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Dotinurad

Phase 3Small molecule

Dotinurad is one of 35 small molecule programs targeting Hyperuricemia. It is currently in Phase 3.

2

Indications

7

Total Trials

5

Active Trials

34

Competitors

Pipeline

Status by Indication[3][1]

Indication

HyperuricemiaRecruiting

GoutNot yet recruiting

HyperuricemiaPhase 3

Recruiting

GoutPhase 3

Not yet recruiting

Competition

Competitive Landscape

26 competitors in Gout

#DrugCompanyPhaseTrials

Uloric

Zyloprim

Jazz Pharmaceuticals

Colcrys

Jazz Pharmaceuticals

Trexall

Jazz Pharmaceuticals

Aleve

Jazz Pharmaceuticals

Cellcept

Prevacid

Otezla

Glucophage

Rayos

RRoxane Laboratories

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2027

ApprovedNot yet recruiting

Gout

NCT07661030

Phase 2Recruiting

Gout

NCT07535034

Q4 2027

Phase 3Recruiting

Gout

NCT07089875

Phase 3Recruiting

Tophaceous Gout

NCT07089888

Q1 2030

Post-ApprovalRecruiting

Hyperuricemia

NCT06834230

Clinical

Trials by Indication[1]

Gout3 trials

A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Dotinurad Compared With Allopurinol in Adult Participants With Hyperuricemia Associated With Gout

Recruiting·CCrystalys Therapeutics·Phase 3·NCT07089875·500 enrolled

A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Dotinurad in Adult Participants With Gout Who Are Intolerant to Xanthine Oxidase Inhibitors or Failed Uricase Treatment

Recruiting·CCrystalys Therapeutics·Phase 2·NCT07535034·90 enrolled

The Impact of Initiating Dotinurad Urate-Lowering Therapy at Different Time Windows on Gout Flare Resolution Time: A Multicenter, Randomized, Parallel-Controlled Study

Not yet recruiting·FFirst Affiliated Hospital of Wenzhou Medical University·Approved·NCT07661030·142 enrolled

ART1 trial

A Single and Multiple Dose Study of Dotinurad in Chinese Healthy Participants

Completed· Eisai logo

Eisai·Phase 1·NCT05278676·26 enrolled

Treatment1 trial

A Study to Evaluate Efficacy of Dotinurad and Febuxostat for the Treatment of Participants With Gout

Completed· Eisai logo

Eisai·Phase 3·NCT05007392·451 enrolled

Hyperuricemia1 trial

Effect of Dotinurad in Hyperuricemia With Hypertension

Recruiting·—·Phase 4·NCT06834230·360 enrolled

Tophaceous Gout1 trial

A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Dotinurad Compared With Allopurinol in Adult Participants With Tophaceous Gout

Recruiting·CCrystalys Therapeutics·Phase 3·NCT07089888·250 enrolled

Sources

References

[1]
ClinicalTrials.gov — 7 trial records for Dotinurad. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Dotinurad compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Dotinurad. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Eisai company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Eisai

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