FYU-981

DRUG10 trials

Conditions

HealthyHepatic InsufficiencyHyperuricemiaHyperuricemia With or Without Gout

Phase 1

Clinical Pharmacology of FYU-981 (Subjects With Hepatic Insufficiency)

CompletedNCT03306667

Mochida Pharmaceutical Company, Ltd.Healthy, Hepatic Insufficiency

Start: 2017-10-06End: 2018-06-25Updated: 2018-09-24

Clinical Pharmacology of FYU-981 (Final Formulation)

CompletedNCT03350373

Mochida Pharmaceutical Company, Ltd.Healthy

Start: 2017-11-06End: 2017-11-29Updated: 2017-12-12

Drug-drug Interaction Study of FYU-981 and Oxaprozin

CompletedNCT03350386

Mochida Pharmaceutical Company, Ltd.Healthy

Start: 2017-11-02End: 2017-12-05Updated: 2022-09-14

Study of FYU-981 in Hyperuricemic Outpatients With or Without Gout (Effect on Two Hyperuricemic Types)

CompletedNCT03375632

Mochida Pharmaceutical Company, Ltd.Hyperuricemia With or Without Gout

Start: 2018-01-04End: 2018-06-05Updated: 2018-09-24

Phase 2

Study of FYU-981 in Hyperuricemia With or Without Gout

CompletedNCT02416167

Fuji Yakuhin Co., Ltd.Hyperuricemia

Start: 2015-05-31End: 2016-11-30Target: 200Updated: 2017-02-14

Clinical Pharmacology of FYU-981 (Effect on QT/QTc Interval)

CompletedNCT02515864

Fuji Yakuhin Co., Ltd.Healthy

Start: 2015-08-31End: 2016-11-30Updated: 2017-09-08

Study of FYU-981 in Hyperuricemia (Effect on Two Hyperuricemic Types)

CompletedNCT02837198

Fuji Yakuhin Co., Ltd.Hyperuricemia

Start: 2016-07-31End: 2018-03-31Updated: 2018-08-21

Phase 3

Study of FYU-981 in Hyperuricemia With or Without Gout

CompletedNCT03006445

Fuji Yakuhin Co., Ltd.Hyperuricemia With or Without Gout

Start: 2016-12-31End: 2018-10-24Updated: 2018-12-06

Benzbromarone-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout

CompletedNCT03100318

Fuji Yakuhin Co., Ltd.Hyperuricemia With or Without Gout

Start: 2017-04-01End: 2018-08-31Updated: 2018-09-26

Febuxostat-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout

CompletedNCT03372200

Mochida Pharmaceutical Company, Ltd.Hyperuricemia With or Without Gout

Start: 2018-01-09End: 2018-07-05Updated: 2018-09-24

Related Papers

Changes in urinary albumin levels with dotinurad oral administration in hyperuricemic patients with microalbuminuria: a post hoc analysis.

2025-08-21

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

Clinical and Experimental Hypertension2021-08-2324 citations

A drug-drug interaction study of a novel, selective urate reabsorption inhibitor dotinurad and the non-steroidal anti-inflammatory drug oxaprozin in healthy adult males.

2020-02-195 citations

Dotinurad versus benzbromarone in Japanese hyperuricemic patient with or without gout: a randomized, double-blind, parallel-group, phase 3 study.

2020-01-2436 citations

Open-label study of long-term administration of dotinurad in Japanese hyperuricemic patients with or without gout.

2019-12-2622 citations

Clinical efficacy and safety of dotinurad, a novel selective urate reabsorption inhibitor, in Japanese hyperuricemic patients with or without gout: randomized, multicenter, double-blind, placebo-controlled, parallel-group, confirmatory phase 2 study.

2019-12-0322 citations

The effect for hyperuricemia inpatient of uric acid overproduction type or in combination with topiroxostat on the pharmacokinetics, pharmacodynamics and safety of dotinurad, a selective urate reabsorption inhibitor.

2019-11-168 citations