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Metoprolol

Phase 4FDA approved

Undisclosed | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Trials Updated: Sep 28, 2012

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 RDYPhase 1
Registered trials 24 across 19 sponsors since May 2003

Metoprolol target and mechanism

Molecular targetADRB1
Target classAntagonist
ModalitySmall molecule
ChEMBLCHEMBL13

Also known as Metoprolol Succinate, TOPROL-XL®

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment96

FDA Designations

No designations recorded

Metoprolol clinical trials

Metoprolol · 2 trials · 1 indication

Phase 1 2
NCT01694797Bioequivalence Study for Metoprolol Succinate ER Tablets 50 mg Under Fasting ConditionHealthy
COMPLETED48 Analytics
NCT01673997Bioequivalence Study of Metoprolol Succinate ER Tablets, 200 mg Under Fasting ConditionsHealthy
COMPLETED48 Analytics
PHASE1COMPLETED
Bioequivalence Study for Metoprolol Succinate ER Tablets 50 mg Under Fasting Condition
HealthyUnlock trial analytics
PHASE1COMPLETED
Bioequivalence Study of Metoprolol Succinate ER Tablets, 200 mg Under Fasting Conditions
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Area under curve (AUC)
Pre-dose (0.00) and 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 11.00, 12.00, 13.00, 14.00, 15.00, 16.00, 18.00, 20.00, 24.00, 36.00 and 48.00 hours post-dose.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Metoprolol Succinate ER Tablets, 50 mgEXPERIMENTALMetoprolol Succinate ER Tablets, 50 mg of Dr.Reddy's Laboratories Ltd
TOPROL-XL ER Tablets 50 mgACTIVE_COMPARATORTOPROL-XL ER Tablets 50 mg of AstraZeneca
Metoprolol Succinate ER Tablets, 200 mgEXPERIMENTALMetoprolol Succinate ER Tablets, 200 mg of Dr.Reddy's Laboratories Ltd
TOPROL-XL ER Tablets 200 mgACTIVE_COMPARATORTOPROL-XL ER Tablets 200 mg of AstraZeneca

Interventions

NameTypeDescription
Metoprolol SuccinateDRUG -
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Eligibility Criteria

Age Range18 Years to 45 Years
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Subjects were selected based on the following inclusion criteria: * Provide written informed consent. * Must be healthy, adult, human beings between 18 and 45 years of age(both inclusive) weighing at least 50 kg. * Having a body mass index between 18.5 and 24.9 (both inclusive)...

Countries:India
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Frequently asked questions about Metoprolol

What is Metoprolol?

Metoprolol is a small molecule drug developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. It is also known as metoprolol succinate. The drug is in Phase 1 clinical development, and its specific indications are undisclosed. Metoprolol is classified in the therapeutic area of Other.

What does Metoprolol target?

Metoprolol targets ADRB1, also known as the beta-1 adrenergic receptor. It acts as an antagonist at this receptor. By blocking ADRB1, metoprolol interferes with the binding of endogenous catecholamines such as epinephrine and norepinephrine, thereby reducing their effects on target tissues.

Who makes Metoprolol?

Metoprolol is developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company that trades under the ticker symbol RDY. The company is responsible for the clinical development of metoprolol succinate, including the bioequivalence studies conducted to date.

What phase is Metoprolol in?

Metoprolol is in Phase 1 clinical development. It has not been approved by the FDA for any indication based on the available information. The drug has completed two Phase 1 trials, and there are currently no active trials. It remains an investigational product.

What clinical trials is Metoprolol in?

Metoprolol has been studied in two completed Phase 1 clinical trials. NCT01694797 was a bioequivalence study of metoprolol succinate ER tablets 50 mg under fasting conditions, enrolling 48 healthy volunteers in India. NCT01673997 was a bioequivalence study of metoprolol succinate ER tablets 200 mg under fasting conditions, also enrolling 48 healthy volunteers in India.

Is Metoprolol the same as Metoprolol Succinate?

Yes, Metoprolol is also known as metoprolol succinate. Metoprolol succinate is the extended-release salt form of metoprolol. Both names refer to the same active pharmaceutical ingredient developed by Dr. Reddy's Laboratories Ltd.