TheraRadar
Data updated: Sep 20, 2026

METOPROLOL SUCCINATE · NESHER PHARMS

Generic · see KAPSPARGO SPRINKLE
Cardiovascular Approved 1992-01-10

METOPROLOL SUCCINATE is FDA-approved to treat 3 conditions (same as KAPSPARGO SPRINKLE).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
28
Indications
--
Phase 3 Trials
34
Years on Market

Details

Status
Prescription
First Approved
1992-01-10
Routes
ORAL
Dosage Forms
TABLET, EXTENDED RELEASE

Companies

NESHER PHARMS HETERO LABS LTD III VISUM PHARM SUNSHINE GRANULES WOCKHARDT BIO AG Teva Dr. Reddy's PHARMADAX REDDYS ZYDUS PHARMS NOVAST LABS ZHEJIANG JUTAI PHARM Viatris Cipla PRINSTON INC Novartis YICHANG HUMANWELL ACCORD HLTHCARE IPCA LABS LTD ALKEM LABS LTD Lupin
Active Ingredient: METOPROLOL SUCCINATE

METOPROLOL SUCCINATE Approval History

2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
249 FDA actions from 2006 to 2026
Aug 2026 SUPPL
Label · Labeling
Jul 2025 SUPPL
Label · Labeling
Jun 2025 ORIGINAL
Update

What METOPROLOL SUCCINATE Treats

3 indications

METOPROLOL SUCCINATE is approved for 3 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as KAPSPARGO SPRINKLE (same active ingredient).

Source: FDA Label
📋

Clinical Trial Registry

18 trials
Trial Sponsor ID Phase Status Title
NCT07490067 HUM00266021 1R01HL178410-01 Ph 4 recruiting Mechanistic Clinical Trial Comparing the Pharmacokinetics/Pharmacodynamics of Metoprolol in Heart Failure With Reduced Ejection Fraction Patients With Low vs. High Polygenic Score
NCT04434664 BLOCK HFpEF results posted 833517 Ph 4 completed BLOCKade of Calcium Channels and Beta Adrenergic Receptors for the Treatment of Hypertension in HFpEF
NCT05931276 BRAVO 2026 Ph 3 recruiting CSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes
NCT06964464 CARVTOP-ICD STUDY00010093 PLACER-2023C3-33489 Ph 4 recruiting Comparative Effectiveness of Carvedilol Versus Metoprolol Succinate in Heart Failure Patients With an Implantable Cardioverter Defibrillator
NCT03778554 DANBLOCK 2018-002699-42 2018-002699-42 Ph 4 active not recruiting Danish Trial of Beta Blocker Treatment After Myocardial Infarction Without Reduced Ejection Fraction
NCT05711810 SARSCoVVaxPoison Ph 4 completed Medicine-induced Cardiac Hemodialysis on COVID-19
NCT01970501 GENETIC-AF results posted BUC-CLIN-303 Ph 2 completed Genetically Targeted Therapy for the Prevention of Symptomatic Atrial Fibrillation in Patients With Heart Failure
NCT05066633 MeDMD NBK 154/1/2020 2020-004901-29 Ph 3 recruiting The Efficacy and Safety of Metoprolol as add-on Treatment to Standard of Care in Preventing Cardiomyopathy in Patients With DMD
NCT03532802 TEMPO 1-10-72-441-17 Ph 2 completed The Effect of Metoprolol in Patients With Hypertrophic Obstructive Cardiomyopathy.
NCT02587351 results posted 1512M81981 Ph 3 terminated Beta-Blockers for the Prevention of Acute Exacerbations of Chronic Obstructive Pulmonary Disease
NCT01502787 results posted STU 062011-072 Ph 4 completed Comparison of Nebivolol and Metoprolol With Exercise and Angiotensin II in Hypertensive Patients
NCT01501929 results posted Bystolic MD52 Ph 4 completed Effects of Nebivolol on Skeletal Muscle During Exercise in Hypertensive Patients
NCT01041287 results posted IRB00013262 BYD-MD-20 Ph 4 completed Effect of Nebivolol on Oxidative Stress and Endothelial Progenitor Cells
NCT01499134 ENCOMPASS results posted 11C.18 Ph 3 completed Comparison of 2 Beta Blocker Drugs on Peripheral Arterial Disease in Patients With High Blood Pressure
NCT01676285 CARE Cirrhosis 0010/11 Ph 3 completed Metoprolol Succinate in Cardiac Remodeling Related to Cirrhosis
NCT01605370 Inapprop results posted 11-007035 Ph 4 terminated Can Nebivolol Reverse Inappropriate Left Ventricular Mass in Hypertensive Patients?
NCT01694797 642/09 Ph 1 completed Bioequivalence Study for Metoprolol Succinate ER Tablets 50 mg Under Fasting Condition
NCT01673997 P-643/09 Ph 1 completed Bioequivalence Study of Metoprolol Succinate ER Tablets, 200 mg Under Fasting Conditions
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

METOPROLOL SUCCINATE FDA Label Details

Indications & Usage

METOPROLOL SUCCINATE is FDA-approved to treat 3 conditions — same approved indications as KAPSPARGO SPRINKLE.

Looking for the branded version?

KAPSPARGO SPRINKLE

Full clinical data, patents, trials, and competitive landscape for metoprolol succinate.

See KAPSPARGO SPRINKLE

Data Sources

FDA Approval: ANDA077779 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.