BREVIBLOC (esmolol hydrochloride) · Baxter
Brevibloc is a short-acting, beta-1 selective intravenous medication used for the rapid, short-term control of ventricular rate in patients with supraventricular tachycardia, including atrial fibrillation and atrial flutter. It is also indicated for the treatment of noncompensatory sinus tachycardia when the rapid heart rate requires specific intervention. Additionally, Brevibloc is used to manage acute spikes in heart rate and blood pressure that occur during surgical procedures, such as during induction, tracheal intubation, or emergence from anesthesia. It is intended for the treatment of these conditions rather than for prophylaxis.
How BREVIBLOC Works
Brevibloc 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 dosages, it possesses no significant intrinsic sympathomimetic or membrane-stabilizing activity. It works by inhibiting beta-1 receptors located primarily in cardiac muscle; however, this selectivity is not absolute. At higher doses, Brevibloc also inhibits beta-2 receptors located in the bronchial and vascular musculature.
Details
- Status
- Prescription
- First Approved
- 1986-12-31
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
BREVIBLOC Approval History
What BREVIBLOC Treats
8 indicationsBREVIBLOC is approved for 8 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
- Perioperative Tachycardia
- Perioperative Hypertension
- Postoperative Tachycardia
- Postoperative Hypertension
BREVIBLOC 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's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications BREVIBLOC treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to BREVIBLOC
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
6 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 |
| NCT01741519 | AOP LDLL600.101 | Ph 1 | completed | Long-term PK and Safety/Tolerability Testing LDLL600 Against Esmolol in Healthy Volunteers |
| 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 FDA Label Details
Indications & Usage
FDA Label (PDF)BREVIBLOC injection is a beta adrenergic blocker indicated for the short-term treatment of: • Control of ventricular rate in supraventricular tachycardia including atrial fibrillation and atrial flutter and control of heart rate in noncompensatory sinus tachycardia • Control of perioperative tachycardia and hypertension 1.1 Supraventricular Tachycardia or Noncompensatory Sinus Tachycardia BREVIBLOC (Esmolol Hydrochloride) injection is indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent cir...
Track BREVIBLOC with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.