant therapies in PD when levodopa wanes. AJMC^®. March 19, 2022. Accessed September 28, 2026. https://www.ajmc.com/view/examining-adjuvant-therapies-in-pd-when-levodopa-wanes