When will Opicapone be launched in China?

Opicapone is a new generation of long-acting COMT inhibitor, mainly used for adjuvant treatment of Parkinson's disease patients to extend the action time of levodopa and reduce the "end-of-dose phenomenon". As an innovative drug, Opicapone has been successively approved in many countries and regions, and its launch time in China is also a focus of concern for Parkinson's disease patients and the medical community.

Opicapone was first approved for marketing by the European Medicines Agency (EMA) in 2016 under the trade name Ongentys. It was subsequently approved by the U.S. Food and Drug Administration (FDA) in 2020 and will be officially sold in the U.S. market in 2021. Its development company is the Belgian pharmaceutical company Bial, and it is commercialized and promoted in some areas by Neurocrine Biosciences.

Although Opicapone has been approved and marketed in many countries and regions, as of 2025, it is still not officially launched in the Chinese market. The main reasons for this situation include the complexity of the domestic drug approval process and the lack of relevant clinical data. China's drug regulatory agencies have increasingly stringent review standards for new drugs and require sufficient clinical trial data to prove their safety and effectiveness, which makes the entry process for some foreign drugs relatively lengthy.

In China, although the incidence of Parkinson's disease is gradually increasing and the number of patients is increasing, the treatment options for this disease on the market are relatively limited. While there are a variety of drugs on the market, not every drug meets the needs of all patients. Opicapone may be an important treatment option for certain disease processes and symptoms. However, because it is not yet on the market, patients have to rely on other existing treatments, which face limitations in efficacy and side effects.

Reference materials:https://www.ongentys.com/