Doxolipad

Doxolipad is a pegylated liposomal formulation of doxorubicin, an anthracycline cytotoxic antibiotic. Developed by TLC Biopharmaceuticals B.V., it was designed as a hybrid medicine intended to be bioequivalent to the reference product Caelyx. The formulation consists of doxorubicin encapsulated within pegylated liposomes—microscopic fatty spheres coated with polyethylene glycol—which are designed to prolong the drug's circulation time and reduce its distribution to non-cancerous tissues, thereby mitigating toxicities such as cardiotoxicity. Doxolipad was primarily developed for the treatment of metastatic breast cancer in patients with cardiac risk factors and for platinum-resistant ovarian cancer. In May 2019, the European Medicines Agency (EMA) refused marketing authorization for Doxolipad because bioequivalence studies failed to demonstrate that the levels of free (unencapsulated) doxorubicin were equivalent to those of the comparator drug Caelyx.

Brand names

Doxolipad

Other names

pegylated liposomal doxorubicin