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A Phase IIb Open-label, Multi-centre, Extension Study to Explore the Long-term Safety and Efficacy of KH176 in Subjects With a Genetically Confirmed Mitochondrial DNA tRNALeu(UUR) m.3243A>G Mutation Who Have Completed the KHENERGYZE Study KH176-202

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Trial Profile

A Phase IIb Open-label, Multi-centre, Extension Study to Explore the Long-term Safety and Efficacy of KH176 in Subjects With a Genetically Confirmed Mitochondrial DNA tRNALeu(UUR) m.3243A>G Mutation Who Have Completed the KHENERGYZE Study KH176-202

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 24 Mar 2025

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At a glance

  • Drugs Sonlicromanol (Primary)
  • Indications Mitochondrial disorders
  • Focus Adverse reactions
  • Acronyms KHENEREXT; The KHENEREXT Study
  • Sponsors Khondrion

Most Recent Events

  • 06 Mar 2025 Results of phase 2b program consisting of a randomized controlled (RCT) study (dose-selection) followed by a 52-week open-label extension study (EXT, long-term tolerability, safety and efficacy of sonlicromanol), published in the Brain.
  • 08 Nov 2024 According to a Khondrion media release, the company announced the publication of results from its integrated Phase 2b clinical development program of sonlicromanol in the peer-reviewed scientific journal, Brain.
  • 04 Sep 2023 This trial has been completed in Denmark, according to European Clinical Trials Database record.

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