TheraRadar
Data updated: May 26, 2026

PROPRANOLOL HYDROCHLORIDE

Trial Activity: Stable 24 active trials
Cardiovascular Approved 1967-11-13

Propranolol hydrochloride is a non-selective beta-adrenergic blocker indicated for the management of hypertension, angina pectoris, and atrial fibrillation (specifically to control ventricular rate). It is utilized to reduce cardiovascular mortality in clinically stable survivors of the acute phase of myocardial infarction. Additionally, it is indicated for the prophylaxis of common migraine headaches, the management of familial or hereditary essential tremor, and the improvement of functional class in symptomatic hypertrophic subaortic stenosis. It is also indicated as an adjunct to alpha-adrenergic blockade in the management of pheochromocytoma to control blood pressure and symptoms.

Source: FDA Label • Merck
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How PROPRANOLOL HYDROCHLORIDE Works

Propranolol is a non-selective beta-adrenergic receptor antagonist that competitively blocks both beta-1 and beta-2 receptors. It lacks intrinsic sympathomimetic activity. By blocking beta-1 receptors in cardiac tissue, it decreases heart rate, myocardial contractility, and cardiac output, which reduces myocardial oxygen demand. Its antihypertensive mechanism involves a reduction in cardiac output, decreased plasma renin activity, and a reduction in sympathetic outflow from the central nervous system. In essential tremor, it acts by blocking peripheral beta-2 receptors in skeletal muscle. For migraine prophylaxis, the mechanism likely involves the modulation of cerebral vasodilation and the inhibition of central beta-receptors.

Source: FDA Label

Development Insights

University of North Carolina, Chapel Hill conducting 3 trials (3%)
131 indications explored (Broad Platform)
→ hemangioma (4 trials)
→ infantile hemangioma (3 trials)
→ retinopathy of prematurity (3 trials)
43
Indications
--
Phase 3 Trials
1
Priority Reviews
58
Years on Market

Details

Status
Discontinued
First Approved
1967-11-13
Routes
ORAL, INJECTION
Dosage Forms
TABLET, CAPSULE, EXTENDED RELEASE, INJECTABLE, SOLUTION

Companies

Merck WATSON LABS PH HEALTH Teva WARNER CHILCOTT ROXANE PUREPAC PHARM DAVA PHARMS INC Novartis NORTHSTAR HLTHCARE UPSHER SMITH LABS IPCA LABS LTD DURAMED PHARMS BARR INNOGENIX WATSON LABS TEVA INTERPHARM SUPERPHARM Hikma EXTROVIS ANI PHARMS IVAX SUB TEVA PHARMS Fresenius Kabi ANDA REPOSITORY Lupin AMTA SMITH AND NEPHEW SOLOPAK CHARTWELL RX PAI HOLDINGS PHARM LEDERLE CHARTWELL INJECTABLE IMPAX LABS INC INWOOD LABS ADARE PHARMS INC VINTAGE PHARMS Viatris ZYDUS PHARMS USA INC MANKIND PHARMA AIPING PHARM INC Baxter ALLIED
Active Ingredient: PROPRANOLOL HYDROCHLORIDE

PROPRANOLOL HYDROCHLORIDE Approval History

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Original
New Indication
New Form
Label Update
930 FDA actions from 1967 to 2026
May 2026 ORIGINAL
Update
Jan 2026 ORIGINAL
Update
May 2025 SUPPL
Label · Labeling

What PROPRANOLOL HYDROCHLORIDE Treats

6 indications

PROPRANOLOL HYDROCHLORIDE is approved for 6 conditions since its original approval in 1967. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypertension
  • Angina Pectoris
  • Atrial Fibrillation
  • Myocardial Infarction
  • Migraine
  • Essential Tremor
Source: FDA Label

PROPRANOLOL HYDROCHLORIDE 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 PROPRANOLOL HYDROCHLORIDE

3 of 20

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

INDERAL LA
PROPRANOLOL HYDROCHLORIDE
3 shared
ANI PHARMS
Shared indications:
HypertensionAngina PectorisMigraine
METOPROLOL TARTRATE
METOPROLOL TARTRATE
3 shared
Sun Pharma
Shared indications:
HypertensionAngina PectorisMyocardial Infarction
TIMOLOL MALEATE
TIMOLOL MALEATE
3 shared
QUANTUM PHARMICS
Shared indications:
HypertensionMyocardial InfarctionMigraine
View all 20 similar drugs Pro
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Clinical Trial Registry

