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SEP 26 2026
UPCOMING · 57 DAYS TO PDUFA

AbbVie tavapadon $ABBV

for Parkinson's disease

NDA · Standard Review

Accepted NOV 26 2025.

About

Parkinson's disease is a neurodegenerative condition that causes tremors, slowed movement, stiffness, and balance problems, alongside non-motor symptoms like sleep issues and cognitive changes. Tavapadon is a selective partial agonist that activates specific dopamine receptors in the brain. By mimicking dopamine's role in movement control, it could potentially help manage the motor symptoms of the disease.

Pivotal trial

TEMPO-4 Phase 3 completed NCT04760769

The purpose of this study is to evaluate the safety and efficacy of long-term administration of flexible doses of tavapadon in participants with Parkinson's Disease.

Source: ClinicalTrials.gov

Also in development