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Hydrochlorothiazide

Phase 4FDA approved

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

Hydrochlorothiazide development status

FDA approval on record Mar 6, 1998
Approval holderNovartis
ApplicationNDA020818
Highest phase Phase 4 run by Sanofi (NCT00500604)
Phase scored for VTRSPhase 1
Registered trials 31 across 11 sponsors since Sep 2004

Label indication Diovan HCT (valsartan and hydrochlorothiazide, USP) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. FDA label

Hydrochlorothiazide target and mechanism

Molecular targetSLC12A3
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL435

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Hydrochlorothiazide clinical trials

Hydrochlorothiazide · 1 trial · 1 indication

Early Phase 1 1
NCT00649324Fasting Study of Hydrochlorothiazide Tablets 50 mg to Hydrochlorothiazide Tablets 50 mgHealthy
COMPLETED40 Analytics
EARLY_PHASE1COMPLETED
Fasting Study of Hydrochlorothiazide Tablets 50 mg to Hydrochlorothiazide Tablets 50 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
1EXPERIMENTALHydrochlorothiazide Tablets 50 mg
2ACTIVE_COMPARATORHydrochlorothiazide Tablets 50 mg

Interventions

NameTypeDescription
Hydrochlorothiazide Tablets 50 mgDRUG50mg, single dose fasting
Hydrochlorothiazide Tablets (50 mgDRUG50mg, 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 a. Women of childbearing potential must have a negative serum (β-HCG) pregnancy test performed within 21 days prior to the start of the study and on the evening prior to each dose administration. I...

Countries:United States
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Frequently asked questions about Hydrochlorothiazide

What is Hydrochlorothiazide?

Hydrochlorothiazide is a small molecule drug candidate that Viatris Inc. is developing under the name Hydrochlorothiazide Tablets 50 mg. It is being studied in a Phase 1 clinical program. The specific therapeutic indication for this formulation has not been disclosed.

What does Hydrochlorothiazide target?

Hydrochlorothiazide targets SLC12A3. It acts as an inhibitor of this target. SLC12A3 is the molecular target listed for the drug, and the compound is classified as a small molecule.

Who makes Hydrochlorothiazide?

Hydrochlorothiazide is being developed by Viatris Inc., which trades under the ticker symbol VTRS. The company is responsible for the Hydrochlorothiazide Tablets 50 mg program.

What phase is Hydrochlorothiazide in?

Hydrochlorothiazide is in Phase 1 clinical development. It is an investigational drug candidate and has not been approved by the FDA for the studied formulation. The program includes one completed early Phase 1 trial.

What clinical trials is Hydrochlorothiazide in?

Hydrochlorothiazide has been studied in one completed clinical trial, NCT00649324, titled Fasting Study of Hydrochlorothiazide Tablets 50 mg to Hydrochlorothiazide Tablets 50 mg. The trial enrolled 40 healthy volunteers in the United States and was active-controlled and randomized.