# Tavapadon PDUFA Event: Parkinson's disease

Canonical URL: https://biopharmsignal.com/pdufa-calendar/ABBV/tavapadon-parkinsons-disease

Ticker: ABBV

Company: AbbVie Inc

Event date: 2026-07-26

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: NDA

Reported FDA decision date passed without a disclosed outcome. The supplied catalyst record identifies July 26, 2026 as the FDA decision date. As of August 1...

## Event Timeline

### July 26, 2026 — Reported FDA decision date passed without a disclosed outcome

The supplied catalyst record identifies July 26, 2026 as the FDA decision date. As of August 13, 2026, neither FDA nor AbbVie had publicly disclosed an approval, Complete Response Letter or revised action date, so the event remains pending rather than approved.

### September 26, 2025 — AbbVie submitted the NDA

AbbVie submitted an NDA covering tavapadon as a once-daily treatment across Parkinson's disease, supported by the monotherapy TEMPO-1 and TEMPO-2 trials and adjunctive TEMPO-3 trial.

[AbbVie — Tavapadon NDA submission](https://news.abbvie.com/2025-09-26-AbbVie-Submits-New-Drug-Application-to-U-S-FDA-for-Tavapadon-for-the-Treatment-of-Parkinsons-Disease)

### December 9, 2024 — TEMPO-2 met its primary endpoint

Flexible-dose tavapadon monotherapy significantly improved the combined MDS-UPDRS Parts II and III score at week 26 versus placebo in adults with early Parkinson's disease.

[AbbVie — Positive TEMPO-2 topline results](https://news.abbvie.com/2024-12-09-AbbVie-Announces-Positive-Topline-Results-for-the-Phase-3-TEMPO-2-Trial-Evaluating-Tavapadon-as-a-Monotherapy-for-Parkinsons-Disease)

### September 26, 2024 — TEMPO-1 met its primary endpoint

Both fixed-dose tavapadon monotherapy groups significantly improved the combined MDS-UPDRS Parts II and III score at week 26 versus placebo.

[AbbVie — Positive TEMPO-1 topline results](https://news.abbvie.com/2024-09-26-AbbVie-Announces-Positive-Topline-Results-from-Phase-3-TEMPO-1-Trial-Evaluating-Tavapadon-as-a-Monotherapy-for-Parkinsons-Disease)

### April 18, 2024 — TEMPO-3 met its primary endpoint

Adjunctive tavapadon significantly increased total daily on time without troublesome dyskinesia versus placebo over 27 weeks in patients receiving levodopa.

[AbbVie — Positive TEMPO-3 topline results](https://news.abbvie.com/2024-04-18-Cerevel-Therapeutics-Announces-Positive-Topline-Results-for-Tavapadon-in-Phase-3-Adjunctive-Trial-for-People-Living-with-Parkinsons-Disease)

### September 23, 2020 — Phase 3 TEMPO-3 study started

The adjunctive pivotal study began evaluating tavapadon in adults with Parkinson's disease and motor fluctuations receiving levodopa.

[ClinicalTrials.gov — TEMPO-3 study record (NCT04542499)](https://clinicaltrials.gov/study/NCT04542499)

### January 6, 2020 — Phase 3 TEMPO-2 study started

The flexible-dose monotherapy trial began evaluating tavapadon in adults with early Parkinson's disease.

[ClinicalTrials.gov — TEMPO-2 study record (NCT04223193)](https://clinicaltrials.gov/study/NCT04223193)

### December 13, 2019 — Phase 3 TEMPO-1 study started

The fixed-dose monotherapy trial began evaluating tavapadon in adults with early Parkinson's disease.

[ClinicalTrials.gov — TEMPO-1 study record (NCT04201093)](https://clinicaltrials.gov/study/NCT04201093)

## Related Pages

- ABBV PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/ABBV.md

- ABBV company profile: https://biopharmsignal.com/company/ABBV.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md