BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER (esmolol hydrochloride)
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.
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
Details
- Status
- Prescription
- First Approved
- 1986-12-31
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER Approval History
What BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER Treats
6 indicationsBREVIBLOC 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
BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER treats. First-in-class if their pivotal trials read out positive.
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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 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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