Drug intelligence / Profile preview

galicaftor + navocaftor + ABBV-119

Development stage
Discontinued
Lead developer
AbbVie
Modality
Small Molecules
Administration
Oral
01

Overview

A triple combination investigational therapy composed of **galicaftor**, **navocaftor**, and **ABBV-119** developed for the treatment of **cystic fibrosis** (CF), particularly in patients who are homozygous or heterozygous for the F508del CFTR mutation. The drug is given as **oral capsules**—galicaftor and navocaftor once daily, ABBV-119 twice daily. - **Mechanism of action**: All three components are **CFTR modulators** designed to improve function of the cystic fibrosis transmembrane conductance regulator (CFTR). - Galicaftor and navocaftor act as potentiators and correctors to facilitate proper folding and trafficking of the CFTR protein. - ABBV-119 is a CFTR modulator intended to further enhance CFTR activity. - **Primary indication:** Cystic fibrosis. - **Developmental status:** The drug underwent phase 2 studies. However, the combination was discontinued in trials due to lack of incremental efficacy and safety signals (notably elevated liver enzymes with ABBV-119) compared to the galicaftor/navocaftor dual combination[2][3][4]. - **Developer:** AbbVie[1][3][6]. - **Primary benefit/risk:** Hypothesized improvement in lung function and sweat chloride in CF patients, with safety signals mainly related to liver enzyme elevations[2][3].

Other names
galicaftor/navocaftor/ABBV-119 triple combination therapy
02

Targets

CFTR (Cystic fibrosis transmembrane conductance regulator)

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