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Verinurad+Febuxostat

Phase 2

Hyperuricemia | Small molecule | Metabolic |AstraZeneca PLC|Last Updated: Jan 10, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

Verinurad+Febuxostat · 1 trial · 3 indications

Phase 2 1
NCT03118739Intensive Uric Acid Lowering With Verinurad and Febuxostat in Patients With AlbuminuriaHyperuricemia
COMPLETED60 Analytics
PHASE2COMPLETED
Intensive Uric Acid Lowering With Verinurad and Febuxostat in Patients With Albuminuria
HyperuricemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Urinary Albumin to Creatinine Ratio (UACR)
From Baseline to 12 Weeks of Treatment

LS Mean Percentage Change (95% CI) from Baseline in UACR

Urinary Albumin to Creatinine Ratio (UACR) Compared to Placebo
From Baseline to 24 Weeks of Treatment

LS Mean Percentage Change (90% CI) from Baseline in UACR Compared to Placebo

Secondary Endpoints

sUA
From Baseline to 12 Weeks and 24 Weeks of Treatment
eGFR
From Baseline to 12 Weeks and 24 Weeks of Treatment
Serum Creatinine
From Baseline to 12 Weeks and 24 Weeks of Treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Verinurad 9 mg+Febuxostat 80 mgEXPERIMENTALCapsule administered orally, once daily for 24 weeks
PlaceboPLACEBO_COMPARATORCapsule administered orally, once daily for 24 weeks

Interventions

NameTypeDescription
Verinurad 9 mg+Febuxostat 80 mgDRUGCapsule administered orally, once daily for 24 weeks
PlaceboDRUGCapsule administered orally, once daily for 24 weeks
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Eligibility Criteria

Age Range18 Years to 99 Years
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * Serum Uric Acid ≥6.0 mg/dL * eGFR ≥30 mL/min/1.73 m2 * UACR between 30 mg/g and 3500 mg/g inclusive * Diagnosed with T2DM Exclusion Criteria: * Treated with any drug for hyperuricemia in the 6 months preceding randomization.Drugs for hyperuricemia include all XO inhibitors (...

Countries:United States
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Frequently asked questions about Verinurad+Febuxostat

What is Verinurad used for?

Verinurad is an investigational small molecule being studied for chronic kidney disease, hyperuricemia, asymptomatic hyperuricemia, and heart failure with preserved ejection fraction (HFpEF). It has been evaluated in Phase 2 clinical trials for these conditions, though it remains investigational and is not approved.

What does Verinurad target?

Verinurad is a uric acid lowering agent. It has been studied in combination with febuxostat and dapagliflozin to assess its effect on urinary excretion of uric acid in patients with asymptomatic hyperuricemia. Its mechanism involves reducing uric acid levels.

Who is developing Verinurad?

Verinurad is being developed by AstraZeneca PLC, which is listed on the stock exchange under the ticker AZN. The company has sponsored clinical trials of Verinurad across multiple countries, including the United States and Germany.

What phase is Verinurad in?

Verinurad has completed Phase 2 clinical trials for hyperuricemia, asymptomatic hyperuricemia, and heart failure with preserved ejection fraction. It has also completed a Phase 1 trial in healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is Verinurad in?

Verinurad has been studied in several completed trials. NCT03118739 evaluated it with febuxostat in patients with hyperuricemia and albuminuria. NCT03316131 assessed its effect on uric acid excretion with febuxostat and dapagliflozin. NCT04256629 examined its effect on heart electrical activity in healthy volunteers, and NCT04327024 studied it in heart failure with preserved ejection fraction.

Is Verinurad the same as RDEA3170?

Verinurad is also known as RDEA3170. In clinical trial NCT03316131, the study title refers to RDEA3170, which is the same drug as Verinurad. This alternative name may appear in older or related research documentation.