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Nebulized Midazolam
Nebulized Midazolam is a Small molecule drug developed by Nourhan M.Aly. It is currently in Phase 2 development. Also known as: Dormicum.
Nebulized midazolam is used as a premedication in pediatric dental surgeries. It works by positively modulating the GABA-A receptor, an anion channel, which is a mechanism consistent with its classification as a small molecule positive allosteric modulator.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Nebulized Midazolam |
|---|---|
| Also known as | Dormicum |
| Sponsor | Nourhan M.Aly |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Effects of Different Drugs for Glottic Atomization on Postoperative Sore Throat After Thyroid Surgery (PHASE4)
- Oral Melatonin Versus Nebulized Dexmedetomidine on Emergence Agitation in Children Undergoing Adenotonsillectomy (NA)
- Nebulized Ketamine for the Treatment of Major Depressive Disorder in an Inpatient Setting (PHASE3)
- Comparative Study Between Nebulised Dexmedetomidine and Nebulised Midazolam in Children Undergoing Lower Abdominal Surgeries (PHASE1)
- Dexmedetomidine and Midazolam Nebulization as Sedation During Cesarean Delivery in Pre-eclampsia (PHASE2)
- Role of Nebulized Dexmedetomidine in Blunting the Effects of Direct Laryngoscopy and Endotracheal Tube on Heart Rate and Blood Pressure. (PHASE4)
- Intranasal Versus Nebulized Midazolam in Behaviuor Modification of Preschool Children Undergoing Dental Treatment (PHASE2, PHASE3)
- Nebulized Lidocaine and Intranasal Midazolam for NGT Insertion in Children (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Nebulized Midazolam CI brief — competitive landscape report
- Nebulized Midazolam updates RSS · CI watch RSS
- Nourhan M.Aly portfolio CI
Frequently asked questions about Nebulized Midazolam
What is Nebulized Midazolam?
Who makes Nebulized Midazolam?
Is Nebulized Midazolam also known as anything else?
What development phase is Nebulized Midazolam in?
Related
- Manufacturer: Nourhan M.Aly — full pipeline
- Also known as: Dormicum
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing