Brevibloc

(Esmolol)

ApprovedSmall molecule

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Esmolol is used to quickly lower heart rate and blood pressure in patients during surgery or in emergency situations when the heart is beating too fast or irregularly.[2] Brevibloc is currently approved and in use across 23 indications[4].[1]

Brevibloc is one of 445 small molecule programs targeting Functional Endoscopic Sinus Surgery. It is currently in Approved.

Indications

Total Trials

Active Trials

444

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Functional Endoscopic Sinus SurgeryNot yet recruiting

Subarachnoid HemorrhageActive, not recruiting

Cardiovascular DiseaseActive, not recruiting

Brain AneurysmApproved

Coronary Artery DiseaseApproved

Brain NeoplasmApproved

Ovarian CystApproved

SinusitisApproved

Cerebral Arterial DiseaseApproved

Cerebral AneurysmNot yet recruiting

Functional Endoscopic Sinus SurgeryPreclinical

Not yet recruiting

Subarachnoid HemorrhagePreclinical

Active, not recruiting

Cardiovascular DiseaseApproved

Active, not recruiting

Brain AneurysmApproved

Approved

Coronary Artery DiseaseApproved

Approved

Brain NeoplasmApproved

Approved

Ovarian CystApproved

Approved

SinusitisApproved

Approved

Cerebral Arterial DiseaseApproved

Approved

Cerebral AneurysmPreclinical

Not yet recruiting

Showing 10 of 20 indications

Competition

Competitive Landscape

350 competitors in Treatment

#DrugCompanyPhaseTrials

Brevibloc

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Approved

1 2

Alfenta

Jazz Pharmaceuticals

Preclinical

1 3

Levulan

Sun Pharmaceutical Industries, Inc.

Preclinical

1 4

Hivid

CConrado Roberto Hoffmann Filho

Preclinical

6 5

Valium

Akero Therapeutics

Preclinical

2 6

Clomid

Ferring

Preclinical

1 7

Aurlumyn

BBTG International Inc.

Preclinical

1 8

Barhemsys

Tibotec Pharmaceuticals, Ireland

Preclinical

1 9

Crixivan

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

5 10

Somavert

PPharmacia and Upjohn

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Recruiting

Acute Respiratory Distress Syndrome

NCT06013319

Post-ApprovalRecruiting

Injury

NCT05635877

Q3 2027

PreclinicalNot yet recruiting

Cerebral Aneurysm

NCT07660861

Phase 3Recruiting

Diabetes Mellitus

NCT05769868

Q2 2028

Phase 1/2Not yet recruiting

Septic Shock

NCT07313605

Clinical

Trials by Indication[1]

Septic Shock9 trials

Effects of Heart Control at Different Stages in Patients of Septic Shock With Tachycardia

Unknown status·CChinese Medical Association·N/A·NCT05389176·96 enrolled

Heart Rate Control With Esmolol in Septic Shock

Completed·AAndrea Morelli·Phase 2·NCT01231698·154 enrolled

Esmolol Infusion for Patients With Septic Shock and Persistent Tachycardia

Completed·IIntermountain Health Care, Inc.·Phase 2·NCT02841241·7 enrolled

Show 6 more trials

POCUS-Guided Esmolol in Septic Shock: A Pilot RCT

Not yet recruiting·JJohn Basmaji·Phase 1/2·NCT07313605·100 enrolled

Echocardiographic and Arterial Pressure Waveform Changes After Reducing Heart Rate With Esmolol in Septic Shock Patients

Completed·UUniversity of Roma La Sapienza··NCT02188888·45 enrolled

Esmolol to Treat the Hemodynamic Effects of Septic Shock

Terminated·—·Phase 2·NCT02369900·40 enrolled

Pilot Study: Echocardiographic and Hemodynamic Effects of Esmolol in Septic Shock Patients

Unknown status·PPeking Union Medical College Hospital·Phase 2/3·NCT02842983·36 enrolled

Esmolol Effects on Heart and Inflammation in Septic Shock

Unknown status·—·Phase 2·NCT02068287·25 enrolled

Esmolol to Control Adrenergic Storm in Septic Shock- ROLL-IN 2

Unknown status·SSamuel Brown·Phase 2·NCT03208257·10 enrolled

Hemodynamic Response4 trials

Hemodynamic Response to Intubation

Unknown status·UUfuk University·Phase 4·NCT02844894·60 enrolled

The Effects of Lidocaine and Esmolol on Attenuation of Hemodynamic Response to Orotracheal Intubation

