Last reviewed · How we verify
Infasurf (CALFACTANT)
At a glance
| Generic name | CALFACTANT |
|---|---|
| Sponsor | ONY |
| Drug class | Surfactant [EPC] |
| Therapeutic area | Respiratory |
| Phase | FDA-approved |
| First approval | 1998 |
Approved indications
- Respiratory distress syndrome in the newborn
Common side effects
- Endotracheal intubation complication
Key clinical trials
- Little Lungs Study (PHASE1,PHASE2)
- Calfactant vs Poractant Alfa Using a Less Invasive Technique in Preterm Infants With Respiratory Distress Syndrome (PHASE4)
- Non Inferiority Trial Investigating Surfactants Administered Via MIST (PHASE4)
- Steroids and Surfactant in Extremely Low Gestation Age Infants Dose Escalation Trial (PHASE1,PHASE2)
- InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS (PHASE3)
- Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients (PHASE3)
- Aerosolized Infasurf Treatment Protocol: Aerosolized Infasurf for Spontaneously Breathing Patients With Early RDS (AERO-03)
- Administration of Surfactant Through an Instillation Device Infasurf® (Calfactant) in Neonates- A Pilot Study (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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Infasurf CI brief — competitive landscape report
- Infasurf updates RSS · CI watch RSS
- ONY portfolio CI