On February 17, 2026 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), reported that the Japan Patent Office (JPO) has issued a notice of allowance for Patent Application No. 2021-577862 titled, "METHOD OF RECONSTITUTING LIPOSOMAL ANNAMYCIN." A patent from the application is expected to be issued in the coming months.
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The allowed claims cover proprietary methods for reconstituting and preparing liposomal Annamycin from a preliposomal lyophilizate under controlled temperature conditions to achieve precise concentrations suitable for intravenous administration. These methods are designed to ensure consistent dosing, stability, and handling during preparation and delivery, including maintaining the formulation at physiologic temperatures throughout reconstitution and dilution. Annamycin, Moleculin’s novel, lipid-based anthracycline drug candidate, is being developed for the treatment of acute myeloid leukemia (AML) and other hematologic malignancies and is positioned to potentially become the first non-cardiotoxic anthracycline approved for clinical use. Additional preclinical studies conducted at leading cancer centers suggest Annamycin may have broader applicability across multiple cancer types. This Japanese patent allowance complements Moleculin’s existing U.S. and European patent coverage, with additional Annamycin-related patent applications pending in major jurisdictions worldwide.
"Securing strong patent protection across key global markets remains a core strategic priority as we advance our non-cardiotoxic therapy for relapsed or refractory acute myeloid leukemia through pivotal Phase 3 development," commented Walter Klemp, Chairman and CEO of Moleculin. "This newly allowed Japanese patent further strengthens our international intellectual property position by protecting critical methods supporting the preparation and clinical use of our therapy, reinforcing our confidence in its long-term value as we work toward potential regulatory approval and commercialization in key territories worldwide."
Annamycin, also known by its non-proprietary name of naxtarubicin, currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory AML, in addition to Orphan Drug Designation for the treatment of STS lung mets. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory AML from the EMA.
(Press release, Moleculin, FEB 17, 2026, https://moleculin.com/moleculin-announces-notice-of-allowance-for-japanese-patent-covering-annamycin/ [SID1234662715])