- |||||||||| sonlicromanol (KH176) / Khondrion
Trial suspension: The KHENERGYC Study (clinicaltrials.gov) - Jan 10, 2025
P2, N=24, Suspended,
Active, not recruiting --> Suspended
- |||||||||| sonlicromanol (KH176) / Khondrion
Enrollment closed, Trial completion date, Trial primary completion date: The KHENERGYC Study (clinicaltrials.gov) - May 28, 2024
P2, N=24, Active, not recruiting,
Long-term treatment showed more pronounced changes from baseline. Recruiting --> Active, not recruiting | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
- |||||||||| sonlicromanol (KH176) / Khondrion
Trial completion, Phase classification, Trial completion date, Trial primary completion date: The KHENEREXT Study (clinicaltrials.gov) - Mar 6, 2024
P2, N=11, Completed,
Recruiting --> Active, not recruiting | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025 Active, not recruiting --> Completed | Phase classification: P2b --> P2 | Trial completion date: Sep 2023 --> Jun 2023 | Trial primary completion date: Sep 2023 --> Jun 2023
- |||||||||| sonlicromanol (KH176) / Khondrion
Trial completion date, Trial primary completion date: The KHENERGYC Study (clinicaltrials.gov) - Mar 8, 2023
P2, N=24, Recruiting,
Cardioprotection by sonlicromanol was achieved by moderating inflammatory and oxidative responses, and AMPK/eNOS/mitochondrial signaling is a crucial regulator of these actions. Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
- |||||||||| sonlicromanol (KH176) / Khondrion
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: The KHENEREXT Study (clinicaltrials.gov) - Mar 8, 2023
P2b, N=15, Active, not recruiting,
Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024 Recruiting --> Active, not recruiting | N=27 --> 15 | Trial completion date: Mar 2023 --> Sep 2023 | Trial primary completion date: Mar 2023 --> Sep 2023
- |||||||||| sonlicromanol (KH176) / Khondrion
Trial completion: The KHENERGYZE Study (clinicaltrials.gov) - Aug 31, 2022
P2b, N=27, Completed,
Recruiting --> Active, not recruiting | N=27 --> 15 | Trial completion date: Mar 2023 --> Sep 2023 | Trial primary completion date: Mar 2023 --> Sep 2023 Active, not recruiting --> Completed
- |||||||||| sonlicromanol (KH176) / Khondrion
Enrollment closed: The KHENERGYZE Study (clinicaltrials.gov) - Mar 31, 2022
P2b, N=27, Active, not recruiting,
This study will assess the pharmacokinetics, efficacy, and safety of sonlicromanol in children with genetically confirmed PMDs, suffering from motor symptoms. Recruiting --> Active, not recruiting
- |||||||||| sonlicromanol (KH176) / Khondrion
Trial completion date, Trial primary completion date: The KHENERGYC Study (clinicaltrials.gov) - Jan 27, 2022
P2, N=24, Recruiting,
Overall, we provide insight in transcriptomic changes in iPSC-derived neurons with high m.3243A>G heteroplasmy, and show the pathology is partially reversible by sonlicromanol. Trial completion date: Sep 2022 --> Dec 2023 | Trial primary completion date: Jul 2022 --> Dec 2023
- |||||||||| sonlicromanol (KH176) / Khondrion
Enrollment open, Trial completion date, Trial primary completion date: The KHENEREXT Study (clinicaltrials.gov) - Sep 8, 2021
P2b, N=27, Recruiting,
Based on the results obtained we propose selective mPGES-1 targeting by the sonlicromanol metabolite KH176m as a potential novel treatment approach for cancer patients with high mPGES-1 expression. Not yet recruiting --> Recruiting | Trial completion date: Dec 2022 --> Mar 2023 | Trial primary completion date: Sep 2022 --> Mar 2023
- |||||||||| sonlicromanol (KH176) / Khondrion
Trial primary completion date: The KHENERGYZE Study (clinicaltrials.gov) - Aug 27, 2021
P2b, N=27, Recruiting,
Not yet recruiting --> Recruiting | Trial completion date: Dec 2022 --> Mar 2023 | Trial primary completion date: Sep 2022 --> Mar 2023 Trial primary completion date: Dec 2021 --> Apr 2022
- |||||||||| sonlicromanol (KH176) / Khondrion
New P2 trial: The KHENERGYC Study (clinicaltrials.gov) - Apr 14, 2021
P2, N=24, Recruiting,
- |||||||||| sonlicromanol (KH176) / Khondrion
