New Parkinson's Medications (2024-2026)

Three new Parkinson's medications were approved by the FDA in 2024-2025: Crexont (extended-release carbidopa/levodopa capsules, August 2024), Vyalev (foscarbidopa/foslevodopa 24-hour subcutaneous infusion, October 2024), and Onapgo (apomorphine subcutaneous infusion, February 2025). A fourth medication, tavapadon (a novel D1/D5 dopamine receptor agonist), is pending FDA approval with a decision expected in Q3 2026.

The treatment landscape for Parkinson's disease is evolving faster than at any point in recent memory. Between August 2024 and February 2025, the FDA approved three new medications — each addressing a different treatment challenge in PD management. A fourth medication, tavapadon, is currently under FDA review. This page provides a detailed overview of each medication: what it does, who it is designed for, how it works, and what patients should know.

Important: All treatment decisions should be made in consultation with your movement disorder specialist. The information below is educational and does not constitute medical advice or a recommendation for any specific medication.

Crexont (Carbidopa/Levodopa Extended-Release Capsules)

FDA Approved: August 2024

Crexont represents a significant advance in the delivery of carbidopa/levodopa — the gold standard treatment for Parkinson's motor symptoms. It is the first oral levodopa formulation to combine both immediate-release and extended-release components in a single capsule.

How It Works

Standard immediate-release carbidopa/levodopa (Sinemet) has a relatively short duration of action — typically 3 to 5 hours — which means many patients must take multiple doses throughout the day. As the disease progresses, the therapeutic window narrows and patients experience motor fluctuations: periods when the medication is working (“on” time) alternating with periods when it wears off (“off” time).

Crexont's dual-layer design addresses this by providing an initial burst of levodopa for rapid symptom relief, followed by a gradual extended release that sustains therapeutic levels for a longer period. This can potentially reduce motor fluctuations and the number of daily doses needed.

Who It Is For

• People with Parkinson's disease at any stage who take oral carbidopa/levodopa
• Patients who experience wearing-off between doses of immediate-release levodopa
• People who want to reduce the number of daily medication doses

What Patients Should Know

• Crexont capsules can be swallowed whole or opened and sprinkled on soft food for people who have difficulty swallowing — an important feature for PD patients with dysphagia.
• The most common side effects are similar to other levodopa formulations: nausea, dizziness, headache, and dyskinesia (involuntary movements).
• Switching from another levodopa formulation to Crexont requires careful dose adjustment with your neurologist. Do not attempt to switch on your own.
• Insurance coverage may vary. If cost is a concern, the manufacturer may offer a patient assistance program.

Vyalev (Foscarbidopa/Foslevodopa Subcutaneous Infusion)

FDA Approved: October 2024

Vyalev is the first FDA-approved subcutaneous 24-hour continuous infusion of carbidopa and levodopa. It represents a new delivery method designed for people with advanced Parkinson's disease who experience significant motor fluctuations despite optimized oral medication.

How It Works

Vyalev delivers foscarbidopa and foslevodopa — prodrugs that are converted to carbidopa and levodopa in the body — through a small pump worn on the body connected to a subcutaneous (under-the-skin) infusion site. Because the medication is delivered continuously over 24 hours, it maintains more stable levodopa levels in the blood than oral dosing, which produces peaks and troughs with each dose.

Stable levodopa levels translate to more consistent motor control — reducing both the unpredictable “off” time when medication wears off and the dyskinesia that can occur at peak medication levels.

Who It Is For

• People with advanced Parkinson's disease who have motor fluctuations not adequately controlled by oral medications
• Patients who may have considered intestinal levodopa gel infusion (Duopa) but prefer a less invasive delivery method (subcutaneous vs. surgically placed intestinal tube)
• Patients who are not candidates for deep brain stimulation or who prefer a non-surgical option

What Patients Should Know

• Vyalev requires a portable infusion pump and subcutaneous infusion set. Training in pump operation and infusion site management is provided by healthcare professionals.
• The infusion site must be changed every three days. Common infusion site reactions include nodules, redness, bruising, and inflammation.
• Oral levodopa may still be needed in some situations (for example, if the pump is temporarily disconnected).
• The pump is worn outside the body (similar to an insulin pump) and can be concealed under clothing.
• This is a prescription device that requires coordination between your neurologist and a specialty pharmacy. Your neurologist can determine whether you are a candidate.

Onapgo (Apomorphine Hydrochloride Subcutaneous Infusion)

FDA Approved: February 4, 2025

Onapgo is the first subcutaneous infusion-based apomorphine therapy approved in the United States. Apomorphine is a potent dopamine agonist that has been used for decades to treat “off” episodes in Parkinson's disease, previously available only as an injection (APOKYN) or sublingual film (Kynmobi). Onapgo provides continuous subcutaneous delivery.

How It Works

Apomorphine directly stimulates dopamine receptors (both D1 and D2 subtypes) without requiring conversion by dopaminergic neurons — meaning it works even as the number of dopamine-producing neurons continues to decline. As a continuous infusion, Onapgo provides more stable dopamine receptor stimulation than intermittent injections, potentially reducing the frequency and severity of “off” episodes.

