FDA Approves AbbVie's Juvmo for Parkinson Disease

The FDA approved tavapadon (Juvmo) tablets for the treatment of adults with Parkinson disease (PD). The company described the once daily oral drug as the first and only selective D1/D5 receptor agonist approved for the condition and said it expects to make Juvmo available in the US in October 2026.¹

AbbVie said the approval rests on the phase 3 TEMPO program, which tested the drug in early PD without oral levodopa and as an add-on to levodopa in patients with motor fluctuations.¹

Approval Covers Adults With Parkinsos Disease

Juvmo is a prescription medicine for the treatment of PD in adults. It is not known whether the drug is safe and effective in children, according to AbbiVe. Patients take it once daily, with or without levodopa. It comes in 5 mg, 10 mg, and 15 mg tablets, plus 0.25 mg and 1 mg tablets supplied in a titration pack.¹

"The approval of Juvmo marks the first dopaminergic breakthrough for Parkinson disease in decades," Roopal Thakkar, MD, executive vice president, research and development, and chief scientific officer of AbbVie, said in a news release. He said clinicians "now have a new treatment option that targets dopamine pathways differently and reduces the difficult tradeoffs associated with D2/D3 selective dopamine agonists."¹

"Each therapy approval is an important milestone in building a diverse treatment pipeline needed to meet the full range of unmet needs across the Parkinson community," Brian Fiske, PhD, chief scientist of The Michael J. Fox Foundation for Parkinson Research, said in the release.¹

Phase 3 Data Cover Early Disease and Motor Fluctuations

The TEMPO program included TEMPO-1 (NCT04201093) and TEMPO-2 (NCT04223193), both monotherapy trials in early PD, and TEMPO-3 (NCT04542499), which evaluated tavapadon as an adjunct to levodopa in adults with motor fluctuations.^1,2

TEMPO-1, published in JAMA Neurology, randomized 529 adults with early PD to fixed once-daily doses of tavapadon, 5 mg or 15 mg, or placebo for 27 weeks. The primary end point was the change from baseline to week 26 in the combined Movement Disorder Society–Unified Parkinson's Disease Rating Scale (MDS-UPDRS) parts 2 and 3 score, where lower scores indicate better function.³

Scores fell by 9.7 points with 5 mg and 10.2 points with 15 mg, while placebo scores rose by 1.8 points (treatment difference, −11.5 points; 95% CI, −13.8 to −9.2; P < .001 for 5 mg; treatment difference, −12.1 points; 95% CI, −14.4 to −9.8; P < .001 for 15 mg).³

AbbVie reported that tavapadon also significantly improved MDS-UPDRS part 2 scores versus placebo in TEMPO-2, a flexible-dose monotherapy trial, at week 26 (0.0 with placebo vs −1.5 with 5-15 mg; P = .0007). For the parts 2 and 3 combined score, the change was −1.2 with placebo and −10.3 with tavapadon (P < .0001).^1,2

In TEMPO-3, 507 adults with PD and motor fluctuations received flexible-dose tavapadon (5 to 15 mg once daily) or placebo alongside stable oral levodopa for 27 weeks. Participants averaged 5.5 hours of daily off time at baseline.⁴

At week 26, daily on time without troublesome dyskinesia rose by a least-squares mean of 1.70 hours with tavapadon and 0.60 hours with placebo (difference, 1.1 hours; 95% CI, 0.6-1.7; P < .001). Daily off time fell by 1.88 hours with tavapadon and 0.93 hours with placebo (difference, −0.94 hours; 95% CI, −1.48 to −0.41; P < .001).⁴

"Now we have a novel therapy that selectively targets D1/D5 receptors, which addresses a longstanding need for innovation and provides health care providers with greater flexibility to tailor treatment to individual patient needs," Hubert Fernandez, MD, professor of neurology at the Cleveland Clinic Lerner College of Medicine and global principal TEMPO trial investigator, said in the release.¹

AbbVie also reported data from the TEMPO-4 (NCT04760769) open-label extension. After 85 weeks, 93% of patients taking Juvmo plus oral levodopa had not increased their levodopa dose (96 of 103), and 94% of those taking tavapadon without levodopa had not started it (257 of 273). The company cited data on file for these figures.^1,3

Adverse Events and Patient Warnings

In TEMPO-3, adverse events (AEs) occurred in 71.7% of patients taking tavapadon and 55.1% of those taking placebo. Most AEs were nonserious (93.2%) and mild to moderate in severity. Nausea (14.3%), dyskinesia (10.0%), and dizziness (7.6%) were the most common with tavapadon, and orthostatic hypotension was reported as an AE in 6.0% of the tavapadon group vs 1.2% of the placebo group. AEs led to discontinuation in 17.1% of patients taking tavapadon and 9.1% of those taking placebo.⁴

TEMPO-1 showed a similar pattern. AEs occurred in 281 of 354 patients (79.4%) in the combined tavapadon groups and 100 of 175 (57.1%) in the placebo group, with nausea (25.4%), headache (16.7%), and dizziness (12.7%) leading the list for tavapadon. AEs led to discontinuation in 18.1% of the tavapadon groups vs 4.0% of the placebo group.³

Events suggestive of impulse control disorders were reported in three tavapadon-treated participants in TEMPO-1 and in six (2.4%) tavapadon-treated vs three (1.2%) placebo-treated participants in TEMPO-3.^3,4

REFERENCES

1. AbbVie. U.S. FDA approves AbbVie's JUVMO (tavapadon) for Parkinson's disease. News release. AbbVie. 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

2. Massaro L. AbbVie announces positive topline results from phase 3 Parkinson's disease monotherapy trial. Drug Topics. September 26, 2024. Accessed September 28, 2026. https://www.drugtopics.com/view/abbvie-announces-positive-topline-results-from-phase-3-parkinson-s-disease-monotherapy-trial

3. Pahwa R, Moro E, Espay AJ, et al. Fixed-Dose Tavapadon for Early Parkinson Disease: A Randomized Clinical Trial. JAMA Neurol. 2026;83(5):452-460. doi:10.1001/jamaneurol.2026.0590

4. Fernandez HH, Isaacson SH, Hauser RA, et al. Tavapadon as Adjunctive Treatment for Parkinson Disease: The TEMPO-3 Randomized Clinical Trial. JAMA Neurol. 2026;83(5):442-451. doi:10.1001/jamaneurol.2026.0577