A Phase 3 interventional study of FYU-981 and Febuxostat in Hyperuricemia With or Without Gout, sponsored by Mochida Pharmaceutical Company, Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2018-09-24.
Sponsored by Mochida Pharmaceutical Company, Ltd. · Phase 3, Interventional, and Treatment
Among 10 studies testing dotinurad in Gout — 4 open to participants now, 4 under way, 1 of them phase 3. dotinurad · Gout.
Among the 10 studies testing dotinurad in Gout, this one is the 5th largest by enrollment, is one of 2 that started in 2018, is one of 5 in phase 3, and was the 3rd registered.
345 studies on the registry are indexed under Gout; 49 are open to participants now.
Browse Gout studies →4 of the 10 studies testing dotinurad in Gout are open now, in 4 countries. Recruiting first, the newest first:
Crystalys Therapeutics · Sites in United States
Ages 18–75
Crystalys Therapeutics · Sites in United States, Poland, Spain
Ages 18–75
Saga University · Sites in Japan
Ages 20+
First Affiliated Hospital of Wenzhou Medical University
Ages 18–70
By country, each count listing its studies:
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 30 Gout studies recruiting now, 14 (47%) set no upper age limit and 10 (33%) stop at 75 or younger; none take children under 18; none take healthy volunteers.
This study: 20 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 2 · Phase 3 5 · Phase 4 2
First in 2016; this study’s year is marked. 2 started in 2018.
This study's enrollment of 203 is above the median of 83 across 286 interventional studies indexed under Gout.
Median enrollment 202 across the 10 interventional studies. Of the 6 that completed or were terminated, 2 (33%) have results posted.
This tab as a report to print or save as PDF → With an account.
8 of 10 have an industry lead sponsor. The 7 most frequent:
Mochida Pharmaceutical Company, Ltd. is the lead sponsor of 12 studies on the registry; none are open to participants now.
Mochida Pharmaceutical Company, Ltd. has 2 studies filed under Gout — fewer than ten, so there is no comparison to draw.
4 of the studies testing dotinurad in Gout that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07089875Phase 3Crystalys TherapeuticsA Study of Dotinurad Versus Allopurinol in Participants With Gout | 2027-11-29 |
| NCT07535034Crystalys TherapeuticsA Phase 2 Trial of Dotinurad in Xanthine Oxidase Inhibitor (XOI) Intolerant/Uricase Failure Gout Participants | 2027-07 |
| NCT07661030First Affiliated Hospital of Wenzhou Medical UniversityThe Impact of Initiating Dotinurad Urate-Lowering Therapy at Different Time Windows on Gout Flare Resolution Time | 2027-07-30 |
| NCT06834230Saga UniversityEffect of Dotinurad in Hyperuricemia With Hypertension | 2027-07-31 |
Add all 4 to your calendar (.ics) → With an account.
Among the 10 studies testing dotinurad in Gout, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
FYU-981 or Febuxostat are administrated to hyperuricemia patients (underexcretion and mixed types) with or without gout for 14 weeks to compare the efficacy and safety of these drugs by the method of multicenter, randomized, double-blind, ascending dose regimen.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Serum urate level:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: FYU-981
Drug: Febuxostat
Oral daily dosing for 14 weeks
Oral daily dosing for 14 weeks
Percent reduction from baseline in serum urate level at the final visit
Percent reduction from baseline in serum urate level at the final visit
Time frame: 14 weeks
Ran from Jan 2018 to primary completion in Jun 2018, 4 months.
Of 21 phase 3 interventional studies under Gout, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 25. This study's 4 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Dotinurad
Mochida Pharmaceutical Company, Ltd.