AbbVie JUVMO (tavapadon) has won U.S. Food and Drug Administration approval for adults with Parkinson’s disease, AbbVie (NYSE: ABBV) announced on Sept. 28, 2026, from North Chicago, Illinois. The company says the tablet is the first and only selective D1/D5 receptor agonist approved for the condition, a progressive neurological disorder that affects millions of people worldwide.
According to AbbVie, the once-daily medicine can be taken with or without levodopa therapy and offers a differentiated approach to motor symptom control across the Parkinson’s disease continuum. The approval is supported by the Phase 3 TEMPO program, which the company says showed significant improvements in daily functioning, increased “on” time without troublesome dyskinesia and a favorable safety profile.
AbbVie expects to make the medicine available to patients in the U.S. in October 2026. That availability timeline is a forward-looking statement, and the company has not disclosed a launch date, list price or coverage details in its announcement.
Roopal Thakkar, M.D., AbbVie’s executive vice president of research and development and chief scientific officer, called the decision the “first dopaminergic breakthrough for Parkinson’s disease in decades.” He said people living with Parkinson’s and their clinicians have long faced difficult trade-offs among motor control, treatment burden and tolerability, and that AbbVie JUVMO gives prescribers a new option.
AbbVie JUVMO Targets D1/D5 Receptors Instead of the D2/D3 Pathway
Thakkar said the therapy targets dopamine pathways differently and reduces the difficult trade-offs associated with D2/D3 selective dopamine agonists. AbbVie explains that currently available dopamine agonists primarily target D2/D3 receptors and that tolerability concerns may limit their use. By selectively targeting D1/D5 receptors, AbbVie JUVMO gives health care providers and patients a new route to managing motor symptoms.
Table 1: JUVMO (tavapadon) approval snapshot, per AbbVie news release dated Sept. 28, 2026
| Attribute | Detail |
|---|---|
| Company | AbbVie Inc. (NYSE: ABBV), North Chicago, Illinois |
| Product | JUVMO (tavapadon) tablets |
| Regulator | U.S. Food and Drug Administration (FDA) |
| Announcement date | Sept. 28, 2026 |
| Indication | Treatment of Parkinson’s disease in adults |
| Mechanism | Selective D1/D5 receptor agonist |
| Dosing frequency | Once daily, with or without levodopa |
| Tablet strengths | 5 mg, 10 mg, 15 mg; Titration Pack with 0.25 mg and 1 mg tablets |
| Pediatric use | Not known if safe and effective in children |
| Expected U.S. availability | October 2026 (forward-looking) |
| Price | Not disclosed |
| Pivotal program | Phase 3 TEMPO (TEMPO-1, TEMPO-2, TEMPO-3; open-label extension TEMPO-4) |
Hubert Fernandez, M.D., a professor of neurology at the Cleveland Clinic Lerner College of Medicine and global principal TEMPO trial investigator, said clinicians have long needed to balance dependable motor symptom control against tolerability. In his view, a novel therapy that selectively targets D1/D5 receptors answers a longstanding need for innovation and gives providers more flexibility to tailor treatment to individual patients.
Brian Fiske, PhD, chief scientist of The Michael J. Fox Foundation for Parkinson’s Research, said progress for people with Parkinson’s and their families means options that deliver meaningful benefit in everyday life. He described each therapy approval as a milestone toward the diverse treatment pipeline needed to meet the full range of unmet needs, a perspective that places AbbVie JUVMO within a wider community effort.
Why AbbVie JUVMO Matters as Oral Levodopa Doses Rise Over Time
Oral levodopa remains the foundation of Parkinson’s treatment and is often effective at controlling symptoms, AbbVie notes, but many patients need higher and more frequent doses as the disease progresses. Those adjustments can restore symptom control yet may contribute to treatment-related complications such as dyskinesia. AbbVie cites data on file indicating that about 70% of people with Parkinson’s disease have their oral levodopa dose increased within the first year of therapy.
Long-term extension data add context. After 85 weeks on AbbVie JUVMO, 93% of clinical trial participants had not increased their oral levodopa dose, and 94% of participants with early Parkinson’s disease had not started oral levodopa. The release attributes these figures to company data on file, so peer-reviewed confirmation of the 85-week findings is not included in the announcement.
Table 2: Parkinson’s disease context and levodopa data cited by AbbVie
| Metric | Figure | Source cited in release |
|---|---|---|
| People living with Parkinson’s disease worldwide | More than 11 million | Luo et al., Frontiers in Aging Neuroscience, 2025 (Global Burden of Disease Study 2021) |
| Patients whose oral levodopa dose rises in first year | About 70% | AbbVie data on file |
| Dopamine-producing cells lost when motor symptoms begin | Approximately 60-80% | NINDS, Hope Through Research |
| Participants on JUVMO plus levodopa with no dose increase at 85 weeks | 93% (96/103) | AbbVie data on file (TEMPO-4) |
| Participants on JUVMO alone who did not start levodopa at 85 weeks | 94% (257/273) | AbbVie data on file (TEMPO-4) |
Parkinson’s disease is characterized by tremor, muscle rigidity, slowness of movement and difficulty with balance, according to the Michael J. Fox Foundation material AbbVie cites. The company adds that more than 11 million people live with the condition worldwide.
As the disease advances, patients may move from an “on” state, when symptoms are generally well controlled, to an “off” state in which tremor and stiffness can return. Later-stage patients may also develop dyskinesia, involuntary movements that can significantly hinder daily activities. These complications form the clinical backdrop against which AbbVie JUVMO was studied, particularly in TEMPO-3, which examined people already experiencing motor fluctuations.
