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surfactant administration
surfactant administration is a Small molecule drug developed by HaEmek Medical Center, Israel. It is currently in Phase 1 development. Also known as: Curosurf - a porcine surfactant routinely used for RDS.
Surfactant is administered to treat conditions such as Respiratory Distress Syndrome and Surfactant Deficiency Syndrome Neonatal, as well as to provide analgesia. The administration of surfactant can be done via various methods, including thin catheter technique, standard endotracheal tube, and laryngeal mask airway.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 administration |
|---|---|
| Also known as | Curosurf - a porcine surfactant routinely used for RDS |
| Sponsor | HaEmek Medical Center, Israel |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa (PHASE4)
- SHAPE Pilot Trial: Skin Health and Allergy Prevention Exposure (NA)
- Hydroxychloroquin (HCQ) in chILD of Genetic Defect (NA)
- 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:
- surfactant administration CI brief — competitive landscape report
- surfactant administration updates RSS · CI watch RSS
- HaEmek Medical Center, Israel portfolio CI
Frequently asked questions about surfactant administration
What is surfactant administration?
Who makes surfactant administration?
Is surfactant administration also known as anything else?
What development phase is surfactant administration in?
Related
- Manufacturer: HaEmek Medical Center, Israel — full pipeline
- Also known as: Curosurf - a porcine surfactant routinely used for RDS
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing