TheraRadar
Data updated: May 26, 2026

BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER (esmolol hydrochloride)

Trial Activity: Declining 1 active trials
Cardiovascular Approved 1986-12-31

Brevibloc is a short-acting beta-1 selective adrenergic blocker indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in emergent, perioperative, or postoperative settings. It is also indicated for the short-term treatment of noncompensatory sinus tachycardia when, in the physician's judgment, the heart rate requires specific intervention. Additionally, it is used for the short-term treatment of tachycardia and hypertension occurring during induction, tracheal intubation, surgery, and emergence from anesthesia. It is intended for short-term use only and is not recommended for the prevention of perioperative hypertensive or tachycardic events.

Source: FDA Label • Baxter

How BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER Works

Esmolol hydrochloride is a beta-1 selective (cardioselective) adrenergic receptor blocking agent characterized by a rapid onset and a very short duration of action, with an elimination half-life of approximately 9 minutes. At therapeutic doses, it possesses no significant intrinsic sympathomimetic activity (ISA) or membrane-stabilizing activity (MSA). It works by inhibiting beta-1

Development Insights

Novalead Pharma Private Limited conducting 4 trials (57%)
7 indications explored (Moderate)
diabetic foot ulcer (4 trials)
opioid use, unspecified (1 trials)
anesthesia (1 trials)
2
Indications
--
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 DOUBLE STRENGTH IN PLASTIC CONTAINER Approval History

1987
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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 DOUBLE STRENGTH IN PLASTIC CONTAINER Treats

6 indications

BREVIBLOC DOUBLE STRENGTH 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 DOUBLE STRENGTH 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 DOUBLE STRENGTH IN PLASTIC CONTAINER

3 of 20

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

BREVIBLOC IN PLASTIC CONTAINER
ESMOLOL HYDROCHLORIDE
6 shared
Baxter
ESMOLOL HYDROCHLORIDE
ESMOLOL HYDROCHLORIDE
6 shared
EUGIA PHARMA
ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER
ESMOLOL HYDROCHLORIDE
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 DOUBLE STRENGTH IN PLASTIC CONTAINER FDA Label Details

Indications & Usage

FDA Label (PDF)

BREVIBLOC DOUBLE STRENGTH 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.

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