- |||||||||| Urece (dotinurad) / Fuji Yakuhin, Mochida, Fortress, Eisai
Review, Journal: A Possible Therapeutic Application of the Selective Inhibitor of Urate Transporter 1, Dotinurad, for Metabolic Syndrome, Chronic Kidney Disease, and Cardiovascular Disease. (Pubmed Central) - Mar 17, 2024 OAT1/3 inhibitors suppress IS uptake into the kidneys, thereby increasing plasma IS, which produces oxidative stress and induces vascular endothelial dysfunction in CKD patients. The highly selective inhibition of URAT1 by dotinurad may be beneficial for metabolic syndrome, CKD, and CVD.
- |||||||||| Review, Journal: Pipeline Therapies for Gout. (Pubmed Central) - Dec 22, 2023
A new xanthine oxidase inhibitor (XOI), tigulixostat, is under study...Dapansutrile, an oral agent under investigation, inhibits activation of the NLRP3 inflammasome and may be an effective anti-inflammatory. New treatments for gout that are under study may work in the setting of comorbidities, simplify management, utilize new mechanisms, or have reduced side effects.
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Journal: Efficacy of dotinurad in patients with severe renal dysfunction. (Pubmed Central) - Oct 21, 2023 With the 12-month dotinurad treatment, the annual change in the patients' eGFR was significantly improved from -6.0? Dotinurad may have UA-lowering effects and the potential to improve kidney function in patients with severe renal dysfunction.
- |||||||||| Urece (dotinurad) / Fuji Yakuhin, Mochida, Fortress, Eisai
Journal: URAT1 is expressed in cardiomyocytes and dotinurad attenuates the development of diet-induced metabolic heart disease. (Pubmed Central) - Sep 11, 2023 Intriguingly, among various factors related to the pathophysiology of diet-induced obesity, palmitic acid significantly increased URAT1 expression in NRCMs and subsequently induced apoptosis, oxidative stress, and inflammatory responses via MAPK pathway, all of which were reduced by dotinurad. These results indicate that URAT1 is a potential therapeutic target for metabolic heart disease.
- |||||||||| Urece (dotinurad) / Fuji Yakuhin, Mochida, Fortress, Eisai
Trial completion, Trial completion date, Trial primary completion date, Head-to-Head: A Study to Evaluate Efficacy of Dotinurad and Febuxostat for the Treatment of Participants With Gout (clinicaltrials.gov) - Aug 2, 2023 P3, N=451, Completed, These results indicate that URAT1 is a potential therapeutic target for metabolic heart disease. Active, not recruiting --> Completed | Trial completion date: Sep 2023 --> Jun 2023 | Trial primary completion date: Sep 2023 --> Jun 2023
- |||||||||| Urece (dotinurad) / Fuji Yakuhin, Mochida, Fortress, Eisai
Enrollment closed, Head-to-Head: A Study to Evaluate Efficacy of Dotinurad and Febuxostat for the Treatment of Participants With Gout (clinicaltrials.gov) - Mar 2, 2023 P3, N=451, Active, not recruiting, No abstract available Recruiting --> Active, not recruiting
- |||||||||| Urece (dotinurad) / Fuji Yakuhin, Mochida, Fortress, Eisai
Journal: Efficacy and safety of switching from febuxostat to dotinurad, a novel selective urate reabsorption inhibitor, in hyperuricemic patients with type 2 diabetic kidney disease: Protocol for a single-arm, open-label, prospective, exploratory study. (Pubmed Central) - Jan 31, 2023 The results of this study will be published through submission to a peer-reviewed scientific journal. https://jrct.niph.go.jp/en-latest-detail/jRCTs031220080, identifier jRCTs031220080.
- |||||||||| Urece (dotinurad) / Fuji Yakuhin, Mochida, Fortress, Eisai
Enrollment open: A Single and Multiple Dose Study of Dotinurad in Chinese Healthy Participants (clinicaltrials.gov) - Jul 20, 2022 P1, N=26, Recruiting, Therefore, effects of uricosuric agents can be evaluated by the novel method, which is closer to the physiological system compared with previous methods. Not yet recruiting --> Recruiting
- |||||||||| Urece (dotinurad) / Fuji Yakuhin, Mochida
Journal: Identification of human UDP-glucuronosyltransferase and sulfotransferase as responsible for the metabolism of dotinurad, a novel selective urate reabsorption inhibitor. (Pubmed Central) - Mar 25, 2022 The present study revealed that dotinurad glucuronidation is catalyzed mainly by UGT1A1, UGT1A3, UGT1A9, and UGT2B7 and that its sulfation is catalyzed by many SULT isoforms, including SULT1B1 and SULT1A3. Therefore, dotinurad, a selective urate reabsorption inhibitor, is considered safe for use with a small risk of DDIs and low interindividual variability.
- |||||||||| Clinical, Journal: Inequalities in enrollment of women and racial minorities in trials testing uric acid lowering drugs. (Pubmed Central) - Feb 16, 2022
Febuxostat 40 mg and dotinurad 2 mg tended to be more effective than benzbromarone 50 mg, while dotinurad 2 mg and benzbromarone 50 mg tended to be safer than febuxostat 40 mg in hyperuricemic patients with or without gout. Our analysis shows that women and racial and ethnical minorities are underrepresented in controlled clinical trials testing SUA-lowering drugs, with similar pattern across drug classes.
