CISATRACURIUM BESYLATE
Cisatracurium besylate is a nondepolarizing neuromuscular blocker used as an adjunct to general anesthesia to facilitate tracheal intubation in adults and pediatric patients 1 month to 12 years of age. It is also indicated to provide skeletal muscle relaxation during surgery in adults and children (2 to 12 years of age), and for mechanical ventilation in the ICU in adults. Because of its intermediate onset of action, it is not recommended for rapid sequence intubation.
How CISATRACURIUM BESYLATE Works
Cisatracurium besylate works by binding competitively to cholinergic receptors on the motor end-plate to antagonize the action of acetylcholine. This process blocks neuromuscular transmission, resulting in skeletal muscle relaxation. This action can be reversed using acetylcholinesterase inhibitors, such as neostigmine.
Details
- Status
- Prescription
- First Approved
- 2012-02-03
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
Companies
CISATRACURIUM BESYLATE Approval History
What CISATRACURIUM BESYLATE Treats
3 indicationsCISATRACURIUM BESYLATE is approved for 3 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Tracheal intubation
- Skeletal muscle relaxation during surgery
- Skeletal muscle relaxation during mechanical ventilation in the ICU
CISATRACURIUM BESYLATE 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 CISATRACURIUM BESYLATE
3 of 4FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02509078 ROSE results posted | PETAL01ROSE 1U01HL123009-01 | Ph 3 | completed | Reevaluation Of Systemic Early Neuromuscular Blockade |
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.
CISATRACURIUM BESYLATE FDA Label Details
Indications & Usage
CISATRACURIUM BESYLATE is indicated for the treatment of Tracheal intubation; Skeletal muscle relaxation during surgery; Skeletal muscle relaxation during mechanical ventilation in the ICU.
Looking for the branded version?
CISATRACURIUM BESYLATE PRESERVATIVE FREE
Full clinical data, patents, trials, and competitive landscape for cisatracurium besylate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.