Unknown status·HHospital de Base·Phase 4·NCT03612492·80 enrolled

Genetic Determinants of Hemodynamic Response to Esmolol

Unknown status·HHadassah Medical Organization·N/A·NCT01388036·100 enrolled

Show 1 more trial

Comparison of Effects of Scalp Block and Intravenous Esmolol on Hemodynamic Response Following the Skull Pins Application for Elective Supratentorial Craniotomy

Completed·KKhon Kaen University·N/A·NCT06268275·90 enrolled

Laparoscopic Cholecystectomy3 trials

Intraoperative Lidocaine Infusion vs. Esmolol Infusion for Postoperative Analgesia in Laparoscopic Cholecystectomy

Completed·—·Phase 4·NCT02327923·90 enrolled

Dose Esmolol Infusion Have an Adjuvant Effect to TAP Block for Pain Control in Laparoscopic Cholecystectomy.

Completed·—·Phase 4·NCT04752111·60 enrolled

Efficacy of Esmolol Versus Magnesium Sulphate on Quality of Recovery in Patients Undergoing Laparoscopic Cholecystectomy: Randomized Controlled Study

Completed·—·Phase 2/3·NCT05850832·60 enrolled

Sepsis3 trials

The Effect of Esmolol on Patients With Sepsis

Unknown status·SShanghai Zhongshan Hospital·N/A·NCT04537767·120 enrolled

Esmolol in Sepsis Management:Evaluating Immunomodulatory Effects and Impact on Patient Outcomes

Completed·LLin Chen·Phase 2·NCT06390748·150 enrolled

The Effect of Esmolol on Clinical Prognosis of Patients With Severe Sepsis

Completed·FFujian Provincial Hospital·N/A·NCT02794025·151 enrolled

Quality of Recovery2 trials

Effect of Lidocaine and Esmolol to Improve the Quality of Recovery

Terminated·—·Phase 4·NCT01114997·32 enrolled

Esmolol Infusion During Laminectomy: Effect on Quality of Recovery

Terminated·—·Phase 4·NCT01179113·33 enrolled

40 more indications

Remifentanil2 trials

A Comparison of the Perioperative Hemodynamic Effects of Remifentanil and Esmolol in Intracranial Surgery

Completed·—·Phase 4·NCT01628562·40 enrolled

A Comparison of Esmolol and Remifentanil to Reduce Blood Loss

Unknown status·—·Phase 4·NCT01752959·60 enrolled

Functional Endoscopic Sinus Surgery2 trials

Pre-operative Phentolamine Vs Intraoperative Esmolol Efficacy for Hypotensive Anesthesia in Functional Endoscopic Sinus Surgery

Not yet recruiting·—·N/A·NCT06620991·60 enrolled

Esmolol Versus Lidocaine on the Quality of Postoperative Recovery in Patients Undergoing Functional Endoscopic Sinus Surgery

Active, not recruiting·TThe Second People's Hospital of Huai'an·Phase 1/2·NCT06457100·60 enrolled

Injury2 trials

Effects of Low-dose Esmolol on Myocardial Injury After Non-cardiac Surgery in Elderly Frail Patients

Recruiting·YYongtao Sun·Phase 4·NCT05635877·2,000 enrolled

Controlling Hyperadrenergic Activity in Neurologic Injury

Withdrawn·JJohns Hopkins University·Phase 1/2·NCT01343329

Craniotomy2 trials

Nicardipine vs Esmolol Craniotomy Emergence

Completed·NNorthwestern University·Phase 1·NCT01951950·40 enrolled

Esmolol Infusion in Patients Undergoing Craniotomy

Completed·GGeorge Papanicolaou Hospital·Phase 3·NCT02455440·50 enrolled

Cardiopulmonary Bypass1 trial

Esmolol or Nitroglycerin Infusion for Blood Pressure Control Prior to Cardiopulmonary Bypass (CPB) in Cardiac Surgery

Completed·LLoma Linda University·N/A·NCT01212874·70 enrolled

Sinus Surgery1 trial

Esmolol vs. Labetalol in Endoscopic Sinus Surgery

Completed·TThe University of Texas Medical Branch, Galveston·Phase 2·NCT03661346·28 enrolled

