The European Commission has granted centralized approval for Onerji® (ND0612), a continuous subcutaneous levodopa/carbidopa infusion developed by Mitsubishi Tanabe Pharma Corporation, for advanced Parkinson’s disease with motor fluctuations.
Written By: Dr. Preethi Putti, PharmD
Reviewed By: Pharmacally Editorial Team
Mitsubishi Tanabe Pharma Corporation has announced that the European Commission has granted centralized marketing authorization on April 27 in the European Union (EU) for Onerji® (project code: ND0612), a continuous subcutaneous infusion of liquid levodopa/carbidopa (LD/CD). The therapy is designed for patients with advanced Parkinson’s disease (PD) who experience motor fluctuations that are not adequately controlled by oral anti-Parkinson medications. Onerji® is being developed by the company’s wholly owned subsidiary, NeuroDerm Ltd.
Onerji® is a drug-device combination therapy that delivers a continuous, 24-hour subcutaneous infusion of liquid levodopa/carbidopa using a portable infusion pump system, including the YURWAY® Delivery System or the Crono Twin Pump. The therapy is designed to maintain stable plasma levodopa concentrations through continuous delivery. By providing steady drug exposure, Onerji® aims to reduce motor fluctuations commonly observed with oral levodopa-based treatments.
A global Phase 3 clinical study, the BouNDless trial (NCT04006210), demonstrated the benefits of this approach. In patients with PD experiencing motor fluctuations, Onerji® administered alongside supplemental oral LD/CD as part of the study protocol showed a significant increase in ON time without troublesome dyskinesia and a reduction in OFF time compared with immediate-release oral LD/CD. In addition, favorable results were reported from a late Phase 2 long-term safety study, the BeyoND study (NCT02726386), which evaluated long-term safety and tolerability.
Parkinson’s disease is a progressive neurological disorder affecting more than ten million people worldwide. It is characterized by a decline in dopamine signaling due to the loss of dopaminergic neurons, leading to symptoms such as bradykinesia, tremor, muscle rigidity, and postural instability. Patients may also experience non-motor symptoms affecting sleep, cognition, behavior, and autonomic function.
Levodopa, typically administered with carbidopa, remains the most widely used treatment for Parkinson’s disease as it helps restore dopamine levels. However, oral administration often results in fluctuating drug concentrations, leading to alternating periods of symptom control and poor control. Onerji® addresses this limitation by providing continuous drug delivery, helping to stabilize plasma levels and improve symptom consistency.
NeuroDerm Ltd, based in Israel, focuses on developing drug-device combination therapies aimed at reducing disease burden and improving patient quality of life.
Overall, the European Commission’s approval of Onerji® reflects the clinical benefit of continuous levodopa delivery in reducing motor fluctuations and offers an additional treatment option for patients with advanced Parkinson’s disease.
References
https://www.tanabe-pharma.com/en/news/rel_260430/main/0/link/e_rel_260430.pdf
About the Writer
Dr.Preethi Putti, PharmD (Linkedin) is a pharmaceutical researcher with experience in healthcare and pharmaceutical market research and competitive intelligence. She specializes in analyzing drug pipelines, clinical data, and industry trends and translating complex scientific data into clear and structured medical content. Strong foundation in clinical research, data interpretation, and evidence-based healthcare analysis. Committed to advancing a global career in clinical research and healthcare innovation.