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Curosurf (PORACTANT ALFA)
Curosurf works by reducing the surface tension in the lungs, allowing for easier breathing and improving oxygenation.
Curosurf (PORACTANT ALFA) is a surfactant medication originally developed by CHIESI USA INC and currently owned by the same company. It is a small molecule drug that belongs to the surfactant class and was FDA approved in 1999 for the treatment of respiratory distress syndrome in newborns. Curosurf works by reducing the surface tension in the lungs, allowing for easier breathing and improving oxygenation. It is a patented medication with a commercial status that is not off-patent. Key safety considerations include the potential for allergic reactions and the need for careful dosing.
At a glance
| Generic name | PORACTANT ALFA |
|---|---|
| Sponsor | Chiesi Usa Inc |
| Drug class | Surfactant [EPC] |
| Therapeutic area | Respiratory |
| Phase | FDA-approved |
| First approval | 1999 |
Mechanism of action
Endogenous pulmonary surfactant reduces surface tension at the air-liquid interface of the alveoli during ventilation and stabilizes the alveoli against collapse at resting transpulmonary pressures. deficiency of pulmonary surfactant in preterm infants results in Respiratory Distress Syndrome (RDS) characterized by poor lung expansion, inadequate gas exchange, and gradual collapse of the lungs (atelectasis).CUROSURF compensates for the deficiency of surfactant and restores surface activity to the lungs of these infants.
Approved indications
- Respiratory distress syndrome in the newborn
Common side effects
- Intracranial Hemorrhage
- Patent Ductus Arteriosus
- Bronchopulmonary Dysplasia
- Acquired Septicemia
- Acquired Pneumonia
- Pneumothorax
- Pulmonary Interstitial Emphysema
- Pulmonary hemorrhage
Key clinical trials
- The Budesonide in Babies (BiB) Trial (PHASE3)
- Calfactant vs Poractant Alfa Using a Less Invasive Technique in Preterm Infants With Respiratory Distress Syndrome (PHASE4)
- LISA in the Delivery Room for Extremely Preterm Infants (NA)
- Early Caffeine and LISA Compared to Caffeine and CPAP in Preterm Infants (NA)
- EXTERNAL NEGATIVE PRESSURE DURING LISA (NA)
- Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minutes Versus 5 Minutes (PHASE4)
- Surfactant Therapy Via Supraglottic Airway to Preterm Neonates With RDS in Vietnam (NA)
- Surfactant Using a Supraglottic Airway Device in Late Preterm to Early Term Infants (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 |
|---|---|
| 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:
- Curosurf CI brief — competitive landscape report
- Curosurf updates RSS · CI watch RSS
- Chiesi Usa Inc portfolio CI