ROCURONIUM BROMIDE
Rocuronium bromide helps patients undergoing surgery or those requiring mechanical ventilation by providing necessary skeletal muscle relaxation. It is used for both inpatients and outpatients as an addition to general anesthesia. This medication also helps medical professionals perform both routine and rapid sequence tracheal intubation more effectively.
How ROCURONIUM BROMIDE Works
This drug works by competing for cholinergic receptors at the motor end-plate, which prevents normal signaling and leads to muscle relaxation. Depending on the dose, it has a rapid to intermediate onset and lasts for an intermediate duration. Its actions can be reversed by using specific medications known as acetylcholinesterase inhibitors.
Details
- Status
- Prescription
- First Approved
- 2008-11-26
- Patent Cliff
- 2039
- Routes
- INJECTION, INTRAVENOUS
- Dosage Forms
- INJECTABLE, SOLUTION
Companies
ROCURONIUM BROMIDE Approval History
What ROCURONIUM BROMIDE Treats
4 indicationsROCURONIUM BROMIDE is approved for 4 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Routine tracheal intubation
- Rapid sequence tracheal intubation
- Skeletal muscle relaxation during surgery
- Skeletal muscle relaxation during mechanical ventilation
ROCURONIUM BROMIDE 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.
Drugs Similar to ROCURONIUM BROMIDE
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07044180 | AITT 2025/1 DE RKEB/IKEB 7109-2025, NNGYK/ETGY/08360-4/2025 | Ph 4 | active not recruiting | Reversal of Pipecuronium-induced Neuromuscular Blockade With Sugammadex During Propofol Anesthesia |
| NCT07044193 RPINMBWS | AITT 2025/2 DE RKEB/IKEB 7108-2025, NNGYK/ETGY/08365-4/2025 | Ph 4 | not yet recruiting | Reversal of Pipecuronium-induced Neuromuscular Blockade With Sugammadex During Sevoflurane Anesthesia |
| NCT05562999 HIPPO | NL81931.091.22 | Ph 4 | completed | Impact of Deep Neuromuscular Blockade During Total Hip Replacement Surgery on Postoperative Recovery and Immune Function |
| NCT05687253 | BDX-22-006 | Ph 2 | completed | Evaluation of Intubation Conditions Following BX1000 or Rocuronium in Subjects Undergoing Surgery |
| NCT03572413 RECOVER-PLUS | NL65290.091.18 substudy | Ph 4 | completed | The Effect of Low Pressure Pneumoperitoneum During Laparoscopic Colorectal Surgery on Innate Immune Homeostasis. |
| NCT03608436 RECOVER | NL65290.091.18 | Ph 4 | completed | The Effect of Low Pressure Pneumoperitoneum During Laparoscopic Colorectal Surgery on Early Quality of Recovery |
| NCT04105764 | elite NMB | Ph 4 | completed | Deep NMB in Ambulatory Gynecological Laparoscopy |
| NCT03881423 | wbakhet | Ph 4 | completed | Deep vs Moderate Neuromuscular Blockade in Day Case Laparoscopic Cholecystectomy. |
| NCT03669484 | CN01082020 | Ph 3 | completed | Comparative Clinical Study of Efficacy and Safety of Remimazolam and Propofol in Patients Undergoing Elective Surgery Under General Anaesthesia |
| NCT01142635 | R08197M 2008-008129-31 | Ph 4 | completed | Electromyographic (EMG) on the Anaesthesia Monitor |
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.
ROCURONIUM BROMIDE FDA Label Details
Indications & Usage
FDA Label (PDF)ROCURONIUM BROMIDE is indicated for the treatment of Routine tracheal intubation; Rapid sequence tracheal intubation; Skeletal muscle relaxation during surgery; Skeletal muscle relaxation during mechanical ventilation.
ROCURONIUM BROMIDE Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for ROCURONIUM BROMIDE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2039
- • 1 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 3 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.