Trial completion date, Trial primary completion date: The KHENERGYZE Study (clinicaltrials.gov) - Mar 4, 2021
P2b, N=27, Recruiting,
Based on the results obtained we discuss potential new therapeutic applications of KH176m and its clinical stage parent drug candidate sonlicromanol in mitochondrial disease and beyond. Trial completion date: Jun 2021 --> Mar 2022 | Trial primary completion date: Mar 2021 --> Dec 2021
- |||||||||| sonlicromanol (KH176) / Khondrion
Trial initiation date: The KHENEREXT Study (clinicaltrials.gov) - Feb 7, 2021
P2b, N=27, Not yet recruiting,
Trial completion date: Jun 2021 --> Mar 2022 | Trial primary completion date: Mar 2021 --> Dec 2021 Initiation date: Jan 2021 --> Apr 2021
- |||||||||| Journal: Treatment of Leber's hereditary optic neuropathy: An overview of recent developments. (Pubmed Central) - Jan 5, 2021
The aim of this article was to summarise interventional clinical trials published over the past 5 years (between 2014 and 2019) with the primary purpose of treating LHON. Therapeutic approaches discussed include modulating agents of the mitochondrial electron transport chain such as Raxone, cysteamine bitartrate and KH176, inhibitors of apoptosis such as elamipretide, gene therapy medicinal products such as GS010 and scAAV2P1ND4 and retinal tissue regeneration medicinal products such as bone marrow-derived stem cells.
- |||||||||| sonlicromanol (KH176) / Khondrion
New P2b trial: The KHENEREXT Study (clinicaltrials.gov) - Oct 26, 2020
P2b, N=27, Not yet recruiting,
- |||||||||| sonlicromanol (KH176) / Khondrion, Lacromid (bezafibrate) / Remedica
Preclinical, Journal: Effects of clofibrate and KH176 on life span and motor function in mitochondrial complex I-deficient mice. (Pubmed Central) - Oct 24, 2020
As described previously, single treatment with KH176 was beneficial, however, combining clofibrate with KH176 did not result in an additive effect on disease phenotype in Ndufs4 mice. Overall, both drugs have promising, but independent and nonadditive, properties for the pharmacological treatment of CI-deficiency-related mitochondrial diseases.
- |||||||||| sonlicromanol (KH176) / Khondrion
Trial completion date, Trial primary completion date: The KHENERGYZE Study (clinicaltrials.gov) - Jun 22, 2020
P2b, N=27, Recruiting,
Overall, both drugs have promising, but independent and nonadditive, properties for the pharmacological treatment of CI-deficiency-related mitochondrial diseases. Trial completion date: Nov 2020 --> Jun 2021 | Trial primary completion date: Nov 2020 --> Mar 2021
- |||||||||| sonlicromanol (KH176) / Khondrion
Trial completion date, Trial primary completion date: The KHENERGYZE Study (clinicaltrials.gov) - Jan 22, 2020
P2b, N=27, Recruiting,
Trial completion date: Nov 2020 --> Jun 2021 | Trial primary completion date: Nov 2020 --> Mar 2021 Trial completion date: Jul 2020 --> Nov 2020 | Trial primary completion date: Jul 2020 --> Nov 2020
- |||||||||| sonlicromanol (KH176) / Khondrion
New P2b trial: The KHENERGYZE Study (clinicaltrials.gov) - Nov 15, 2019
P2b, N=27, Recruiting,
- |||||||||| sonlicromanol (KH176) / Khondrion
Trial completion, Trial completion date, Trial primary completion date: The KHENERGY Study (clinicaltrials.gov) - Feb 23, 2018
P2, N=20, Completed,
Trial completion date: Jul 2020 --> Nov 2020 | Trial primary completion date: Jul 2020 --> Nov 2020 Recruiting --> Completed | Trial completion date: May 2017 --> Jul 2017 | Trial primary completion date: May 2017 --> Jul 2017
- |||||||||| sonlicromanol (KH176) / Khondrion
New P2 trial: The KHENERGY Study (clinicaltrials.gov) - Sep 21, 2016
P2, N=20, Recruiting,
- |||||||||| sonlicromanol (KH176) / Khondrion
Trial completion: A Dose-escalating Clinical Trial With KH176 (clinicaltrials.gov) - Feb 8, 2016
P1, N=30, Completed,
Recruiting --> Completed | Trial completion date: May 2017 --> Jul 2017 | Trial primary completion date: May 2017 --> Jul 2017 Recruiting --> Completed
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