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Doxisome (doxorubicin)
- Development stage
- Discontinued
- Lead developer
- Taiwan Liposome Company
- Modality
- Small Molecules, Lipid-based Nanoparticles → Nanoparticles → Drug Delivery Systems
- Administration
- Intravenous
01
Overview
Doxisome (TLC177 / Doxolipad) is a pegylated liposomal formulation of the anthracycline chemotherapy agent doxorubicin hydrochloride, developed by Taiwan Liposome Company (TLC). It was designed as a bioequivalent hybrid version of pegylated liposomal doxorubicin (Doxil/Caelyx) to treat various cancers, including metastatic breast cancer, advanced ovarian cancer, and AIDS-related Kaposi's sarcoma. Doxisome utilizes TLC's proprietary NanoX active drug loading technology to encapsulate doxorubicin within small unilamellar liposomes, which enhances drug stability, prolongs circulation time, and reduces cardiotoxicity compared to conventional doxorubicin. The drug exerts its antineoplastic effect by intercalating into DNA and inhibiting topoisomerase II, thereby disrupting DNA replication and RNA synthesis in rapidly dividing cancer cells. Although TLC sought regulatory approval in Europe, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion in 2019 due to concerns regarding bioequivalence of free doxorubicin, leading to the suspension of its clinical development.
- Brand names
- DoxisomeDoxolipad
- Other names
- doxorubicin liposomalliposomal doxorubicinpegylated liposomal doxorubicin
02
Targets
DNADNA polymerase familyTOP2A (DNA topoisomerase II)TOP2B (DNA topoisomerase II beta)RNAP (Bacterial dna-dependent RNA polymerase)
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