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 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. In the US alone, 1.1 million individuals are living with the progressive neurodegenerative movement disorder and 90,000 are diagnosed each year.²

AbbVi gained tavapadon through its $8.7 billion acquisition of Cereval Therapeutics in 2023.³ The approval covers use as a monotherapy in early Parkinson disease and as an add-on to levodopa for patients with motor fluctuations. In AbbVie’s phase 3 TEMPO trial program, the drug improved daily living and motor scores vs placebo in early Parkinson disease and alongside levodopa increased “on” time without troublesome dyskinesia by approximately 1 hour relative to placebo; in an 85-week extension, most patients on combination therapy avoided a levodopa dose increase.1 Common adverse effects across the trials included nausea, dizziness, and headache.^1,4

Tavapadon’s D1/D5 mechanism, distinct from the D2/D3 pathway used by existing dopamine agonists, offers a potential option for patients limited by tolerability on current therapies, a gap previously examined through research of adjuvant treatment for Parkinson disease.⁵ 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. Statistics. Parkinson’s Foundation. Accessed September 28, 2026. https://www.parkinson.org/understanding-parkinsons/statistics
3. 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
4. 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/
5. 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