Drugs / Poractant alfa

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) CUROSURF — 2002-03-01 fda.gov ↗
Approved US (FDA) CUROSURF — 1999-11-18 fda.gov ↗

Trials 19

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT04181255 Feb → Jun 2020 hypoplastic left heart syndrome University of Michigan Terminated No outcome recorded
Phase 24 trials · 1 missed
Phase 2 NCT04825197 Dec 2021 → Feb 2023 bronchopulmonary dysplasia, lung disorder VENTO GIOVANNI Unknown No outcome recorded
Phase 2 NCT04502433 Jan 2021 → Mar 2022 adult acute respiratory distress syndrome Chiesi Farmaceutici S.p.A. Terminated No outcome recorded
Phase 2 NCT04384731 May 2020 → May 2021 COVID-19, adult acute respiratory distress syndrome Dr Christophe LENCLUD Unknown No outcome recorded
Phase 2 NCT03235986 Aug 2017 → May 2020 newborn respiratory distress syndrome Chiesi Farmaceutici S.p.A. Terminated Missed primary
Phase 2/31 trial · 1 missed
Phase 2/3 NCT02305160 Apr 2005 → May 2006 respiratory distress syndrome in premature infants University of Sao Paulo Completed Missed primary
Phase 34 trials · 2 missed
Phase 3 NCT04862377 Oct 2021 → Apr 2024 bronchopulmonary dysplasia, respiratory distress syndrome in premature infants Hospital Clinic of Barcelona Unknown No outcome recorded
Phase 3 NCT04315636 Mar → Nov 2021 respiratory distress syndrome in premature infants, surfactant metabolism dysfunction, pulmonary, 1 University of Zurich Completed Missed primary
Phase 3 NCT03959384 Jan 2019 → Apr 2021 bronchiolitis Azienda Ospedaliera Universitaria Integrata Verona Terminated No outcome recorded
Phase 3 NCT01709409 Mar 2013 → Aug 2016 respiratory distress syndrome in premature infants Ottawa Hospital Research Institute Completed Missed primary
Phase 48 trials · 1 met primary · 1 missed
Phase 4 NCT07261787 Feb 2026 → Jul 2028 expected chronic respiratory distress with surfactant metabolism deficiency, respiratory distress syndrome in premature infants Medical University of Graz Recruiting No outcome recorded
Phase 4 NCT06074380 Jan 2024 → Dec 2025 overdue newborn respiratory distress syndrome Endeavor Health Recruiting No outcome recorded
Phase 4 NCT06007547 Jan 2024 → Dec 2025 overdue newborn respiratory distress syndrome Endeavor Health Recruiting No outcome recorded
Phase 4 NCT04199364 Jun 2021 → Jul 2024 newborn respiratory distress syndrome Virgilio Paolo Carnielli Unknown No outcome recorded
Phase 4 NCT01923844 Mar 2012 → Apr 2013 respiratory distress syndrome in premature infants Ege University Completed No outcome recorded
Phase 4 NCT01039285 Dec 2009 → Sep 2021 bronchopulmonary dysplasia, newborn respiratory distress syndrome Jean Michel Hascoet Completed No outcome recorded
Phase 4 NCT00501982 Mar 2007 → May 2008 newborn respiratory distress syndrome Chiesi Farmaceutici S.p.A. Completed Missed primary
Phase 4 NCT00767039 Jan 2005 → Sep 2008 patent ductus arteriosus, respiratory distress syndrome in premature infants Alan Fujii Terminated Met primary Stop: Enrollment
Phase not applicable1 trial · 1 met primary
— NCT01116921 Feb 2011 → Apr 2015 newborn respiratory distress syndrome University of Minnesota Completed Met primary
Comparator or background therapy15 trials
Phase 2 NCT02452476 Comparator Jan 2016 → May 2018 newborn respiratory distress syndrome Chiesi Farmaceutici S.p.A. Completed Missed primary
Phase 3 NCT02772081 Comparator May 2021 → Aug 2022 respiratory distress syndrome in premature infants Chiesi Farmaceutici S.p.A. Terminated No outcome recorded Stop: Business
Phase 3 NCT04545866 Comparator Apr 2021 → Sep 2024 overdue bronchopulmonary dysplasia, respiratory distress syndrome in premature infants NICHD Neonatal Research Network Active not recruiting Missed primary
Phase 4 NCT07350018 Comparator Jan 2026 → Feb 2027 expected respiratory distress syndrome in premature infants Uludag University Recruiting No outcome recorded
Phase 4 NCT03521063 Background Jan 2018 → Oct 2019 bronchopulmonary dysplasia, pulmonary immaturity, respiratory distress syndrome in premature infants Hospital Central "Dr. Ignacio Morones Prieto" Unknown No outcome recorded

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 35 sources stand behind the page.

