FDA Approves JUVMO, First Selective D1/D5 Receptor Agonist, for Parkinson's Disease

The FDA has approved tavapadon (JUVMO, AbbVie) tablets for the treatment of adults with Parkinson's disease, AbbVie announced. The company described tavapadon as the first and only selective D1/D5 receptor agonist approved for the disease.

Tavapadon is taken once daily with or without levodopa. According to AbbVie, currently available dopamine agonists primarily target D2/D3 receptors, and their use may be limited by tolerability concerns. The drug is available as 5mg, 10mg, and 15mg tablets, as well as 0.25mg and 1mg tablets in a titration pack. AbbVie expects to make tavapadon available in the US in October 2026.

The approval was supported by the phase 3 TEMPO program. In TEMPO-1, which enrolled patients with early Parkinson's disease not taking levodopa, tavapadon 5mg and 15mg improved MDS-UPDRS Part II scores at week 26 compared with placebo (−1.6 and −1.7 vs +0.9; P < .0001 for each dose). TEMPO-2 showed a similar result with tavapadon 5-15mg (−1.5 vs 0.0; P = .0007). In TEMPO-3, tavapadon added to levodopa in patients with motor fluctuations increased total daily "on" time without troublesome dyskinesia by 1.7 hours, compared with 0.6 hours with placebo plus levodopa (P < .0001).

Most treatment-emergent adverse events were nonserious and mild or moderate in severity. The most common adverse events without levodopa included nausea, headache, dizziness, fatigue, dysgeusia, vomiting, dry mouth, and anxiety; with levodopa, they included nausea, dyskinesia, dizziness, headache, hallucinations, and orthostatic hypotension. The safety information warns of low blood pressure, unusual urges such as gambling and compulsive eating, hallucinations, and dyskinesia.

In the open-label TEMPO-4 extension, AbbVie reported sustained efficacy through 85 weeks, citing company data on file. Among patients taking tavapadon with levodopa, 93% did not increase their levodopa dose, and among those taking tavapadon without levodopa, 94% did not initiate levodopa.

Source: AbbVie. U.S. FDA approves AbbVie's JUVMO (tavapadon) for Parkinson's disease. News release. AbbVie; September 28, 2026. Accessed September 28, 2026.