Tavapadon

Not yet reviewed: Listed from FDA or ClinicalTrials.gov records; an editor has not checked it yetListed from FDA or ClinicalTrials.gov records; an editor has not checked it yet.

Also known as Juvmo

AbbVie Inc. ABBV · Parkinson Disease

Key figures

  • Next catalyst

    None scheduled

    Only dates with a source are listed

  • Phase

    Approved

    Not recorded

  • Linked trials

    4

    From ClinicalTrials.gov

  • Latest FDA action

    Approved

    NDA220415,

Recalls, shortages, patents and EU status at a glance

Key information

Indication
Parkinson Disease Source: Conditions from ClinicalTrials.gov (opens in a new tab)
Designations
None recorded
Next catalyst
None scheduled

Development timeline

  1. Preclinical Completed
  2. Phase 1 Completed
  3. Phase 2 Completed
  4. Phase 3 CompletedFirst trial start 13 Dec 20194 linked trials
  5. Filed Completed
  6. Approved Current stageFirst approval 25 Sep 2026

Overview

Mechanism
Not recorded
Route
Not recorded
Modality
Not recorded
Specialties
Not recorded

Overview text is written by HealthTrade editors.

Key dates

No catalysts yet. Editors add each date together with its source.

FDA designations

No FDA designations are on record for Tavapadon. Editors add each one with its source.

Filed application

No filed application is on record for Tavapadon. Approvals are listed under FDA actions.

FDA advisory committees

No FDA advisory committee meetings are on record for Tavapadon.

Clinical trials

Trials linked to Tavapadon
TrialTitlePhaseStatusEnrollmentPrimary completionResults posted
NCT04760769ClinicalTrials.gov record for NCT04760769 (opens in a new tab)TEMPO-4Open-label Trial in Parkinson's Disease (PD)Phase 3Completed992 (actual)1 Dec 2025 (actual) No
NCT04542499ClinicalTrials.gov record for NCT04542499 (opens in a new tab)Flexible-Dose, Adjunctive Therapy Trial in Adults With Parkinson's Disease With Motor Fluctuations (TEMPO-3)Phase 3Completed507 (actual)29 Jan 2024 (actual) Yes First posted Results on ClinicalTrials.gov for NCT04542499 (opens in a new tab)

Posted results on ClinicalTrials.gov for NCT04542499

  • Change From Baseline in the Total "On" Time Without Troublesome Dyskinesia Based on the 2-day Average of the Self-completed Home Diary for Motor Function Status (Hauser Diary) (hours)
    • Placebo vs Tavapadon: LS Mean of Difference 1.103 (95% CI 0.553 to 1.653), p-value <0.0001, Mixed-effect Model Repeated Measurement, superiority

Serious adverse events (All-cause mortality were reported from enrollment to the end of study, median time on follow up (median time subjects were followed) was 190 and 189 days for Placebo and Tavapadon, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug; mean duration on study drug was 169.6 and 151.7 days for Placebo and Tavapadon, respectively.): Placebo 14 of 255; Tavapadon 17 of 252

Source: ClinicalTrials.gov results for NCT04542499 (opens in a new tab)· imported

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Publications listing NCT04542499 (1), newest first

  1. Tavapadon as Adjunctive Treatment for Parkinson Disease: The TEMPO-3 Randomized Clinical Trial.

    JAMA neurology · 2026 May 1

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

NCT04223193ClinicalTrials.gov record for NCT04223193 (opens in a new tab)TEMPO-2Flexible-Dose Trial in Early Parkinson's Disease (PD)Phase 3Completed304 (actual)1 Oct 2024 (actual) Yes First posted Results on ClinicalTrials.gov for NCT04223193 (opens in a new tab)

Posted results on ClinicalTrials.gov for TEMPO-2

  • Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III Combined Score (score on a scale)
    • Placebo vs Tavapadon: LS Mean of Difference -9.1 (95% CI -11.7 to -6.5), p-value <0.0001, Mixed-effect Model Repeated Measurement, superiority

Serious adverse events (All-cause mortality were reported from enrollment until 4 weeks after the end of study. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 4 weeks after the last dose of study drug. Mean duration on study drug was 176.7 and 144.5 days for Placebo and Tavapadon, respectively. Median time on follow up (median time subjects were followed) was 200 and 198 days for Placebo and Tavapadon, respectively.): Placebo 2 of 153; Tavapadon 7 of 151

Source: ClinicalTrials.gov results for NCT04223193 (opens in a new tab)· imported

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Publications listing TEMPO-2 (1), newest first

  1. Safety, tolerability, and efficacy of flexible-dose tavapadon for Parkinson's disease (TEMPO-2): a phase 3, randomised, placebo-controlled, double-blind trial.

    The Lancet. Neurology · 2026 Aug

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

NCT04201093ClinicalTrials.gov record for NCT04201093 (opens in a new tab)TEMPO-1Fixed-Dose Trial in Early Parkinson's Disease (PD)Phase 3Completed529 (actual)28 Jun 2024 (actual) Yes First posted Results on ClinicalTrials.gov for NCT04201093 (opens in a new tab)

Posted results on ClinicalTrials.gov for TEMPO-1

  • Change From Baseline in the MDS-UPDRS Parts II and III Combined Score (score on a scale)
    • Placebo vs Tavapadon 5 mg: LS Mean of Difference -11.5 (95% CI -13.8 to -9.2), p-value <0.0001, Mixed-effect Model Repeated Measurement, superiority
    • Placebo vs Tavapadon 15 mg: LS Mean of Difference -12.1 (95% CI -14.4 to -9.8), p-value <0.0001, Mixed-effect Model Repeated Measurement, superiority

Serious adverse events (All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.): Placebo 11 of 175; Tavapadon 5mg QD 4 of 177; Tavapadon 15mg QD 10 of 177

Source: ClinicalTrials.gov results for NCT04201093 (opens in a new tab)· imported

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Publications listing TEMPO-1 (1), newest first

  1. Fixed-Dose Tavapadon for Early Parkinson Disease: A Randomized Clinical Trial.

    JAMA neurology · 2026 May 1

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.

Trial quality

About CT-VCA

Loading trial quality…

FDA actions

Original approvals and new-indication supplements for Tavapadon, newest first
ApplicationActionDateOutcomeReviewSource
NDA220415Action letter for NDA220415 (opens in a new tab) Original 1 Type 1 - New Molecular EntityApprovedstandardDrugs@FDA via openFDA (opens in a new tab)

Data provided by the U.S. Food and Drug Administration.

FDA recalls load here.

FDA drug shortages load here.

Orange Book patents load here.

FAERS adverse event counts load here.

Papers and preprints load here.

Community discussion loads here.

EU status (EMA)

EMA's medicines data lists no human medicine with the same active substance as Tavapadon.

Source: European Medicines Agency (EMA), medicines data download.

Related news

Sources

Record updated .

Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.