The Front Room — a clinical regulatory commons
RSS
← Back to The Docket
SEP 25 2026
APPROVED · 4 DAYS AGO

AbbVie — Juvmo (tavapadon) $ABBV

for Parkinson's disease

NDA · Standard Review

FDA approved Juvmo (tavapadon), a once-daily pill, for Parkinson's disease in adults on September 25, 2026, one day ahead of the September 26 PDUFA date.

About

Parkinson's disease is a brain disorder that gradually damages nerve cells controlling movement and other body functions, causing tremors, stiffness, slowed movement, and balance problems, along with sleep, smell, mood, and thinking changes that worsen over time. Tavapadon is an oral drug that binds to D1 and D5 dopamine receptors in the brain and partially switches them on, mimicking dopamine's signal without fully overstimulating it. Because Parkinson's is tied to falling dopamine signaling, topping up that signal with tavapadon may help ease movement symptoms and could offer a steadier option for people whose symptoms fluctuate.

Pivotal trial

TEMPO-2 Phase 3 completed NCT04223193

The purpose of this study is to assess the efficacy, safety, tolerability and pharmacokinetics (PK) of flexible doses of tavapadon in participants with Parkinson's Disease.

Source: ClinicalTrials.gov

Also in development