Juvmo

Juvmo is a once-daily tablet used to treat Parkinson's disease (PD) in adults. It belongs to a group of medicines called dopamine agonists, which work like dopamine, a natural chemical messenger in the brain.

Juvmo partly activates two types of dopamine receptors, called D1 and D5. This makes it different from other dopamine agonists, such as pramipexole and ropinirole, which work mainly on D2 and D3 receptors.

Juvmo (tavapadon) received FDA approval on September 28, 2026, and is approved for use as monotherapy in early Parkinson's disease (without oral levodopa) or alongside oral levodopa for patients experiencing motor fluctuations.

Juvmo led to statistically significant improvements compared with placebo in three 27-week clinical trials in adults with Parkinson's disease, in people taking it with or without levodopa.

In people not taking levodopa (Studies 1 and 2), Juvmo improved activities of daily living scores on the MDS-UPDRS Part II scale, where a lower score indicates improvement. In people taking levodopa (Study 3), Juvmo added about 1.1 hours a day of "ON" time without troublesome dyskinesia (uncontrolled movements) and reduced "OFF" time by about 0.9 hours a day, compared with placebo.

It is not known if Juvmo is safe and effective in children.

Take Juvmo exactly as your healthcare provider tells you to. Your healthcare provider may change your dose if needed.

When you first start Juvmo, your healthcare provider will prescribe a titration pack. This gives you the right doses to increase gradually, following the recommended schedule, up to the usual maintenance dose of 5 mg.

• Take Juvmo once a day by mouth with or without food.
• If you miss a dose of Juvmo, take it as soon as you remember on the same day, but do not take 2 doses at one time. If you do not remember until the following day, skip the missed dose and take Juvmo at your regular time.
• If you take too much Juvmo, call your healthcare provider or go to the nearest hospital emergency room right away.

Before taking Juvmo, tell your healthcare provider about all your medical conditions, including if you:

• have low blood pressure (hypotension), or if your blood pressure decreases when standing (orthostatic hypotension)
• have or have had unusual urges such as problems with gambling, compulsive eating, compulsive shopping, and increased sex drive
• have a mental health problem, such as psychosis
• have seen or have been seeing things that are not there, hearing sounds, or feeling sensations that are not real (hallucinations)
• have trouble controlling your muscles (dyskinesia)
• are pregnant or plan to become pregnant. It is not known if Juvmo will harm your unborn baby
• are breastfeeding or plan to breastfeed. It is not known if Juvmo passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Juvmo

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicine, vitamins, and herbal supplements.

Serious side effects

Juvmo may cause serious side effects, including:

• low blood pressure. This is a common side effect and may be serious. Juvmo can lower your blood pressure and make you feel dizzy, especially when you stand up (orthostatic hypotension). To help avoid this, do not get up too fast from sitting or after lying down. You may be more likely to feel dizzy after starting Juvmo or when your dose is increased.
• unusual urges. Some people taking certain medicines to treat PD, including Juvmo, have had unusual urges. This may include gambling, compulsive eating, compulsive shopping, and increased sex drive. If you or your family members notice that you are having unusual urges or behaviors, talk to your healthcare provider.
• seeing things that are not there, hearing sounds, or feeling sensations that are not real (hallucinations). This is a common side effect and may be serious. Hallucinations can happen in people who use Juvmo. Tell your healthcare provider if you have hallucinations.
• uncontrolled sudden movements (dyskinesia). This is a common side effect and may be serious. If you have new dyskinesia, or your dyskinesia gets worse, tell your healthcare provider. This may be a sign that your dose of Juvmo or other medicines to control your PD may need to be adjusted.

Common side effects

The most common side effects of Juvmo include:

• nausea
• headache
• change in taste
• feeling tired (fatigue)
• vomiting
• dry mouth
• anxiety.

Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Juvmo. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

The table below shows how often common side effects were reported in clinical studies of Juvmo, in people not taking levodopa (Studies 1 and 2) and in people taking Juvmo with levodopa (Study 3).

A dash (-) means the side effect was not listed for that group in the prescribing information.

Other side effects reported in 3% to 4% of people taking Juvmo included indigestion (dyspepsia), abnormal dreams, gastroesophageal reflux disease, constipation, abdominal pain, and weakness (asthenia).

Side effects led 20% of people taking Juvmo without levodopa and 17% of people taking Juvmo with levodopa to stop treatment. Most of these people stopped during the period when the dose was being increased.

Juvmo contains tavapadon, a non-ergot dopamine agonist. Tavapadon is a selective partial agonist at the dopamine D1 and D5 receptors. This means it attaches to and activates these receptors, which are normally activated by dopamine, a chemical messenger in the brain. As a partial agonist, it produces a smaller response at these receptors than a full agonist.

Other dopamine agonists used for Parkinson's disease, such as pramipexole and ropinirole, act mainly on dopamine D2 and D3 receptors.

Tavapadon has an average elimination half-life of about 25.5 hours, and Juvmo is taken once a day.

* Dose and titration should be guided by tolerability and clinical response. If required, longer intervals between dose adjustment can be used.

• Do not change your body position too fast. Get up slowly from sitting or lying down. Juvmo can lower your blood pressure, which can cause nausea, sweating, dizziness, falling, or fainting when you stand up too quickly.

Tell your healthcare provider about all the medicines you take, including over-the-counter medicines, dietary supplements, and herbal products such as St. John's Wort, and tell them if you start or stop any medicine. Juvmo and certain other medicines may affect each other and how they work. Tavapadon is broken down in the body by the liver enzyme CYP3A, so medicines that affect this enzyme can change the amount of Juvmo in your blood:

• Strong or moderate CYP3A inhibitors (such as itraconazole and fluconazole) increase Juvmo levels and may increase the risk of side effects, including hallucinations. They should be avoided while the Juvmo dose is being increased. If one is started during maintenance treatment, Juvmo is taken less often: every 7 days with a strong inhibitor or every 3 days with a moderate inhibitor.
• Strong CYP3A inducers (such as carbamazepine) lower Juvmo levels and are not recommended with Juvmo.
• Moderate CYP3A inducers (such as efavirenz) lower Juvmo levels, so Juvmo may need to be taken twice or three times daily.

Juvmo can also affect other medicines. It may lower the levels of medicines broken down by CYP3A, and raise the levels of medicines broken down by CYP2C8 or carried by the BCRP transporter.

Know the medicines you take. Keep a list of them and show your healthcare provider and pharmacist when you get a new medicine.

• Store Juvmo at room temperature between 68°F and 77°F (20°C to 25°C).

Keep Juvmo and all medicines out of the reach of children.

Active ingredient: tavapadon

Inactive ingredients:

0.25 mg and 1 mg tablets contain: lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, red iron oxide, sodium starch glycolate, talc, titanium dioxide, and yellow iron oxide.

5 mg, 10 mg, and 15 mg tablets contain: carmine, FD&C Blue No. 2, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, talc and titanium dioxide.