- |||||||||| verinurad (RDEA3170) / AstraZeneca, Urece (dotinurad) / Fuji Yakuhin, Mochida
Review, Journal: A historical journey of searching for uricosuric drugs. (Pubmed Central) - Jan 6, 2022 Pharmacotherapeutically, a negative urate balance should be the aim of clinicians and then the rational choice of treatment with uricosurics seems quite logical and promising, but has not had a thorough attention of pharma, researchers nor of clinicians, though most gout patients were and still are low excretors. Here, an overview on the 70-year-old journey mankind has made in a search for uricosurics resulting so far in only 1 registered uricosuric per continent.
- |||||||||| Urece (dotinurad) / Fuji Yakuhin, Mochida
P2 data, P3 data, Retrospective data, Journal: Uric acid-lowering effect of dotinurad, a novel selective urate reabsorption inhibitor, in hypertensive patients with gout or asymptomatic hyperuricemia: a pooled analysis of individual participant data in phase II and III trials. (Pubmed Central) - Nov 29, 2021 P2, P3 In the pooled analysis, dotinurad lowered serum uric acid levels. Dotinurad has an achievement rate of over 80% for serum uric acid level of ≤6.0 mg/dL in both analyses, and will be clinically useful for the management of hyperuricemic states in hypertensive patients.
- |||||||||| Urece (dotinurad) / Fuji Yakuhin, Mochida, Fortress, Eisai
Trial completion, Trial completion date, Trial primary completion date: Study of FYU-981 in Hyperuricemia With or Without Gout (clinicaltrials.gov) - Dec 6, 2018 P3, N=330, Completed, Dotinurad is expected to be a new therapeutic option in hyperuricemic patients with and without gout. Active, not recruiting --> Completed | Trial completion date: Jan 2020 --> Oct 2018 | Trial primary completion date: Jan 2020 --> Aug 2018
- |||||||||| Urece (dotinurad) / Fuji Yakuhin, Mochida, Fortress, Eisai
Trial completion, Trial completion date, Trial primary completion date, Head-to-Head: Benzbromarone-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout (clinicaltrials.gov) - Sep 26, 2018 P3, N=201, Completed, Active, not recruiting --> Completed | Trial completion date: Jan 2020 --> Oct 2018 | Trial primary completion date: Jan 2020 --> Aug 2018 Active, not recruiting --> Completed | Trial completion date: Jan 2020 --> Aug 2018 | Trial primary completion date: Jun 2019 --> Apr 2018
- |||||||||| Urece (dotinurad) / Fuji Yakuhin, Mochida, Fortress, Eisai
Trial completion, Head-to-Head: Febuxostat-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout (clinicaltrials.gov) - Sep 24, 2018 P3, N=203, Completed, Recruiting --> Completed Recruiting --> Completed
- |||||||||| Urece (dotinurad) / Fuji Yakuhin, Mochida, Fortress, Eisai
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: Study of FYU-981 in Hyperuricemia (Effect on Two Hyperuricemic Types) (clinicaltrials.gov) - Aug 21, 2018 P2, N=24, Completed, Recruiting --> Completed | Trial completion date: Oct 2018 --> Jun 2018 Active, not recruiting --> Completed | N=18 --> 24 | Trial completion date: Dec 2017 --> Mar 2018 | Trial primary completion date: Dec 2017 --> Aug 2017
- |||||||||| Urece (dotinurad) / Fuji Yakuhin, Mochida, Fortress, Eisai
Trial completion, Trial completion date, Trial primary completion date: Mass Balance Study of FYU-981 (clinicaltrials.gov) - Aug 21, 2018 P2, N=6, Completed, Active, not recruiting --> Completed | N=18 --> 24 | Trial completion date: Dec 2017 --> Mar 2018 | Trial primary completion date: Dec 2017 --> Aug 2017 Active, not recruiting --> Completed | Trial completion date: Oct 2017 --> Jul 2018 | Trial primary completion date: Oct 2017 --> Jan 2017
- |||||||||| Urece (dotinurad) / Fuji Yakuhin, Mochida, Fortress, Eisai
Enrollment open, Head-to-Head: Febuxostat-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout (clinicaltrials.gov) - Jan 24, 2018 P3, N=200, Recruiting, Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||||||||| Urece (dotinurad) / Fuji Yakuhin, Mochida, Fortress, Eisai
New P3 trial, Head-to-Head: Febuxostat-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout (clinicaltrials.gov) - Dec 12, 2017 P3, N=200, Not yet recruiting,
- |||||||||| Urece (dotinurad) / Fuji Yakuhin, Mochida, Fortress, Eisai
Trial completion: Clinical Pharmacology of FYU-981 (Final Formulation) (clinicaltrials.gov) - Dec 12, 2017 P1, N=12, Completed, Not yet recruiting --> Recruiting Not yet recruiting --> Completed
- |||||||||| Urece (dotinurad) / Fuji Yakuhin, Mochida, Fortress, Eisai
Trial completion: Drug-drug Interaction Study of FYU-981 and Oxaprozin (clinicaltrials.gov) - Dec 12, 2017 P1, N=12, Completed, Not yet recruiting --> Completed Not yet recruiting --> Completed
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