AbbVie JUVMO Phase 3 TEMPO Results Behind the FDA Decision
The TEMPO program evaluated AbbVie JUVMO in people with early Parkinson’s disease who were not taking oral levodopa (TEMPO-1 and TEMPO-2) and as an add-on to oral levodopa in people experiencing motor fluctuations (TEMPO-3).
In TEMPO-1 at week 26, the medicine significantly improved activities of daily living scores versus placebo, measured by MDS-UPDRS Part II, which covers everyday tasks such as dressing, eating and personal hygiene. Scores changed by +0.9 points with placebo, -1.6 with the 5 mg dose and -1.7 with the 15 mg dose (p < 0.0001 for each dose). Against baseline, AbbVie JUVMO improved scores by 22-23%, while the placebo group worsened by 12%. On the combined Part II plus Part III measure, placebo moved +1.8 points versus -9.7 for 5 mg and -10.2 for 15 mg (p < 0.0001).
Table 3: TEMPO program efficacy results at week 26 unless noted, per AbbVie release
| Trial | Population | Endpoint | Placebo | JUVMO | p-value |
|---|---|---|---|---|---|
| TEMPO-1 | Early PD, no oral levodopa | MDS-UPDRS Part II change | +0.9 | 5 mg: -1.6; 15 mg: -1.7 | <0.0001 each dose |
| TEMPO-1 | Early PD, no oral levodopa | MDS-UPDRS Part II + III change | +1.8 | 5 mg: -9.7; 15 mg: -10.2 | <0.0001 each dose |
| TEMPO-2 | Early PD, no oral levodopa | MDS-UPDRS Part II change | 0.0 | 5-15 mg: -1.5 | 0.0007 |
| TEMPO-2 | Early PD, no oral levodopa | MDS-UPDRS Part II + III change | -1.2 | 5-15 mg: -10.3 | <0.0001 |
| TEMPO-3 | PD with motor fluctuations, adjunct to levodopa | Gain in daily “on” time without troublesome dyskinesia | 0.6 hours | 1.7 hours | <0.0001 |
| TEMPO-3 | PD with motor fluctuations, adjunct to levodopa | Reduction in total daily “off” time | 0.9 hours | 1.9 hours | 0.0006 |
| TEMPO-4 (open-label, 85 weeks) | Continuing participants | No levodopa increase / no levodopa start | Not applicable | 93% (96/103) / 94% (257/273) | Not disclosed |
TEMPO-2 pointed in the same direction. At week 26, participants receiving 5-15 mg of AbbVie JUVMO showed a significantly greater improvement in MDS-UPDRS Part II scores than placebo (0.0 for placebo versus -1.5; p = 0.0007). On the combined Part II plus Part III measure, placebo moved -1.2 points while the treated group moved -10.3 (p < 0.0001). The Lancet Neurology title describes the study as a phase 3, randomised, placebo-controlled, double-blind trial of flexible-dose tavapadon.
In TEMPO-3, people with motor fluctuations who added 5-15 mg of AbbVie JUVMO to oral levodopa gained 1.7 hours of total daily “on” time without troublesome dyskinesia at week 26, compared with 0.6 hours for placebo plus levodopa (p < 0.0001). Total daily “off” time fell by 1.9 hours with the combination versus 0.9 hours with placebo (p = 0.0006). AbbVie reports sustained efficacy through 85 weeks for participants who continued into the open-label TEMPO-4 extension. Enrollment sizes for the individual TEMPO studies are not disclosed in the release.
AbbVie JUVMO Safety Information, Availability and Outlook
AbbVie states that most treatment-emergent adverse events (TEAEs) seen with AbbVie JUVMO in the trials were non-serious and mild or moderate in severity. Among patients taking the medicine without oral levodopa, events reported in at least 5% included nausea, headache, dizziness, fatigue, dysgeusia, vomiting, dry mouth and anxiety. When combined with levodopa, the most common events were nausea, dyskinesia, dizziness, headache, hallucinations and orthostatic hypotension.
Table 4: JUVMO safety and access information, per AbbVie release
| Category | Detail |
|---|---|
| Overall TEAE profile in trials | Majority non-serious, mild or moderate |
| TEAEs at 5% or more, without oral levodopa | Nausea, headache, dizziness, fatigue, dysgeusia, vomiting, dry mouth, anxiety |
| TEAEs at 5% or more, with oral levodopa | Nausea, dyskinesia, dizziness, headache, hallucinations, orthostatic hypotension |
| Warnings in Important Safety Information | Low blood pressure; unusual urges (gambling, compulsive eating, compulsive shopping, increased sex drive); hallucinations; dyskinesia |
| Most common side effects (patient information) | Nausea, headache, change in taste, fatigue, vomiting, dry mouth, anxiety |
| Side effect reporting | FDA MedWatch or 1-800-FDA-1088 |
| Patient access support | AbbVie.com/PatientAccessSupport |
| Serious adverse event and discontinuation rates | Not disclosed |
The Important Safety Information lists four concerns to raise with a health care provider before and during treatment: low blood pressure that can cause dizziness on standing, unusual urges, hallucinations and dyskinesia. Patients are told to report new or worsening dyskinesia because it may signal that the dose of AbbVie JUVMO or other Parkinson’s medicines needs adjusting. It is not known whether the medicine is safe and effective in children.
AbbVie says its neuroscience portfolio spans psychiatry, migraine and pain, movement disorders and neurodegeneration, an area that includes Parkinson’s disease.
