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Drug intelligence / Profile preview
ML-061 (docetaxel)
- Development stage
- Approved
- Lead developer
- Meridian Laboratories
- Modality
- Small Molecules
- Administration
- Intravenous
01
Overview
ML-061 (marketed as Docivyx) is a polysorbate-80-free, water-soluble formulation of the taxane chemotherapeutic agent docetaxel. Developed by Meridian Lab using Captisol (sulfobutylether beta-cyclodextrin) technology, ML-061 is designed to improve the solubility and safety profile of docetaxel compared to traditional formulations (such as Taxotere) that rely on polysorbate-80 (Tween-80) and ethanol, which are associated with severe hypersensitivity reactions and hemolysis. ML-061 acts as a microtubule inhibitor, binding to beta-tubulin to promote microtubule assembly and inhibit disassembly, thereby arresting the cell cycle in the G2/M phase and inducing apoptosis. It is FDA-approved for the treatment of various cancers, including breast cancer, non-small cell lung cancer (NSCLC), castration-resistant prostate cancer (CRPC), gastric adenocarcinoma, and squamous cell carcinoma of the head and neck (SCCHN).
- Brand names
- Docivyx
- Other names
- Captisol-enabled docetaxeldocetaxel injection
02
Targets
TUBB (Tubulin (alpha and beta subunits))
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