TheraRadar
Data updated: May 26, 2026

BREVIBLOC IN PLASTIC CONTAINER (esmolol hydrochloride)

Cardiovascular Approved 1986-12-31

Brevibloc is a short-acting beta-blocker indicated for the rapid, short-term control of ventricular rate in patients with supraventricular tachycardia (including atrial fibrillation and atrial flutter) and noncompensatory sinus tachycardia. It is also used to treat acute tachycardia and hypertension occurring during surgical procedures, including induction, intubation, and the postoperative period. It is intended for the treatment of existing conditions rather than for prophylactic prevention of such events.

Source: FDA Label • Baxter

How BREVIBLOC IN PLASTIC CONTAINER Works

Esmolol hydrochloride is a beta-1-selective (cardioselective) adrenergic receptor blocker characterized by a rapid onset and a very short duration of action, with an elimination half-life of approximately 9 minutes. It lacks significant intrinsic sympathomimetic or membrane stabilizing activity at therapeutic doses. By inhibiting beta-1 receptors primarily in the cardiac muscle, it reduces heart rate and blood pressure. This selectivity is dose-dependent; at higher doses, the drug also inhibits beta-2 receptors located in the bronchial and vascular musculature.

2
Indications
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Phase 3 Trials
1
Priority Reviews
39
Years on Market

Details

Status
Prescription
First Approved
1986-12-31
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Active Ingredient: ESMOLOL HYDROCHLORIDE

BREVIBLOC IN PLASTIC CONTAINER Approval History

1987
1988
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1994
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1996
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2026
Original
New Indication
New Form
Label Update
31 FDA actions from 1986 to 2025 · 1 indication expansions
Sep 2025 SUPPL
Mfg · Manufacturing (CMC)
Jun 2023 SUPPL
Label · Labeling
Aug 2015 SUPPL Priority
Mfg · Manufacturing (CMC)

What BREVIBLOC IN PLASTIC CONTAINER Treats

6 indications

BREVIBLOC IN PLASTIC CONTAINER is approved for 6 conditions since its original approval in 1986. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Supraventricular Tachycardia
  • Atrial Fibrillation
  • Atrial Flutter
  • Sinus Tachycardia
  • Tachycardia
  • Hypertension
Source: FDA Label

BREVIBLOC IN PLASTIC CONTAINER Competitive Set

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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 BREVIBLOC IN PLASTIC CONTAINER

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BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER
ESMOLOL HYDROCHLORIDE
6 shared
Baxter
ESMOLOL HYDROCHLORIDE
ESMOLOL HYDROCHLORIDE
6 shared
EUGIA PHARMA
ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER
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6 shared
HQ SPCLT PHARMA
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Clinical Trial Registry

5 trials
Trial Sponsor ID Phase Status Title
NCT06291363 ESMONOL 2024-3612 Ph 4 recruiting Impact of Administration of Esmolol on Nociception Level-guided Control of Nociception.
NCT01113515 results posted Novalead-Galnobax-0210 Ph 1, Ph 2 completed Clinical Investigation of Galnobax® for the Treatment of Diabetic Foot Ulcers
NCT03998436 results posted NG-A16 Ph 3 completed Phase 3 Study to Evaluate the Safety and Efficacy of Galnobax® in Treating Diabetic Foot Ulcers
NCT02967029 IstanbulUn Ph 4 completed Effect of Controlled Hypotension on Cerebral Oxygen Saturation
NCT01652898 AOP LDLA202.101 Ph 1 completed A Pharmacokinetic, Pharmacodynamic, Safety Study With AOP LDLA202, ONO LDL50 and Esmolol in Healthy Volunteers
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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

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.

BREVIBLOC IN PLASTIC CONTAINER FDA Label Details

Indications & Usage

FDA Label (PDF)

BREVIBLOC IN PLASTIC CONTAINER is indicated for the treatment of Supraventricular Tachycardia; Atrial Fibrillation; Atrial Flutter; Sinus Tachycardia; Tachycardia; Hypertension.

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Data Sources

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