Drug intelligence / Profile preview

QTX-2101

Development stage
Phase 3
Lead developer
Quetzal Therapeutics
Modality
Small Molecules
Administration
Oral
01

Overview

QTX-2101 is an investigational oral capsule formulation of arsenic trioxide being developed by Quetzal Therapeutics for the treatment of acute promyelocytic leukemia (APL). As an oral alternative to the standard intravenous arsenic trioxide, QTX-2101 is designed to reduce the treatment burden on patients by eliminating the need for daily clinic visits and prolonged infusions. The drug's mechanism of action involves targeting the PML-RARA fusion protein, a hallmark of APL, leading to its degradation and subsequent differentiation and apoptosis of leukemic promyelocytes. QTX-2101 is currently undergoing Phase III clinical trials in patients with newly diagnosed APL and has been granted Fast Track designation by the FDA as of January 2026.

Other names
oral arsenic trioxide
02

Targets

PML-RARA (PML-retinoic acid receptor alpha fusion protein)

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