Which countries around the world have Trientine been approved for marketing?

Trientine(Trientine) is an oral copper chelator used to treat Wilson's disease. As an alternative treatment to penicillamine, it is gradually gaining recognition and marketing approval worldwide. This drug is widely recommended by the international medical community because of its high safety, good tolerability, and is especially suitable for patients who are intolerant to penicillamine. It has gradually established a stable clinical application status in many countries.

Trientine was first approved by the FDA in November 1985 in the form of hydrochloride (Trientine hydrochloride) in the United States under the trade name Syprine. In the years since, it has been supplied domestically, mainly by U.S. pharmaceutical companies, and has become one of the key drugs in the treatment of Wilson's disease. As one of the drugs of choice to replace penicillamine, Syprine has long been used in patients of all ages in the United States.

In Europe, another preparation form of trientine Trientine tetrahydrochloride has also made an important breakthrough. In 2017, this form was approved by the EMA (European Medicines Agency) in the EU under the trade name Cuprior, specifically for the treatment of Wilson's disease patients who cannot tolerate penicillamine. The approval of Cuprior marks the official launch of trientine on the European market, providing European patients with a wider range of treatment options. The drug has obtained marketing approval in many EU member states, including Germany, France, Italy, and Spain, and has become one of the important drugs for the treatment of Wilson's disease in Europe.

Although China started late, with the opening of international drug channels, trientine was approved for sale in November 2023 in Hainan Boao Lecheng International Medical Tourism Pilot Zone through a licensed import policy, providing domestic patients with urgently needed new treatment options. Although it has not yet passed nationwide drug registration approval, the licensed use in this region provides an important window for the introduction of more international advanced drugs into the domestic market.

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