Tavapadon
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
- Sponsor
- AbbVie Inc. ABBV Source: Company record for AbbVie Inc. (opens in a new tab)
- Indication
- Parkinson Disease Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Application
- NDA 220415 · Standard review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 220415 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 CompletedFirst trial start 13 Dec 20194 linked trials
- Filed Completed
- 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
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT04760769ClinicalTrials.gov record for NCT04760769 (opens in a new tab)TEMPO-4 | Open-label Trial in Parkinson's Disease (PD) | Phase 3 | Completed | 992 (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 3 | Completed | 507 (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
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
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-2 | Flexible-Dose Trial in Early Parkinson's Disease (PD) | Phase 3 | Completed | 304 (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
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
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-1 | Fixed-Dose Trial in Early Parkinson's Disease (PD) | Phase 3 | Completed | 529 (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
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
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-VCALoading trial quality…
FDA actions
| Application | Action | Date | Outcome | Review | Source |
|---|---|---|---|---|---|
| NDA220415Action letter for NDA220415 (opens in a new tab) | Original 1 Type 1 - New Molecular Entity | Approved | standard | Drugs@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
- Drugs@FDA 220415 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT04760769 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04542499 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04223193 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04201093 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA NDA220415 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.