Drug intelligence / Profile preview

docetaxel + sonidegib

Development stage
Phase 1
Lead developer
Novartis
Modality
Classical Binding Small Molecules → Small Molecules, Covalent Small Molecules → Small Molecules, Nucleic Acid-Directed Small Molecules → Small Molecules
Administration
Intravenous, Oral
01

Overview

This is a combination of two antineoplastic agents, docetaxel and sonidegib, investigated for the treatment of advanced cancers such as triple-negative breast cancer (TNBC). Docetaxel is a taxane-class chemotherapeutic that inhibits microtubule depolymerization, leading to cell cycle arrest and apoptosis. Sonidegib is an oral small molecule inhibitor of the Hedgehog signaling pathway via antagonism of Smoothened (SMO), developed by Novartis. The combination has been studied in phase I clinical trials for advanced TNBC to determine safety, tolerability, and preliminary efficacy. At recommended doses—docetaxel 75 mg/m² IV every 21 days plus oral sonidegib up to 800 mg daily—the regimen showed manageable toxicity and some antitumor activity[1][2]. Sonidegib is FDA-approved as monotherapy for locally advanced basal cell carcinoma but remains investigational in this combination.

Other names
erismodegib
02

Targets

SMO (Smoothened)TUBB (Tubulin (alpha and beta subunits))

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