FDA Approves First D1/D5 Dopamine Agonist for Parkinson's

Overview

• Tavapadon, branded Juvmo by AbbVie, was approved by the FDA on Thursday, Oct. 1, 2026, and is expected to be available in U.S. pharmacies in October 2026.
• The drug works by selectively stimulating D1 and D5 dopamine receptors, a different brain target than most existing Parkinson's drugs that act mainly on D2 and D3 receptors.
• A pivotal phase 3 trial of 507 patients on levodopa found tavapadon increased daily 'on' time by 1.7 hours versus 0.6 hours for placebo, a net benefit of 1.1 hours after 26 weeks.
• Safety signals included more adverse events (71.7% on tavapadon versus 55.1% on placebo), about 17% treatment discontinuation, common nausea and dizziness, and orthostatic drops with 6% experiencing clinically significant postural hypotension versus 1.2% with placebo.
• Experts say the drug relieves motor symptoms but does not slow neurodegeneration and that post‑marketing surveillance plus head‑to‑head trials will be needed to judge long‑term safety and whether it offers clear advantages over current therapies.