How many clinical trials are studying Remimazolam?

5 recruiting trials in our tracked data involve Remimazolam.

What conditions is Remimazolam being studied for?

In our tracked recruiting trials, Remimazolam is being studied in trials for Depression, Anxiety, Atrial fibrillation.

Remimazolam: clinical trials recruiting now

Q: Is Remimazolam FDA-approved?

Yes. According to the FDA drug label available through openFDA, Remimazolam is an FDA-approved drug. Its FDA label carries a boxed warning.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Remimazolam appears in the FDA drug-label database. Marketed as BYFAVO.
Boxed warning: The FDA label for Remimazolam carries a boxed warning (the FDA's most serious warning). See the full label for details.

FDA-approved use

BYFAVO ® is indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. BYFAVO (remimazolam) for injection is a benzodiazepine indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. ( 1 )

FDA label via openFDA

Phase breakdown

Phase 2 1 Phase 4 1 Not applicable 3

Conditions being studied

Condition	Trials
Depression	2
Anxiety	1
Atrial fibrillation	1
Constipation	1
Coronary Artery Bypass Grafting	1
Hypoxia	1
Hysteroscopy	1
Obesity	1
Overweight or Obesity	1
Parkinson's Disease	1
Postoperative Complications	1
Postoperative Nausea	1
Remimazolam	1
Respiratory Depression	1
Sleep Disturbance	1

Recruiting trials involving Remimazolam

Comparison of Remimazolam and Propofol in Endoscopic Examinations and Treatments
NCT06777758 · Phase: Phase 4 · Ages: 20 Years to 80 Years · Sex: All (male and female) · 1 location
Esketamine Combined With Remimazolam on Postoperative Sleep Disturbance and Anxiety in Patients
NCT06108830 · Phase: Not applicable (e.g. observational or device study) · Ages: 20 Years to 65 Years · Sex: All (male and female) · 1 location
Ketamine for Veterans With Parkinson's Disease
NCT06231563 · Phase: Phase 2 · Ages: 40 Years to 80 Years · Sex: All (male and female) · 1 location
Remimazolam for Postoperative Atrial Fibrillation
NCT05891145 · Phase: Not applicable (e.g. observational or device study) · Ages: 50 Years to 70 Years · Sex: All (male and female) · 1 location
The Effects of Remimazolam on the Incidence of Severe Hypoxia During Sedated Hysteroscopy for Assisted Reproduction in Overweight or Obese Patients
NCT06187896 · Phase: Not applicable (e.g. observational or device study) · Ages: 20 Years to 50 Years · Sex: Female · 1 location

Common questions

Is Remimazolam FDA-approved?

Yes, marketed as BYFAVO. Its FDA label carries a boxed warning.

How many recruiting trials involve Remimazolam?

5 recruiting trials across 15 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.