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16 News |  |
- | R-troloxamide quinone (EPI-589) / Sumitomo Pharma
Journal: Characterization and expression of highly active recombinant human Glucuronyl C5-epimerase in mammalian cells. (Pubmed Central) - Jun 8, 2023
A high-yield expression strategy was established using the lentiviral-based transduction system to produce recombinant HSepi (HSepi589) with a specific activity of up to 1.6
- | R-troloxamide quinone (EPI-589) / Sumitomo Pharma
Journal: An Exploratory Trial of EPI-589 in Amyotrophic Lateral Sclerosis (EPIC-ALS): Protocol for a Multicenter, Open-Labeled, 24-Week, Single-Group Study. (Pubmed Central) - Jan 31, 2023
A high-yield expression strategy was established using the lentiviral-based transduction system to produce recombinant HSepi (HSepi589) with a specific activity of up to 1.6 This study can provide useful data to understand the characteristics of EPI-589.
- || R-troloxamide quinone (EPI-589) / Sumitomo Dainippon
P1 data, PK/PD data, Journal: Phase 1 Study to Investigate the Safety, Tolerability, and Pharmacokinetics of EPI-589 in Healthy Participants. (Pubmed Central) - Oct 5, 2022
At both doses studied (500 mg twice daily and 750 mg twice daily), C t , and AUC were generally comparable between day 1 and day 7 and between the Japanese and White participants. EPI-589 was well tolerated as a single daily dose up to 1000 mg and as twice-daily doses up to 750 mg, with a linear pharmacokinetic profile.
- || R-troloxamide quinone (EPI-589) / Sumitomo Pharma
Biomarker, Trial completion: Safety and Biomarker Study of PTC-589 in Participants With Parkinson's Disease (clinicaltrials.gov) - May 20, 2020
P2a, N=44, Completed, Sponsor: PTC Therapeutics
EPI-589 was well tolerated as a single daily dose up to 1000 mg and as twice-daily doses up to 750 mg, with a linear pharmacokinetic profile. Active, not recruiting --> Completed
- | R-troloxamide quinone (EPI-589) / Sumitomo Pharma
Biomarker, Trial completion date, Trial primary completion date: Safety and Biomarker Study of PTC-589 in Participants With Parkinson's Disease (clinicaltrials.gov) - Jul 16, 2019
P2a, N=44, Active, not recruiting, Sponsor: Edison Pharmaceuticals Inc
Active, not recruiting --> Completed Trial completion date: Dec 2018 --> Dec 2019 | Trial primary completion date: Dec 2018 --> Dec 2019
- | R-troloxamide quinone (EPI-589) / Sumitomo Pharma
Biomarker, Enrollment closed: Safety and Biomarker Study of PTC-589 in Participants With Parkinson's Disease (clinicaltrials.gov) - Aug 23, 2018
P2a, N=44, Active, not recruiting, Sponsor: Edison Pharmaceuticals Inc
Trial completion date: Dec 2018 --> Dec 2019 | Trial primary completion date: Dec 2018 --> Dec 2019 Recruiting --> Active, not recruiting
- | R-troloxamide quinone (EPI-589) / Sumitomo Pharma
Biomarker, Trial completion date, Trial primary completion date: Safety and Biomarker Study of PTC-589 in Participants With Parkinson's Disease (clinicaltrials.gov) - Jul 24, 2018
P2a, N=40, Recruiting, Sponsor: Edison Pharmaceuticals Inc
Recruiting --> Active, not recruiting Trial completion date: Jul 2018 --> Dec 2018 | Trial primary completion date: Apr 2018 --> Dec 2018
- | R-troloxamide quinone (EPI-589) / Sumitomo Pharma
Biomarker, Trial completion, Trial primary completion date: Safety and Biomarker Study of EPI-589 in Participants With Amyotrophic Lateral Sclerosis (ALS) (clinicaltrials.gov) - Jul 24, 2018
