Naxtarubicin is the WHO-approved international nonproprietary name for annamycin, Moleculin's next-generation anthracycline candidate in oncology. The program is in clinical development for relapsed/refractory acute myeloid leukemia and soft tissue sarcoma lung metastases, including a pivotal adaptive Phase 3 trial in AML. It remains investigational.
Moleculin said its MIRACLE Phase 2B/3 AML trial is nearing first unblinding, with blinded CRc above 40% and CR around 30%. The first 45-subject readout is expected before June 30, 2026.
Moleculin Biotech announced a preliminary blinded composite complete remission rate of 40% in the first 30 subjects of its Phase 2B/3 MIRACLE trial testing Annamycin plus cytarabine for relapsed or refractory acute myeloid leukemia.
Moleculin Biotech announced the Japan Patent Office has issued a notice of allowance for a patent covering proprietary methods for reconstituting liposomal Annamycin, strengthening the company's international intellectual property position.
