Midazolam: clinical trials recruiting now
14
Recruiting trials
15
Conditions studied
26
US states with sites
26
Countries
FDA drug label
- FDA-approved
- Yes. Midazolam appears in the FDA drug-label database. Marketed as Nayzilam.
- Drug class
- Benzodiazepine (FDA established pharmacologic class)
- Boxed warning
- The FDA label for Midazolam carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
NAYZILAM is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 12 years of age and older. NAYZILAM is a benzodiazepine indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 12 years of age and older. ( 1 )
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles. — Fresenius Kabi USA, LLC | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2012-09-27 |
| Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL — Fresenius Kabi USA, LLC | Class I (FDA: reasonable probability of serious harm or death) | Terminated | 2017-10-27 |
| Failed Impurities/Degradation Specifications — Fresenius Kabi USA, LLC | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2016-12-16 |
Phase breakdown
Phase 1 6
Phase 2 1
Phase 3 4
Not applicable 4
Conditions being studied
Recruiting trials involving Midazolam
- A Drug-Drug Interaction Study of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin
- A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy
- A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder
- A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants
- A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
- A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations.
- A Study to Learn How Different Amounts of the Study Medicine Called PF-08103402 Are Tolerated and Act in the Body in Healthy Adults or Adults With Mild To-moderate Asthma
- A Survey of Midazolam in People With Status Epilepticus
- An Early-Stage Study in Multiple Clinics of How Afimkibart May Affect the Body's Processing of Medicines That Rely on Cytochrome P450 Enzymes in Participants With Ulcerative Colitis
- Effect of Sedative and Anxiolytic Premedication on Children Experience After General Anesthesia
- Intranasal Dexmedetomidine vs Oral Midazolam for Premedication in Pediatric Surgery
- Ketamine in OCD: Efficacy and Effects on Stress and Cognition
- Prehospital Early Administration of Ketamine for Status Epilepticus in Epileptic Kids (PEAK-SEEK)
- Remimazolam for Postoperative Atrial Fibrillation
Common questions
Is Midazolam FDA-approved?
Yes, marketed as Nayzilam. Its FDA label carries a boxed warning.
How many recruiting trials involve Midazolam?
14 recruiting trials across 15 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.