NDANASALSPRAY2 Generics Approved
Approved
May 2019
Lifecycle
LOE Approaching
Competitive Pressure
45/100
Clinical Trials
20
Data completeness
5/8 — Partial
NAYZILAM (midazolam) by UCB Pharma. Approved for benzodiazepine [epc]. First approved in 2019.
Drug data last refreshed 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NAYZILAM is a nasal spray formulation of midazolam, a benzodiazepine approved in 2019 for acute seizure management and anxiety. It delivers rapid CNS penetration via intranasal route, offering non-invasive administration compared to IV alternatives. The product targets emergency and acute care settings where fast-acting sedation or seizure interruption is clinically needed.
$28MPart D
LOE Approaching1.6 years to LOEProduct is mature with approaching loss of exclusivity (2028), suggesting smaller commercial teams and focus shifting toward generic transition planning and cost management.
Mechanism of Action
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 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
28 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
Drug-drug Interaction Study of Vorasidenib With Bupropion, Repaglinide, Flurbiprofen, Omeprazole, Midazolam, and Rosuvastatin in Healthy Adult Participants
Started Oct 2025
28 enrolled
Healthy Adult Participants
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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.