Tavapadon Treatment for Adults With Parkinson Disease Approved by FDA
KEY TAKEAWAYS
- The FDA approved tavapadon, a selective dopamine D1/D5 receptor agonist, for the treatment of adults with Parkinson disease.
- The approval is supported by the phase 3 TEMPO program, which evaluated tavapadon treatment as a monotherapy in people with early Parkinson disease (PD) and as adjunctive treatment along with levodopa in those with Parkinson's and motor fluctuations.
- AbbVie expects tavapadon to become available in the United States in October 2026.
The Food and Drug Administration (FDA) approved Juvmo (tavapadon; AbbVie, North Chicago, IL) for the treatment of adults with Parkinson disease, according to a statement from AbbVie. Juvmo is an oral dopamine D1/D5 receptor agonist and can be used with or without levodopa treatment
The FDA’s decision was supported by results of the phase 3 TEMPO clinical trial program. TEMPO-1 (NCT04201093) and TEMPO-2 (NCT04223193) evaluated Juvmo treatment in people with early Parkinson disease who were not receiving levodopa, whereas TEMPO-3 (NCT04542499) evaluated adjunctive treatment with Juvmo in those receiving levodopa who had motor fluctuations.
Phase 3 Results
- In TEMPO-1, participants treated with Juvmo showed greater improvement in Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part II scores at week 26 than those receiving placebo (5 mg, -1.6; 15 mg, -1.7; placebo, +0.9; P<.0001 for both doses).
- Participants treated with Juvmo also showed greater improvement in combined MDS-UPDRS Parts II and III scores than those receiving placebo (5 mg, -9.7; 15 mg, -10.2; placebo, +1.8; P<.0001).
- In TEMPO-3, participants receiving Juvmo + levodopa had 1.7 additional hours of daily “on” time without troublesome dyskinesia compared with 0.6 hours among those receiving placebo plus levodopa (P<.0001).
- Daily “off” time decreased by 1.9 hours with Juvmo plus levodopa compared with 0.9 hours with placebo plus levodopa (P=.0006).
The most common treatment-emergent adverse events varied by background levodopa use and included nausea, headache, dizziness, fatigue, dysgeusia, dyskinesia, hallucinations, and orthostatic hypotension. AbbVie reported that most events were nonserious and mild or moderate in severity.
Practical Implications in the Clinic
Juvmo adds a once-daily oral treatment option with a D1/D5-selective mechanism for adults with Parkinson disease, including those treated with levodopa who experience motor fluctuations.
Source
AbbVie. U.S. FDA approves AbbVie’s JUVMO (tavapadon) for Parkinson’s disease. Published September 28, 2026. Accessed September 28, 2026. https://news.abbvie.com/2026-09-28-U-S-FDA-Approves-AbbVies-JUVMO-TM-tavapadon-for-Parkinsons-Disease