119 trials
Trial Sponsor ID Phase Status Title
NCT07583134 B-BIT KC26MISV0115 KCT0011912 Ph 4 not yet recruiting Impact of Propranolol Strategies on Myocardial Injury After Breast Cancer Surgery
NCT06982183 WRAIR #2950 MO210072 Ph 4 recruiting The Effects of Propranolol and Hydrocortisone on Military-Relevant Performance Outcomes
NCT06120140 COCOON 61186372NSC2007 61186372NSC2007, 2023-505863-35-00 Ph 2 active not recruiting Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib
NCT03083431 RoProp RoProp 32ER30_173677, 2017-002124-24 Ph 2 recruiting Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity
NCT05853627 1R21MH131987-01A1 Ph 4 recruiting Mismatch vs. Standard Intervention During Memory Reconsolidation Blockade With Propranolol: Effect on Psychophysiological Reactivity During Traumatic Imagery
NCT05587361 2022005-OSU-CHS 1R01DA053342-01A1 Ph 4 recruiting Beta-Adrenergic Modulation of Drug Cue Reactivity
NCT07549906 2025-FXY-242 Ph 2 not yet recruiting Neoadjuvant Iparomlimab/Tuvonralimab Plus CAPEOX Versus Iparomlimab/Tuvonralimab Plus CAPEOX and Propranolol for Locally Advanced pMMR Colon Cancer: A Prospective, Single-Center, Multi-Cohort Study
NCT07353294 SYSKY-2025-837-02 Ph 1 enrolling by invitation Propranolol With Tislelizumab Plus GC in Neoadjuvant Bladder UC
NCT06445166 202408004 Ph 2 recruiting Propranolol for the Treatment of Kaposi Sarcoma in Adults
NCT07091279 NYSPI2024-50 AR230160 Ph 2 recruiting Propranolol for Aggression, Self-Injury, and Severe Disruptive Behavior in Adolescents and Adults With Autism
NCT06798363 RCT20250123 Ph 2, Ph 3 recruiting Efficacy and Safety of Different Initial Doses of Oral Propranolol in the Treatment of Ulcerated Infantile Hemangioma
NCT04848519 STUDY00002186 NCI-2021-00437, WINSHIP5200-20 Ph 2 active not recruiting Immune Checkpoint Inhibitors With or Without Propranolol Hydrochloride In Patients With Urothelial Carcinoma
NCT05741164 STUDY00009637 NCI-2026-00570, I 2612022 Ph 2 not yet recruiting Propranolol and Pembrolizumab for Tumor Re-sensitization and Treatment of Patients With Checkpoint Inhibitor Refractory Metastatic or Unresectable Triple Negative Breast Cancer
NCT05561751 GPC-100-001 Ph 2 completed Ph2, Study to Assess the Safety and Efficacy of GPC 100 and Propranolol With and Without G-CSF for the Mobilization of Stem Cells in Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant
NCT05797662 AMC-116 UM1CA121947 Ph 2 not yet recruiting A Study of Propranolol to Treat Kaposi Sarcoma
NCT07352228 XJLL-KY-20252468 Ph 4 enrolling by invitation Carvedilol vs. Propranolol for Preventing Rebleeding After Endoscopic Treatment of Cirrhotic Varices
NCT05997732 STARS Pro00126600 Ph 4 recruiting Sympathetic Neurovascular Transduction: Role of Adrenergic Receptors and Sex Differences
NCT04682158 I 630420 Ph 2 recruiting Propranolol With Standard Chemoradiation for Esophageal Adenocarcinoma
NCT05651594 I 2734222 NCI-2022-09209, I 2734222 Ph 2 recruiting Propranolol in Combination With Pembrolizumab and Standard Chemotherapy for the Treatment of Unresectable Locally Advanced or Metastatic Esophageal or Gastroesophageal Junction Adenocarcinoma
NCT04713657 23-12026881 R01HL155597 Ph 1 recruiting Beta-blocker Administration for Cardiomyocyte Division
NCT06263452 23-2768 1R01HL157422-01 Ph 4 recruiting Beta-Blocker Influences on Inflammatory and Neural Responses to Stress
NCT06833320 AAAV5303 Ph 1, Ph 2 suspended Propranolol Treatment for Postoperative Chylothorax
NCT05085782 2022-4092 Ph 2 completed Reconsolidation Therapy With Propranolol as a Treatment for Chronic Pain
NCT05968690 092302 Pro2023001214, NCI-2023-06872 Ph 1 recruiting Naltrexone and Propranolol Combined With Immunotherapy
NCT04921982 PROPRADO 35RC18_8852_PROPRADO Ph 2 withdrawn Efficacy of Traumatic Memory Modification Using Memory Reconsolidation and Propranolol Among Adolescents With PTSD
