Last reviewed · How we verify
Nebulized Fentanyl
Nebulized Fentanyl is a Opioid agonist Small molecule drug developed by Hamad Medical Corporation. It is currently in Phase 3 development for Acute pain management, Procedural sedation and analgesia. Also known as: Nebulized fentanyl dosage.
Nebulized fentanyl is an inhaled opioid agonist that binds to mu opioid receptors in the central nervous system to provide rapid analgesia and sedation.
Nebulized fentanyl is an inhaled opioid agonist that binds to mu opioid receptors in the central nervous system to provide rapid analgesia and sedation. Used for Acute pain management, Procedural sedation and analgesia.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 Fentanyl |
|---|---|
| Also known as | Nebulized fentanyl dosage |
| Sponsor | Hamad Medical Corporation |
| Drug class | Opioid agonist |
| Target | Mu opioid receptor (OPRM1) |
| Modality | Small molecule |
| Therapeutic area | Pain Management, Anesthesia |
| Phase | Phase 3 |
Mechanism of action
Fentanyl is a potent synthetic opioid that crosses the blood-brain barrier and activates mu opioid receptors, producing analgesic and sedative effects. The nebulized formulation allows for rapid pulmonary absorption and quick onset of action, making it suitable for acute pain management and procedural sedation. This route of administration bypasses first-pass hepatic metabolism, enabling faster systemic delivery compared to oral routes.
Approved indications
- Acute pain management
- Procedural sedation and analgesia
Common side effects
- Respiratory depression
- Dizziness
- Nausea
- Sedation
- Hypoxemia
Key clinical trials
- Nebulized Ketamine to Nebulized Fentanyl for Treating Acute Painful Conditions in the ED (PHASE4)
- Nebulized Fentanyl in Healthy Volunteers (PHASE1)
- A Randomized Study Comparing of Three Doses Nebulized Fentanyl in Older Adults (NA)
- Nebulized Fentanyl in Patients With Mild to Moderate Interstitial Lung Disease and Chronic Dyspnea (PHASE3)
- Differential Mechanisms of Dyspnea Relief in Advanced COPD: Opiates vs. Bronchodilators (PHASE4)
- Nebulized Fentanyl for Respiratory Symptoms in Patients With COVID-19 (PHASE3)
- Comparison of Nebulized Fentanyl, Midazolam and Dexmedetomidine as a Premedication in Pediatric Dental Surgeries (NA)
- First Evaluation of Morphine Hydrochloride by Nebulisation in Healthy Volunteers (PHASE1, PHASE2)
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 Fentanyl CI brief — competitive landscape report
- Nebulized Fentanyl updates RSS · CI watch RSS
- Hamad Medical Corporation portfolio CI
Frequently asked questions about Nebulized Fentanyl
What is Nebulized Fentanyl?
How does Nebulized Fentanyl work?
What is Nebulized Fentanyl used for?
Who makes Nebulized Fentanyl?
Is Nebulized Fentanyl also known as anything else?
What drug class is Nebulized Fentanyl in?
What development phase is Nebulized Fentanyl in?
What are the side effects of Nebulized Fentanyl?
What does Nebulized Fentanyl target?
Related
- Drug class: All Opioid agonist drugs
- Target: All drugs targeting Mu opioid receptor (OPRM1)
- Manufacturer: Hamad Medical Corporation — full pipeline
- Therapeutic area: All drugs in Pain Management, Anesthesia
- Indication: Drugs for Acute pain management
- Indication: Drugs for Procedural sedation and analgesia
- Also known as: Nebulized fentanyl dosage
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing