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# AbbVie Files NDA for Parkinson’s Drug Tavapadon
- URL: https://www.fdaweb.com/abbvie-files-nda-for-parkinsons-drug-tavapadon/
- Published: 2025-09-26T12:00:00.000Z
- Updated: 2026-09-14T15:22:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159943

AbbVie has filed an NDA for tavapadon, an investigational once-daily oral therapy for Parkinson’s disease, based on data from late-stage clinical trials that showed the treatment improved symptoms across different stages of the condition. Tavapadon is described by the company as a selective dopamine D1/D5 receptor partial agonist. It specifically targets D1 and D5 dopamine receptors, which are more localized to motor neurons, according to the company, adding that this selective action is designed to provide motor benefits while potentially reducing side effects common with other dopamine agonists that target D2/D3 receptors.

In early-stage Parkinson’s disease, two pivotal studies (TEMPO-1 and TEMPO-2) found that tavapadon significantly improved patients’ scores on the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale Parts II and III, which measure motor function and daily activities. In patients with more advanced disease, the TEMPO-3 trial showed that adding tavapadon to levodopa increased “on” time — periods when symptoms are controlled without involuntary movements — compared to placebo. The company’s submission also included interim data from TEMPO-4, a long-term extension study evaluating safety and sustained benefit through 58 weeks of treatment.

Across the three Phase 3 studies, AbbVie says most side effects were mild to moderate. Common adverse events included nausea, headache, and dizziness in early Parkinson’s patients, and nausea and dyskinesia when tavapadon was used alongside levodopa. Serious adverse events and deaths were rare and comparable to placebo.