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pulmonary surfactant
pulmonary surfactant is a Pulmonary surfactant replacement therapy Small molecule drug developed by National Heart, Lung, and Blood Institute (NHLBI). It is currently in Phase 3 development.
Replaces deficient or dysfunctional endogenous lung surfactant to reduce alveolar surface tension and prevent alveolar collapse during respiration.
Pulmonary surfactant is a surface-active complex of phospholipids and proteins formed by type II alveolar cells, which adsorbs to the air-water interface of alveoli to reduce surface tension. It is used as a surfactant agent in the treatment of various respiratory conditions, including Respiratory Distress Syndrome, COPD, and Acute Respiratory Distress Syndrome, as indicated by ClinicalTrials.gov.
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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 | pulmonary surfactant |
|---|---|
| Sponsor | National Heart, Lung, and Blood Institute (NHLBI) |
| Drug class | Pulmonary surfactant replacement therapy |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
Pulmonary surfactant is a complex mixture of lipids and proteins that lines the alveoli. It reduces surface tension at the air-liquid interface, preventing alveolar collapse during exhalation and reducing the work of breathing. Exogenous surfactant replacement restores this function in conditions where surfactant is deficient or inactivated.
Approved indications
Common side effects
Key clinical trials
- Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa (PHASE4)
- Hydroxychloroquin (HCQ) in chILD of Genetic Defect (NA)
- A National Registry For Pulmonary Alveolar Proteinosis
- Vojta Reflex Versus Lung Squeezing Technique in Respiratory Distress Preterm Neonate (NA)
- Premedication for Less Invasive Surfactant Administration Study (PRELISA) (PHASE4)
- Hydroxychloroquine in Children's Interstitial Lung Diseases With Genetic Causes (EARLY_PHASE1)
- Immunomodulatory Treatment of Interstitial Lung Disease Associated With Surfactant Related Gene Variants (PHASE2)
- Utilization of Lung Ultrasound Score in Decision for Minimally Invasive Surfactant Administration (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:
- pulmonary surfactant CI brief — competitive landscape report
- pulmonary surfactant updates RSS · CI watch RSS
- National Heart, Lung, and Blood Institute (NHLBI) portfolio CI
Frequently asked questions about pulmonary surfactant
What is pulmonary surfactant?
How does pulmonary surfactant work?
Who makes pulmonary surfactant?
What drug class is pulmonary surfactant in?
What development phase is pulmonary surfactant in?
Related
- Drug class: All Pulmonary surfactant replacement therapy drugs
- Manufacturer: National Heart, Lung, and Blood Institute (NHLBI) — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing