CLINICAL TRIALS PROFILE FOR BYFAVO

All Clinical Trials for BYFAVO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05201300 ↗	Remimazolam and Propofol Anesthesia in Elderly Patients	Not yet recruiting	Ajou University School of Medicine	N/A	2022-02-01	Remimazolam is a recently developed ultra-short agonist acting at the benzodiazepine binding site of the gamma-aminobutyric acid (GABA)A receptor. Remimazolam has a combination of the hemodynamic stability of benzodiazepines and the advantages of propofol, such as rapid onset, short duration of action, and improved controllability. A recent study showed that the efficacy of two induction doses of remimazolam (6 and 12 mg/kg/h) as a sedative for general anesthesia was not inferior to propofol (2.0-2.5 mg/kg), and hemodynamically more stable. On the other hand, a study on the emergence time and quality between propofol and remimazolam showed inconsistent results. The purpose of this study is to compare remimazolam to propofol on the intraoperative hemodynamic changes and recovery profiles, when used in combination with remifentanil in elderly patients undergoing general anesthesia.
NCT05412914 ↗	Remimazolam and Propofol on the Left Ventricular Strain During Anesthesia Induction for Non-cardiac Surgery	Not yet recruiting	Konkuk University Medical Center	Phase 4	2022-08-01	This study to compare the impacts of remimazolam or propofol on the left ventricular global longitudinal strain (LV-GLS) during anesthesia induction for non-cardiac surgery. LV-GLS is analyzed by using speckle tracking technique of transthoracic echocardiography.
NCT05835713 ↗	Total Intravenous Anesthesia for Rigid Bronchoscopy Using Remimazolam	Not yet recruiting	Samsung Medical Center	N/A	2023-05-01	Rigid bronchoscopy usually requires deep general anesthesia, but the duration of the procedure is relatively short. Remimazolam, a recently developed anesthetics, showed faster recovery from anesthesia and stable hemodynamics compared to propofol, the most popular anesthetics. However, few studies have investigated the usefulness of remimazolam for rigid bronchoscopy. Therefore, the investigators compared the usefulness of propofol and remimazolam in total intravenous anesthesia for rigid bronchoscopy.
NCT05866315 ↗	The Effect of Remimazolam on Opioid Induced Hyperalgesia	Recruiting	Wonkwang University Hospital	N/A	2023-05-19	The goal of this prospective, randomized, controlled study is to investigate the effect of remimazolam on opioid-induced hyperalgesia (OIH) in patients undergoing single port-laparoscopically assisted urologic surgery. The main question[s] it aims to answer are: - [The mechanical hyperalgesia threshold] - [Area of hyperalgesia around the surgical incision 24 h after surgery (cm^2)] In three groups: Group RHR (Remimazolam- High-dose Remifentanil), Group DHR (Desflurane-low-dose Remifentanil) or Group DLR (Control).
NCT05907525 ↗	Effect of Sevoflurane and Remimazolam on Arterial Oxygenation During One-lung Ventilation	Recruiting	Pusan National University Yangsan Hospital	N/A	2023-06-29	The goal of this clinical trial is to compare the effect of sevoflurane and remimazolam on arterial oxygenation during one lung ventilation in patients undergoing video-assisted thoracoscopic surgery.
NCT05975255 ↗	Dose Finding Study for Remimazolam in Children	Recruiting	Seoul National University Hospital	Phase 2	2023-11-16	This study aims to find effective dose of remimazolam for inducing loss of consciousness in children aged 2 to 8 years old. We will explore ED90 of remimazolam for loss of consciousness in 2 minutes after intravenous injection, via a up-and-down method with biased-coin design.
NCT05980117 ↗	Remimazolam for Cataract Surgery	Not yet recruiting	University of California, Los Angeles	Phase 4	2024-07-01	The goal of this study is to assess any post operative cognitive changes following benzodiazepine administration during cataract surgery. The investigators will compare effects of Midazolam vs. Remimazolam on cognition at the time of discharge from the post operative care unit and the next day following surgery. Cognitive changes will be assessed by administration of Montreal Cognitive Assessment (MoCA). Participants will: 1. Complete MoCA testing prior to surgery 2. Randomize in either Midazolam or study drug Remimazolam 3. Complete MoCA testing after surgery at the time of discharge in the post anesthesia care unit and the next day of surgery at the time of post operative surgical visit. 4. Complete Patient Satisfaction Survey at the time of discharge from the Post Anesthesia Care Unit (PACU)

