Treats Respiratory Distress Syndrome (RDS) in premature infants. Sold as Curosurf. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Poractant Alfa (sold as Curosurf), first approved Nov 18, 1999, with 1 new use approved and 0 published complete response letters.
| Calfactant vs Poractant Alfa Using a Less Invasive Technique in Preterm Infants With Respiratory Distress SyndromeRespiratory Distress Syndrome in Premature Infants, Respiratory Distress Syndrome (RDS) · Uludag University | Phase 4 | Recruiting | Jan 20, 2026 |
| EXTERNAL NEGATIVE PRESSURE DURING LISANeonatology · Charles University, Czech Republic | Not applicable | Recruiting | Dec 9, 2025 |
| Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minutes Versus 5 MinutesNeonates and Preterm Infants, Infant Respiratory Distress Syndrome · Medical University of Graz | Phase 4 | Recruiting | Dec 3, 2025 |
| Surfactant Using a Supraglottic Airway Device in Late Preterm to Early Term InfantsRespiratory Distress Syndrome (Neonatal), Surfactant · Sharp HealthCare | Not applicable | Enrolling by invitation | Sep 16, 2025 |
| Surfactant Therapy Via Supraglottic Airway to Preterm Neonates With RDS in VietnamRespiratory Distress Syndrome in Premature Infant · Karolinska Institutet | Not applicable | Recruiting | Aug 1, 2025 |
| Prophylactic Surfactant by Thin Endotracheal Catheter for Preterm Infants At Birth: the ProTeCt TrialInfant, Newborn, Diseases, Prematurity · University College Dublin | Not applicable | Recruiting | Aug 16, 2024 |
| Non Inferiority Trial Investigating Surfactants Administered Via MISTRespiratory Distress Syndrome · Endeavor Health | Phase 4 | Recruiting | Oct 10, 2023 |
| Prophylactic Minimally Invasive Surfactant EvaluationRespiratory Distress Syndrome, Newborn, Premature Birth · Endeavor Health | Phase 4 | Recruiting | Aug 23, 2023 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Nov 18, 1999 | CurosurfBLA 20744 · New molecular entity | Chiesi USA Inc | 19 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
