Dotinurad

Phase 3Small molecule

Eisai

Dotinurad is one of 34 small molecule programs targeting Tophaceous Gout. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Tophaceous GoutRecruiting

GoutNot yet recruiting

HyperuricemiaRecruiting

Tophaceous GoutPhase 3

Recruiting

GoutPhase 3

Not yet recruiting

HyperuricemiaPhase 3

Recruiting

Competition

Competitive Landscape

25 competitors in Gout

#DrugCompanyPhaseTrials

Uloric

Takeda

Approved

11 2

Zyloprim

Jazz Pharmaceuticals

Approved

8 3

Colcrys

Jazz Pharmaceuticals

Approved

3 4

Trexall

Jazz Pharmaceuticals

Approved

1 5

Aleve

Jazz Pharmaceuticals

Approved

1 6

Cellcept

Prevacid

Otezla

Rayos

1 10

Glucophage

EMD Serono

Approved

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 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

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

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

Hyperuricemia1 trial

Effect of Dotinurad in Hyperuricemia With Hypertension

Recruiting·—·Phase 4·NCT06834230·360 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

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

Dotinurad

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q4 2027

Q1 2030

Trials by Indication[1]

Gout3 trials

ART1 trial

Hyperuricemia1 trial

Treatment1 trial

Tophaceous Gout1 trial

References

Drug Info

Quick Facts

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