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trientine tetrahydrochloride once-daily formulation
- Development stage
- Unknown
- Lead developer
- Orphalan
- Modality
- Small Molecules
- Administration
- Oral
01
Overview
The New TETA 4HCl Formulation is an investigational once-daily oral formulation of trientine tetrahydrochloride (TETA 4HCl) developed by Orphalan for the treatment of Wilson's disease, a rare genetic disorder characterized by toxic copper accumulation. While existing formulations of trientine tetrahydrochloride (such as Cuprior/Cuvrior) contain 150 mg of trientine base and require dosing two to four times daily, this novel formulation contains 300 mg of trientine base per film-coated tablet and is designed for once-daily administration to reduce treatment burden and improve patient compliance. As a small-molecule copper chelator, it binds excess copper in the body and facilitates its excretion in the urine. The formulation is currently being evaluated in clinical trials, including a Phase 3 study (TRADITiONAL) comparing its safety and efficacy to D-penicillamine as a first-line treatment.
- Other names
- New TETA 4HCl Formulationonce-daily trientineonce-daily trientine tetrahydrochloridetriethylenetetramine tetrahydrochloride once-daily formulation
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