TheraRadar
Data updated: Nov 8, 2026

JUVMO (tavapadon) · AbbVie

Approved 2026-09-25
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
0
Years on Market

Details

Status
Prescription
First Approved
2026-09-25
Routes
ORAL
Dosage Forms
TABLET

Companies

AbbVie
Active Ingredient: TAVAPADON

JUVMO Approval History

Original
New Indication
New Form
Label Update
4 FDA actions from 2026 to 2026
Sep 2026 ORIGINAL
New Drug · Type 1 - New Molecular Entity
FDA Letter Label

What JUVMO Treats

1 FDA approvals

Originally approved for its first indication in 2026 .

  • Other (1)
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Clinical Trial Registry

9 trials
Trial Sponsor ID Phase Status Title
NCT04760769 TEMPO-4 CVL-751-PD-004 2019-002952-17 Ph 3 completed Open-label Trial in Parkinson's Disease (PD)
NCT04223193 TEMPO-2 results posted CVL-751-PD-002 2019-002950-22 Ph 3 completed Flexible-Dose Trial in Early Parkinson's Disease (PD)
NCT04201093 TEMPO-1 results posted CVL-751-PD-001 2019-002949-38 Ph 3 completed Fixed-Dose Trial in Early Parkinson's Disease (PD)
NCT06895356 M25-974 Ph 1 completed A Study to Assess the Relative Bioavailability of Oral Tavapadon in Healthy Adult Participants
NCT04542499 results posted CVL-751-PD-003 2019-002951-40 Ph 3 completed Flexible-Dose, Adjunctive Therapy Trial in Adults With Parkinson's Disease With Motor Fluctuations (TEMPO-3)
NCT05404542 CVL-751-1004 Ph 1 completed To Evaluate Pharmacokinetics (PK) and Safety of Tavapadon in Participants With Severe Renal Impairment Compared to Participants With Normal Renal Function
NCT05610189 CVL-751-1006 Ph 1 completed Multiple-dose Trial to Determine the Clinical Bioequivalence Between Tavapadon Tablets in Participants With Parkinson's Disease
NCT05404529 CVL-751-1003 Ph 1 completed To Evaluate the Pharmacokinetics (PK) and Safety of Tavapadon in Participants With Mild and Moderate Hepatic Impairment Compared to Participants With Normal Hepatic Function
NCT05581823 CVL-751-1005 Ph 1 completed Study to Evaluate the Effects of Cytochrome P450 (CYP) 3A4 Inducer Carbamazepine on Tavapadon Pharmacokinetics in Healthy Adult Participants
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

JUVMO FDA Label Details

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Data Sources

FDA Approval: NDA220415 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.