
Moleculin Biotech (NASDAQ:MBRX) announced that the International Nonproprietary Names (INN) expert committee of the World Health Organization (WHO) has approved “naxtarubicin” as the non-proprietary name of its next-generation anthracycline in development, Annamycin.
Annamycin is in development for the treatment of relapsed or refractory acute myeloid leukemia (R/R AML) and soft tissue sarcoma (STS) lung metastases. According to Moleculin, Annamycin may have the potential to treat additional indications.
Walter Klemp, chairman and CEO of Moleculin, stated, “The assignment of the non-proprietary name represents an important step in the development and potential future commercialization of Annamycin. The INN naming process meticulously evaluates proposed drug names for adherence to nomenclature guidelines and potential conflicts, followed by expert consensus and public review. With this INN now given and prior approval by the USAN, we have the ability to establish a universally recognized and conflict-free nonproprietary drug name for Annamycin.”
Mr. Klemp added, “Looking ahead, our team remains focused on the successful execution of our ongoing pivotal, adaptive design Phase 3 MIRACLE trial of Annamycin for the treatment R/R AML and look forward to reporting initial data in the second half of 2025.”