The Ministry of Health approved the drug “Trientin Waymade” from the company Waymade. Pharmasyntez trientine was previously approved in Russia. The drug is an analogue of the foreign drug Syprine (Bausch Health), which is not registered in Russia.
Waymade has received a registration certificate from the Russian Ministry of Health for the drug Trientine Waymade (INN Trientine). The drug is approved for the treatment of rare Wilson-Konovalov disease. The information appeared in the State Register of Medicines (GRLS), writes Pharmaceutical Bulletin.
The drug is available in the form of capsules in a dosage of 250 mg. The manufacturer of the drug is the Indian company Apothecon Pharmaceuticals Pvt. Ltd.”
The active substance of the approved drug is a detoxifying agent. Trientine binds copper and removes it from the body, which is necessary for Wilson-Konovalov disease, when excessive accumulation of copper occurs. The disease causes damage to various organs, primarily the liver and brain.
The drug “Trientin Waymade” is approved for children from five years of age and adults who cannot tolerate penicillamine, also used to treat this disease.
In 2022, the GRLS recorded another valid regulatory certificate for the drug trientine from the Pharmasyntez company. In the same year, another drug containing trientine was registered – “Sintersep” LLC “PharmaMondo”, but the RU for this drug is no longer valid (RU has been changed).
The Russian register of clinical trials includes one trial of the drug trientine. In 2021, the American company Navinta received permission to study the bioequivalence of the drugs Trientin Waymade and Siprin (Bausch Health US, USA). The trial was due to end in June 2022, but was abandoned.
The drug Syprine is used in the USA for the treatment of Wilson-Konovalov disease; it is not registered in Russia.