NCT06670976 I-3905123 NCI-2024-08858, I-3905123 Ph 1 withdrawn Propranolol Plus Standard Radiation Therapy Before Surgery for the Treatment of Patients With Soft Tissue Sarcoma
NCT03588754 2000022090 R01AA022285, 1U54AA027989-01 Ph 2 active not recruiting Does Propranolol, a Beta Blocker, Attenuate Stress-Induced Drinking?
NCT05419193 PRO-CHASE KY-2022-05-07-001 Ph 2, Ph 3 completed PROpranolol for Cerebral Hemorrhage-ASsociated pnEumonia (PRO-CHASE)
NCT03384836 I 53217 NCI-2017-02210, I 53217 Ph 1, Ph 2 suspended Propranolol Hydrochloride and Pembrolizumab in Treating Patients With Stage IIIC-IV Melanoma That Cannot Be Removed by Surgery
NCT05451043 IIT-0027 Ph 2 recruiting Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
NCT04950426 PTSD-FMS 2021-000312-36 Ph 2 completed Impact of Post-Traumatic Stress Disorder Treatment by Reconsolidation Therapy on Fibromyalgia Syndrome
NCT04047355 results posted Pro20170001942 CAUT17 APL025 Ph 2 completed Propranolol for Challenging Behaviors in Autism
NCT03633747 SAHZJU-Y2018-059 Ph 1, Ph 2 terminated Efficacy Evaluation of Propranolol Treatment of Hepatic Hemangioma
NCT06836856 2024-37 Ph 1, Ph 2 recruiting Evaluating the Impact of Adjuvant Use of Beta Blockers on Clinical Outcomes in Patients With Traumatic Brain Injury
NCT06870370 36264MS291/8/23 Ph 3 not yet recruiting Role of Non-Selective Beta-Adrenergic Blocker in Severe TBI
NCT03152786 results posted IRB00043227 NCI-2017-00788, CCCWFU 85716 Ph 2 terminated Propranolol Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery
NCT05979818 BRIO XYEYY20230705 Ph 1 recruiting Propranolol Hydrochloride in Combination With Sintilimab and Platinum-based Chemotherapy for Treatment of Advanced Non-small Cell Lung Cancer
NCT01950520 results posted 130200 13-DK-0200 Ph 2 completed Study of Human Non-Shivering Thermogenesis and Basal Metabolic Rate
NCT06499116 PREMI IJG-PREMI-2024 2024-513597-22-00 Ph 4 not yet recruiting Comparison of the Effectiveness of First-line Preventive Treatment of Migraine in Primary Care
NCT06485726 01012019 Ph 4 recruiting Valproate Versus Propranolol in Migraine
NCT05679193 PeP-RALP 488466 Ph 2 completed Perioperative Propranolol During Prostatectomy to Decrease Cancer Recurrence
NCT05851781 112019 Ph 3 completed Lacosamide Versus Propranolol in Migraine
NCT03474614 17-0173-30-12 Ph 2 terminated Effect of Oral Propranolol on mRNA Expresssion in Symptomatic Cavernous Malformation
NCT06145074 IMPULS EU CT 2023-506553-37-00 Ph 2 recruiting Examining Safety, Efficacy and Feasibility of Preoperative Propranolol in Patients With PDAC.
NCT05189977 331-201-00246 Ph 1 terminated A Trial to Assess the Effects of Prazosin or Propranolol on Blood Pressure in the Presence of Brexpiprazole/Sertraline
NCT04518124 N19PCA Ph 2 completed Propranolol in Angiosarcoma
NCT04299438 PROPEL results posted 834760 Ph 3 terminated Propranolol Rescue of Prolonged Labor
NCT05961761 PROPANE SA2115 Ph 2 recruiting Propranolol and Pembrolizumab in Advanced Soft Tissue Sarcoma Patients
NCT03893617 PRO16080092 R01CA211371 Ph 1 terminated Brief Stresses Experimental Study
NCT02790736 results posted 7293 (SAD) Ph 4 terminated Brief Intervention to Reduce Fear of Public Speaking

Showing 50 of 119 trials

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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.

PROPRANOLOL HYDROCHLORIDE FDA Label Details

Indications & Usage

FDA Label (PDF)

PROPRANOLOL HYDROCHLORIDE is indicated for the treatment of Hypertension; Angina Pectoris; Atrial Fibrillation; Myocardial Infarction; Migraine; Essential Tremor.

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Data Sources

FDA Approval: ANDA070120 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment