NDAINTRAVENOUSPOWDER
Approved
Jul 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
6
Data completeness
5/8 — Partial
BYFAVO (remimazolam besylate) by Acacia Pharma is benzodiazepine. First approved in 2020.
Drug data last refreshed 7m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BYFAVO (remimazolam besylate) is an intravenous benzodiazepine that binds to GABA-A receptors in the brain to produce sedation and anxiolysis. It is indicated for procedural sedation in adult patients undergoing diagnostic or therapeutic procedures. The drug's carboxylic acid metabolite (CNS7054) has 300-fold lower receptor affinity, potentially offering a faster offset profile compared to traditional benzodiazepines.
Peak7.3 years to LOE
Product is in peak commercial phase post-2020 approval with stable market position; team size and growth rate cannot be determined from available data.
Mechanism of Action
benzodiazepine. BYFAVO binds to brain benzodiazepine sites (gamma amino butyric acid type A [GABA A ] receptors), while its carboxylic acid metabolite (CNS7054) has a 300 times lower affinity for the receptor. BYFAVO, like other benzodiazepines, did not show clear selectivity between subtypes of…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (6)
Long-term Sedation With Remimazolam Besylate in Critically Ill Patients
Started May 2023
728 enrolled
Light SedationMechanical Ventilation
Step 2 of A Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Sedation in ICU Patients
Started Feb 2023
164 enrolled
SedativeMechanical Ventilation
Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Critically Ill Patients With Deep Sedation
Started Sep 2022
60 enrolled
Critically IllDeep Sedation
Step 1 of A Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Sedation in ICU Patients
Started Apr 2022
36 enrolled
Mechanically Ventilated Patients
The Availability and Safety Study of Remimazolam Besylate for Injection on Sedation of ERAS Patients
Started Sep 2021
84 enrolled
AnalgesiaPostoperative Pain
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.