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Surfactant nebulisation
Surfactant nebulisation is a Pulmonary surfactant replacement therapy Small molecule drug developed by University of Zurich. It is currently in Phase 3 development for Acute respiratory distress syndrome (ARDS), Respiratory distress syndrome in premature infants.
Surfactant nebulisation delivers pulmonary surfactant directly to the lungs via inhalation to improve gas exchange and reduce respiratory distress.
Surfactant nebulisation is used to treat conditions such as Neonatal Respiratory Distress Syndrome and Preterm Birth, particularly in preterm neonates. It involves administering a surfactant agent, specifically Curosurf, via nebulization to help alleviate respiratory distress.
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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 | Surfactant nebulisation |
|---|---|
| Sponsor | University of Zurich |
| Drug class | Pulmonary surfactant replacement therapy |
| Modality | Small molecule |
| Therapeutic area | Respiratory/Pulmonology |
| Phase | Phase 3 |
Mechanism of action
Pulmonary surfactant is a naturally occurring mixture of lipids and proteins that reduces surface tension in the alveoli, preventing alveolar collapse and improving lung compliance. Nebulisation allows direct delivery of exogenous surfactant to the respiratory tract, bypassing systemic absorption and maximizing local therapeutic effect. This approach is intended to treat conditions characterized by surfactant deficiency or dysfunction.
Approved indications
- Acute respiratory distress syndrome (ARDS)
- Respiratory distress syndrome in premature infants
Common side effects
- Transient oxygen desaturation
- Airway obstruction
- Pulmonary inflammation
Key clinical trials
- Surfactant Nebulization for the Early Aeration of the Preterm Lung (PHASE3)
- A Study To InvestigateThe Safety, Tolerability And Efficacy Of Nebulised Curosurf® In Preterm Neonates With Respiratory Distress Syndrome (RDS) (PHASE2)
- Does The Surfactant Administration by Aerosolization Effective? (NA)
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:
- Surfactant nebulisation CI brief — competitive landscape report
- Surfactant nebulisation updates RSS · CI watch RSS
- University of Zurich portfolio CI
Frequently asked questions about Surfactant nebulisation
What is Surfactant nebulisation?
How does Surfactant nebulisation work?
What is Surfactant nebulisation used for?
Who makes Surfactant nebulisation?
What drug class is Surfactant nebulisation in?
What development phase is Surfactant nebulisation in?
What are the side effects of Surfactant nebulisation?
Related
- Drug class: All Pulmonary surfactant replacement therapy drugs
- Manufacturer: University of Zurich — full pipeline
- Therapeutic area: All drugs in Respiratory/Pulmonology
- Indication: Drugs for Acute respiratory distress syndrome (ARDS)
- Indication: Drugs for Respiratory distress syndrome in premature infants
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing