TheraRadar
Data updated: May 26, 2026

ATENOLOL

Adrenergic beta-Antagonists
Cardiovascular Approved 1988-07-15

ATENOLOL is indicated for the treatment of Hypertension; Stroke; Myocardial Infarction.

Source: FDA Label • NOSTRUM LABS
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
24
Indications
--
Phase 3 Trials
37
Years on Market

Details

Status
Discontinued
First Approved
1988-07-15
Routes
ORAL
Dosage Forms
TABLET

Companies

NOSTRUM LABS Sun Pharma ZYDUS PHARMS USA ABLE Aurobindo Pharma UNICHEM APOTHECON WATSON LABS NOVITIUM PHARMA Teva CHARTWELL RX AIPING PHARM INC WATSON LABS TEVA Viatris IPCA LABS LTD PLIVA UNIQUE NORTHSTAR HLTHCARE PHARMOBEDIENT SCS
Active Ingredient: ATENOLOL

ATENOLOL Approval History

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Original
New Indication
New Form
Label Update
703 FDA actions from 1988 to 2025
Jul 2025 SUPPL
Label · Labeling
Jul 2025 SUPPL
Label · Labeling
Mar 2025 SUPPL
Label · Labeling

What ATENOLOL Treats

3 indications

ATENOLOL is approved for 3 conditions since its original approval in 1988. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypertension
  • Stroke
  • Myocardial Infarction
Source: FDA Label

ATENOLOL Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

JAVADIN
AZURITY
2025 3 indic.
CANGRELOR
GLAND
2025 2 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to ATENOLOL

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ALISKIREN HEMIFUMARATE
ALISKIREN HEMIFUMARATE
3 shared
PH HEALTH
Shared indications:
HypertensionStrokeMyocardial Infarction
ATENOLOL AND CHLORTHALIDONE
ATENOLOL
3 shared
NOVITIUM PHARMA
Shared indications:
HypertensionStrokeMyocardial Infarction
AZOR
AMLODIPINE BESYLATE
3 shared
COSETTE
Shared indications:
HypertensionStrokeMyocardial Infarction
View all 20 similar drugs Pro
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Clinical Trial Registry

23 trials
Trial Sponsor ID Phase Status Title
NCT07268170 HEART-BEAT 2025-522741-21-00 2025-522741-21-00 Ph 2, Ph 3 enrolling by invitation Heart Rate Control Before Cardiac Computed Tomography in Adults for the Evaluation of Coronary Artery Disease
NCT02479204 AC-064-102 Ph 1 terminated Clinical Study to Investigate Safety and Effects on Heart Rate, Blood Pressure, and Pharmacokinetic Interactions of ACT-334441
NCT02560805 ANG-P IRB00082400 2025P010213 Ph 2 recruiting Role of Sympathetic Overactivity and Angiotensin II in PTSD and CV
NCT03578354 Pending Ph 2 withdrawn 4-Aminopyridine, Atenolol, or Placebo in Patients With Vestibular Migraine
NCT03082014 TREAT-SVDs TRE-1486--0105-I Ph 3 terminated Effects of Amlodipine and Other Blood Pressure Lowering Agents on Microvascular Function
NCT02342275 results posted 2014-229 Ph 3 completed Efficacy and Safety of Propranolol Versus Atenolol on the Proliferative Phase of Infantile Hemangioma
NCT01522950 EVIDENCE results posted CV-2014-20226 Ph 2 completed A Study Examining the Effects of Nebivolol Compared to Atenolol on Endothelial Function
NCT00925119 results posted HP-00040291 K23HL091120 Ph 4 terminated Examining Genetic Influence on Response to Beta-Blocker Medications in People With Type 2 Diabetes
NCT01202721 BAV results posted BAV-15JUNE2010 Ph 3 terminated Beta Blockers and Angiotensin Receptor Blockers in Bicuspid Aortic Valve Disease Aortopathy (BAV Study)
NCT01132768 CONFIRM DSE-OLM-01-09 Ph 4 terminated The Confirmatory Olmesartan Plaque Regression Study
NCT00669279 results posted 8COG11059 Ph 4 completed Effect of Carvedilol Controlled-Release (CR) and Atenolol on Central Blood Pressure
NCT01715207 results posted 2009-10-025 Ph 3 completed Comparison of Aliskiren vs Negative Controls on Aortic Stiffness in Patients With MFS
NCT03070730 results posted 2011P000246 R01HL059459 Ph 1, Ph 2 terminated Hemodynamic Response of Neuropathic And Non-Neuropathic POTS Patients To Adrenoreceptor Agonist And Antagonist
NCT01251146 results posted EMR200006-515 Ph 4 completed A Randomized Controlled Study to Assess the Effects of Bisoprolol and Atenolol on Resting Heart Rate and Sympathetic Nervous System's Activity in Subjects With Essential Hypertension
NCT01736488 BR-FA-CT-401 Ph 4 completed Clinical Study to Evaluate the Antihypertensive Efficacy and Changes of Neurohormonal Markers of Fimasartan and Atenolol With Exaggerated Blood Pressure Response During Exercise in Essential Hypertensive Patients
NCT02547597 CARVEDILOL Ph 4 completed Comparison of Carvedilol and Atenolol on Anti-anginal and Metabolic Effects in Patients With Stable Angina Pectoris
NCT01230892 results posted IRB00027953 Emory #00000681 Ph 4 completed Evaluation of The Effects of Nebivolol in Comparison to Atenolol on Wall Shear Stress and Rupture Prone Coronary Plaques
NCT01939509 CHAB 1445 Ph 4 completed Hemodynamic Changes of Patients Receiving Atenolol/Bisoprolol
NCT01079962 results posted EMD 084000-505 Ph 4 completed An Active-controlled, Clinical Trial to Assess Central Hemodynamic Effects of Bisoprolol in Hypertensive Patients (Central Hemodynamic Assessment Measured in Patient With HypertensION [CHAMPION])
NCT01762436 Betablocker on CAP and BRS Ph 4 completed Effects of Bisoprolol and Atenolol on Sympathetic Nervous Activity and Central Aortic Pressure in Patients With Essential Hypertension
NCT00593710 H07-01816 Ph 2 completed Losartan Versus Atenolol for the Treatment of Marfan Syndrome
NCT01445964 SNUCPT11_ATE Pan Asian-Atenolol-1 Ph 4 completed Effect of SLCO2B1 Genotype and Apple Juice on Pharmacokinetics of Atenolol After Oral Administration in Healthy Male Korean
NCT01022463 IVA-MS F-2/IEC/MAMC/09/No.192 Ph 3 completed Effect of Ivabradine on Heart Rate & Effort Tolerance in Mitral Stenosis in Sinus Rhythm
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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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.

ATENOLOL FDA Label Details

Indications & Usage

ATENOLOL is indicated for the treatment of Hypertension; Stroke; Myocardial Infarction.

Looking for the branded version?

ATENOLOL AND CHLORTHALIDONE

Full clinical data, patents, trials, and competitive landscape for atenolol.

See ATENOLOL AND CHLORTHALIDONE

Data Sources

FDA Approval: ANDA074127 → Label: DailyMed → Trials: ClinicalTrials.gov →

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