DA Approves Tavapadon for the Treatment of Parkinson Disease

Oct 12, 2026

September 28, 2026 Author(s) Isabella Ciccone, MPH

Key Takeaways

  • Selective partial D1/D5 agonism aims to preserve motor efficacy while potentially avoiding D2/D3-mediated nonmotor tolerability liabilities, representing a mechanistically differentiated approach among dopamine agonists.
  • TEMPO-1 and TEMPO-2 met primary endpoints in early disease, with placebo-adjusted ~9–12 point improvements in combined MDS-UPDRS II/III across fixed and flexible dosing regimens.
  • In levodopa-treated patients with fluctuations, TEMPO-3 increased ON time without troublesome dyskinesia by 1.1 hours versus placebo and reduced OFF time, supporting adjunctive utility.
  • Safety signals included nausea, dizziness, hallucinations, orthostatic hypotension, and dyskinesia; discontinuations were higher with tavapadon, predominantly during titration, with class-consistent impulse control warnings.
  • Open-label extension data suggest delayed levodopa initiation or escalation, but interpretation is constrained by lack of control, survivor bias, exclusion of patients >80 years, and no comparative effectiveness evidence.

FDA approves once-daily oral tavapadon for Parkinson disease, a first-in-class D1/D5 partial agonist that improves motor function and ON time, with key safety warnings.

The FDA has approved tavapadon (AbbVie), a once-daily oral selective dopamine D1/D5 receptor partial agonist, for adults with Parkinson disease (PD). Marketed as Juvmo, it is the first approved dopamine agonist that selectively targets the D1-like receptor family rather than D2/D3 receptors and can be taken with or without levodopa.1

The approval is based on the phase 3 TEMPO program, which evaluated tavapadon as monotherapy in early PD and as an adjunct to levodopa in patients with motor fluctuations.1-4 “What makes tavapadon unique is its D1 selectivity. We can stimulate motor pathways effectively, but the hope is to avoid the baggage that comes with D2 stimulation, particularly the nonmotor side effects," global principal TEMPO trial investigator Hubert Fernandez, MD, a professor of neurology at Cleveland Clinic Lerner College of Medicine, told NeurologyLive® in a recent interview.1 AbbVie expects tavapadon to be available in the US in October 2026.

“The FDA approval of tavapadon is a momentous occasion, as the Parkinson’s community has waited more than 50 years for new, improved medication options. I am very encouraged by the safety and efficacy data that I have seen from the drug’s clinical trials and am hopeful that people in varying stages of the disease will benefit from it,” Sneha Mantri, MD, MS, FAAN, chief medical officer at the Parkinson’s Foundation, told NeurologyLive.

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