Drugs / Calfactant
Calfactant
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | INFASURF PRESERVATIVE FREE | — | 1998-07-01 | fda.gov ↗ |
Trials 14 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03748173 | Jan 2019 → Oct 2020 | bronchiolitis | ONY | Terminated | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06855043 | Sep 2026 → Mar 2029 expected | respiratory distress syndrome in premature infants | University of Wisconsin, Madison | Not yet recruiting | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT04056741 | Feb → Dec 2025 | respiratory distress syndrome in premature infants, surfactant metabolism dysfunction, pulmonary, 1 | ONY | Suspended | No outcome recorded |
| Phase 2 | NCT01268215 | Jul 2010 → Jun 2012 | bronchopulmonary dysplasia | East Carolina University | Unknown | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT00999713 | Jun 2010 → Sep 2015 | acute lung injury | Milton S. Hershey Medical Center | Completed | No outcome recorded |
| Phase 2/3 | NCT00506532 | Jan 2005 → Dec 2008 | — | Rabin Medical Center | Unknown | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT05960929 | Jan 2025 → Jan 2026 overdue | respiratory distress syndrome in premature infants | ONY | Recruiting | No outcome recorded |
| Phase 3 | NCT03058666 | Mar 2017 → Jun 2018 | respiratory distress syndrome in premature infants | ONY | Completed | No outcome recorded |
| Phase 3 | NCT00682500 | May 2008 → Dec 2010 | adult acute respiratory distress syndrome | Pneuma Pharmaceuticals Incorporated | Terminated | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT06074380 | Jan 2024 → Dec 2025 overdue | newborn respiratory distress syndrome | Endeavor Health | Recruiting | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT00628134 | Mar 2008 → Aug 2009 | cystic fibrosis | University of Pittsburgh | Completed | No outcome recorded |
| — | NCT00208039 | Sep 2004 → Nov 2007 | bronchopulmonary dysplasia, respiratory distress syndrome in premature infants | Children's Hospital of Philadelphia | Completed | No outcome recorded |
| — | NCT00165074 | Jun 2003 → Jun 2007 | respiratory distress syndrome in premature infants | Children's Hospital of Philadelphia | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03582930 | — | respiratory distress syndrome in premature infants | ONY | No longer available | No outcome recorded |
Also used as a comparator or background therapy in 5 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02907593 Background | Sep 2016 → Apr 2018 | bronchopulmonary dysplasia | Cynthia McEvoy | Terminated | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT01022580 Comparator | Jan 2010 → Dec 2013 | bronchopulmonary dysplasia | Roberta Ballard | Completed | No outcome recorded |
| Phase 3 | NCT00569530 Comparator | Jan 2008 → Dec 2012 | bronchopulmonary dysplasia, respiratory distress syndrome in premature infants | Roberta Ballard | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT07350018 Comparator | Jan 2026 → Feb 2027 expected | respiratory distress syndrome in premature infants | Uludag University | Recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02834624 Comparator | Jul 2013 → Feb 2015 | respiratory distress syndrome in premature infants | University of Missouri-Columbia | Completed | No outcome recorded |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | calfactant | “Infants who on CPAP who reach the threshold of 30% oxygen will be randomized to calfactant (Infasurf), 3ml/kg or poractant alfa (Curosurf), 2.5ml/kg, administered under direct...” NCT06074380 ↗13“A single dose of Calfactant administered by pacifier interface by inhalation via the Infasurf Aero nebulizer at 6ml/kg.” NCT05960929 ↗ “Patients in this group will have Calfactant at 3ml/kg administered via the supraglottic administration device.” NCT04056741 ↗ “Infasurf (calfactant, manufactured for Forest Pharmaceuticals, Inc. St. Louis, MO, by ONY Inc., Amherst, NY” NCT00165074 ↗ “booster doses of exogenous surfactant (Infasurf®, calfactant) in addition to inhaled nitric oxide” NCT01022580 ↗ |
| Known as | Bovine calf lung surfactant | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201447 ↗ |
| Known as | Infasurf | “Infants who on CPAP who reach the threshold of 30% oxygen will be randomized to calfactant (Infasurf), 3ml/kg or poractant alfa (Curosurf), 2.5ml/kg, administered under direct...” NCT06074380 ↗8“Administration of Surfactant Through an Instillation Device Infasurf® (Calfactant) in Neonates- A Pilot Study” NCT04056741 ↗ |
| Known as | Infasurf preservative free | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201447 ↗ |
| Modality | Other / unclassified | “Infasurf surfactant” NCT00208039 ↗ |
| Route | Other | “instilled via endotracheal tube” NCT00165074 ↗ |