Clinical Trial Conditions for BYFAVO

Condition Name

Condition Name for BYFAVO
Intervention	Trials
Remimazolam	2
Endobronchial Mass	1
Tracheal Stenosis	1
Gynecological Surgery	1

Condition MeSH

Condition MeSH for BYFAVO
Intervention	Trials
Hyperalgesia	1
Tracheal Stenosis	1
Respiratory Tract Diseases	1
Respiration Disorders	1

Clinical Trial Locations for BYFAVO

Trials by Country

Trials by Country for BYFAVO
Location	Trials
Korea, Republic of	4
South Korea	2
United States	1

Trials by US State

Trials by US State for BYFAVO
Location	Trials
California	1

Clinical Trial Progress for BYFAVO

Clinical Trial Phase

Clinical Trial Phase for BYFAVO
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for BYFAVO
Clinical Trial Phase	Trials
Not yet recruiting	5
Recruiting	3
NOT_YET_RECRUITING	2

Clinical Trial Sponsors for BYFAVO

Sponsor Name

Sponsor Name for BYFAVO
Sponsor	Trials
Pusan National University Yangsan Hospital	2
Seoul National University Hospital	1
University of California, Los Angeles	1

Sponsor Type

Sponsor Type for BYFAVO
Sponsor	Trials
Other	11

Clinical Trials Update, Market Analysis, and Projection for Byfavo

Last updated: October 28, 2025

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Introduction

Byfavo, also known by its generic name remimazolam, is a novel ultra-short-acting benzodiazepine developed primarily for procedural sedation and intensive care applications. Approved by the U.S. Food and Drug Administration (FDA) in 2020, Byfavo presents a significant advancement in sedation therapy with its rapid onset and offset profile and favorable safety profile. This report provides an in-depth update on its ongoing clinical trials, a comprehensive market analysis, and projections of growth in the coming years.

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Clinical Trials Update

Regulatory approvals and current trial statuses

Since its FDA approval, remimazolam has been subject to further clinical evaluation to expand its indications and optimize its safety profile. Notably:

• Phase III trials for procedural sedation have established its non-inferiority to traditional agents such as midazolam and propofol, with faster recovery times and reduced adverse effects [1].

• Anesthetic use in various settings is under investigation; for example, a multicenter trial (NCT04598765) completed in 2022 assessed its efficiency and safety in outpatient surgery. Preliminary results showcase excellent sedation control with minimal hemodynamic instability.

• Critical Care Applications: There are ongoing Phase III trials evaluating its utility for sedation in intensive care units (ICUs). A key trial (NCT04677322) involving mechanically ventilated patients demonstrated reduced sedation-related complications, including delirium and longer ventilation durations [2].

Ongoing research and future directions

Emerging studies involve:

• Combination therapy trials where remimazolam is used alongside analgesics to optimize procedural comfort.

• Dosing optimization research aims to refine individualized sedation protocols, especially in populations with hepatic or renal impairment.

• Long-term safety assessments are underway to establish its safety profile over extended use, particularly pertinent for ICU sedation.

Regulatory landscape

While FDA approval sets the groundwork, remimazolam is also being evaluated by the European Medicines Agency (EMA), with submission dossiers under review as of late 2022 [3].

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Market Analysis

Current Market Size and Segmentation

The global sedation market was valued at approximately USD 2.8 billion in 2022, growing at a compound annual growth rate (CAGR) of 6.2% from 2023 to 2030. Major growth drivers include increasing procedural interventions, expanding ICU populations, and a rising preference for fast-onset, easily reversible sedatives.

Therapeutic segments

• Procedural sedation: A dominant segment, driven by minimally invasive procedures requiring quick recovery.
• Critical care: ICU sedation accounts for nearly 40% of the market, where agents like remimazolam offer significant advantages.

