ESMOLOL HYDROCHLORIDE · Viatris
Esmolol hydrochloride is a rapid-onset, ultra-short-acting beta-1 selective adrenergic blocker indicated for the short-term control of ventricular rate in patients with supraventricular tachycardia (including atrial fibrillation and atrial flutter) and noncompensatory sinus tachycardia where rapid intervention is required. It is also indicated for the treatment of perioperative tachycardia and hypertension occurring during induction, tracheal intubation, surgery, and emergence from anesthesia. It is intended for short-term intravenous use and is not recommended for the prophylaxis of perioperative hypertensive or tachycardic events.
How ESMOLOL HYDROCHLORIDE Works
Esmolol hydrochloride is a cardioselective beta-1 adrenergic receptor antagonist characterized by a rapid onset and a very short duration of action (elimination half-life of approximately 9 minutes). At therapeutic doses, it lacks significant intrinsic sympathomimetic or membrane-stabilizing activity. While it preferentially inhibits beta-1 receptors located chiefly in cardiac muscle, this selectivity is dose-dependent; at higher doses, it also inhibits beta-2 receptors in the bronchial and vascular musculature.
Details
- Status
- Prescription
- First Approved
- 1986-12-31
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ESMOLOL HYDROCHLORIDE Approval History
What ESMOLOL HYDROCHLORIDE Treats
6 indicationsESMOLOL HYDROCHLORIDE is approved for 6 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Supraventricular Tachycardia
- Atrial Fibrillation
- Atrial Flutter
- Sinus Tachycardia
- Tachycardia
- Hypertension
ESMOLOL HYDROCHLORIDE 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 ESMOLOL HYDROCHLORIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ESMOLOL HYDROCHLORIDE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ESMOLOL HYDROCHLORIDE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Viatris's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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.
ESMOLOL HYDROCHLORIDE FDA Label Details
Indications & Usage
Esmolol hydrochloride 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 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 circums...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.