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dontinurad

Phase 1

Gout | Small molecule | Musculoskeletal |Fortress Biotech, Inc.|Last Updated: Jan 28, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06056570Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients with HyperuricemiaPHASE1 COMPLETED 20Oct 4, 2023Jul 9, 2024Jan 28, 20254 United States
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Study Endpoints
Primary Endpoints
Peak plasma concentrations (Cmax)
7 days

To evaluate the Cmax of dotinurad 2mg, dotinturad 4mg, and allopurinol 300mg

Area under the plasma concentration versus time curve (AUC)
7 days

To evaluate the AUC of dotinurad 2mg, dotinturad 4mg, and allopurinol 300mg

Time to maximum plasma concentration (Tmax)
7 days

To evaluate the Tmax of dotinurad 2mg, dotinturad 4mg, and allopurinol 300mg

Terminal half life (T1/2)
7 days

To evaluate the T1/2 of dotinurad 2mg, dotinturad 4mg, and allopurinol 300mg

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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
dotinurad 2mgEXPERIMENTALdotinurad 2mg q.d.
dotinurad 4mgEXPERIMENTALdotinurad 4mg q.d.
Interventions
NameTypeDescription
dontinuradDRUGdotinurad alone
dotinurad + allopurinolDRUGdotinurad + allopurinol 300mg
allopurinolDRUGallopurinol 300 mg alone
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * 1\. In the opinion of the investigator, the patient is capable of understanding and complying with protocol requirements. 2\. Patients with a diagnosis of gout based on American College of Rheumatology criteria (1997). Patients must fulfill at least 3 of the following, with...

Countries:United States
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Competitive Landscape -Gout 5 trials