BYFAVO (remimazolam besylate)
Byfavo is used to help adult patients achieve and maintain sedation during short medical procedures. It is specifically intended for clinical interventions that last 30 minutes or less. This injectable medication helps clinicians manage a patient's level of consciousness during these brief sessions.
How BYFAVO Works
This drug works by binding to benzodiazepine sites on GABA A receptors in the brain to produce a sedative effect. It does not show a preference for any specific subtype of these receptors. While the medication eventually breaks down into a metabolite, that byproduct has a significantly lower ability to bind to the receptors than the drug itself.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2020-07-02
- Patent Cliff
- 2034
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
BYFAVO Approval History
What BYFAVO Treats
1 indicationsBYFAVO is approved for 1 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Procedural Sedation
BYFAVO Boxed Warning
PERSONNEL AND EQUIPMENT FOR MONITORING AND RESUSCITATION AND RISKS FROM CONCOMITANT USE WITH OPIOID ANALGESICS WARNING: PERSONNEL AND EQUIPMENT FOR MONITORING AND RESUSCITATION, AND RISKS FROM CONCOMITANT USE WITH OPIOID ANALGESICS AND OTHER SEDATIVE-HYPNOTICS See full prescribing information for complete boxed warning Only personnel trained in the administration of procedural sedation, and not involved in the conduct of the diagnostic or therapeutic procedure, should administer BYFAVO. ( 2.1 , ...
WARNING: PERSONNEL AND EQUIPMENT FOR MONITORING AND RESUSCITATION AND RISKS FROM CONCOMITANT USE WITH OPIOID ANALGESICS WARNING: PERSONNEL AND EQUIPMENT FOR MONITORING AND RESUSCITATION, AND RISKS FROM CONCOMITANT USE WITH OPIOID ANALGESICS AND OTHER SEDATIVE-HYPNOTICS See full prescribing information for complete boxed warning Only personnel trained in the administration of procedural sedation, and not involved in the conduct of the diagnostic or therapeutic procedure, should administer BYFAVO. ( 2.1 , 5.1 ) Administering personnel must be trained in the detection and management of airway obstruction, hypoventilation, and apnea, including the maintenance of a patent airway, supportive ventilation, and cardiovascular resuscitation. ( 2.1 , 5.1 ) BYFAVO has been associated with hypoxia, bradycardia, and hypotension. Continuously monitor vital signs during sedation and through the recovery period. ( 2.1 , 5.1 ) Resuscitative drugs, and age- and size-appropriate equipment for bag/valve/mask assisted ventilation must be immediately available during administration of BYFAVO. ( 2.1 , 5.1 ) Concomitant use of benzodiazepines with opioid analgesics may result in profound sedation, respiratory depression, coma, and death. The sedative effect of intravenous BYFAVO can be accentuated by concomitantly administered CNS depressant medications, including other benzodiazepines and propofol. Continuously monitor patients for respiratory depression and depth of sedation. ( 5.2 , 7.1 ) Personnel and Equipment for Monitoring and Resuscitation Only personnel trained in the administration of procedural sedation, and not involved in the conduct of the diagnostic or therapeutic procedure, should administer BYFAVO [see Dosage and Administration (2.1) , Warnings and Precautions (5.1) ] . Administering personnel must be trained in the detection and management of airway obstruction, hypoventilation, and apnea, including the maintenance of a patent airway, supportive ventilation, and cardiovasc
BYFAVO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06124404 | WHUICU202205 | Ph 2 | completed | Step 1 of A Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Sedation in ICU Patients |
| NCT07456111 Bypro | LOC-100018379 | Ph 4 | recruiting | A Comparison of Remimazolam Besylate and Propofol Sedation in Patients Undergoing Colonoscopic Polypectomy |
| NCT06575530 | IIT2024-001-002 | Ph 4 | recruiting | Sedation Efficacy and Safety of Remazolam Besylate in Ventilated Surgical Critically Ill Patients |
| NCT07213544 | Pro00146765 | Ph 4 | recruiting | Remimazolam vs Propofol in Laser Burn Cases |
| NCT07045467 | YXLL-KY-2024(103) | Ph 1 | recruiting | Remimazolam Infusion in Kidney Transplant Patients: A Multicenter Study |
| NCT07155265 REMIMID-ICU | YCSYY-【2025】-(J-050) | Ph 3 | not yet recruiting | REMIMID-ICU: Remimazolam vs Midazolam for Deep Sedation in Hemodynamically Unstable, Mechanically Ventilated Adults |
| NCT06061159 | SAHoWMU-CR2023-03-107 | Ph 4 | completed | The ED95 of Single Intravenous Bolus Remimazolam Besylate in Pediatric Patients During General Anesthesia Induction |
| NCT05782894 | WHUICU202208 | Ph 3 | completed | Step 2 of A Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Sedation in ICU Patients |
| NCT05994547 | Remimazolam Vs midazolam | Ph 4 | completed | Efficacy and Safety of Remimazolam Compared With Midazolam During Bronchoscopy:Randomised Controlled Trial |
| NCT05486377 | B-2205-757-001 | Ph 4 | completed | Remimazolam vs Desflurane for General Anesthesia for Ablation of Arrhythmia |
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.
BYFAVO FDA Label Details
Indications & Usage
FDA Label (PDF)BYFAVO is indicated for the treatment of Procedural Sedation.
WARNING: PERSONNEL AND EQUIPMENT FOR MONITORING AND RESUSCITATION AND RISKS FROM CONCOMITANT USE WITH OPIOID ANALGESICS WARNING: PERSONNEL AND EQUIPMENT FOR MONITORING AND RESUSCITATION, AND RISKS FROM CONCOMITANT USE WITH OPIOID ANALGESICS AND OTHER SEDATIVE-HYPNOTICS See full prescribing informati...
BYFAVO Patents & Exclusivity
Patents (11 active)
Pro Intelligence Preview
Deep insights for BYFAVO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2034
- • 11 active patents
Trial Analysis
- • 13 total trials
- • Stage: Mature
Competitive Landscape
- • Competitor tracking
- • 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.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment