Is Delamanid already on the market? Availability and information

Delamanid/Delamanid is an innovative anti-tuberculosis drug for the treatment of drug-resistant tuberculosis (especially multidrug-resistant tuberculosis MDR-TB). It was developed by Japan's Otsuka Pharmaceutical Company under the trade name Deltyba. The goal of research and development of this drug is to improve the problems of traditional anti-tuberculosis treatment with long course, high toxicity and high drug resistance rate, and to bring new options for global tuberculosis prevention and treatment.

Since its introduction, delamanid has been considered one of the representatives of tuberculosis drug innovation due to its unique mechanism of action and good tolerability. According to public information, delamanid was first approved by the European Medicines Agency (EMA) in April 2014 for the treatment of multidrug-resistant tuberculosis. Subsequently, it was officially launched in Japan in July 2014, becoming the first approved oral new anti-tuberculosis drug in Japan. Although its original developer is a Japanese company, the US FDA has not yet approved its marketing.

In the Chinese market, the State Food and Drug Administration approved the official launch of delamanid (trade name: Delba) on September 7, 2023, marking an important breakthrough in the field of domestic drug-resistant tuberculosis treatment. This approval also makes China the next country in Asia to approve Dramani after Japan. The dosage of Delba approved for marketing in China is 50mg tablets, which is used for the combined treatment of multidrug-resistant tuberculosis in adults. Delamani's launch timeline also reflects its global strategic layout: from Europe, Japan to China, it will gradually cover areas with high incidence of drug-resistant tuberculosis, which is of great public health significance especially for Asian countries with high tuberculosis burden.

Currently, Dramani has obtained different forms of registration or temporary use authorization in many countries and regions around the world. Due to its outstanding performance in improving treatment compliance and improving efficacy, the World Health Organization (WHO) has also included it in the "Recommended Drug List for Drug-Resistant Tuberculosis" and recommended it in its guidelines as part of the standard treatment regimen.

Reference: https://go.drugbank.com/drugs/DB11637