Randomized1 trial

Outcome of Esmolol Potassium Cardioplegia Compared to Potassium Cardioplegia in Patients With Solitary Valvular Disease; Randomized Controlled Study

Unknown status·KKasr El Aini Hospital·N/A·NCT04306913·80 enrolled

Cardiomyopathy1 trial

Esmolol for Myocardial Protection in Hypertrophic Obstructive Cardiomyopathy

Unknown status·MMeshalkin Research Institute of Pathology of Circulation·Phase 4·NCT05073094·80 enrolled

Atrial Fibrillation1 trial

Safety Study of Tecadenoson to Treat Atrial Fibrillation

Completed· Gilead logo

Gilead·Phase 2·NCT00713401·21 enrolled

Esmolol1 trial

Study to Compare Pharmacokinetics & Pharmacodynamics of Warfarin & Esmolol in the Absence & Presence of MEDI0382

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT03347968·22 enrolled

General Anesthetic1 trial

A Comparison of the Effects of Intraoperative Administration of Metoprolol or Esmolol on General Anesthetic Requirement

Completed·UUniversity of Oklahoma·N/A·NCT00756236·60 enrolled

Delirium1 trial

Effect of Opioid-free Anaesthesia on Postoperative Delirium in Elderly Patients Undergoing Gastrointestinal Surgery

Not yet recruiting·QQianfoshan Hospital·Phase 4·NCT06958393·406 enrolled

Infusion1 trial

Age Comparisons of Exercising Muscle O2 Supply in Healthy Adults: Effects of Esmolol Infusion

Completed·UUnknown Sponsor·Phase 1·NCT04181606·30 enrolled

Diabetes Mellitus1 trial

Efficacy of Esmolol in the Identification of Cardiovascular Disorders by Cirrhosis, Diabetes Mellitus and Cardiotoxic Treatments

Recruiting·CConsorcio Centro de Investigación Biomédica en Red (CIBER)·Phase 3·NCT05769868·1,000 enrolled

Subarachnoid Hemorrhage1 trial

Study to Evaluate Esmolol (Brevibloc) to Manage Cardiac Function in Patients With Subarachnoid Hemorrhage

Withdrawn·UUniversity of Michigan·N/A·NCT01232400

ECMO1 trial

Evaluation of Early CRRT InTerventions in Patients With ECMO(ELITE)

Completed·—·Phase 4·NCT03549923·131 enrolled

Tachycardia1 trial

Esmolol for Treatment of Perioperative Tachycardia

Terminated·—·Phase 3·NCT01208402·76 enrolled

Bariatric Surgery1 trial

Role of Intraoperative Beta Blocker for Morbid Obese Patients Undergoing Laparoscopic Bariatric Surgery

Unknown status·—·Phase 4·NCT04086940·60 enrolled

Closed-Loop1 trial

Influence of Esmolol on a Closed-Loop Anesthesia System

Terminated·HHopital Foch·Phase 3·NCT00922467·15 enrolled

Acute Respiratory Distress Syndrome1 trial

Effect of Esmolol on Oxygenation Index in Patients With Acute Respiratory Distress Syndrome

Recruiting·ZZhiming Jiang·Phase 3·NCT06013319·178 enrolled

Post Operative Pain1 trial

Labetalol and Esmolol: Vital Signs and Post Operative Pain Management

Completed·—·Phase 4·NCT01114971·75 enrolled

Drug1 trial

The Effects of the Drugs Used in Hypotensive Anaesthesia on Cochlea

Completed·TTC Erciyes University·Phase 4·NCT02062333·47 enrolled

Lidocaine1 trial

Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain

Terminated·WWake Forest University Health Sciences·Phase 2/3·NCT04356352·33 enrolled

Blood Pressure1 trial

Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage

Completed·TThe George Institute·N/A·NCT00226096·404 enrolled

Elderly1 trial

Use of Beta Blockers in Elderly Trauma Patients

Unknown status·UUniversity of Texas Southwestern Medical Center·Phase 2·NCT00302692·148 enrolled

