Drug intelligence / Profile preview

Brakiva

Development stage
Unknown
Lead developer
Access Pharmaceuticals
Modality
Lipid-based Nanoparticles → Nanoparticles → Drug Delivery Systems, Small Molecules
Administration
Intravenous
01

Overview

Brakiva (ND-121) is a liposomal formulation of topotecan hydrochloride, a semi-synthetic analogue of camptothecin that functions as a topoisomerase I inhibitor. Developed by Access Pharmaceuticals, this formulation utilizes a specialized liposomal delivery system to encapsulate topotecan, aiming to enhance its pharmacokinetic profile by increasing the drug's half-life and improving its accumulation within tumor tissues via the enhanced permeability and retention (EPR) effect. In clinical studies sponsored by the Gynecologic Oncology Group (GOG), specifically trial GOG-9929, Brakiva was evaluated in combination with cisplatin and pelvic radiation therapy for the treatment of locally advanced cervical cancer. The goal of this liposomal approach is to provide a more effective and potentially less toxic alternative to conventional topotecan (Hycamtin) when used as a radiosensitizer in concurrent chemoradiotherapy regimens.

Brand names
Brakiva
Other names
Topotecan hydrochloride liposomesLiposomal topotecan
02

Targets

TOP1 (DNA Topoisomerase I)

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