Drugs / Tavapadon
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | Parkinson disease | 2025-09-26 | “AbbVie (NYSE: ABBV) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tavapadon” abbvie.com ↗ |
Trials 19
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 112 trials | ||||||
| Phase 1 | NCT06895356 | Mar → Jun 2025 | — | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT05581823 | Oct 2022 → Jan 2023 | Parkinson disease | Cerevel Therapeutics, LLC | Completed | No outcome recorded |
| Phase 1 | NCT05404542 | May 2022 → Aug 2023 | impaired renal function disease | Cerevel Therapeutics, LLC | Completed | No outcome recorded |
| Phase 1 | NCT05404529 | Apr 2022 → Jan 2023 | liver disease, severe congenital | Cerevel Therapeutics, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04241393 | Feb → Nov 2020 | — | Cerevel Therapeutics, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04295642 | Jan 2020 → Jul 2021 | Parkinson disease | Cerevel Therapeutics, LLC | Completed | No outcome recorded |
| Phase 1 | NCT03121664 | Apr → Sep 2017 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02373072 | Mar 2015 → Feb 2016 | Parkinson disease | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02262767 | Nov → Dec 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02224664 | Oct 2014 → Mar 2016 | Parkinson disease | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02066909 | Feb 2014 → Apr 2015 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01981694 | Nov 2013 → Feb 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 23 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT03185481 | Jul → Oct 2017 | Parkinson disease | Pfizer | Terminated | No outcome recorded |
| Phase 2 | NCT02847650 | Oct 2016 → Jan 2018 | Parkinson disease | Pfizer | Terminated | Met primary |
| Phase 2 | NCT02687542 | Mar 2016 → Nov 2017 | Parkinson disease | Pfizer | Terminated | Missed primary |
| Phase 34 trials · 3 met primary | ||||||
| Phase 3 | NCT04760769 | Feb 2021 → Dec 2025 | Parkinson disease | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT04542499 | Sep 2020 → Jan 2024 | Parkinson disease | AbbVie | Completed | Met primary |
| Phase 3 | NCT04223193 | Jan 2020 → Oct 2024 | Parkinson disease | AbbVie | Completed | Met primary |
| Phase 3 | NCT04201093 | Dec 2019 → Jun 2024 | Parkinson disease | AbbVie | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| — | NCT07158827 Background | — | Parkinson disease | AbbVie | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2025-09-26 | AbbVie | Regulatory AbbVie Submits New Drug Application to U.S. FDA for Tavapadon for the Treatment of Parkinson's Disease abbvie.com ↗ |
| 2024-12-09 | AbbVie | Results AbbVie Announces Positive Topline Results for the Phase 3 TEMPO-2 Trial Evaluating Tavapadon as a Monotherapy for Parkinson's Disease abbvie.com ↗
AbbVie (NYSE: ABBV) today announced positive topline results from its pivotal Phase 3 TEMPO-2 trial evaluating investigational tavapadon as a flexible-dose monotherapy in early Parkinson's disease. |
| 2024-09-26 | AbbVie | Results AbbVie Announces Positive Topline Results from Phase 3 TEMPO-1 Trial Evaluating Tavapadon as a Monotherapy for Parkinson's Disease abbvie.com ↗
Tavapadon met the primary endpoint in the pivotal Phase 3, TEMPO-1 fixed-dose monotherapy trial, demonstrating a statistically significant improvement from baseline in the MDS-UPDRS Parts II and III combined score at week 26 |
| 2024-04-18 | AbbVie | Results Cerevel Therapeutics Announces Positive Topline Results for Tavapadon in Phase 3 Adjunctive Trial for People Living with Parkinson’s Disease abbvie.com ↗
Tavapadon met the primary endpoint in the pivotal Phase 3 TEMPO-3 adjunctive trial, demonstrating a statistically significant increase in total “on” time without troublesome dyskinesia compared with placebo over 27 weeks |
| 2022-03-31 | AbbVie | Results Cerevel Therapeutics Announces Upcoming Presentations at AAN 2022 abbvie.com ↗
Cerevel will present data demonstrating consistent clinical pharmacology across a wide range of doses of tavapadon in several Phase 1 clinical trials, supporting its potential as a promising next-generation treatment for Parkinson’s disease. |
| 2019-09-23 | AbbVie | Results Cerevel Therapeutics Announces Positive Results from a Phase 2 Study of Tavapadon in Patients with Early-stage Parkinson’s Disease abbvie.com ↗
BOSTON – September 23, 2019 – Cerevel Therapeutics , a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, announced today positive results from a Phase 2 clinical trial evaluating oral tavapadon (formerly PF-06649751) in patients with early-stage Parkinson’s disease. |
All press releases naming this drug 11 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tavapadon | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04223193 ↗ |
| Known as | CVL-751 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04295642 ↗ |
| Known as | PF-06649751 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02847650 ↗ |
| Action | Activate | “PF-06649751 is a novel, highly selective dopamine D1/D5 agonist targeted for Parkinson's disease treatment.” PMID 30361858 ↗ Oct 20182“Dopamine D1 receptor partial agonist” CHEMBL3697617 ↗ “Dopamine D5 receptor partial agonist” CHEMBL3697617 ↗ |
| Modality | Small molecule | — CHEMBL3697617 ↗ |
| Route | Oral | “given orally” NCT01981694 ↗ |
| Target | DRD1 | “Dopamine D1 receptor partial agonist” CHEMBL3697617 ↗ |
| Target | DRD5 | “Dopamine D5 receptor partial agonist” CHEMBL3697617 ↗ |