Cognitive Functions1 trial

Changes in Cerebral Oxygenation and Cognitive Functions

Completed·—··NCT04948957·40 enrolled

Surgical Field1 trial

Lidocaine Versus Esmolol for Optimizing Surgical Field Visibility

Completed·ZZagazig University·Phase 2·NCT04260685·70 enrolled

Treatment1 trial

Esmolol Pretreatment on Pain During Injection of Propofol

Completed·KKyungpook National University Hospital·N/A·NCT01885364·120 enrolled

Rocuronium1 trial

Effect of Esmolol on Pain Due to Rocuronium

Completed·—·Phase 4·NCT01824758·90 enrolled

Dexmedetomidine1 trial

Esmolol Versus Dexmedetomidine During Intracranial Procedures

Unknown status·GGeorge Papanicolaou Hospital·Phase 3·NCT02563288·60 enrolled

Hemodynamic1 trial

Tight Hemodynamic Control in Patients Who Are Chronically on Metoprolol

Terminated·UUniversity Health Network, Toronto·Phase 4·NCT01404767·20 enrolled

Trial1 trial

REMAP ECMO - Beta Receptor Modulation Trial

Recruiting·EErasmus Medical Center·Phase 2·NCT06522594·20 enrolled

Completed·UUniversità Vita-Salute San Raffaele·Phase 4·NCT00959569·200 enrolled

Intraoperative1 trial

The Effect of Intraoperative Labetalol on Time to Discharge

Completed·—·Phase 2·NCT02997800·172 enrolled

Acute Myocardial Infarction1 trial

Concomitant Milrinone and Esmolol Treatment in Patients with Acute Myocardial Infarction

Completed·SShantou University Medical College·Phase 2·NCT02098629·25 enrolled

Stress Reaction1 trial

Effect of Esmolol on Perioperative Stress Reaction

Unknown status·XXiumei Song·Phase 4·NCT05694585·46 enrolled

Mastectomy1 trial

Effects of Intraoperative Esmolol on Post-mastectomy Pain Syndrome

Unknown status·HHospital de Base··NCT03965442·66 enrolled

Cerebral Aneurysm1 trial

Effects of Remifentanil Versus Esmolol on Optic Nerve Sheath Diameter/Eyeball Transverse Diameter Ratio During Endotracheal Intubation in Patients Undergoing Cerebral Aneurysm Coil Embolization: A Randomized Controlled Trial

Not yet recruiting·FFatih Sultan Mehmet Training and Research Hospital·Preclinical·NCT07660861·84 enrolled

Regulatory

FDA Approval Timeline[5]

Aug 15, 1988

BREVIBLOC

NDA NDA019386

Apr 7, 2016

ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER

NDA NDA205703

Sources

References

[1]
ClinicalTrials.gov — 65 trial records for Esmolol. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Brevibloc drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Esmolol compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Esmolol. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA205703). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Brevibloc. U.S. Food & Drug Administration.
[7]
SEC EDGAR — McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Beta-1 Adrenergic Receptor Antagonist; Beta-2 Adrenergic Receptor Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Patent Landscape[6]

Patent Cliff

Mar 15, 2033

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8829054Mar 15, 2033

8835505Mar 15, 2033

Brevibloc

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Q2 2028

Trials by Indication[1]

Septic Shock9 trials

Hemodynamic Response4 trials

Laparoscopic Cholecystectomy3 trials

Sepsis3 trials

Quality of Recovery2 trials

Remifentanil2 trials

Functional Endoscopic Sinus Surgery2 trials

Injury2 trials

Craniotomy2 trials

Cardiopulmonary Bypass1 trial

Sinus Surgery1 trial

Randomized1 trial

Cardiomyopathy1 trial

Atrial Fibrillation1 trial

Esmolol1 trial

General Anesthetic1 trial

Delirium1 trial

Infusion1 trial

Diabetes Mellitus1 trial

Subarachnoid Hemorrhage1 trial

ECMO1 trial

Tachycardia1 trial

Bariatric Surgery1 trial

Closed-Loop1 trial

Acute Respiratory Distress Syndrome1 trial

Post Operative Pain1 trial

Drug1 trial

Lidocaine1 trial

Blood Pressure1 trial

Elderly1 trial

Cognitive Functions1 trial

Surgical Field1 trial

Treatment1 trial

Rocuronium1 trial

Dexmedetomidine1 trial

Hemodynamic1 trial

Trial1 trial

Opioid Analgesia1 trial

Cardiovascular1 trial

Cardiac Surgery1 trial

Intraoperative1 trial

Acute Myocardial Infarction1 trial

Stress Reaction1 trial

Mastectomy1 trial

Cerebral Aneurysm1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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