New treatments on the Horizon for Parkinson’s
Two new therapies are entering the final stages of clinical trials before potential FDA approval. One is a novel dopamine-based therapy for motor symptom management, and the other is a stem cell therapy poised to replace the lost brain cells of Parkinson’s disease (PD). Together, they represent two very different but complementary paths forward in the fight against PD.
Bringing a new medication or therapy to the market never happens as fast as we’d like, but these two potential therapies are important indicators of significant progress when it comes to PD therapy research.
Tavapadon: A Next-Generation Dopamine Therapy
The pharmaceutical company AbbVie recently announced that it has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for tavapadon, a once-daily pill designed to help manage PD symptoms such as stiffness, tremor, and slowness of movement.
Tavapadon shows fewer side effects than existing medication
Dopamine is the chemical messenger in the brain most affected in PD. A class of PD drugs called dopamine agonists (pramipexole, ropinirole, rotigotine) act by binding and activating the dopamine receptors in the brain. Dopamine agonists that are currently available can sometimes cause unwanted side effects such as excessive daytime sleepiness, compulsivity, and psychosis. Tavapadon is a partial agonist of the D1 and D5 dopamine receptors in the brain, whereas current dopamine agonists primarily target D2 and D3 dopamine receptors. Because of its different binding profile, tavapadon tends to have fewer side effects than traditional dopamine agonists.
In clinical studies known as the TEMPO trials (TEMPO-1, 2, 3), tavapadon showed meaningful improvements in motor control and daily function for people both newly diagnosed and those already on levodopa as compared to those taking a placebo. When tavapadon was added to levodopa, patients gained about an extra hour of improved “On” time per day without negative side effects.
Tavapadon appeared to be well tolerated, with most side effects described as mild to moderate. Because of the positive results of the clinical trials, Abbvie submitted a new drug application (NDA) for tavapadon to the FDA in September 2025. It takes about 10 months for the FDA to review an NDA and potentially approve it. If approved, tavapadon could become a valuable new option that smooths out motor symptoms and may reduce the need for more frequent levodopa dosing, with fewer side effects overall.
Bemdaneprocel: A Cell Therapy for PD
The pharmaceutical company Bayer is taking a much bolder approach to novel therapies in PD – a stem cell-based therapy designed to replace the brain cells that degenerate in PD. The treatment, called bemdaneprocel uses dopamine-producing neurons derived from stem cells. These are implanted directly into the part of the brain affected by PD, with the hope that they will connect correctly within the brain and start restoring dopamine production naturally. This therapy was developed by Blue Rock Therapeutics which is now a Bayer subsidiary specializing in regenerative medicine.
In earlier smaller trials, bemdaneprocel was shown to be safe and potentially beneficial, with patients tolerating the treatment well, and imaging suggesting that the transplanted cells survived and integrated into the brain. Now, the company has launched a phase 3 trial called exPDite-2 that will be the first large study of its kind to test a stem cell therapy for PD in people on a global scale.
If successful, bemdaneprocel could represent the first therapy to repair the underlying damage caused by the disease and not just mask its symptoms. Bayer expects early results in the next few years, though final outcomes will take time to confirm.
Why These Two Therapies Matter
These two therapies highlight how PD research is pushing forward on two fronts: improving quality of life now and pursuing long-term solutions.
Tavapadon, as an advanced oral medication, could reach patients relatively soon if approved by the FDA, offering more consistent symptom relief and fewer side effects. Bemdaneprocel represents the frontier of regenerative medicine, and although it will take a bit longer to validate in trials, it could be the first therapy to restore what PD takes away.
Neither has a sure path to approval, as late-stage trials face many challenges, including safety and long-term benefits that both must be proven. Regardless, the fact that two very different therapies have reached the phase 3 stage of clinical trials marks genuine progress in the field and may provide PD patients with much needed options in the future.
Tips & Takeaways
- A new medication for PD, tavapadon, is being reviewed by the FDA for potential approval.
- The first stem cell therapy for PD, bemdaneprocel, is entering a phase 3 clinical trial.
- APDA will continue to provide updates as these medications move along the research pipeline.
- You can learn more about all current medications approved for PD on our website.