Who It Is For

• People with advancing Parkinson's disease who experience “off” episodes and motor fluctuations
• Patients who need rescue therapy for unpredictable off periods
• Patients who require an alternative to oral levodopa adjustments for motor fluctuation control

What Patients Should Know

• Like Vyalev, Onapgo requires a portable pump and subcutaneous infusion set. It requires training in pump operation.
• An anti-nausea medication (trimethobenzamide) is typically started several days before beginning Onapgo to prevent the nausea that is common with apomorphine. This pre-treatment is essential.
• Common side effects include nausea, injection site reactions, yawning, drowsiness, and dizziness. Hallucinations and impulse control disorders can occur with dopamine agonists.
• Apomorphine must not be used with ondansetron (Zofran) or other 5-HT3 antagonist anti-nausea medications, as the combination can cause severe hypotension and loss of consciousness.
• Onapgo is typically used in conjunction with oral levodopa, not as a replacement for it.

Tavapadon (Pending FDA Approval)

NDA Submitted: September 26, 2025 | FDA Decision Expected: Q3 2026

Tavapadon is a novel oral, once-daily medication that represents a fundamentally new approach to dopamine receptor agonism. Unlike existing dopamine agonists — which primarily target D2 and D3 receptors — tavapadon is a selective partial agonist at D1 and D5 receptors.

How It Differs from Existing Dopamine Agonists

The distinction between D1/D5 and D2/D3 receptor targeting is potentially important:

• D2/D3 agonists (pramipexole, ropinirole, rotigotine) are effective for motor symptoms but carry significant risks of impulse control disorders (compulsive gambling, shopping, eating, sexual behavior), hallucinations, and excessive daytime sleepiness. These side effects limit their use, particularly in older patients and those with cognitive impairment.
• D1/D5 receptors play a different role in motor circuit function. Tavapadon's selective targeting of these receptors may provide motor benefit with a different side effect profile. As a partial agonist, it stimulates the receptor enough to provide therapeutic benefit but not enough to cause overstimulation.

Clinical Trial Results

The NDA submission is based on positive results from the Phase 3 TEMPO clinical trial program, which evaluated tavapadon as both a monotherapy (for early PD) and as an adjunctive therapy (added to levodopa for patients with motor fluctuations):

• As monotherapy: Statistically significant improvement on the MDS-UPDRS Part II (motor experiences of daily living) and Part III (motor examination) compared to placebo.
• As adjunct to levodopa: Significant increase in “on” time without troublesome dyskinesia and reduction in “off” time.
• Long-term safety: Open-label extension data showed a favorable long-term safety and tolerability profile.
• Convenience: Once-daily oral dosing.

What Patients Should Know

• Tavapadon is not yet approved. If the FDA grants approval, it would become available by prescription, likely in the second half of 2026.
• If approved, it would be the first new oral dopamine agonist for Parkinson's disease in over a decade.
• It may offer an option for patients who cannot tolerate existing dopamine agonists or who need an adjunctive therapy to levodopa.
• As with all new medications, post-marketing surveillance will be important for identifying rare side effects not captured in clinical trials.

Adaptive Deep Brain Stimulation (aDBS)

While not a medication, adaptive DBS represents a significant recent advance in Parkinson's treatment technology. Conventional DBS delivers constant electrical stimulation to brain targets. Adaptive DBS uses real-time brain signal monitoring to adjust stimulation intensity based on the patient's current state — increasing stimulation when symptoms worsen and decreasing it when the patient is doing well.

Early clinical data show that adaptive DBS yields approximately 35 percent greater motor improvement than conventional DBS, with gait showing the most consistent benefits. Five-year outcome data for conventional DBS published in JAMA Neurology (2025) demonstrated sustained motor improvements, medication reduction, and dyskinesia suppression.

Comparing the New Options

*Tavapadon is not yet FDA-approved. Approval is pending.

What This Means for Patients

The approval of three new medications in six months — and a fourth pending — is a significant moment for the Parkinson's community. These medications do not cure Parkinson's disease and do not slow its underlying progression. They are symptomatic treatments that provide new options for managing motor symptoms and motor fluctuations. However, more options mean more ability to tailor treatment to individual needs:

• If you are currently well-controlled on existing medications, there may be no reason to switch. These new options are most relevant for people whose current treatment is not providing adequate symptom control.
• If you are experiencing motor fluctuations or wearing-off with your current regimen, ask your movement disorder specialist whether any of these new options might be appropriate for you.
• New medications are typically more expensive than established generics. Discuss cost, insurance coverage, and patient assistance programs with your pharmacy and neurologist.
• No medication should be started, stopped, or changed without the guidance of your neurologist. Parkinson's medication management requires careful titration and monitoring.

Parkinson's Foundation Helpline: 1-800-4PD-INFO (1-800-473-4636), Monday through Friday, 9 AM to 7 PM ET. Specialists can help with medication questions and insurance navigation.