FDA Approves Tavapadon

The U.S. Food and Drug Administration (FDA) has approved a new medication for Parkinson’s called Tavapadon (brand name JUVMO™). While this is encouraging news, Tavapadon is not currently approved or available in Canada. Here’s what you need to know. 

What is Tavapadon? 

Tavapadon is a once-daily pill, developed by AbbVie, that belongs to a group of medications called dopamine agonists. These medications mimic the effects of dopamine, a brain chemical that helps control movement and is reduced in people living with Parkinson’s. 

Why is this approval notable? 

Unlike most existing dopamine agonists, that target dopamine receptors called D2 and D3, Tavapadon selectively targets dopamine receptors called D1 and D5. Tavapadon is the first medication of its kind to receive FDA approval. This unique approach offers an additional path to managing symptoms medically for people living with Parkinson’s. 

Importantly, Tavapadon helps manage symptoms but has not been shown to slow or stop Parkinson’s progression. 

What evidence supported the FDA approval? 

The approval was supported by three Phase 3 clinical trials, known as TEMPO-1, TEMPO-2 and TEMPO-3, which evaluated Tavapadon at different points in people’s Parkinson’s journey. 

  • TEMPO-1 and TEMPO-2 studied people with early-stage Parkinson’s who were not taking levodopa. Both trials found that Tavapadon improved movement symptoms and the ability to carry out everyday activities. 
  • TEMPO-3 studied people already taking levodopa who experienced periods when their medication was less effective. Adding Tavapadon provided approximately one additional hour each day when symptoms were well controlled, without troublesome involuntary movements. 

Notably, the global TEMPO-1 trial included two Canadian research sites, located in Ottawa and Toronto. The study is now completed and closed to new participants. 

Together, these findings demonstrate the potential of Tavapadon to help manage movement symptoms at different points in the Parkinson’s journey. 

Read the published clinical trial results: TEMPO-1, TEMPO-2 and TEMPO-3. 

What does this approval mean for people living with Parkinson’s in Canada? 

Although the FDA approved Tavapadon on September 25, 2026, this authorization applies only to the United States. AbbVie expects to make the medication available to people in the United States, in October 2026. 

It is not yet clear whether AbbVie will seek approval in Canada or when Tavapadon might become available here. Not all medications approved in the U.S. become available in Canada. This can depend on whether the manufacturer seeks Canadian approval, Health Canada’s review process, and decisions about bringing the medication to the Canadian market. Before a new medication can be prescribed and sold in Canada, it must undergo Health Canada’s regulatory review and receive authorization. 

If you have questions about your medications, speak with your neurologist or health care team.  

Looking ahead 

New treatment approvals are important because they expand the range of options available to people living with Parkinson’s. Even when a medication is not yet available in Canada, these developments help advance Parkinson’s care and may influence future treatment choices. 

Parkinson Canada will continue to monitor developments related to tavapadon and other emerging treatments, including engaging with AbbVie to learn more about the potential for tavapadon to become available in Canada, while advocating for timely access to medications and quality care for people living with Parkinson’s across Canada. 

Further resources 

AbbVie FDA approval announcement 

How Drugs are Reviewed in Canada – Canada.ca