NDAINTRAVENOUSSOLUTION
Approved
Jul 2022
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
MIDAZOLAM IN 0.8% SODIUM CHLORIDE (midazolam) by Hikma is short-acting benzodiazepine central nervous system (cns) depressant. First approved in 2022.
Drug data last refreshed 43m ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Midazolam in 0.8% sodium chloride is a short-acting benzodiazepine CNS depressant formulated as an intravenous solution for rapid sedation and anxiolysis. It is indicated for procedural sedation, induction of anesthesia, and acute agitation management in clinical settings. The pre-formulated IV solution represents a convenience-focused offering in the generic midazolam market.
Peak
Product is in peak lifecycle phase with moderate competitive pressure (30); team size and hiring activity currently unknown but likely focused on institutional market penetration.
Mechanism of Action
short-acting benzodiazepine central nervous system (CNS) depressant.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Clinical Trial of MK-6916 With Midazolam and Rosuvastatin in Healthy Participants (MK-6916-012)
Started Nov 2026
18 enrolled
Healthy
DDI Study of ECC0509 With Metformin, Midazolam, and Caffeine
Started Nov 2026
40 enrolled
Steatohepatitis, NonalcoholicOsteo Arthritis
A Study to Assess the Potential CYP3A Induction Effect of Brensocatib on the Pharmacokinetics (PK) of Midazolam in Healthy Participants
Started Oct 2026
26 enrolled
Healthy Volunteers
A Research Study on How UBT251 Affects Levels of Midazolam, Caffeine and Warfarin in the Blood of Participants With Excess Body Weight
Started Jul 2026
44 enrolled
ObesityOverweight
A Drug-drug Interaction Study to Evaluate the Effects of Pelabresib on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Oral Contraceptive in Patients With Advanced Malignancies
Started Jun 2026
24 enrolled
Advanced Malignancies
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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.