CISATRACURIUM BESYLATE PRESERVATIVE FREE (cisatracurium besylate)
Cisatracurium besylate is a nondepolarizing neuromuscular blocker indicated as an adjunct to general anesthesia to facilitate tracheal intubation in adults and pediatric patients (1 month to 12 years of age). It is used to provide skeletal muscle relaxation during surgery in adults and in pediatric patients (2 to 12 years of age) via bolus or infusion maintenance. Additionally, it is indicated for skeletal muscle relaxation during mechanical ventilation in the ICU for adults. Because of its intermediate onset of action, it is not recommended for rapid sequence intubation.
How CISATRACURIUM BESYLATE PRESERVATIVE FREE Works
Cisatracurium besylate binds competitively to cholinergic receptors on the motor end-plate to antagonize the action of acetylcholine. This antagonism blocks neuromuscular transmission, resulting in skeletal muscle relaxation. This action can be reversed by acetylcholinesterase inhibitors, such as neostigmine.
Details
- Status
- Discontinued
- First Approved
- 2012-02-03
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
Companies
CISATRACURIUM BESYLATE PRESERVATIVE FREE Approval History
What CISATRACURIUM BESYLATE PRESERVATIVE FREE Treats
3 indicationsCISATRACURIUM BESYLATE PRESERVATIVE FREE 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
- Mechanical ventilation in the ICU
CISATRACURIUM BESYLATE PRESERVATIVE FREE 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.
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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 PRESERVATIVE FREE FDA Label Details
Indications & Usage
CISATRACURIUM BESYLATE PRESERVATIVE FREE is indicated for the treatment of Tracheal intubation; Skeletal muscle relaxation during surgery; Mechanical ventilation in the ICU.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.