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SEP 26 2026
UPCOMING · 115 DAYS TO PDUFA

AbbVie tavapadon $ABBV

for Parkinson's disease

NDA · Standard Review

Accepted NOV 26 2025.

About

Parkinson's disease is a neurodegenerative disorder that causes tremors, slowed movement, stiffness, and balance problems, along with non-motor symptoms like sleep disturbances and cognitive decline. Tavapadon is a selective dopamine receptor activator that mimics natural dopamine signals in the brain. By targeting specific dopamine pathways, it may help restore motor control and ease symptoms in Parkinson's patients.

Pivotal trial

TEMPO-1 Phase 3 completed NCT04201093

The purpose of this study is to evaluate the clinical efficacy, safety and pharmacokinetics (PK) of 2 fixed doses of tavapadon and placebo in participants with early PD.

Source: ClinicalTrials.gov

Also in development