Trial Profile

An interventional, randomised, double-blind, parallel-group, placebo-controlled, flexible-dose, adaptive study of the efficacy of KL1333 in adult patients with primary mitochondrial disease

Status: Recruiting

Phase of Trial: Phase II/III

Latest Information Update: 04 Nov 2026

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At a glance

22 Oct 2026 According to Pharming Group NV media release, the company expect enrollment to be completed in the first half of 2027. Topline results from the pivotal FALCON study are expected approximately one year after the completion of enrollment.
22 Oct 2026 According to Pharming Group NV media release, the company expect approximately 145 of the planned 180 subjects to be enrolled in the pivotal FALCON clinical trial by the end of 2026.
12 Mar 2026 According to Pharming Group NV media release, the company is on track to complete enrollment in the pivotal FALCON study of napazimone (KL1333) in 2026, with data readout anticipated in late 2027.

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