What are the results of clinical trials of bedaquiline?

Clinical trial results for bedaquiline (Bedaquiline) have been generally positive. Bedaquiline has been shown to be highly effective in treating multidrug-resistant tuberculosis in multiple clinical trials. The optimal dosage and treatment duration of bedaquiline still require further research and exploration. At the same time, because the mechanism of action of bedaquiline is different from other anti-tuberculosis drugs, it cannot be used as a first-line anti-tuberculosis drug and needs to be used under the guidance of an experienced doctor.

A pivotal randomized, double-blind, placebo-controlled clinical trial shows that adding bedaquiline to other anti-tuberculosis drug treatments can significantly shorten the treatment time of patients, increase the rate of sputum negative conversion, and reduce the incidence of drug-resistant cases. At the same time, the trial also showed that bedaquiline's resistance to other anti-tuberculosis drugs does not affect its efficacy.

In addition, bedaquiline has demonstrated good safety and tolerability in clinical trials. Although some adverse effects and side effects have been reported, most are mild to moderate and can be controlled and managed. Cardiotoxic effects are the biggest safety concern for bedaquiline, but study results show that its cardiac safety profile is similar to that of placebo at conventional therapeutic doses.

The drug is sold in China under the name of daquiline fumarate tablets and has been included in the scope of medical insurance. The price of a common specification of 100mg*24 tablets per box may be around 10,000 yuan, which is relatively expensive. The price of the Russian version of Bedaquiline sold overseas, Specifications100mg*188 tablets per box, may be around RMB 15,000 (the price may fluctuate due to the exchange rate). The pharmaceutical ingredients of Bedaquiline sold domestically and abroad are basically the same. Currently, there are no generic bedaquiline drugs produced and marketed overseas. For specific prices and drug information of overseas drugs, please consult Yaode Medical Consultant.