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Metolazone

Phase 1

Undisclosed | Small molecule | Other |Viatris Inc.|Trials Updated: Apr 24, 2024

Metolazone target and mechanism

Molecular targetSLC12A3
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL878

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials3
Total Enrollment160

FDA Designations

No designations recorded

Metolazone clinical trials

Metolazone · 3 trials · 1 indication

Phase 1 3
NCT00650195Fasting Study of Metolazone Tablets 10 mg and Zaroloxyn® Tablets 10 mgHealthy
COMPLETED56 Analytics
NCT00649181Fasting Study of Metolazone Tablets 5 mg and Zaroloxyn® Tablets 5 mgHealthy
COMPLETED52 Analytics
NCT00649051Fasting Study of Metolazone Tablets 2.5 mg and Zaroloxyn® Tablets 2.5 mgHealthy
COMPLETED52 Analytics
PHASE1COMPLETED
Fasting Study of Metolazone Tablets 10 mg and Zaroloxyn® Tablets 10 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fasting Study of Metolazone Tablets 5 mg and Zaroloxyn® Tablets 5 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fasting Study of Metolazone Tablets 2.5 mg and Zaroloxyn® Tablets 2.5 mg
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence
within 30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALMetolazone Tablets 10 mg
2ACTIVE_COMPARATORZaroloxyn® Tablets 10 mg

Interventions

NameTypeDescription
Metolazone Tablets 10 mgDRUG10mg, single dose fasting
Zaroloxyn® Tablets 10 mgDRUG10mg, single dose fasting
Metolazone Tablets 5 mgDRUG2x5mg, single dose fasting
Zaroloxyn® Tablets 5 mgDRUG2x5mg, single dose fasting
Metolazone Tablets 2.5 mgDRUG4x2.5mg, single dose fasting
Zaroloxyn® Tablets 2.5 mgDRUG4x2.5mg, single dose fasting
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age: 18 years and older 2. Sex: Male and/or non-pregnant, non-lactating female 1. Women of childbearing potential must have negative serum b-human chorionic gonadotropin (β-HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening pr...

Countries:United States
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Frequently asked questions about Metolazone

What is Metolazone?

Metolazone is a small molecule drug developed by Viatris Inc. (ticker VTRS). It is an inhibitor of SLC12A3 and is currently in Phase 1 clinical development. Its therapeutic area is classified as Other, and the specific indications being studied are undisclosed.

What does Metolazone target?

Metolazone targets SLC12A3 and acts as an inhibitor of this target. SLC12A3 is a sodium chloride cotransporter. By inhibiting SLC12A3, Metolazone affects sodium reabsorption. This mechanism underlies its pharmacological activity as a small molecule therapeutic agent.

Who makes Metolazone?

Metolazone is developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the company responsible for the development program. The drug is formulated as Metolazone Tablets in 2.5 mg, 5 mg, and 10 mg strengths.

What phase is Metolazone in?

Metolazone is in Phase 1 clinical development. It is an investigational drug and is not approved. Three Phase 1 trials have been completed, with no active trials currently ongoing. The completed trials enrolled a total of 160 participants across the studies.

What clinical trials is Metolazone in?

Metolazone has been studied in three completed Phase 1 trials: NCT00650195, NCT00649181, and NCT00649051. These were fasting studies comparing Metolazone Tablets at 10 mg, 5 mg, and 2.5 mg against Zaroloxyn Tablets at matching strengths. All trials enrolled healthy volunteers in the United States.