P2a, N=20, Completed, Sponsor: Edison Pharmaceuticals Inc
Trial completion date: Jul 2018 --> Dec 2018 | Trial primary completion date: Apr 2018 --> Dec 2018 Recruiting --> Completed | Trial primary completion date: Feb 2018 --> Jul 2018
- R-troloxamide quinone (EPI-589) / Sumitomo Pharma
Biomarker, Trial primary completion date: Safety and Biomarker Study of PTC-589 in Participants With Parkinson's Disease (clinicaltrials.gov) - Apr 21, 2017
P2a, N=40, Recruiting, Sponsor: Edison Pharmaceuticals Inc
Recruiting --> Completed | Trial primary completion date: Feb 2018 --> Jul 2018 Trial primary completion date: Apr 2017 --> Apr 2018
- R-troloxamide quinone (EPI-589) / Sumitomo Pharma
Biomarker, Trial primary completion date: Safety and Biomarker Study of EPI-589 in Participants With Amyotrophic Lateral Sclerosis (ALS) (clinicaltrials.gov) - Apr 21, 2017
P2a, N=20, Recruiting, Sponsor: Edison Pharmaceuticals Inc
Trial primary completion date: Apr 2017 --> Apr 2018 Trial primary completion date: Feb 2017 --> Feb 2018
- | R-troloxamide quinone (EPI-589) / Sumitomo Pharma
Biomarker, Enrollment open, Trial initiation date, Trial primary completion date: Safety and Biomarker Study of PTC-589 in Participants With Parkinson's Disease (clinicaltrials.gov) - Apr 20, 2016
P2a, N=40, Recruiting, Sponsor: Edison Pharmaceuticals Inc
Trial primary completion date: Feb 2017 --> Feb 2018 Not yet recruiting --> Recruiting | Initiation date: Nov 2015 --> Mar 2016 | Trial primary completion date: Nov 2016 --> Apr 2017
- | R-troloxamide quinone (EPI-589) / Sumitomo Pharma
Biomarker, Enrollment open: Safety and Biomarker Study of EPI-589 in Participants With Amyotrophic Lateral Sclerosis (ALS) (clinicaltrials.gov) - Feb 1, 2016
P2a, N=20, Recruiting, Sponsor: Edison Pharmaceuticals Inc
Not yet recruiting --> Recruiting | Initiation date: Nov 2015 --> Mar 2016 | Trial primary completion date: Nov 2016 --> Apr 2017 Not yet recruiting --> Recruiting
- | R-troloxamide quinone (EPI-589) / Sumitomo Pharma
Biomarker, Trial initiation date: Safety and Biomarker Study of PTC-589 in Participants With Parkinson's Disease (clinicaltrials.gov) - Sep 16, 2015
P2a, N=40, Not yet recruiting, Sponsor: Edison Pharmaceuticals Inc
Not yet recruiting --> Recruiting Initiation date: Jun 2015 --> Nov 2015
- | R-troloxamide quinone (EPI-589) / Sumitomo Pharma
Biomarker, Trial initiation date, Trial primary completion date: Safety and Biomarker Study of EPI-589 in Participants With Amyotrophic Lateral Sclerosis (ALS) (clinicaltrials.gov) - Sep 16, 2015
P2a, N=20, Not yet recruiting, Sponsor: Edison Pharmaceuticals Inc
Initiation date: Jun 2015 --> Nov 2015 Initiation date: Jun 2015 --> Oct 2015 | Trial primary completion date: May 2016 --> Dec 2016
- | R-troloxamide quinone (EPI-589) / Sumitomo Pharma
Biomarker, New P2a trial: Safety and Biomarker Study of PTC-589 in Participants With Parkinson's Disease (clinicaltrials.gov) - Jun 4, 2015
P2a, N=40, Not yet recruiting, Sponsor: Edison Pharmaceuticals Inc
Initiation date: Jun 2015 --> Oct 2015 | Trial primary completion date: May 2016 --> Dec 2016 .
- | R-troloxamide quinone (EPI-589) / Sumitomo Pharma
Biomarker, New P2a trial: Safety and Biomarker Study of EPI-589 in Participants With Amyotrophic Lateral Sclerosis (ALS) (clinicaltrials.gov) - Jun 2, 2015
P2a, N=20, Not yet recruiting, Sponsor: Edison Pharmaceuticals Inc
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