NDAINTRAVENOUSSOLUTION
Approved
Mar 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
4/8 — Partial
MIDAZOLAM IN 0.9% SODIUM CHLORIDE (midazolam) by Hikma is short-acting benzodiazepine central nervous system (cns) depressant. First approved in 2021.
Drug data last refreshed 19h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Midazolam in 0.9% sodium chloride is a pre-filled intravenous solution containing midazolam, a short-acting benzodiazepine CNS depressant. It is used for sedation, anxiolysis, and anesthesia induction in clinical settings. The formulation provides convenient, ready-to-use delivery of this widely-established agent.
Peak11.7 years to LOE
Product is at peak commercial maturity with no direct competitors in this formulation; team focus is on market penetration and retention in institutional/hospital channel.
Mechanism of Action
short-acting benzodiazepine central nervous system (CNS) depressant.
Pharmacologic Class:
Benzodiazepine
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
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
A Phase 1 Study to Assess the Effect of ABBV-722 on Midazolam, Digoxin, Pitavastatin, Metformin, and Sitagliptin Drug Levels in Healthy Adults.
Started Apr 2026
12 enrolled
Healthy Volunteers
A Clinical Trial in Healthy Participants to Learn How Itraconazole Affects MK-2828 Levels and How MK-2828 Affects Midazolam Levels (MK-2828-007)
Started Mar 2026
29 enrolled
Healthy
A Study to Investigate the Effects of Multiple Doses of Rezatapopt on the Pharmacokinetics of Metformin, Rosuvastatin, Repaglinide, and Midazolam in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation.
Started Jan 2026
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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.