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FDA approves AbbVie's tavapadon, a once-daily Parkinson's pill

An amber prescription pill bottle with a single tablet sits on a wooden clinic desk beside a stethoscope, with brain-scan films softly out of focus in the background.

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The U.S. Food and Drug Administration approved tavapadon on 25 September 2026 to treat Parkinson’s disease in adults. AbbVie will sell the once-daily pill as Juvmo. The FDA lists it among its novel drug approvals for 2026, meaning the molecule had never before been cleared in the United States.

Tavapadon is a selective partial agonist of the dopamine D1 and D5 receptors. It stands in for the dopamine that the brain’s motor circuits lose as Parkinson’s progresses, the loss behind the slowness, stiffness and tremor of the disease. AbbVie acquired the drug through its $8.7 billion purchase of Cerevel Therapeutics in 2023.

The application rested on the Phase 3 TEMPO program. TEMPO-1 (529 participants) and TEMPO-2 (304) tested the drug alone in people diagnosed less than three years earlier, and both improved the combined MDS-UPDRS Part II and III score, which covers daily activities and motor examination, at week 26. TEMPO-3 (507) added tavapadon to levodopa in patients with motor fluctuations and increased their “on” time, when symptoms are controlled without involuntary movements. The most common side effects were nausea, dizziness and headache, according to Reuters. AbbVie did not disclose a launch price.

Sources

  1. [1]Novel Drug Approvals for 2026U.S. Food and Drug Administration··Regulatory filing
  2. [2]US FDA approves AbbVie's drug for Parkinson's diseaseReuters (via 102.7 WBOW)··Article
  3. [3]AbbVie Submits New Drug Application to U.S. FDA for Tavapadon for the Treatment of Parkinson's DiseaseAbbVie··Press release