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: 07 May 2026

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At a glance

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.
03 Feb 2026 According to Pharming Group media release, the trial remains on track for a readout in 2027.
31 Jul 2025 According to Pharming Group NV media release, company continue to anticipate trial read-out in 2027 with potential FDA approval by end of 2028.

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