Moleculin Announces World Health Organization Approval of “naxtarubicin” as International Non-Proprietary Name for Annamycin

Core Viewpoint - Annamycin, a next-generation anthracycline, is being developed by Moleculin Biotech, Inc. for the treatment of serious cancers, particularly relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases, with the potential to be safer and more effective than current treatments [1][4] Group 1: Drug Development and Trials - The ongoing pivotal Phase 3 clinical trial, named the "MIRACLE" trial, is evaluating Annamycin in combination with cytarabine (referred to as AnnAraC) for treating relapsed or refractory AML, with initial data expected in the second half of 2025 [1][3] - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for AML treatment, as well as Orphan Drug Designation from the European Medicines Agency (EMA) [3] - The recruitment of patients for the MIRACLE trial commenced in March 2025, following a successful Phase 1B/2 study, which has de-risked the development pathway towards potential approval [5] Group 2: Regulatory Approvals and Naming - The World Health Organization's International Nonproprietary Names (INN) Expert Committee has approved "naxtarubicin" as the non-proprietary name for Annamycin, marking a significant step in its development and future commercialization [2] - The INN naming process ensures that drug names adhere to guidelines and are conflict-free, facilitating safe prescription and dispensing [2] Group 3: Company Overview - Moleculin Biotech, Inc. is a late-stage pharmaceutical company focused on developing therapeutic candidates for hard-to-treat tumors and viral infections, with Annamycin as its lead program [4] - The company is also developing other candidates, including WP1066, an immune/transcription modulator targeting various cancers, and WP1122, aimed at treating pathogenic viruses [6]