FieldValueCited text
Known as Poractant alfa “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 ↗
24

“Preparations of poractantalfa (Curosurf, 200 mg/kg) (n = 15) or beractant (Survanta, 100 mg/kg) (n = 15) were administered in a consecutive randomized manner within the first 6...” NCT01923844 ↗

“200 mg/kg body weight nebulised surfactant (Poractant alfa, Chiesi Farmaceutici SpA, Parma, Italy) via a customised vibrating membrane nebuliser” NCT04315636 ↗

“Inhaled Nebulised Poractant Alfa (Porcine Surfactant, Curosurf®) In Comparison With Nasal Continuous Positive Airway Pressure (nCPAP) Alone” NCT03235986 ↗

“Poractant alfa and beractant treatment of very premature infants with respiratory distress syndrome.” PMID 20336076 ↗ Mar 2010

“REGISTRY NAME: Lung Lavage With Dilute Poractant Alfa for Meconium Aspiration Syndrome.” PMID 30690595 ↗ Oct 2019

“Infants received 200 mg/kg of poractant alfa (surfactant) or air after randomization.” PMID 26928567 ↗ Apr 2016

“porcine surfactant (poractant alfa, Curosurf®)” NCT02772081 ↗

NCT07350018 ↗

NCT07261787 ↗

NCT06007547 ↗

Show 14 more sources

Known as Curosurf “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 ↗
18

“Chiesi Farmaceutici S.p.A (Chiesi) conducted this study with its porcine-derived surfactant, Curosurf® (poractant alfa), to evaluate the efficacy and safety in ventilated adult...” NCT04502433 ↗

“Preparations of poractantalfa (Curosurf, 200 mg/kg) (n = 15) or beractant (Survanta, 100 mg/kg) (n = 15) were administered in a consecutive randomized manner within the first 6...” NCT01923844 ↗

“Poractant alfa (Curosurf®, Chiesi Pharmaceuticals) administered intratracheally via the Less Invasive Surfactant Administration (LISA) technique over 1 minute.” NCT07261787 ↗

“Inhaled Nebulised Poractant Alfa (Porcine Surfactant, Curosurf®) In Comparison With Nasal Continuous Positive Airway Pressure (nCPAP) Alone” NCT03235986 ↗

“Poractant alfa (Curosurf) 200mg/kg administered under direct laryngoscopy using a surfactant instillation catheter” NCT06007547 ↗

“surfactant (Curosurf®, 2.5 ml/kg, Chiesi USA, Inc., Cary, NC) was administered” NCT01116921 ↗

“treatment with nebulized surfactant (Curosurf) or to serve as controls” PMID 10830460 ↗ Apr 2000

“Curosurf - a porcine surfactant routinely used for RDS” NCT03846960 ↗

“Poractant Alfa Intratracheal Suspension [Curosurf]” NCT04825197 ↗

“porcine surfactant (Poractant alfa, Curosurf ®)” NCT02452476 ↗

Show 8 more sources

Known as Curosurf - a porcine surfactant routinely used for RDS “Curosurf - a porcine surfactant routinely used for RDS” NCT03846960 ↗
Known as PORACTANT ALFA COMPONENT OF CHF-6440 ChEMBL registry synonym — accepted as the source's own label CHEMBL1201622 ↗
Known as poractant alfa;Curosurf “Poractant alfa (curosurf)” NCT01852461 ↗
1

“poractant alfa;Curosurf” NCT04545866 ↗

Known as poractant alpha “Patient receiving surfactant (3 mL/kg of a poractant alpha solution diluted to 16 mg/mL, resulting in a total dose of 48mg/kg) administred by bronchial fibroscopy. The total...” NCT04384731 ↗
Modality Other / unclassified “surfactant application” NCT00751959 ↗
Route Other “via a thin endotracheal catheter” NCT00751959 ↗