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: 21 Aug 2025

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At a glance

Drugs KL 1333 (Primary)
Indications Mitochondrial disorders
Focus Registrational; Therapeutic Use
Acronyms FALCON
Sponsors Abliva

Most Recent Events

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.
31 Jul 2025 According to Pharming Group NV media release, company finally dosed the first patients in the second wave of the pivotal clinical trial for KL1333 in primary mitochondrial diseases
27 Apr 2025 Status changed from active, no longer recruiting to recruiting.

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