The newest FDA-approved treatments for Parkinson’s disease are two advanced delivery systems that reached the market in late 2024 and early 2025: Vyalev, a continuous under-the-skin infusion of levodopa and carbidopa approved in October 2024, and Onapgo, a continuous under-the-skin infusion of apomorphine approved in February 2025. Both target advanced Parkinson’s, where oral medications no longer provide smooth symptom control throughout the day. Beyond these approvals, several experimental therapies in clinical trials are attempting something no current treatment can do: slow or stop the disease itself.
Vyalev: 24-Hour Levodopa Delivery
Vyalev is the first subcutaneous 24-hour continuous infusion of a levodopa-based therapy to receive FDA approval. It delivers a steady stream of levodopa and carbidopa (the gold-standard Parkinson’s combination) through a small wearable pump placed just under the skin, rather than through pills taken several times a day. The target population is people with advanced Parkinson’s who experience motor fluctuations, those unpredictable swings between periods when medication is working (“on” time) and periods when it wears off (“off” time).
In clinical trials, people using Vyalev had significantly more “on” time without troublesome involuntary movements compared to those taking standard oral levodopa. The treatment is started in a healthcare provider’s office, where the pump and dosing are set up, and then worn continuously at home. For people whose symptoms have become difficult to manage with pills alone, this represents a major shift: instead of peaks and valleys in medication levels throughout the day, the pump aims to keep drug levels steady.
Onapgo: Continuous Apomorphine Infusion
Approved in February 2025, Onapgo delivers apomorphine hydrochloride continuously under the skin for advanced Parkinson’s disease. Apomorphine itself isn’t new. It’s been available as an on-demand injection for years, used as a “rescue” treatment when oral medications suddenly stop working. What’s new is the continuous delivery method, which provides a steadier supply of the drug rather than a single quick dose. This approach is designed for people who need more consistent symptom control than intermittent injections or oral medications can provide.
Crexont: A Better Oral Levodopa
For people who aren’t yet at the advanced stage requiring a pump, Crexont (approved in 2023) represents the newest improvement to the standard oral pill. It’s an extended-release capsule of carbidopa and levodopa that maintains therapeutic blood levels for about 6 to 7 hours after an initial peak at roughly one hour. The key advantage is smoother drug levels. In pharmacokinetic testing, the fluctuation between peak and trough blood levels was approximately 1.7 with Crexont, compared to 2.7 with standard immediate-release pills. That tighter range means fewer of the wearing-off dips that cause symptoms to break through between doses.
Focused Ultrasound for Tremor-Dominant Parkinson’s
Focused ultrasound is an FDA-approved, incision-free procedure for people whose primary Parkinson’s symptom is tremor that hasn’t responded to medication. Using MRI guidance, concentrated sound waves create a tiny, precise lesion in the brain area responsible for tremor. There’s no surgery in the traditional sense: no cutting, no implanted hardware, and no general anesthesia. You must be at least 30 years old with a confirmed diagnosis of tremor-dominant Parkinson’s, and your tremor needs to be limiting daily activities despite medication.
This option doesn’t help with slowness, stiffness, or other non-tremor symptoms, so it’s not appropriate for everyone. But for the subset of people whose lives are primarily disrupted by shaking, it offers meaningful relief without the risks of open brain surgery.
Diabetes Drugs That May Slow Progression
Every treatment above manages symptoms. None slows the underlying loss of dopamine-producing brain cells. That’s what makes a class of diabetes drugs called GLP-1 receptor agonists so noteworthy. In a phase 2 trial published in the New England Journal of Medicine, participants with early Parkinson’s disease who received lixisenatide (a GLP-1 drug) showed less motor decline over 12 months compared to placebo. After a two-month washout period where everyone stopped taking the drug, the lixisenatide group still had better motor scores (17.7 points on a standard motor scale vs. 20.6 for placebo), suggesting the benefit wasn’t just masking symptoms but reflected a genuine slowing of disease progression.
The trial was small and short, and lixisenatide did cause gastrointestinal side effects like nausea. Larger, longer trials are underway. But these results are significant because they represent one of the first credible signals that a drug might actually modify the course of Parkinson’s, not just treat its symptoms.
Antibodies Targeting the Disease’s Root Cause
Parkinson’s disease is driven in large part by the buildup of a misfolded protein called alpha-synuclein in the brain. Prasinezumab is an antibody designed to bind to this protein and help the body clear it. In the phase 2 PASADENA study, the drug didn’t meet its overall primary endpoint, but a closer look at the data revealed something interesting: among people whose disease was progressing rapidly, prasinezumab significantly slowed the worsening of motor symptoms. This suggests the drug may work best in people with more aggressive disease, where there’s more abnormal protein to target. Larger trials are testing this idea.
Stem Cell Transplants Enter Human Testing
The STEM-PD trial, a first-in-human study in Europe, is testing whether dopamine-producing cells grown from human embryonic stem cells can be transplanted into the brains of people with moderate Parkinson’s disease. The concept is straightforward: replace the brain cells that the disease destroys. The first patient received a transplant in February 2023, and the final participant was grafted in October 2024. Eight people total are enrolled in two groups receiving different cell doses, with the primary goal right now being safety, specifically confirming that the transplanted cells don’t form abnormal growths or cause other serious complications over 12 months.
This is very early-stage work. Even if the results are positive, stem cell therapy for Parkinson’s is likely years away from widespread availability. But the trial crossing from laboratory into living patients marks a significant milestone for an approach that scientists have been working toward for decades.
Gene-Targeted Therapies for Specific Mutations
Not all Parkinson’s disease is the same at the molecular level, and a new wave of treatments targets specific genetic subtypes. Two approaches are furthest along.
The first focuses on people with mutations in the LRRK2 gene, one of the most common genetic causes of Parkinson’s. BIIB122 is a drug designed to block the overactive LRRK2 protein. Phase 1 trials in healthy participants and people with mild to moderate Parkinson’s have been completed, establishing that the drug penetrates the brain and is well tolerated over 28 days. It’s now in larger trials testing whether it can slow disease progression in LRRK2 carriers.
The second targets mutations in the GBA1 gene, which reduce the activity of a cellular cleanup enzyme. A drug called LTI-291 (also known as BIA 28-6156) activates this enzyme. In a phase 1B trial, 28 days of oral treatment was well tolerated, reached drug levels in the cerebrospinal fluid considered high enough to at least double the enzyme’s activity, and showed measurable biological changes in participants’ blood cells. Longer trials will determine whether restoring this enzyme activity translates into clinical benefit.
These gene-targeted approaches matter because they treat the specific biological malfunction causing disease in a defined group of patients, rather than applying a one-size-fits-all approach. Genetic testing can identify who carries these mutations, making it possible to match patients to the therapy most likely to help them.