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Annamycin

Drug

Drug Profile

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.

Drug Class
Next-generation anthracycline antineoplastic candidate
Approval Status
Investigational; in Phase 3 development with FDA Fast Track and Orphan Drug designations
Mechanism of Action
Designed anthracycline profile intended to avoid multidrug-resistance mechanisms and reduce cardiotoxicity compared with legacy anthracyclines
Brand Names
  • naxtarubicin
  • Annamycin
Indications
  • \Relapsed or refractory acute myeloid leukemia (AML)\
  • \Soft tissue sarcoma (STS) lung metastases\

Related News

Annamycin-Cytarabine Combination Shows Promising Remission Rates in Relapsed AML Trial

Moleculin Biotech's Phase 2B/3 MIRACLE trial of Annamycin plus cytarabine in relapsed or refractory acute myeloid leukemia reported a preliminary complete remission rate of approximately 30% and composite remission rate exceeding 40% in the first 45 subjects. The blinded data show a substantial improvement over historical rates with cytarabine alone. The trial is expected to reach its first unblinding milestone in mid-2026.