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 · a red edge is where a trial was stopped

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
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 No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT02305160 Apr 2005 → May 2006 respiratory distress syndrome in premature infants University of Sao Paulo Completed No outcome recorded
Phase 34 trials
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 No outcome recorded
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 No outcome recorded
Phase 48 trials
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 No outcome recorded
Phase 4 NCT00767039 Jan 2005 → Sep 2008 patent ductus arteriosus, respiratory distress syndrome in premature infants Alan Fujii Terminated No outcome recorded
Phase not applicable1 trial
NCT01116921 Feb 2011 → Apr 2015 newborn respiratory distress syndrome University of Minnesota Completed No outcome recorded
Also used as a comparator or background therapy in 15 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 21 trial
Phase 2 NCT02452476 Comparator Jan 2016 → May 2018 newborn respiratory distress syndrome Chiesi Farmaceutici S.p.A. Completed No outcome recorded
Phase 32 trials
Phase 3 NCT02772081 Comparator May 2021 → Aug 2022 respiratory distress syndrome in premature infants Chiesi Farmaceutici S.p.A. Terminated No outcome recorded
Phase 3 NCT04545866 Comparator Apr 2021 → Sep 2024 overdue bronchopulmonary dysplasia, respiratory distress syndrome in premature infants NICHD Neonatal Research Network Active not recruiting No outcome recorded
Phase 44 trials
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
Phase 4 NCT02041546 Comparator Sep 2013 → Dec 2014 meconium aspiration syndrome Zekai Tahir Burak Women's Health Research and Education Hospital Completed No outcome recorded
Phase 4 NCT01941524 Comparator Mar 2013 → Jun 2015 newborn respiratory distress syndrome Poznan University of Medical Sciences Completed No outcome recorded
Phase not applicable8 trials
NCT03846960 Background Nov 2019 → Dec 2020 respiratory distress syndrome in premature infants HaEmek Medical Center, Israel Unknown No outcome recorded
NCT02825953 Comparator Jan 2016 → Jan 2017 respiratory distress syndrome in premature infants nihat demir Unknown No outcome recorded
NCT02482766 Background Nov 2015 → Sep 2018 respiratory distress syndrome in premature infants Catholic University of the Sacred Heart Completed No outcome recorded
NCT02834624 Comparator Jul 2013 → Feb 2015 respiratory distress syndrome in premature infants University of Missouri-Columbia Completed No outcome recorded
NCT01537354 Comparator Jun 2012 → Dec 2013 respiratory distress syndrome in premature infants University of Michigan Withdrawn 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

NCT00501982

NCT06007547

NCT02452476

NCT02482766

NCT04384731

NCT04862377

NCT01860014

NCT04502433

NCT02834624

NCT03521063

NCT07350018

NCT04545866

NCT07261787

NCT04199364

NCT04825197

NCT01852461

NCT01941524

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

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

“surfactants: Survanta® or Curosurf®” PMID 25628188 Oct 2014

“Poractant alfa (Curosurf®)” NCT00501982

NCT01537354

NCT00751959

NCT01709409

NCT03959384

NCT04181255

Known as Curosurf - a porcine surfactant routinely used for RDS Curosurf - a porcine surfactant routinely used for RDSNCT03846960
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;CurosurfNCT04545866

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