Tavapadon Sets Development Benchmark for Parkinson's

The FDA has approved AbbVie's JUVMO (tavapadon), as the first and only selective D1/D5 receptor agonist for adults with Parkinson's disease.1 The once-daily oral tablet can be taken with or without levodopa.

Currently available dopamine agonists primarily act on D2/D3 receptors, and their use can be limited by tolerability.1 Tavapadon instead selectively targets D1/D5 receptors, giving clinicians a mechanistically distinct option across the disease continuum, from early Parkinson's through the later stage when patients experience motor fluctuations.

"The approval of JUVMO marks the first dopaminergic breakthrough for Parkinson's disease in decades," said Roopal Thakkar, MD, executive vice president, research and development, chief scientific officer, AbbVie, in a press release.1 "People living with Parkinson's and the clinicians who care for them have long faced difficult tradeoffs between motor control, treatment burden and tolerability. Clinicians now have a new treatment option that targets dopamine pathways differently and reduces the difficult tradeoffs associated with D2/D3 selective dopamine agonists."

What Did the Phase III Program Show?

The approval rests on the phase III TEMPO program.1 TEMPO-1 and TEMPO-2 enrolled people with early Parkinson's disease who were not taking levodopa, while TEMPO-3 evaluated tavapadon as an add-on in patients with motor fluctuations.

In TEMPO-1, both the 5 mg and 15 mg doses significantly improved activities of daily living scores at week 26 compared with placebo (−1.6 and −1.7 versus +0.9). TEMPO-2 showed a similar benefit with flexible dosing (−1.5 versus 0.0).1 In TEMPO-3, tavapadon plus levodopa increased daily on time without troublesome dyskinesia by 1.7 hours, compared with 0.6 hours for placebo plus levodopa, and reduced "off" time by 1.9 hours versus 0.9 hours.

In the open-label extension, 93% of participants on tavapadon plus levodopa had not increased their levodopa dose after 85 weeks, and 94% of those on tavapadon alone had not started levodopa.1 A marked improvement considering roughly 70% of patients have their oral levodopa dose increased within the first year of therapy. Most adverse events were mild or moderate. Nausea, headache, and dizziness were common, and the label warns of low blood pressure on standing, hallucinations, dyskinesia, and impulse-control urges.

"Parkinson's disease treatment has long required health care providers to balance the need for dependable motor symptom control with considerations around treatment tolerability," said Hubert Fernandez, MD, global principal TEMPO trial investigator, in the press release.1 "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."

How Did Abbvie Build the Regulatory Package?

AbbVie submitted its new drug application in September 2025, roughly a year before the approval decision.2 The filing drew on three placebo-controlled, 27-week trials enrolling 1,340 adults aged 40 to 80. Both early-disease studies were limited to patients diagnosed within the previous three years, and participants could remain on a monoamine oxidase B inhibitor. The adjunctive study required a stable levodopa dose for at least four weeks before screening and relied on patient-completed home diaries to measure motor function. The submission also incorporated an interim data cut from the ongoing open-label extension, supporting long-term safety evidence without awaiting results.

What is the Significance of this Approval?

The approval is a return on a major neuroscience bet.1 Tavapadon came to AbbVie through its acquisition of Cerevel Therapeutics. The deal was valued at $8.7 billion, and AbbVie recorded a $4.5 billion impairment charge related to emraclidine, the schizophrenia candidate that anchored the transaction. With tavapadon approved, the Parkinson's asset now carries much of the deal's commercial rationale.

The product is launching in five strengths: 5 mg, 10 mg, and 15 mg tablets, plus 0.25 mg and 1 mg tablets in a titration pack.1 Moving from approval to commercial availability within weeks points to validated oral solid dose processes and launch inventory built ahead of the decision, while the titration pack adds packaging and serialization complexity that single-strength launches avoid.

The approval also contrasts with AbbVie's previous Parkinson's launch. In 2024, the first subcutaneous, 24-hour infusion of levodopa-based therapy for motor fluctuations in the US.1 That product carries the sterile manufacturing and device considerations of an infused therapy. A once-daily tablet offers a far simpler route to broad patient access.

References

1. 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
2. AbbVie. AbbVie submits new drug application to U.S. FDA for tavapadon for the treatment of Parkinson’s disease. Published September 26, 2025. Accessed September 28, 2026. https://news.abbvie.com/2025-09-26-AbbVie-Submits-New-Drug-Application-to-U-S-FDA-for-Tavapadon-for-the-Treatment-of-Parkinsons-Disease