Sorfequiline did not show dose-dependent QTc prolongation, with a predicted mean effect on placebo-corrected change-from-baseline in QTcF of -1.1 ms (90% CI -9.5 to 7.4) at maximum Cmax.
RCT
Does sorfequiline prolong the QTc interval in healthy adults?
In a first-in-human study, the novel tuberculosis drug sorfequiline demonstrated no clinically meaningful QTc prolongation at doses up to 200 mg daily for 14 days.
Mean Difference: -1.1 (95% CI -9.5–7.4)
ABSTRACT Sorfequiline (TBAJ-876) is a novel diarylquinoline under development for tuberculosis. In a first-in-human, multiple-ascending-dose study, electrocardiogram and pharmacokinetic data were analyzed to assess cardiac repolarization. Placebo-corrected change-from-baseline in QTcF (ΔΔQTcF) ranged from −11.4 to +2.4 ms without dose dependency. Concentration–QTc modeling showed a shallow, non-significant slope. The predicted mean effect on ΔΔQTcF at the maximum geometric mean C max of sorfequiline’s M3 metabolite was −1.1 ms (90% CI −9.5 to 7.4). CLINICAL TRIALS This study is registered with ClinicalTrials.gov as NCT06058299.
Darpö et al. (2026) conducted an RCT in Tuberculosis. Sorfequiline (TBAJ-876) vs. Placebo was evaluated on Placebo-corrected change-from-baseline in QTcF (ΔΔQTcF) (MD -1.1 ms, 95% CI -9.5 to 7.4). Sorfequiline did not show dose-dependent QTc prolongation, with a predicted mean effect on placebo-corrected change-from-baseline in QTcF of -1.1 ms (90% CI -9.5 to 7.4) at maximum Cmax.