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Metoprolol

Phase 4FDA approved

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

Metoprolol development status

FDA approval on record Aug 28, 2025 as Lopressor
Approval holderXtm Consulting
ApplicationNDA218698
Highest phase Phase 4 run by Sahlgrenska University Hospital (NCT00718406)
Phase scored for VTRSPhase 1
Registered trials 24 across 19 sponsors since May 2003

Metoprolol target and mechanism

Molecular targetADRB1
Target classAntagonist
ModalitySmall molecule
ChEMBLCHEMBL13

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials4
Total Enrollment103

FDA Designations

No designations recorded

Metoprolol clinical trials

Metoprolol · 4 trials · 1 indication

Phase 1 4
NCT00649233Food Study of Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg to Lopressor HCT® Tablets 100/50 mgHealthy
COMPLETED32 Analytics
NCT00649688Fasting Study of Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg and Lopressor HCT® Tablets 100/50 mgHealthy
COMPLETED32 Analytics
NCT00648271Fed Study of Metoprolol Tartrate Tablets 25 mg and Lopressor® 50 mgHealthy
COMPLETED19 Analytics
NCT00649116Fed Study of Metoprolol Tartrate Tablets 100 mg and Lopressor® 100 mgHealthy
COMPLETED20 Analytics
PHASE1COMPLETED
Food Study of Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg to Lopressor HCT® Tablets 100/50 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fasting Study of Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg and Lopressor HCT® Tablets 100/50 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fed Study of Metoprolol Tartrate Tablets 25 mg and Lopressor® 50 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fed Study of Metoprolol Tartrate Tablets 100 mg and Lopressor® 100 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
1EXPERIMENTALMetoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg
2ACTIVE_COMPARATORLopressor HCT® Tablets 100/50 mg

Interventions

NameTypeDescription
Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mgDRUG100/50mg, single dose fed
Lopressor HCT® Tablets 100/50 mgDRUG100/50mg, single dose fed
Metoprolol Tartrate Tablets 25 mgDRUG2x50mg, single dose fed
Lopressor® Tablets 50 mgDRUG1x50mg, single dose fed
Metoprolol Tartrate Tablets 100 mgDRUG100mg, single dose fed
Lopressor® Tablets 100 mgDRUG100mg, single dose fed
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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 non-pregnant, non-lactating female 1. Women of childbearing potential must have negative serum Beta-human chorionic gonadotropin (HCG) pregnancy tests performed within 14 days prior to the start of the study and the evening prior ...

Countries:United States
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Frequently asked questions about Metoprolol

What is metoprolol?

Metoprolol is a small molecule drug developed by Viatris Inc. (ticker VTRS). It is an antagonist of ADRB1, also known as the beta-1 adrenergic receptor. The drug has been studied in Phase 1 clinical trials, with four completed trials involving a total of 103 healthy volunteers.

What does metoprolol target?

Metoprolol targets ADRB1, the beta-1 adrenergic receptor. It acts as an antagonist at this receptor. By blocking ADRB1, metoprolol interferes with the binding of catecholamines such as epinephrine and norepinephrine, which are involved in regulating heart rate and blood pressure.

Who makes metoprolol?

Metoprolol is developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the company responsible for the clinical development of the metoprolol formulations described in these trials.

What phase is metoprolol in?

Metoprolol is in Phase 1 clinical development. Four Phase 1 trials have been completed, and there are currently no active trials. The completed trials enrolled a total of 103 participants. The drug is investigational and has not been approved by the FDA for any indication based on the available information.

What clinical trials is metoprolol in?

Metoprolol has been studied in four completed Phase 1 trials: NCT00649688, NCT00649233, NCT00649116, and NCT00648271. These trials evaluated metoprolol tartrate and metoprolol tartrate/hydrochlorothiazide tablets in healthy volunteers under fasting and fed conditions, with enrollment ranging from 19 to 32 participants per trial.