Is Elafibranor currently officially on the market at home and abroad?

As of2025, Elafibranor (trade name: Iqirvo) has been officially launched in many countries and regions, and is mainly used to treat primary biliary cholangitis (PBC). However, the drug has not yet been approved for marketing in mainland China.

In the United States,Elafibranor will be available in20246 On May 10th, it received accelerated approval from the FDA as the first new drug for the treatment of PBC. The approval is based on results from the Phase IIIELATIVE trial showingElafibrano rhas a significant biochemical response in PBC patients in combined treatment with ursodeoxycholic acid (UDCA). The drug is marketed in the United States under the brand name Iqirvo and is commercialized by Ipsen.

In Europe, Elafibranor will be released in 20249month pan>On 19, it obtained conditional marketing authorization from the European Medicines Agency (EMA), and the indication is also PBC. The approval is also based on data from the ELATIVE trial, which aims to provide new treatment options for patients with PBC who have had an inadequate response to or intolerance to UDCA.

In mainland China, Elafibranor has not yet been approved by the National Medical Products Administration (NMPA). However, Terns Pharmaceuticals) has obtained the exclusive rights to develop, register and commercialize the drug in Greater China (Mainland China, Hong Kong, Macau, Taiwan). The indications include non-alcoholic steatohepatitis (NASH) and PBC. The progress of the drug's launch in mainland China is currently unclear.

In short, Elafibranor has been officially launched in the United States and Europe for the treatment of PBC, but it has not yet been approved in mainland China. Patients in mainland China may need to wait for the drug to be approved for marketing, or consider obtaining the drug through other channels.

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