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Bukwang Announces approval of Clinical Trial Application by European authority to initiate Phase 2 s

Bukwang Pharmaceutical announces that the company’s application to conduct phase 2 clinical study for new CNS drug candidate 'JM-010' has recently been approved by French authority. The study is planned to include major European countries, including Germany, France, and Spain, with approvals from other countries are also expected to be completed within this month with first patient is expected to be enrolled early next year. JM-010 is a new drug candidate developed by Contera Pharma, a subsidiary of Bukwang Pharmaceuticals based in Copenhagen, to treat dyskinesia in Parkinson’s disease. As a number of Parkinson’s disease patients continues to grow, US market size of dyskinesia, citing Adamas Pharmaceutical whose dyskinesia product ‘Gocovri’ (amantadine SR capsule) is currently marketed in the US, is expected to be approximately 2 trillion won. JM-010 has been tested in phase 1 PK study and clinical proof of concept study demonstrating excellent efficacy without safety concern observed so far. Bukwang Pharmaceutical has been accelerating the development of JM-010 and is aiming to deliver JM-010 as a ‘best-in-class’ treatment choice that offer complete solution to treat dyskinesia in Parkinson’s disease patients.

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