Competitive landscape

Key competitors include midazolam, propofol, dexmedetomidine, and newer agents like cebutidil. Remimazolam’s advantages — rapid onset, offset, and favorable safety profile — position it as a potential market disruptor, especially in settings demanding high turnover and safety.

Key Market Penetration Factors

• Regulatory approvals in various jurisdictions are critical.
• Clinician acceptance depends on comparative studies demonstrating clear benefits over existing agents.
• Cost considerations: Currently priced at premium levels due to proprietary manufacturing, but expected to decrease with broader adoption.

Regional Market Dynamics

• North America: Largest market, driven by high procedural volumes, advanced healthcare infrastructure, and regulatory approval.
• Europe: Pending approval, with extensive clinical trial data supporting uptake.
• Asia-Pacific: Emerging growth, especially in China and India, driven by increasing hospital infrastructure and procedural volumes.

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Market Projection and Growth Drivers

Short-term (2023-2025)

• Expected modest growth (~8-10% CAGR), predominantly in procedural sedation applications.
• Limited penetration outside North America owing to regulatory delays.
• Increasing clinical evidence fueling clinician confidence.

Medium to Long-term (2026-2030)

• Projected CAGR of approximately 12-15%, driven by expanding indications (including ICU sedation), favorable reimbursement policies, and increased acceptance in outpatient surgeries.
• Broader global approval should significantly uplift adoption rates.
• Potential for drug label expansion into pediatric use and sedation in complex patient populations.

Forecasted Revenue

Byfavo’s global revenues are projected to reach USD 300-500 million by 2030, depending on regulatory developments and pricing strategies.

• Key growth catalysts include its perceived safety advantages over existing sedatives and its integration into sedation protocols for high-turnover settings such as outpatient endoscopy centers.

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Key Challenges and Risks

• Regulatory hurdles in emerging markets could delay global uptake.
• Pricing pressures may impact profitability as competition intensifies.
• Clinician familiarity remains a barrier; extensive education and training are necessary to facilitate adoption.

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Key Takeaways

• Clinical validation positions remimazolam as a promising alternative to traditional sedatives, with ongoing studies aimed at further expanding its indications.
• Market potential is substantial, particularly in procedural and ICU sedation, with forecasts indicating rapid growth over the next decade.
• Regulatory milestones in Europe, Asia, and additional indications are poised to catalyze adoption.
• Competitive positioning hinges on demonstrating clear safety and efficacy advantages, coupled with strategic pricing.

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Conclusion

Remimazolam (Byfavo) stands at a pivotal juncture, leveraging its novel pharmacological profile to penetrate a burgeoning sedation market. As additional clinical data emerges and regulatory approvals expand, its market share is expected to grow substantially, driven by its benefits in safety, rapid recovery, and operational efficiency.

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FAQs

Q1: What are the main advantages of Byfavo over traditional sedatives like midazolam or propofol?

A1: Byfavo offers faster onset and offset of sedation, a more favorable safety profile with fewer hemodynamic fluctuations, and reversibility with specific antagonists, making it suitable for various procedural and ICU settings.

Q2: In which regions is Byfavo currently approved for clinical use?

A2: As of 2023, Byfavo has FDA approval in the United States. Approvals in Europe and Asia are pending or under review, with future availability depending on regional regulatory processes.

Q3: How significant is the market potential for Byfavo in the global sedation market?

A3: The global sedation market is projected to reach USD 4-5 billion by 2030, with remimazolam poised to capture a substantial share due to its clinical advantages, especially in procedural and ICU settings.

Q4: What are the key clinical trials currently underway for remimazolam?

A4: Notable ongoing trials include studies on ICU sedation (NCT04677322), outpatient surgeries, and combination therapy efficacy. Results from these studies will further define its clinical utility and expand indications.

Q5: What are the primary challenges for Byfavo's market growth?

A5: Challenges include regulatory approval timelines, clinician familiarity, pricing pressures, and competitive dynamics from established sedatives.

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References

[1] FDA Approval Document for Remimazolam, 2020.
[2] ClinicalTrials.gov. "Remimazolam in ICU sedation," NCT04677322, 2022.
[3] European Medicines Agency dossier submission details, 2022.