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Metolazone

Phase 1

Healthy | Small molecule | Other |Viatris Inc.|Last Updated: Apr 24, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials3
Total Enrollment160

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

Metolazone is a small molecule drug being developed by Viatris Inc. for use in healthy volunteers. It is currently in Phase 1 clinical development, with three completed trials studying the drug in healthy individuals. The drug is not yet approved and remains investigational.

Who makes Metolazone?

Metolazone is developed by Viatris Inc., a company traded on the stock exchange under the ticker VTRS. The drug is currently in Phase 1 clinical development, with all three completed trials conducted in healthy volunteers in the United States.

What phase is Metolazone in?

Metolazone is in Phase 1 clinical development. All three clinical trials for the drug have been completed, with a total enrollment of 160 healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is Metolazone in?

Metolazone has three completed Phase 1 clinical trials: NCT00649051, NCT00649181, and NCT00650195. These fasting studies compared Metolazone tablets at doses of 2.5 mg, 5 mg, and 10 mg against Zaroloxyn tablets in healthy volunteers in the United States.

Is Metolazone the same as Zaroloxyn?

Metolazone is being studied in clinical trials as a generic version of Zaroloxyn. The three Phase 1 trials compare Metolazone tablets at 2.5 mg, 5 mg, and 10 mg doses to Zaroloxyn tablets at the same strengths in healthy volunteers.